Daisys and Diamonds
Super_Ideal_Rock
- Joined
- Apr 30, 2019
- Messages
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There are still lots of us who havn't caught it
Are we lucky ?
Or just careful ?
Or some other reason ?
Coronavirus updates June 2022
- Thread starter missy
- Start date
There are still lots of us who havn't caught it
Are we lucky ?
Or just careful ?
Or some other reason ?
- Joined
- Aug 16, 2007
- Messages
- 5,821
My son Harry (almost 18 months already!) is in the pediatric Moderna trial. They are expecting to unblind next week after the final reviews. I'm so excited! If he did not get the vaccine he's first in line to get it if approved. They are fully expecting either the Pfizer or Moderna (or both) to get approval. My older son is getting his third Pfizer next Friday. At this point I've had three full doses already and I'm waiting for the targeted booster.
Daisys and Diamonds
Super_Ideal_Rock
- Joined
- Apr 30, 2019
- Messages
- 24,739
The 2nd booster has only just been approved here
Its for people over 65 and Maori and Pacific people over 50 so i wont be eligible - not sure about ginger people with certain preexisting conditions but probably immune compromised people too ?
But ill make sure Gary gets it once its time
he only recently had his booster
Its for people over 65 and Maori and Pacific people over 50 so i wont be eligible - not sure about ginger people with certain preexisting conditions but probably immune compromised people too ?
But ill make sure Gary gets it once its time
he only recently had his booster
- Joined
- Jun 8, 2008
- Messages
- 55,492
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- Joined
- Jun 8, 2008
- Messages
- 55,492
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June 13, 2022Updated
June 13, 2022, 10:50 p.m. ET6 hours ago
6 hours ago
A 5-year-old received a dose of the Pfizer-BioNTech vaccine in Lansdale, Pa., in December.Credit...Hannah Beier/Reuters
By Sharon LaFraniere
The Food and Drug Administration said on Sunday that three doses of the Pfizer-BioNTech coronavirus vaccine appeared to be effective in preventing Covid illness in children under 5, judging by the level of virus-blocking antibodies the shots induced.
The agency’s evaluation was posted online ahead of Wednesday’s meeting of outside vaccine experts, summoned to recommend how the F.D.A. should rule on applications from both Pfizer and Moderna on vaccinating the nation’s youngest children.
Some public health experts are expecting the F.D.A. to authorize both Moderna’s and Pfizer’s vaccines, offering parents a choice between the two. The Centers for Disease Control and Prevention must also weigh in with its recommendations after the F.D.A. acts. Roughly 18 million children younger than 5 are the only Americans who are not yet eligible for shots.
In a staff analysis, the F.D.A. said the data submitted by Pfizer and its German partner, BioNTech, suggests that three doses are more effective than two. But the agency said it was hard to draw definitive conclusions because there were so few cases of Covid among the 1,415 children who received three doses of the vaccine during the clinical trial.
Pfizer has said only eight children in the placebo group and two in the vaccinated group fell ill. The trial protocol said 21 cases were required to render a judgment on efficacy.
So far, the F.D.A. appears to view both Pfizer’s and Moderna’s requests for pediatric vaccines favorably. Parents are so eager to have a coronavirus vaccine for their youngest children that some have said they would accept even low rates of effectiveness, as long as the vaccines were safe.
In its analysis of Pfizer’s data, the agency said that rates of hospitalization and death due to Covid among children under 5 were higher than among those age 5 to 17, “underscoring the benefit of an effective Covid- 19 vaccine in this age group.”
The agency also noted that among children 5 or older, who are already eligible for Pfizer’s vaccine, the shots have helped prevent hospitalization and other serious outcomes, including during the current year, when the highly contagious Omicron variant and its rapidly evolving subvariants became the dominant forms of the virus.
“Given the uncertainty of the Covid-19 pandemic and likelihood of continued SARS-CoV-2 transmission during the ensuing months, deployment of the vaccine for use among children 6 months through 4 years of age will likely have a beneficial effect on Covid-19-associated morbidity and mortality in this age group,” the F.D.A. said. The agency identified minimal side effects.
On Friday, the F.D.A. said Moderna’s coronavirus vaccine for children under 6 was also effective in preventing symptomatic infection without causing worrisome side effects. The two vaccines are based on the same type of technology, but the dosage and regimens differ. Moderna is proposing two doses at one-quarter the strength of adult doses. Pfizer is proposing three doses at one-tenth the strength of adult shots.
Image
A 6-year-old received a Covid-19 vaccine in Connecticut last year.Credit...Joseph Prezioso/Agence France-Presse — Getty Images
By Sharon LaFraniere
Moderna’s coronavirus vaccine for children under 6 is effective in preventing symptomatic infection without causing worrisome side effects, the Food and Drug Administration said on Friday night.
Advisers to the F.D.A. are scheduled to meet next week to decide whether to recommend that the agency grant Moderna’s request for emergency authorization of its vaccine for children ages 6 months to 17 years. They will also consider an application from Pfizer and its German partner, BioNTech, to clear its pediatric vaccine for children under 5. The F.D.A. is expected to release its analysis of Pfizer’s application on Monday.
The F.D.A. cautioned that estimates of the efficacy of Moderna’s two-dose pediatric vaccine were based on relatively few cases of Covid-19. The agency also said that, like adults, pediatric recipients would probably require a booster shot to counteract the vaccine’s waning potency over time.
But the agency said that two shots of Moderna’s vaccine triggered an immune response in clinical trial participants comparable to that of young adults, meeting the criterion set for effectiveness. The results were measured by the level of neutralizing antibodies, which work to block the virus, in the children’s blood.
Children 11 and younger generally experienced fewer side effects from the vaccine than adolescents, probably because their doses were weaker, the F.D.A. said. Although fevers were more frequent in children under 6, the rates were not substantially different from those produced by other routine childhood vaccines, the agency said.
There were no cases of myocarditis or pericarditis, conditions involving inflammation of the heart muscle and surrounding tissue that are known risks for young men who receive Moderna or Pfizer coronavirus vaccines.
The roughly 18 million children under 5 are the only group in the United States not eligible for Covid shots. Those 5 or over are covered by the Pfizer-BioNTech vaccine.
Moderna and Pfizer are proposing different regimens to cover the youngest children. Pfizer is seeking authorization for a three-dose regimen with doses one-tenth the strength of adult shots. Moderna has proposed two doses at one-quarter the strength of adult doses.
Moderna’s vaccine was 51 percent effective in preventing symptomatic infection in children 6 months to 2 years old and 37 percent effective in children 2 to 5 years old. Pfizer said its clinical trial suggested that its vaccine was 80 percent effective, but the trial was based on 10 cases. More than twice that number is required to assess the efficacy of the shots.
Anticipating regulatory authorization of one or both vaccines, the White House outlined this week its initial plan to make shots available for children under 5, starting the week of June 19. Biden administration officials said that the government had made 10 million doses available to states and health providers.
Image
Sonia Gandhi, left, the Indian National Congress party president, with her son Rahul Gandhi, a former president of the party, during a committee meeting in New Delhi in March.Credit...Altaf Qadri/Associated Press
By Anushka Patil and Maria Cramer
Sonia Gandhi, a towering public figure in India and the president of the opposition Indian National Congress party, has been hospitalized in Delhi with “Covid-related issues,” the party said on Sunday.
Ms. Gandhi, 75, was in stable condition, a party spokesman said on Twitter. She tested positive for the coronavirus on June 2. Her daughter, Priyanka Gandhi Vadra, reported her own positive test result the next day.
The Congress party governed India for the majority of its history since independence from British rule in 1947, but in recent years its power has declined, while the Bharatiya Janata Party of Narendra Modi established itself as a dominant force in national elections.
Ms. Gandhi was born in Italy and married into the Nehru-Gandhi dynasty. She was thrust into politics following the assassinations of her mother-in-law, Indira Gandhi, and her husband, Rajiv Gandhi. In the 2010s she was frequently ranked as one of the most powerful women in the world.
The party has habitually been tight-lipped about her health. She disappeared from the public eye for a period in 2011 to have surgery for an undisclosed condition that Indian media outlets later reported was cancer.
As of Sunday, India was reporting an average of nearly 6,800 new cases a day according to the Center for Systems Science and Engineering at Johns Hopkins University. The figure, which has nearly tripled from two weeks ago, is probably a significant undercount, because of a decline in testing and weariness with the pandemic.
Other political figures around the world have also tested positive recently, including Prime Minister Jacinda Ardern of New Zealand and, most recently, Prime Minister Justin Trudeau of Canada, who announced his result on Monday.
“I feel okay, but that’s because I got my shots,” Mr. Trudeau wrote on Twitter. He also tested positive in January, a few weeks after receiving a booster shot of vaccine.
Mr. Trudeau met with President Biden in Los Angeles last week on the sidelines of the Ninth Summit of the Americas. Photos taken at an event on Thursday showed the two men, unmasked, sitting several feet apart. Video footage of a different meeting also showed them embracing and shaking hands while unmasked.
Image
President Biden and Prime Minister Justin Trudeau of Canada Thursday on the sidelines of the Summit of the Americas in Los Angeles.Credit...Samuel Corum for The New York Times
Sarah Lovenheim, a spokeswoman for Xavier Becerra, the health and human services secretary, said on Monday that Mr. Becerra, who is vaccinated and boosted, tested positive and was experiencing mild symptoms. Mr. Becerra, who tested also positive in mid-May and was at the summit last week, “will continue to perform his duties as H.H.S. secretary, working in isolation,” Ms. Lovenheim said.
Neither Mr. Trudeau nor Mr. Becerra had close contact with Biden “as defined by the C.D.C.,” said Kevin Munoz, a White House spokesman. The Centers for Disease Control and Prevention defines close contact as being less than six feet away from an infected person for 15 minutes or more during a 24-hour period.
Gov. Doug Ducey of Arizona, a Republican, canceled a scheduled appearance on Monday with Mike Pence, the former vice president, after the governor tested positive for the coronavirus on Sunday, according to C.J. Karamargin, Mr. Ducey’s spokesman. Mr. Ducey, 58, is fully vaccinated, has received at least one booster, has no symptoms and is working from home, Mr. Karamargin said.
Image
The Rolling Stones postponed a stadium concert in Amsterdam on Monday after Mick Jagger, pictured in Madrid earlier this month, tested positive for the coronavirus.Credit...Manu Fernandez/Associated Press
By Ben Sisario and Michael Paulson
The Rolling Stones postponed a stadium concert in Amsterdam on Monday, after Mick Jagger tested positive for the coronavirus.
According to a statement from the band, Jagger — who has said in interviews that he was vaccinated, and urged fans to get their shots — tested positive “after experiencing symptoms” upon arriving at the Johan Cruijff Arena. The announcement came shortly before the show was to begin, and The Associated Press reported that some fans were already in the stadium when the announcement went out. Jagger, 78, had posted a short video to Twitter on Sunday saying he was looking forward to the show.
The band said the Amsterdam show would be rescheduled. The next date on its 60th anniversary tour is set for Friday in Bern, Switzerland.
The music industry has been moving forward at full steam for the return of concerts and festivals, after two years when live events were shut down entirely or held in reduced numbers. While new tours are being announced regularly, artists as varied as the Strokes, Ringo Starr, J Balvin and Haim have canceled individual shows and even entire tours.
Broadway has also rebounded. And at least one show will go on despite the news that its star has been infected: Hugh Jackman, who plays Professor Harold Hill in a strong-selling revival of “The Music Man,” on Monday said he had tested positive for the coronavirus, one day after he attended and performed at the Tony Awards. The producers of “The Music Man” said that the actor Max Clayton, who is Jackman’s standby, would play Harold Hill, the character ordinarily played by Jackman, through June 21.
This is the second time he has tested positive; he previously did so in late December, when the show was forced to cancel several dates, just after its opening.
June 13, 2022Updated
June 13, 2022, 10:50 p.m. ET6 hours ago
6 hours ago
Coronavirus Updates
Pfizer’s vaccine is effective in children under 5, the F.D.A. says.
Outside experts will make their recommendations this week on how the agency should rule on applications from Pfizer and Moderna to vaccinate the nation’s youngest children.- Moderna’s vaccine is effective in children under 6, the F.D.A. says.
- Sonia Gandhi, India’s opposition leader, is hospitalized with ‘Covid-related issues’.
- The Rolling Stones postpone a concert in Amsterdam after Mick Jagger tests positive.
- Andrew Giuliani’s vaccination status will bar him from the debate studio.
Pfizer’s vaccine is effective in children under 5, the F.D.A. says.
A 5-year-old received a dose of the Pfizer-BioNTech vaccine in Lansdale, Pa., in December.Credit...Hannah Beier/Reuters
By Sharon LaFraniere
The Food and Drug Administration said on Sunday that three doses of the Pfizer-BioNTech coronavirus vaccine appeared to be effective in preventing Covid illness in children under 5, judging by the level of virus-blocking antibodies the shots induced.
The agency’s evaluation was posted online ahead of Wednesday’s meeting of outside vaccine experts, summoned to recommend how the F.D.A. should rule on applications from both Pfizer and Moderna on vaccinating the nation’s youngest children.
Some public health experts are expecting the F.D.A. to authorize both Moderna’s and Pfizer’s vaccines, offering parents a choice between the two. The Centers for Disease Control and Prevention must also weigh in with its recommendations after the F.D.A. acts. Roughly 18 million children younger than 5 are the only Americans who are not yet eligible for shots.
In a staff analysis, the F.D.A. said the data submitted by Pfizer and its German partner, BioNTech, suggests that three doses are more effective than two. But the agency said it was hard to draw definitive conclusions because there were so few cases of Covid among the 1,415 children who received three doses of the vaccine during the clinical trial.
Pfizer has said only eight children in the placebo group and two in the vaccinated group fell ill. The trial protocol said 21 cases were required to render a judgment on efficacy.
So far, the F.D.A. appears to view both Pfizer’s and Moderna’s requests for pediatric vaccines favorably. Parents are so eager to have a coronavirus vaccine for their youngest children that some have said they would accept even low rates of effectiveness, as long as the vaccines were safe.
In its analysis of Pfizer’s data, the agency said that rates of hospitalization and death due to Covid among children under 5 were higher than among those age 5 to 17, “underscoring the benefit of an effective Covid- 19 vaccine in this age group.”
The agency also noted that among children 5 or older, who are already eligible for Pfizer’s vaccine, the shots have helped prevent hospitalization and other serious outcomes, including during the current year, when the highly contagious Omicron variant and its rapidly evolving subvariants became the dominant forms of the virus.
“Given the uncertainty of the Covid-19 pandemic and likelihood of continued SARS-CoV-2 transmission during the ensuing months, deployment of the vaccine for use among children 6 months through 4 years of age will likely have a beneficial effect on Covid-19-associated morbidity and mortality in this age group,” the F.D.A. said. The agency identified minimal side effects.
On Friday, the F.D.A. said Moderna’s coronavirus vaccine for children under 6 was also effective in preventing symptomatic infection without causing worrisome side effects. The two vaccines are based on the same type of technology, but the dosage and regimens differ. Moderna is proposing two doses at one-quarter the strength of adult doses. Pfizer is proposing three doses at one-tenth the strength of adult shots.
Tracking the Coronavirus ›
| United StatesAvg. on Jun. 13 | 14-day change | ||
|---|---|---|---|
| New cases | 106,795 | –2% |  |
| Hospitalized | 29,765 | +10% |  |
| New deaths | 324 | –12% |  |
U.S. hot spots ›
Vaccinations ›
Global hot spots ›
Global vaccinations ›
Cases rising fastest
Other trackers
Moderna’s vaccine is effective in children under 6, the F.D.A. says.
Image
A 6-year-old received a Covid-19 vaccine in Connecticut last year.Credit...Joseph Prezioso/Agence France-Presse — Getty Images
By Sharon LaFraniere
Moderna’s coronavirus vaccine for children under 6 is effective in preventing symptomatic infection without causing worrisome side effects, the Food and Drug Administration said on Friday night.
Advisers to the F.D.A. are scheduled to meet next week to decide whether to recommend that the agency grant Moderna’s request for emergency authorization of its vaccine for children ages 6 months to 17 years. They will also consider an application from Pfizer and its German partner, BioNTech, to clear its pediatric vaccine for children under 5. The F.D.A. is expected to release its analysis of Pfizer’s application on Monday.
The F.D.A. cautioned that estimates of the efficacy of Moderna’s two-dose pediatric vaccine were based on relatively few cases of Covid-19. The agency also said that, like adults, pediatric recipients would probably require a booster shot to counteract the vaccine’s waning potency over time.
But the agency said that two shots of Moderna’s vaccine triggered an immune response in clinical trial participants comparable to that of young adults, meeting the criterion set for effectiveness. The results were measured by the level of neutralizing antibodies, which work to block the virus, in the children’s blood.
Children 11 and younger generally experienced fewer side effects from the vaccine than adolescents, probably because their doses were weaker, the F.D.A. said. Although fevers were more frequent in children under 6, the rates were not substantially different from those produced by other routine childhood vaccines, the agency said.
There were no cases of myocarditis or pericarditis, conditions involving inflammation of the heart muscle and surrounding tissue that are known risks for young men who receive Moderna or Pfizer coronavirus vaccines.
The roughly 18 million children under 5 are the only group in the United States not eligible for Covid shots. Those 5 or over are covered by the Pfizer-BioNTech vaccine.
Moderna and Pfizer are proposing different regimens to cover the youngest children. Pfizer is seeking authorization for a three-dose regimen with doses one-tenth the strength of adult shots. Moderna has proposed two doses at one-quarter the strength of adult doses.
Moderna’s vaccine was 51 percent effective in preventing symptomatic infection in children 6 months to 2 years old and 37 percent effective in children 2 to 5 years old. Pfizer said its clinical trial suggested that its vaccine was 80 percent effective, but the trial was based on 10 cases. More than twice that number is required to assess the efficacy of the shots.
Anticipating regulatory authorization of one or both vaccines, the White House outlined this week its initial plan to make shots available for children under 5, starting the week of June 19. Biden administration officials said that the government had made 10 million doses available to states and health providers.
Advertisement
Continue reading the main storySonia Gandhi, India’s opposition leader, is hospitalized with ‘Covid-related issues’.
Image
Sonia Gandhi, left, the Indian National Congress party president, with her son Rahul Gandhi, a former president of the party, during a committee meeting in New Delhi in March.Credit...Altaf Qadri/Associated Press
By Anushka Patil and Maria Cramer
Sonia Gandhi, a towering public figure in India and the president of the opposition Indian National Congress party, has been hospitalized in Delhi with “Covid-related issues,” the party said on Sunday.
Ms. Gandhi, 75, was in stable condition, a party spokesman said on Twitter. She tested positive for the coronavirus on June 2. Her daughter, Priyanka Gandhi Vadra, reported her own positive test result the next day.
The Congress party governed India for the majority of its history since independence from British rule in 1947, but in recent years its power has declined, while the Bharatiya Janata Party of Narendra Modi established itself as a dominant force in national elections.
Ms. Gandhi was born in Italy and married into the Nehru-Gandhi dynasty. She was thrust into politics following the assassinations of her mother-in-law, Indira Gandhi, and her husband, Rajiv Gandhi. In the 2010s she was frequently ranked as one of the most powerful women in the world.
The party has habitually been tight-lipped about her health. She disappeared from the public eye for a period in 2011 to have surgery for an undisclosed condition that Indian media outlets later reported was cancer.
As of Sunday, India was reporting an average of nearly 6,800 new cases a day according to the Center for Systems Science and Engineering at Johns Hopkins University. The figure, which has nearly tripled from two weeks ago, is probably a significant undercount, because of a decline in testing and weariness with the pandemic.
Other political figures around the world have also tested positive recently, including Prime Minister Jacinda Ardern of New Zealand and, most recently, Prime Minister Justin Trudeau of Canada, who announced his result on Monday.
“I feel okay, but that’s because I got my shots,” Mr. Trudeau wrote on Twitter. He also tested positive in January, a few weeks after receiving a booster shot of vaccine.
Mr. Trudeau met with President Biden in Los Angeles last week on the sidelines of the Ninth Summit of the Americas. Photos taken at an event on Thursday showed the two men, unmasked, sitting several feet apart. Video footage of a different meeting also showed them embracing and shaking hands while unmasked.
Image
President Biden and Prime Minister Justin Trudeau of Canada Thursday on the sidelines of the Summit of the Americas in Los Angeles.Credit...Samuel Corum for The New York Times
Sarah Lovenheim, a spokeswoman for Xavier Becerra, the health and human services secretary, said on Monday that Mr. Becerra, who is vaccinated and boosted, tested positive and was experiencing mild symptoms. Mr. Becerra, who tested also positive in mid-May and was at the summit last week, “will continue to perform his duties as H.H.S. secretary, working in isolation,” Ms. Lovenheim said.
Neither Mr. Trudeau nor Mr. Becerra had close contact with Biden “as defined by the C.D.C.,” said Kevin Munoz, a White House spokesman. The Centers for Disease Control and Prevention defines close contact as being less than six feet away from an infected person for 15 minutes or more during a 24-hour period.
Gov. Doug Ducey of Arizona, a Republican, canceled a scheduled appearance on Monday with Mike Pence, the former vice president, after the governor tested positive for the coronavirus on Sunday, according to C.J. Karamargin, Mr. Ducey’s spokesman. Mr. Ducey, 58, is fully vaccinated, has received at least one booster, has no symptoms and is working from home, Mr. Karamargin said.
The Rolling Stones postpone a concert in Amsterdam after Mick Jagger tests positive.
Image
The Rolling Stones postponed a stadium concert in Amsterdam on Monday after Mick Jagger, pictured in Madrid earlier this month, tested positive for the coronavirus.Credit...Manu Fernandez/Associated Press
By Ben Sisario and Michael Paulson
The Rolling Stones postponed a stadium concert in Amsterdam on Monday, after Mick Jagger tested positive for the coronavirus.
According to a statement from the band, Jagger — who has said in interviews that he was vaccinated, and urged fans to get their shots — tested positive “after experiencing symptoms” upon arriving at the Johan Cruijff Arena. The announcement came shortly before the show was to begin, and The Associated Press reported that some fans were already in the stadium when the announcement went out. Jagger, 78, had posted a short video to Twitter on Sunday saying he was looking forward to the show.
The band said the Amsterdam show would be rescheduled. The next date on its 60th anniversary tour is set for Friday in Bern, Switzerland.
The music industry has been moving forward at full steam for the return of concerts and festivals, after two years when live events were shut down entirely or held in reduced numbers. While new tours are being announced regularly, artists as varied as the Strokes, Ringo Starr, J Balvin and Haim have canceled individual shows and even entire tours.
Broadway has also rebounded. And at least one show will go on despite the news that its star has been infected: Hugh Jackman, who plays Professor Harold Hill in a strong-selling revival of “The Music Man,” on Monday said he had tested positive for the coronavirus, one day after he attended and performed at the Tony Awards. The producers of “The Music Man” said that the actor Max Clayton, who is Jackman’s standby, would play Harold Hill, the character ordinarily played by Jackman, through June 21.
This is the second time he has tested positive; he previously did so in late December, when the show was forced to cancel several dates, just after its opening.
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Part two from above post
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Andrew Giuliani, center, will not be allowed to attend the first Republican debate in the New York State governor’s race.Credit...Jeenah Moon for The New York Times
By Jesse McKinley
ALBANY — With the first Republican debate in the governor’s race scheduled for Monday night on WCBS-TV, the roster of in-person candidates has shrunk by one, as Andrew Giuliani — proudly unvaccinated against the coronavirus — announced on Sunday that he will not be allowed to attend.
Mr. Giuliani, the son of the former New York City mayor Rudolph W. Giuliani, said on Sunday that he had been informed late last week that the station would not permit him in the studio unless he sent proof of his vaccination status — something he said he would not do and suggested might be unconstitutional.
“I chose very clearly that I was not going to get the shot,” said Mr. Giuliani, 36, in an impromptu news conference on Sunday outside CBS headquarters in Manhattan, saying he had “looked at the data” on the vaccination and decided against it.
As of Sunday, according to a New York Times database, 91 percent of New Yorkers of all ages have received at least one dose of a coronavirus vaccine, and 78 percent of residents are fully vaccinated.
Mr. Giuliani preceded his news conference by releasing a letter he sent to WCBS, the CBS network’s flagship affiliate, arguing that their policy was “arbitrary” and “serves to discriminate against a political candidate and their access to equal opportunity and religious liberty.”
In a statement, WCBS said that its broadcast center requires that visitors are vaccinated against the coronavirus, and that the policy — which dates to last year — was made “in consultation with health care experts, government officials and the many unions representing our employees.”
“Any candidate who doesn’t meet this requirement is encouraged to participate in Monday’s debate remotely,” the station said, adding it hoped the debate would “allow Republican candidates to share their views on matters of importance to the residents of New York State.”
The debate is scheduled to feature other Republican candidates for governor, including Representative Lee M. Zeldin, the party’s anointed nominee; Rob Astorino, the former Westchester County executive; and Harry Wilson, a corporate turnaround expert.
At Sunday’s news conference, Mr. Giuliani said he had “natural immunity” to Covid-19, which has killed more than one million Americans, and that he had offered to take multiple tests to prove he was not infected, but that he had nonetheless been disinvited from the debate.
Instead, Mr. Giuliani said he would, in fact, participate virtually, a prospect that was almost immediately criticized by Mr. Zeldin, who tweeted that “the remote option is a nonstarter,” while adding “the reason to have him virtual is ridiculous.”
Mr. Astorino echoed this, saying that “all four candidates should be onstage,” and that “discriminatory and unscientific vaccine mandates” wouldn’t prevent transmission of the disease. (The vaccines have been proven to prevent most serious cases of the disease.)
Mr. Giuliani, who is making his first run for public office and has been regularly campaigning with his father, has argued that the candidates should debate almost every day before the June 28 primary, while also railing against mandates for emergency medical workers and others, something he reiterated on Sunday.
“I’m obviously seeing consequences in what I believe is my informed decision on this,” he said, adding that if elected, he will “throw all of these mandates in the dust bin of history.”
Image
Credit...Leonardo Santamaria
By Knvul Sheikh
If you’re one of the millions of Americans who have already had Covid-19, you may be wondering how long you will have immunity from the coronavirus. Earlier in the pandemic, most people assumed that getting infected had at least one upside: that you would be protected against future encounters with the virus. But as the latest wave heads toward the Western region of the country and the virus shows no signs of easing up, reinfections seem to have become common. Already, many people are reporting second or even third infections with newer variants.
Experts have warned that exposure to the coronavirus — through vaccination or infection — does not mean that you are completely protected from future infections. Rather, the coronavirus is evolving to behave more like its closely related cousins, which cause common colds and infect people repeatedly throughout their lives.
“I’ve thought, almost since the beginning of this pandemic, that Covid-19 is eventually going to become an inevitable infection that everybody gets multiple times, because that’s just how a new respiratory virus gets established in the human population,” said Dr. Amesh Adalja, an infectious-disease specialist at Johns Hopkins University.
However, the coronavirus doesn’t yet fit into clear seasonal patterns like the other common cold viruses. It can also cause debilitating symptoms that persist for months or years in some people, and has claimed the lives of millions of others. So what can you do to protect yourself, not only from infection but also reinfection? We asked experts for answers to common questions.
After Omicron emerged, prior infections only provided about 50 percent protection against reinfection, Dr. Abu-Raddad’s study showed. The coronavirus had acquired so many mutations in its spike protein that newer versions became more transmissible and better able to evade immunity. That means you can catch a version of Omicron after recovering from an older, non-Omicron variant. You can even get sick with one of the newer Omicron subvariants after getting over a different version of it.
Other factors also increase your vulnerability to reinfection, starting with how long it has been since you had Covid. Immune defenses tend to wane after an infection. A study published in October 2021 estimated that reinfection could occur as soon as 3 months after contracting Covid-19. While these findings were based on the genome of the coronavirus and accounted for expected declines in antibodies that could fight off the virus, the study did not account for new variants like Omicron that were radically different from older variants. Because of how different Omicron is, your protection may wane even sooner. In a study published in February that has not yet been peer-reviewed, scientists from Denmark found that some people got reinfected with the BA.2 sublineage of Omicron as soon as 20 days after they got infected with the original Omicron BA.1.
Because the virus is infecting more people now, your chances of being exposed and getting reinfected are also higher, Dr. Abu-Raddad said. And while it’s unclear if some people are simply more susceptible to Covid-19 reinfection, researchers are beginning to find some clues. People who are older or immunocompromised may make very few or very poor quality antibodies, leaving them more vulnerable to reinfection, Dr. Abu-Raddad said. And early research shows that a small group of people have a genetic flaw that cripples a crucial immune molecule called interferon type I, putting them at higher risk of severe Covid symptoms. Further studies could find that such differences play a role in reinfection as well.
For now, you should treat any new symptoms, including a fever, sore throat, runny nose or change in taste or smell, as a potential case of Covid, and get tested to confirm if you are positive again.
“Your immune system has all kinds of weapons to try and stop the virus even if it gets past the front door,” said Shane Crotty, a virologist at the La Jolla Institute for Immunology in California.
Many of these immune cells build up their protections iteratively, Dr. Crotty said. That means that people who are vaccinated and boosted are especially well equipped to duke it out with the coronavirus. Similarly, people who have been infected before are able to keep the virus from replicating at high levels if they get reinfected. And most people who have logged encounters with both the vaccine and the coronavirus build up a hybrid immunity that may offer the best protection.
The result is that second or third infections are likely to be shorter and less severe.
Dr. Abu-Raddad, who has been tracking reinfections among large groups of people in Qatar, has already started seeing this promising pattern in patient records: Of more than 1,300 reinfections that his team identified from the beginning of the pandemic to May 2021, none led to hospitalization in an I.C.U., and none were fatal.
But just because reinfections are less severe, it doesn’t mean that they are not terrible. You may still run a fever and experience body aches, brain fog and other symptoms. And there’s no way of knowing if your symptoms will linger and become long Covid, Dr. Adalja said.
It is possible that each Covid infection forces you into a game of Russian roulette, though some researchers hypothesize that the risk is highest right after your first infection. One of the risk factors for long Covid is having high levels of virus in your system early in an infection, and you are likely to have such a high viral load the first time you are infected, Dr. Abu-Raddad said. In subsequent infections, your body is better prepared to fight off the coronavirus so you may be able to keep the virus at low levels until it is completely cleared, he said.
Getting vaccinated and boosted, for example, is a good idea even after you’ve had Covid. You only need to wait a few weeks after an infection to get a shot. The vaccines will bolster your antibody levels, and research shows that they are effective in preventing severe outcomes if you get sick again. “Scientific confidence in vaccine-induced immunity was and is much higher than infection-induced immunity,” Dr. Crotty said.
Additional measures, like masking indoors and in crowded spaces, social distancing and improving ventilation where possible, can provide another layer of protection. But because most people and communities have largely dropped these protections, it is up to individuals to decide when to adopt extra precautions based on their risk of getting Covid and how much they’d like to avoid it.
“If you had an infection just last week, you probably don’t have to mask up,” Dr. Adalja said. “But as a month or so passes from your infection and new variants start circulating in the U.S., it may make sense for high risk individuals to do that. People who are trying to avoid getting Covid because they’re going on a cruise soon or because they need a negative P.C.R. test for some other reason may consider taking precautions. Covid protections don’t have to be one-size-fits-all.”
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Credit...Gracia Lam
By Emma Goldberg
The tone of the typical isolation postcard is sunny, insistent and aspirational as a holiday greeting: “Thanks to everyone who sent well wishes for @VP,” wrote Doug Emhoff, the second gentleman, on Twitter. “She is feeling good and is working from home.”
Like so many Americans, Vice President Kamala Harris got Covid in late April. Like so many Americans, she worked right through it, seated at her desk surrounded by the signifiers of productivity: binders, pens, pastel Post-it notes. Other Covid-positive political figures assured the public they, too, were forging ahead on their to-do lists: Jen Psaki, Gavin Newsom. Donald J. Trump, when he had Covid, posed for his own working-through-it photos, though he appeared to be signing a blank sheet of paper.
In the world’s only wealthy country that does not guarantee paid sick leave, just working through it — even for those who could take paid time off — is the norm.
“I’m trying to work out in my head why I had that thought of, ‘Oh, I’ll work through it,’” said William Fitzgerald, 36, who runs a strategy firm. He got Covid in late April and took meetings throughout his illness. “Why didn’t I just rest for the week?”
Working while sick is an American pastime — one that a vicious pandemic, which sickened millions, somehow didn’t disrupt. Over 100 other countries guarantee some form of paid sick leave. In the United States, a survey of 3,600 hourly workers this spring found that two-thirds of those who had been sick with Covid or other illnesses went to work while sick, according to the Shift Project at Harvard, a research project on work scheduling. Many of them cited fear of getting in trouble with their managers, or financial pressures.
Some 33 million Americans don’t have paid sick leave. Low-income workers are far less likely to be able to take time off when they’re sick; just over half of people in the bottom quarter of wages get paid sick leave, compared to 94 percent in the top quarter.
But even salaried workers who have paid leave often don’t use the time that they’re allotted. Americans in private industry get an average of seven sick days per year. A survey of large employers, by Mercer, found that non-hourly workers used just half of their sick days in 2021. This number was virtually unchanged from before the pandemic, in 2018, which Mercer analysts attribute partly to the prevalence of sick people working from home. In other words, for some people Covid did away with the sick day instead of reinforcing it.
“There is this culture that everyone around you is working, so you feel obliged to go along with it,” Mr. Fitzgerald said. “The most important value in America seems to be how much money is in your bank account, and I think that’s what drives so much of working through sickness.”
Mr. Fitzgerald, who is still fatigued from his bout of Covid, designed generous time off policies for his own staff: unlimited sick days, a minimum of 25 vacation days. But when he came down with chills in late April, and tested positive for coronavirus, he couldn’t bring himself to take advantage of that paid time off. After all, it was a high-pressure week at work, with client calls on top of a staff retreat.
So Mr. Fitzgerald pressed through video meetings, and even invited his team to sit in his yard while he wore a mask so that he wouldn’t miss out on their time for in-person collaboration.
“I don’t think it sent a nice signal to the people who work for me,” he said.
By the time he was two weeks into his illness, cramming each day with 20 calls, he felt like collapsing. He logged off one client meeting, got in bed and slept from 1 to 7 p.m.
In an office, workers said, it is sometimes easier to delineate the boundary between work days, which meant coffee and commutes, and sick days, which meant chicken soup.
“You’d go to the doctor and you’d get a note and they’d be like, ‘You can take off three days,’” Mr. Fitzgerald said. “It would be very much like ‘them’s the rules, we gotta obey them.’”
But those don’t seem to be the rules now. Why do people stay plugged in even when they’re aching, coughing, feverish — and have paid time off? With many people now vaccinated, a positive coronavirus test is sometimes treated with a shrug, even with the virus still surging.
Some office workers said they can’t shake the sense of guilt formed by a system that makes productivity seem like a virtue, the same system that tolerates a lack of legally mandated paid sick leave. James Carr, 38, a data scientist, who got Covid in February and worked through it, remembered being chided for trying to use his sick days at a previous job because of a looming deadline. A.Z. Madonna, 28, a music journalist, got Covid recently, and couldn’t silence the voice in her head asking why she wasn’t getting anything done.
“I’ve definitely had managers who with one minute are encouraging me to actually take a break, but they’re still responding to emails when they’re on vacation or sick,” Ms. Madonna said. “It might be a bit of a ‘do as I say, not as I do’ kind of thing.”
Many workers find themselves, consciously or not, mimicking the way their bosses behave. They witness managers answering emails from bed, and feel they should do the same.
So some bosses are taking a firmer line on using their leave. Jim Canales, head of the Barr Foundation, a philanthropic organization focused on arts, education and climate, got Covid about a month ago. Mr. Canales spent the past two years urging his team to take care of themselves, and he knew that working through his illness would undermine that message. He sent out a morning email to his staff noting that it was Friday the 13th, Mercury was in retrograde and he had tested positive for Covid — and wasn’t planning to be available for meetings or emails.
“I can’t preach a message of self-care for two years and then behave in a different way,” he said.
Mr. Canales refashioned his organization’s sick leave policies during the pandemic, with the aim of encouraging employees to actually make use of their time off. He relabeled sick days as health days, so workers know they can be used to take care of family members, too. That health leave was also made unlimited, so nobody felt the pressure to save it up for the future.
But even as some employers are encouraging workers to use their time off, many others are dropping benefits introduced during the pandemic. This spring, Amazon announced a return to its prepandemic sick leave. Walmart stopped offering emergency paid leave for most of its workers with Covid at the end of March, instead asking employees to use their regular bank of paid time off and sick days.
Some argue the disappearance of sick days is preventing them from making full recoveries. Angela Lewis, who works at a speakers bureau, tested positive for coronavirus last month, along with the rest of her household. Her son stayed home from school and her husband, who is self-employed, slept. Ms. Lewis, meanwhile, dropped a note in Slack to say she had Covid and then forged through her standard workweek, though her congested head felt like it weighed 100 pounds.
“Some people kind of have a badge of honor, like ‘Yeah, I worked through it, it was fine,’” she said. “Ultimately, I could say I did the same.”
“I didn’t have a fever, so I felt obligated to work through it,” she added, noting that she does have paid time off that she didn’t use. “But then I felt annoyed about feeling obligated.”
And even some of those managers most vocally committed to rest and recovery are struggling to accept their own advice.
“I’m talking about this in hindsight, what I’ve learned, but I’m still at work this week trying to move through it,” said Mr. Fitzgerald, who said he does not feel that he has fully recovered.
A day later, he called back with an update: He’d decided to take one day off.
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Ivermectin is an inexpensive drug that has been safely used in people for decades against parasitic worm infections.Credit...Mike Stewart/Associated Press
By Carl Zimmer
The antiparasite drug ivermectin does not meaningfully reduce the time needed to recover from Covid, according to a large study posted online Sunday. It is the largest of several clinical trials to show that the drug, popular since the early pandemic as an alternative treatment, is not effective against the virus.
The new trial, conducted by researchers at Duke University and Vanderbilt University, tested more than 1,500 people with Covid, about half getting the drug and the others a placebo. The study has not yet been published in a scientific journal.
“Given these results, there does not appear to be a role for ivermectin outside of a clinical trial setting, especially considering other available options with proven reduction in hospitalizations and death,” Dr. Adrian Hernandez, the executive director of the Duke Clinical Research Institute who led the trial, said in a statement on Sunday night.
In 2020, laboratory experiments on cells suggested that ivermectin might block the coronavirus. The results triggered widespread excitement because ivermectin is an inexpensive drug that has been safely used in people for decades against parasitic worm infections.
The drug grew wildly popular, despite a lack of results from large randomized clinical trials. When those studies finally finished, they proved disappointing. In March, researchers published a study in which 679 people diagnosed with Covid received ivermectin. The drug did not significantly reduce their risk of going to a hospital for Covid compared with people who took a placebo.
The new study of ivermectin was part of a larger effort, organized by the National Institutes of Health, to identify existing drugs that might help treat Covid. Known as Accelerating COVID-19 Therapeutic Interventions and Vaccines-6, or ACTIV-6 for short, the program has also been testing an antidepressant and an antiasthma drug.
Dr. Hernandez and his colleagues gave ivermectin to 877 volunteers who were diagnosed with Covid, while 774 others received a placebo. The researchers then observed how their cases progressed.
People on ivermectin felt unwell for an average of 10.96 days, while people on the placebo took 11.45 days — a difference of about 12 hours. There was no statistically significant difference in the risk each group faced of going to the hospital. One death was observed during the trial — of a volunteer who received ivermectin.
Almost half of the volunteers had been vaccinated, the researchers said. Their shots may have reduced the overall number of severe Covid cases, making it harder to detect a benefit.
Despite the negative results, the researchers did not entirely rule out the possibility that ivermectin might have a place in treating Covid. Among 90 people who were already suffering from severe Covid when they entered the trial, those who tried ivermectin appeared to fare better than did those on the placebo. But the small numbers made it impossible to draw any firm statistical conclusions about ivermectin’s benefit. The effect might have been the result of chance.
To investigate that result further, the researchers will keep testing ivermectin at higher doses. A new set of volunteers will receive 50 percent more of the drug in each dose and for six days instead of three.
“Given the favorable safety profile and continued public interest in ivermectin, the ACTIV-6 team will continue to study this higher dose to determine whether it will make enough of a difference to be considered for the treatment of mild-to-moderate COVID-19,” Dr. Susanna Naggie, an infectious disease expert at Duke University, said in the statement.
Correction:
June 12, 2022
A previous version of this article misstated ivermectin’s effect on Covid. It has no clinically meaningful effect on recovery time, not no effect.
In the United States
Research
Health Guidance
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Andrew Giuliani’s vaccination status will bar him from the debate studio.
Andrew Giuliani, center, will not be allowed to attend the first Republican debate in the New York State governor’s race.Credit...Jeenah Moon for The New York Times
By Jesse McKinley
ALBANY — With the first Republican debate in the governor’s race scheduled for Monday night on WCBS-TV, the roster of in-person candidates has shrunk by one, as Andrew Giuliani — proudly unvaccinated against the coronavirus — announced on Sunday that he will not be allowed to attend.
Mr. Giuliani, the son of the former New York City mayor Rudolph W. Giuliani, said on Sunday that he had been informed late last week that the station would not permit him in the studio unless he sent proof of his vaccination status — something he said he would not do and suggested might be unconstitutional.
“I chose very clearly that I was not going to get the shot,” said Mr. Giuliani, 36, in an impromptu news conference on Sunday outside CBS headquarters in Manhattan, saying he had “looked at the data” on the vaccination and decided against it.
As of Sunday, according to a New York Times database, 91 percent of New Yorkers of all ages have received at least one dose of a coronavirus vaccine, and 78 percent of residents are fully vaccinated.
Mr. Giuliani preceded his news conference by releasing a letter he sent to WCBS, the CBS network’s flagship affiliate, arguing that their policy was “arbitrary” and “serves to discriminate against a political candidate and their access to equal opportunity and religious liberty.”
In a statement, WCBS said that its broadcast center requires that visitors are vaccinated against the coronavirus, and that the policy — which dates to last year — was made “in consultation with health care experts, government officials and the many unions representing our employees.”
“Any candidate who doesn’t meet this requirement is encouraged to participate in Monday’s debate remotely,” the station said, adding it hoped the debate would “allow Republican candidates to share their views on matters of importance to the residents of New York State.”
The debate is scheduled to feature other Republican candidates for governor, including Representative Lee M. Zeldin, the party’s anointed nominee; Rob Astorino, the former Westchester County executive; and Harry Wilson, a corporate turnaround expert.
At Sunday’s news conference, Mr. Giuliani said he had “natural immunity” to Covid-19, which has killed more than one million Americans, and that he had offered to take multiple tests to prove he was not infected, but that he had nonetheless been disinvited from the debate.
Instead, Mr. Giuliani said he would, in fact, participate virtually, a prospect that was almost immediately criticized by Mr. Zeldin, who tweeted that “the remote option is a nonstarter,” while adding “the reason to have him virtual is ridiculous.”
Mr. Astorino echoed this, saying that “all four candidates should be onstage,” and that “discriminatory and unscientific vaccine mandates” wouldn’t prevent transmission of the disease. (The vaccines have been proven to prevent most serious cases of the disease.)
Mr. Giuliani, who is making his first run for public office and has been regularly campaigning with his father, has argued that the candidates should debate almost every day before the June 28 primary, while also railing against mandates for emergency medical workers and others, something he reiterated on Sunday.
“I’m obviously seeing consequences in what I believe is my informed decision on this,” he said, adding that if elected, he will “throw all of these mandates in the dust bin of history.”
How long does Covid immunity last? Will a second illness be worse?
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Credit...Leonardo Santamaria
By Knvul Sheikh
If you’re one of the millions of Americans who have already had Covid-19, you may be wondering how long you will have immunity from the coronavirus. Earlier in the pandemic, most people assumed that getting infected had at least one upside: that you would be protected against future encounters with the virus. But as the latest wave heads toward the Western region of the country and the virus shows no signs of easing up, reinfections seem to have become common. Already, many people are reporting second or even third infections with newer variants.
Experts have warned that exposure to the coronavirus — through vaccination or infection — does not mean that you are completely protected from future infections. Rather, the coronavirus is evolving to behave more like its closely related cousins, which cause common colds and infect people repeatedly throughout their lives.
“I’ve thought, almost since the beginning of this pandemic, that Covid-19 is eventually going to become an inevitable infection that everybody gets multiple times, because that’s just how a new respiratory virus gets established in the human population,” said Dr. Amesh Adalja, an infectious-disease specialist at Johns Hopkins University.
However, the coronavirus doesn’t yet fit into clear seasonal patterns like the other common cold viruses. It can also cause debilitating symptoms that persist for months or years in some people, and has claimed the lives of millions of others. So what can you do to protect yourself, not only from infection but also reinfection? We asked experts for answers to common questions.
How long will my immunity last after getting Covid?
Before Omicron, reinfections were rare. A team of scientists, led by Laith Abu-Raddad at Weill Cornell Medicine-Qatar, estimated that a bout with Delta or an earlier coronavirus strain was roughly 90 percent effective in preventing a reinfection in both vaccinated and unvaccinated people. “But Omicron really changed that calculus,” said Dr. Abu-Raddad, an infectious disease epidemiologist.After Omicron emerged, prior infections only provided about 50 percent protection against reinfection, Dr. Abu-Raddad’s study showed. The coronavirus had acquired so many mutations in its spike protein that newer versions became more transmissible and better able to evade immunity. That means you can catch a version of Omicron after recovering from an older, non-Omicron variant. You can even get sick with one of the newer Omicron subvariants after getting over a different version of it.
Other factors also increase your vulnerability to reinfection, starting with how long it has been since you had Covid. Immune defenses tend to wane after an infection. A study published in October 2021 estimated that reinfection could occur as soon as 3 months after contracting Covid-19. While these findings were based on the genome of the coronavirus and accounted for expected declines in antibodies that could fight off the virus, the study did not account for new variants like Omicron that were radically different from older variants. Because of how different Omicron is, your protection may wane even sooner. In a study published in February that has not yet been peer-reviewed, scientists from Denmark found that some people got reinfected with the BA.2 sublineage of Omicron as soon as 20 days after they got infected with the original Omicron BA.1.
Because the virus is infecting more people now, your chances of being exposed and getting reinfected are also higher, Dr. Abu-Raddad said. And while it’s unclear if some people are simply more susceptible to Covid-19 reinfection, researchers are beginning to find some clues. People who are older or immunocompromised may make very few or very poor quality antibodies, leaving them more vulnerable to reinfection, Dr. Abu-Raddad said. And early research shows that a small group of people have a genetic flaw that cripples a crucial immune molecule called interferon type I, putting them at higher risk of severe Covid symptoms. Further studies could find that such differences play a role in reinfection as well.
For now, you should treat any new symptoms, including a fever, sore throat, runny nose or change in taste or smell, as a potential case of Covid, and get tested to confirm if you are positive again.
Will subsequent infections be more or less severe?
The good news is that your body can call on immune cells, like T cells and B cells, to quash a reinfection if the virus sneaks past your initial antibody defenses. T cells and B cells can take a few days to get activated and start working, but they tend to remember how to battle the virus based on previous encounters.“Your immune system has all kinds of weapons to try and stop the virus even if it gets past the front door,” said Shane Crotty, a virologist at the La Jolla Institute for Immunology in California.
Many of these immune cells build up their protections iteratively, Dr. Crotty said. That means that people who are vaccinated and boosted are especially well equipped to duke it out with the coronavirus. Similarly, people who have been infected before are able to keep the virus from replicating at high levels if they get reinfected. And most people who have logged encounters with both the vaccine and the coronavirus build up a hybrid immunity that may offer the best protection.
The result is that second or third infections are likely to be shorter and less severe.
Dr. Abu-Raddad, who has been tracking reinfections among large groups of people in Qatar, has already started seeing this promising pattern in patient records: Of more than 1,300 reinfections that his team identified from the beginning of the pandemic to May 2021, none led to hospitalization in an I.C.U., and none were fatal.
But just because reinfections are less severe, it doesn’t mean that they are not terrible. You may still run a fever and experience body aches, brain fog and other symptoms. And there’s no way of knowing if your symptoms will linger and become long Covid, Dr. Adalja said.
It is possible that each Covid infection forces you into a game of Russian roulette, though some researchers hypothesize that the risk is highest right after your first infection. One of the risk factors for long Covid is having high levels of virus in your system early in an infection, and you are likely to have such a high viral load the first time you are infected, Dr. Abu-Raddad said. In subsequent infections, your body is better prepared to fight off the coronavirus so you may be able to keep the virus at low levels until it is completely cleared, he said.
What can you do to reduce your risk of reinfection?
Many of the tools and behaviors that help protect against infection can still help you avoid reinfection, Dr. Abu-Raddad said. “There is no magical solution against Covid reinfection.”Getting vaccinated and boosted, for example, is a good idea even after you’ve had Covid. You only need to wait a few weeks after an infection to get a shot. The vaccines will bolster your antibody levels, and research shows that they are effective in preventing severe outcomes if you get sick again. “Scientific confidence in vaccine-induced immunity was and is much higher than infection-induced immunity,” Dr. Crotty said.
Additional measures, like masking indoors and in crowded spaces, social distancing and improving ventilation where possible, can provide another layer of protection. But because most people and communities have largely dropped these protections, it is up to individuals to decide when to adopt extra precautions based on their risk of getting Covid and how much they’d like to avoid it.
“If you had an infection just last week, you probably don’t have to mask up,” Dr. Adalja said. “But as a month or so passes from your infection and new variants start circulating in the U.S., it may make sense for high risk individuals to do that. People who are trying to avoid getting Covid because they’re going on a cruise soon or because they need a negative P.C.R. test for some other reason may consider taking precautions. Covid protections don’t have to be one-size-fits-all.”
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Here’s how Covid did away with the sick day off from work.
Credit...Gracia Lam
By Emma Goldberg
The tone of the typical isolation postcard is sunny, insistent and aspirational as a holiday greeting: “Thanks to everyone who sent well wishes for @VP,” wrote Doug Emhoff, the second gentleman, on Twitter. “She is feeling good and is working from home.”
Like so many Americans, Vice President Kamala Harris got Covid in late April. Like so many Americans, she worked right through it, seated at her desk surrounded by the signifiers of productivity: binders, pens, pastel Post-it notes. Other Covid-positive political figures assured the public they, too, were forging ahead on their to-do lists: Jen Psaki, Gavin Newsom. Donald J. Trump, when he had Covid, posed for his own working-through-it photos, though he appeared to be signing a blank sheet of paper.
In the world’s only wealthy country that does not guarantee paid sick leave, just working through it — even for those who could take paid time off — is the norm.
“I’m trying to work out in my head why I had that thought of, ‘Oh, I’ll work through it,’” said William Fitzgerald, 36, who runs a strategy firm. He got Covid in late April and took meetings throughout his illness. “Why didn’t I just rest for the week?”
Working while sick is an American pastime — one that a vicious pandemic, which sickened millions, somehow didn’t disrupt. Over 100 other countries guarantee some form of paid sick leave. In the United States, a survey of 3,600 hourly workers this spring found that two-thirds of those who had been sick with Covid or other illnesses went to work while sick, according to the Shift Project at Harvard, a research project on work scheduling. Many of them cited fear of getting in trouble with their managers, or financial pressures.
Some 33 million Americans don’t have paid sick leave. Low-income workers are far less likely to be able to take time off when they’re sick; just over half of people in the bottom quarter of wages get paid sick leave, compared to 94 percent in the top quarter.
But even salaried workers who have paid leave often don’t use the time that they’re allotted. Americans in private industry get an average of seven sick days per year. A survey of large employers, by Mercer, found that non-hourly workers used just half of their sick days in 2021. This number was virtually unchanged from before the pandemic, in 2018, which Mercer analysts attribute partly to the prevalence of sick people working from home. In other words, for some people Covid did away with the sick day instead of reinforcing it.
“There is this culture that everyone around you is working, so you feel obliged to go along with it,” Mr. Fitzgerald said. “The most important value in America seems to be how much money is in your bank account, and I think that’s what drives so much of working through sickness.”
Mr. Fitzgerald, who is still fatigued from his bout of Covid, designed generous time off policies for his own staff: unlimited sick days, a minimum of 25 vacation days. But when he came down with chills in late April, and tested positive for coronavirus, he couldn’t bring himself to take advantage of that paid time off. After all, it was a high-pressure week at work, with client calls on top of a staff retreat.
So Mr. Fitzgerald pressed through video meetings, and even invited his team to sit in his yard while he wore a mask so that he wouldn’t miss out on their time for in-person collaboration.
“I don’t think it sent a nice signal to the people who work for me,” he said.
By the time he was two weeks into his illness, cramming each day with 20 calls, he felt like collapsing. He logged off one client meeting, got in bed and slept from 1 to 7 p.m.
In an office, workers said, it is sometimes easier to delineate the boundary between work days, which meant coffee and commutes, and sick days, which meant chicken soup.
“You’d go to the doctor and you’d get a note and they’d be like, ‘You can take off three days,’” Mr. Fitzgerald said. “It would be very much like ‘them’s the rules, we gotta obey them.’”
But those don’t seem to be the rules now. Why do people stay plugged in even when they’re aching, coughing, feverish — and have paid time off? With many people now vaccinated, a positive coronavirus test is sometimes treated with a shrug, even with the virus still surging.
Some office workers said they can’t shake the sense of guilt formed by a system that makes productivity seem like a virtue, the same system that tolerates a lack of legally mandated paid sick leave. James Carr, 38, a data scientist, who got Covid in February and worked through it, remembered being chided for trying to use his sick days at a previous job because of a looming deadline. A.Z. Madonna, 28, a music journalist, got Covid recently, and couldn’t silence the voice in her head asking why she wasn’t getting anything done.
“I’ve definitely had managers who with one minute are encouraging me to actually take a break, but they’re still responding to emails when they’re on vacation or sick,” Ms. Madonna said. “It might be a bit of a ‘do as I say, not as I do’ kind of thing.”
Many workers find themselves, consciously or not, mimicking the way their bosses behave. They witness managers answering emails from bed, and feel they should do the same.
So some bosses are taking a firmer line on using their leave. Jim Canales, head of the Barr Foundation, a philanthropic organization focused on arts, education and climate, got Covid about a month ago. Mr. Canales spent the past two years urging his team to take care of themselves, and he knew that working through his illness would undermine that message. He sent out a morning email to his staff noting that it was Friday the 13th, Mercury was in retrograde and he had tested positive for Covid — and wasn’t planning to be available for meetings or emails.
“I can’t preach a message of self-care for two years and then behave in a different way,” he said.
Mr. Canales refashioned his organization’s sick leave policies during the pandemic, with the aim of encouraging employees to actually make use of their time off. He relabeled sick days as health days, so workers know they can be used to take care of family members, too. That health leave was also made unlimited, so nobody felt the pressure to save it up for the future.
But even as some employers are encouraging workers to use their time off, many others are dropping benefits introduced during the pandemic. This spring, Amazon announced a return to its prepandemic sick leave. Walmart stopped offering emergency paid leave for most of its workers with Covid at the end of March, instead asking employees to use their regular bank of paid time off and sick days.
Some argue the disappearance of sick days is preventing them from making full recoveries. Angela Lewis, who works at a speakers bureau, tested positive for coronavirus last month, along with the rest of her household. Her son stayed home from school and her husband, who is self-employed, slept. Ms. Lewis, meanwhile, dropped a note in Slack to say she had Covid and then forged through her standard workweek, though her congested head felt like it weighed 100 pounds.
“Some people kind of have a badge of honor, like ‘Yeah, I worked through it, it was fine,’” she said. “Ultimately, I could say I did the same.”
“I didn’t have a fever, so I felt obligated to work through it,” she added, noting that she does have paid time off that she didn’t use. “But then I felt annoyed about feeling obligated.”
And even some of those managers most vocally committed to rest and recovery are struggling to accept their own advice.
“I’m talking about this in hindsight, what I’ve learned, but I’m still at work this week trying to move through it,” said Mr. Fitzgerald, who said he does not feel that he has fully recovered.
A day later, he called back with an update: He’d decided to take one day off.
Ivermectin has little effect on recovery time from Covid, a study finds.
Image
Ivermectin is an inexpensive drug that has been safely used in people for decades against parasitic worm infections.Credit...Mike Stewart/Associated Press
By Carl Zimmer
The antiparasite drug ivermectin does not meaningfully reduce the time needed to recover from Covid, according to a large study posted online Sunday. It is the largest of several clinical trials to show that the drug, popular since the early pandemic as an alternative treatment, is not effective against the virus.
The new trial, conducted by researchers at Duke University and Vanderbilt University, tested more than 1,500 people with Covid, about half getting the drug and the others a placebo. The study has not yet been published in a scientific journal.
“Given these results, there does not appear to be a role for ivermectin outside of a clinical trial setting, especially considering other available options with proven reduction in hospitalizations and death,” Dr. Adrian Hernandez, the executive director of the Duke Clinical Research Institute who led the trial, said in a statement on Sunday night.
In 2020, laboratory experiments on cells suggested that ivermectin might block the coronavirus. The results triggered widespread excitement because ivermectin is an inexpensive drug that has been safely used in people for decades against parasitic worm infections.
The drug grew wildly popular, despite a lack of results from large randomized clinical trials. When those studies finally finished, they proved disappointing. In March, researchers published a study in which 679 people diagnosed with Covid received ivermectin. The drug did not significantly reduce their risk of going to a hospital for Covid compared with people who took a placebo.
The new study of ivermectin was part of a larger effort, organized by the National Institutes of Health, to identify existing drugs that might help treat Covid. Known as Accelerating COVID-19 Therapeutic Interventions and Vaccines-6, or ACTIV-6 for short, the program has also been testing an antidepressant and an antiasthma drug.
Dr. Hernandez and his colleagues gave ivermectin to 877 volunteers who were diagnosed with Covid, while 774 others received a placebo. The researchers then observed how their cases progressed.
People on ivermectin felt unwell for an average of 10.96 days, while people on the placebo took 11.45 days — a difference of about 12 hours. There was no statistically significant difference in the risk each group faced of going to the hospital. One death was observed during the trial — of a volunteer who received ivermectin.
Almost half of the volunteers had been vaccinated, the researchers said. Their shots may have reduced the overall number of severe Covid cases, making it harder to detect a benefit.
Despite the negative results, the researchers did not entirely rule out the possibility that ivermectin might have a place in treating Covid. Among 90 people who were already suffering from severe Covid when they entered the trial, those who tried ivermectin appeared to fare better than did those on the placebo. But the small numbers made it impossible to draw any firm statistical conclusions about ivermectin’s benefit. The effect might have been the result of chance.
To investigate that result further, the researchers will keep testing ivermectin at higher doses. A new set of volunteers will receive 50 percent more of the drug in each dose and for six days instead of three.
“Given the favorable safety profile and continued public interest in ivermectin, the ACTIV-6 team will continue to study this higher dose to determine whether it will make enough of a difference to be considered for the treatment of mild-to-moderate COVID-19,” Dr. Susanna Naggie, an infectious disease expert at Duke University, said in the statement.
Correction:
June 12, 2022
A previous version of this article misstated ivermectin’s effect on Covid. It has no clinically meaningful effect on recovery time, not no effect.
Our Coverage of the Coronavirus Pandemic
In the United States
- The Centers for Disease Control and Prevention said it would lift the requirement that all travelers coming into the United States by air show a negative coronavirus test result before boarding their flights. That policy is expected to expire on June 12 at 12:01 a.m.
- The Food and Drug Administration said that Moderna’s coronavirus vaccine for children under 6 is effective in preventing symptomatic infection without causing worrisome side effects. Advisers to the F.D.A. are scheduled to meet next week to decide whether to recommend that the agency grant Moderna’s request for emergency authorization of its vaccine for children ages 6 months to 17 years. They will also consider an application from Pfizer to clear its pediatric vaccine for children under 5.
Research
- A veterinarian in Thailand likely contracted the coronavirus from an infected cat last year, according to a new study. It is the first documented case of suspected cat-to-human transmission, although the risk of cats infecting humans with the virus remains low.
- A team of international scientists assembled by the World Health Organization to advise on the origins of the coronavirus said in its first report that bats likely carried an ancestor of the coronavirus that may have then spilled over into a mammal sold at a wildlife market. More data was needed, however, to study how the virus spread to people.
Health Guidance
- F.A.Q.: What is long Covid? Do I need a booster shot if I’ve had Covid? Here are answers to your nagging questions.
- Long Covid in Kids: Studies suggest that the condition is rarer in children, but they can develop it, too.
- At Home: When someone in your house tests positive for Covid, there are some guidelines to follow — including when you test negative but develop symptoms.
- Test Results: In many places, there is no system for sharing home test results with health officials, even though the information can be useful to them. Here is how to report a positive case.
- Covid Treatments in N.Y.C.: Antiviral pills and monoclonal antibodies are available across the city. Find out how to get them.
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We got the call yesterday, my son Harry was in the pediatric Moderna trial and he got the vaccine! He got the shots in October and November when he was 10/11 months old and it was finally unblinded yesterday. I honestly thought he got the placebo since he had ZERO reaction to either shot. My son Benjamin (6.5yo) got his third Pfizer yesterday and FINALLY had some kind of reaction, a sore arm today. That's it. I took Harry to the grocery store for the first time today. He was amazed!
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Wonderful update!
Speaking of which...
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FDA Allows mRNA COVID Vaccines in Kids 6 Months and Up
— Vaccines expected to protect against most severe outcomes, says FDA Commissioner
by Ian Ingram, Managing Editor, MedPage Today June 17, 2022
The FDA has authorized mRNA COVID-19 vaccines for children as young as 6 months of age, the agency announced on Friday.
The emergency use authorization (EUA) for Pfizer-BioNTech's vaccine -- which is already authorized or approved in individuals 5 years and older -- will now include children ages 6 months to 4 years. Moderna's EUA will now include children and adolescents ages 6 months to 17 years (the vaccine is approved for use in adults).
"Many parents, caregivers, and clinicians have been waiting for a vaccine for younger children and this action will help protect those down to 6 months of age," FDA Commissioner Robert Califf, MD, said in a statement. "As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19."
"While COVID-19 does affect older and immunocompromised populations more adversely than young children, young children can still suffer the severe consequences of COVID-19, including severe illness and death," Califf warned during a press briefing following the announcement.
The move follows 2 days of deliberation by the agency's Vaccines and Related Biological Products Advisory Committee (VRBPAC), which unanimously endorsed both mRNA vaccines in the youngest age group, as well as the older group of children and teens in the case of Moderna's vaccine.
Asked by reporters how parents of young children should decide between the two vaccines, Peter Marks, MD, PhD, director of the agency's Center for Biologics Evaluation and Research, said "the correct answer here is whatever vaccine your healthcare provider, pediatrician has. That's what I would give my child."
"It may be that the Moderna vaccine brings an immune response slightly more rapidly," said Marks. "On the other hand, the three-dose Pfizer regimen may also bring a greater immune response after the third dose. And there are some subtle differences in the safety profile."
On the possibility of potential strain changes, Marks noted that these available vaccines offer "excellent foundational immunity" against a broad range of COVID variants already. "I would have children start this right now."
Marks said he does not anticipate substantial delays if younger children should need a vaccine with an updated strain down the line. "I say 'if' because we will have to see where the data take us."
Pfizer's Vaccine
Data supporting the effectiveness in children 6 months to 4 years were based on immunobridging criteria and showed that three doses (3 mcg each, second dose given after 3 weeks and the third at least 8 weeks later) resulted in similar immune responses compared with teens and adults ages 16-25 years who received a primary series at the recommended dosage for their age group. Typical efficacy data were "determined not to be reliable due to the low number of COVID-19 cases that occurred in study participants," the FDA noted.
Safety analyses involved approximately 400 children who received the vaccine in the 6- to 23-month age group and 600 in the 2- to 4-year age group, with 2 months of safety data following the third dose. Commonly reported adverse events (AEs) in the younger group included irritability, decreased appetite, fever, and pain, as well as injection-site tenderness, redness, or swelling. In the older group, vaccine AEs included these plus headache and chills.
Moderna's Vaccine
Immunobridging criteria were also used as the primary support for Moderna's vaccine in children ages 6-23 months and 2-5 years. With a two-dose 25-mcg primary series, the two groups achieved similar immune responses when compared with an adult group receiving the adult mRNA doses. Efficacy data involving 5,400 children showed a vaccine efficacy of 50.6% following the second dose in the younger group and 36.8% for the older children during a period when Omicron was circulating.
Similarly, children ages 6-11 years (two 50-mcg doses) and adolescents ages 12-17 years (two 100-mcg doses) had similar immune responses to an adult comparator group. Efficacy analyses were again not "reliable" in the younger group, but vaccine recipients in the 12-17 group had a 93.3% vaccine efficacy during a pre-Omicron study period.
For the younger subset, safety data involved 1,100 vaccine recipients ages 6-23 months and 2,200 recipients ages 2-5 years, with 2 months of follow-up data. Commonly reported AEs across all ages included pain, injection-site redness or swelling, fever, and lymph node swelling or tenderness in the underarm or groin. In the younger group, irritability or crying, sleepiness, and loss of appetite were also observed. In the 2- to 5-year age group, AEs also included fatigue, headache, muscle ache, chills, nausea or vomiting, and joint stiffness.
For the older group, safety analyses were derived from 3,000 children ages 6-11 years and 2,500 adolescents ages 12-17 years, most of whom had 2 months of safety data. Common AEs included pain, redness, and swelling at the injection site, as well as fatigue, headache, muscle or joint pain, chills, swollen lymph nodes in the injection-site arm, nausea or vomiting, and fever.
No cases of myocarditis or pericarditis occurred in either company's trial, but the FDA noted that a higher risk has been observed with the mRNA vaccines in males ages 12-24 years. Both Moderna and Pfizer will monitor for cases of these AEs as part of the terms of their EUAs.
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Despite Another COVID Surge, Deaths Remain Low
Carolyn CristJune 21, 2022
"
Although new Omicron subvariants have led to another rise in coronavirus cases in the US in recent weeks, deaths have remained at some of the lowest levels of the pandemic.
The recent death toll breaks with the trend seen so far during the pandemic, where deaths tend to rise a few weeks after a surge in infections. That likely means most Americans now carry some form of immune protection, whether from vaccines or previous infections, according to The New York Times.
"In previous waves, there were still substantial pockets of people who had not been vaccinated or exposed to the virus, and so were at the same risk of dying as people at the beginning of the pandemic," David Dowdy, MD, an infectious disease epidemiologist at Johns Hopkins Bloomberg School of Public Health, told the newspaper.
"Those pockets don't exist anymore," he said.
At a regional level, deaths have slightly increased in the Northeast, where the latest wave began. The national death toll will likely climb slowly in coming weeks as the wave moves across the South and West, the Times reported, though the death rates will likely remain lower than in previous surges.
Some populations continue to die at higher rates. Adults older than age 65 years now account for a larger share of COVID-19 deaths than they did last year, according to the latest CDC data. Unvaccinated people continue to die at much higher rates than vaccinated people despite gaining some protection from prior infections. And people with compromised immune systems also continue to face higher risks.
With infections surging and remaining steadily above 100,000 daily cases for the past month, and hospitalizations rising above 30,000, deaths have hovered between 300 and 350 per day, according to the data tracker from the Times.The death rate is now one-tenth the number recorded in January 2021, when deaths reached the highest point of the pandemic, and remains at the lowest levels seen since the summer of 2021.
But 300 deaths per day means that the coronavirus is killing more than twice the number of Americans daily as suicide or car crashes, the newspaper reported. Those who survive after severe cases may develop long COVID and have disabling symptoms for life. About 1 in 5 adult survivors ages 18 to 64 years and 1 in 4 survivors over age 65 years have reported some version of long COVID, according to a recent study published in the CDC's Morbidity and Mortality Weekly Report.
Several Omicron subvariants are adding to the current caseload. BA.2.12.1 remains the dominant form of the coronavirus in the US, making up about 64% of cases as of mid-June, according to the latest CDC data. BA.2 accounts for 14%, followed by BA.5 with 13.3%, and BA.4 with 8.3%. Sometime this summer, BA.4 and BA.5 are expected to become the dominant forms of the virus.
Now, public health officials are turning their thoughts to what's next. As congressional funding for the coronavirus response dwindles and many Americans pass on booster shots, the separation between infection surges, hospitalizations, and deaths may not last, according to the Times. The Omicron subvariants continue to evolve, and immunity from vaccines and infections will decline this summer.
"As the time since people got vaccinated becomes longer and longer, the efficacy of the immune response will be lessened," Abraar Karan, MD, an infectious disease doctor at Stanford University, told the newspaper.
"We can be caught off guard later this year," he said.
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Pfizer or Moderna: Which COVID Vaccine Is the Best Bet for Your Toddler?
— Jeremy Faust, MD, shares pros and cons of both, and urges all parents "to choose vaccination"
by Emily Hutto, Associate Video Producer June 22, 2022"
In this video, Jeremy Faust, MD, of Brigham and Women's Hospital in Boston, discusses the important differences to consider when choosing between the Pfizer and Moderna COVID-19 vaccines for children ages 6 months to 5 years.
The following is a transcript of his remarks:
Hello, I'm Jeremy Faust, editor-in-chief of MedPage Today. Thank you for joining us.
Today, I would like to talk about an article I wrote in my newsletter over on Inside Medicine about the pediatric vaccinations just voted "yes" by the FDA for children 6 months and up. Both Pfizer and Moderna are getting the go ahead to move on to the CDC for final approval. This means that really, by the end of the month of June 2022, we will finally have vaccines for all ages across the spectrum, except for 0 to 6 months.
So number one, Pfizer and Moderna both are effective in preventing COVID-19. We see that symptomatic disease is prevented by both of them. The antibody levels met their prespecified goals, which implies very strong protection against severe disease. This is the immune-bridging strategy that's been talked so much about, that strategy using antibody levels to correlate to levels of protection against severe disease that has worked in older kids and teenagers so we know that that played out well. We are feeling confident that the antibody levels get us where we need to go.
The second question that people always ask: Is it safe? The answer is, it looks very safe. The levels of side effects were similar to the other age groups. We do not have a big enough trial to detect any cases of myocarditis, which has been detected primarily in teen and young adult males. That's good news.
The trial was big enough that if the rates were extremely high, we would see it. And we're reassured by the lower dose; we think that the lower dose for the toddlers and, quite frankly, the lower dose for the kids ages 5 to 11, has meant that the myocarditis rates have been lower in the 5-to-11 group where we already have a rollout. We think that'll be the same for 6 months up to 5 years, or in the case of Moderna, up to 6 years.
The next question that I'm getting a lot, especially as a parent, is: Between Pfizer's three-dose series and Moderna's two-dose series, which is better for kids under 5 years old'; for the littlest kids, the ones we're talking about. There's been this headline that's been around that would seem to suggest that Pfizer is better, and that's because Pfizer found in their interim analysis an 80% efficacy against symptomatic COVID in these 0- to 5-year-olds after the third dose.
Now, Moderna, for their part, they only have on average in the mid-40% efficacy range for the same question, so that would seem to suggest that Pfizer has this big edge over Moderna, but there are two reasons why I think they are probably quite similar.
The first is that Pfizer's 80% number wasn't really a prespecified interim analysis. They said 'We would do that analysis, looking at the efficacy on symptomatic disease, after a certain number of cases.' And they actually did this before that, because they wanted to get the FDA to look at the emergency use authorization, and they've met their endpoint goals on the antibodies. So this 80% number is kind of a little early; the confidence intervals are extremely wide, so much so as to make it almost unreliable.
In addition, there is this thing that a lot of us call a 'halo effect' or a 'honeymoon period,' which is that after the vaccine, there's this period where it's almost as if the recipient has what's called sterilizing immunity. That is, it's really hard to get infected with COVID in the first 5, 6, 7, 8 weeks after that vaccine because of the circulating antibodies.
Now that fades, and what's left over is a longer-term protection against severe disease, which is very important. But Pfizer looks like they did their little interim check right at the period, that point where the halo or honeymoon period was ending, and some infections in the intervention arm -- in the vaccine arm -- were starting to occur. I suspect that if we had a couple more weeks or a couple more months of data, that 80% efficacy would drop closer to Moderna's and they'd probably be considered similar.
On the other hand, Moderna has an advantage, and that's another reason why I think that these are kind of closer than people might realize, and maybe even Moderna is better. That is that Moderna is only a two dose series given 28 days apart. So, if you enrolled your kid to get Pfizer, they'd get a first dose and they'd get a second dose 21 days later, but they wouldn't be protected. Then 60 days after that, they'd get the third dose, and then another week after that is where the study data starts to be relevant.
So really, it takes up to 80 or 90 days for a child to have protection from Pfizer, whereas with Moderna, the doses are on the first day and the 28th day, and then 2 weeks later is when their data set starts to take off. Therefore, you could assume that 42 days after getting Moderna, the kid is protected.
Well, if you're a parent and you want your kid to be protected against SARS-CoV-2 by the first day of school this fall, Moderna's gonna get you there, but Pfizer will not, because for 40 some-odd days, the ones who got Pfizer don't have protection until that third dose. Whereas with Moderna, those kids got it pretty much right after that second dose.
I might choose, and I probably really will choose, Moderna for my 4-year-old because I just want her protected as soon as possible. But someone might say 'You know what? I think that in December or so, there's going to be another terrible surge, like Omicron, and we'll have a 100 times more cases than ever. I'd like my kid to have the maximum protection possible.' So for that reason, Pfizer is better because actually it starts working later, just in time for that surge. There's a little bit of gaming going on there, right? And we don't know what the future holds.
The bottom line is, I think that there are good reasons to give either one of them, and what's nice is we finally have options, whereas before we didn't. So that's the next move. For me, the real frontier is not convincing someone 'Pfizer or Moderna; Moderna or Pfizer.' The real challenge for all of us is to get parents to make that choice, to actually choose one of them, to choose vaccination.
We know in 5-to-11-year-olds, vaccine rates are just way low. They are still in the 30% range, and that's just very, very bad. That's because people don't understand that on the population level, COVID is causing a problem for kids.
What I think we need to do to move forward is just to speak the truth. Look, this [COVID] isn't the same for a kid as it is for an advanced senior citizen. Yes, that's true. And yet, it's so common a disease that we need to prevent it from happening as much as we can and prevent bad outcomes. That's where the vaccine comes in. We need to convince parents that it's necessary. We certainly need to talk about the safety profiles, and we'll continue to monitor that.
The last thing I'll say is that I think the way to get out of this period where we are so afraid of this virus is to maximize vaccination over time. We will see with better vaccinations, with better therapeutics, that COVID-19 won't be as fearful of a disease to get as it was a year ago, let alone now. I think that using these tools in our kit will actually do the thing that a lot of people want to do, which is to help us move on. We do that by making COVID into a 'shrug-off' event; no big deal. I think that we are closer to that than ever, but without vaccinating everybody, we will not reach that point.
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Who Gets Long COVID? USPSTF Snubs Supplements; Feds Aim to Slash Nicotine
— A daily roundup of news on COVID-19 and the rest of medicine
by Judy George, Deputy Managing Editor, MedPage Today June 22, 2022"
Moderna said its Omicron-targeting booster candidate for the fall induced "potent" neutralizing antibody responses against the BA.4 and BA.5 subvariants.
Women were significantly more likely to experience long COVID than men, a literature review suggested. (Current Medical Research and Opinion)
President Biden nominated former DARPA head Arati Prabhakar, PhD, an applied physicist, as the new White House science adviser to head the Office of Science and Technology Policy.
The U.S. Preventive Services Task Force issued its final recommendation stating there's not enough evidence to recommend most vitamin and mineral supplements to prevent cardiovascular disease or cancer and reiterated its position that vitamin E and beta-carotene supplements should be avoided. (JAMA)
As of Wednesday at 8:00 a.m. EDT, the unofficial U.S. COVID toll reached 86,426,606 infections and 1,012,819 deaths, increases of 160,878 and 456, respectively, since yesterday morning.
COVID-19 rebound after nirmatrelvir/ritonavir (Paxlovid) treatment may be due to insufficient drug exposure, a case study suggested. (Clinical Infectious Diseases)
Antiviral dispensing rates for COVID-19 drugs like nirmatrelvir/ritonavir were lowest in high vulnerability zip codes, despite these areas having the most dispensing sites. (Morbidity and Mortality Weekly Report)
An algorithm based on wrist tracker data identified 68% of COVID-positive people 2 days before symptom onset. (BMJ Open)
The FDA is drafting a proposed requirement to reduce nicotine in cigarettes to minimally addictive or nonaddictive levels.
The agency also expanded the indication for Merck's pneumococcal 15-valent conjugate vaccine (Vaxneuvance) to include infants and children, the company announced.
FDA also approved a second generic naloxone nasal spray to treat known or suspected opioid overdose.
The Supreme Court ruled that health insurance plans can make all dialysis providers out-of-network. (Reuters)
A predictive model reliably discriminated between people with and without Alzheimer's-related pathologies based on a single MRI. (Communications Medicine)
South Carolina Gov. Henry McMaster (R) signed a new law that lets healthcare providers and medical students refuse non-emergency care that conflicts with their religious, moral, or ethical beliefs. (WIS-TV 10 News)
Some parents can't wait to vaccinate their young children against SARS-CoV-2; others strongly oppose or are hesitant. (USA Today)
Florida Gov. Ron DeSantis (R) continues to take heat for his decision not to pre-order COVID-19 vaccines for infants and young kids from the federal government. (The Hill)
Three members of an Australian family developed symptoms of rhabdomyolysis after eating recently thawed and cooked queen snapper fish. (Newsweek)
A federal appeals court ordered the EPA to re-examine its 2020 finding that glyphosate -- the active ingredient in the weed killer Roundup -- did not pose a health risk for people exposed to it on farms, yards, or roadsides, or as residue on food crops. (Time)
Merck and Sanofi will join Novartis in a 10-year commitment to boost diversity in clinical research by collaborating with historically Black colleges and universities. (Endpoints News)
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So for those who may not be aware about how study participants are being treated. Currently we are not getting the booster. Moderna had decided that if we want it, its on our own and initially said if we got it, we'd be out of the study. Research facilities raised hell on that (good for them) so now we just have to report if we got the booster. I will not get it until Octoberish which is when I get my flu shot. By then I will be out of the study (I'll be out in August actually).
Things are relatively normal. Some still wear their masks. I will wear one on bad pollen days but no one around here says anything about them....they're just background noise at this point.
In most of the local restaurants that I've been to, employees are still wearing them. I've been out to a few restaurants but mostly outdoor ones (we have lots of them here)
Things are relatively normal. Some still wear their masks. I will wear one on bad pollen days but no one around here says anything about them....they're just background noise at this point.
In most of the local restaurants that I've been to, employees are still wearing them. I've been out to a few restaurants but mostly outdoor ones (we have lots of them here)
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What We Know About the Omicron Clan of Virus Variants
By Jason Gale"
The global spread of SARS-CoV-2 has spawned a plethora of virus variants, each competing to more efficiently spread and evade the antibodies people generated from past infections and vaccinations. The highly transmissible omicron variant sent daily cases of Covid-19 to new heights early this year and its subvariants continue to evolve, driving fresh outbreaks across the world. That’s challenging the achievement of community protection via so-called herd immunity, prompting the development of updated vaccines as well as testing the public’s tolerance for pandemic-mitigation efforts like booster shots, frequent testing and mask-wearing.
1. How is omicron evolving?
- Omicron, also known as BA.1, was first identified in southern Africa late last year. It’s characterized by some 30 mutations in the gene for the spike protein, which gives the coronavirus its crown-like appearance and allows it to invade cells. Changes there can make the pathogen less recognizable to the antibodies the immune system makes in response to vaccination or a case of Covid, increasing the risk of infection in such cases. At least three mutations are associated with helping the virus escape detection from antibodies, and another appears to increase its ability to gain entry to human cells.
- Laboratory studies, including experiments with animals, found omicron was less likely to spread to the lungs. However it infects and multiplies in the upper airways -- the nose, throat and windpipe -- as much as 70 times faster than earlier strains. Patients infected with it were shown to shed viral particles -- meaning they could infect other people -- for longer after symptoms emerge than with previous strains.
- Over time, subvariants of the original omicron strain have evolved, with the “fittest” superseding earlier versions. Several have been shown to cause different patterns of symptoms and may carry different risks of persistent or “long-haul” symptoms.
2. What about these subvariants?
Scientists divide omicron viruses broadly into five branches that descend from an ancestor strain. These are BA.1, BA.2, BA.3, BA.4 and BA.5. Each comprises a different constellation of genetic mutations that affect antibody evasion, infectivity, and possibly virulence. Soon after BA.1 emerged and spread, it was eclipsed by BA.2, which became the main lineage circulating worldwide. In the US, one of BA.2’s descendants -- BA.2.12.1 -- accounted for more than half of new Covid cases as of mid-June. By then, the global prevalence of BA.2.12.1 had declined to 17% from 31% in early June, according to the World Health Organization. BA.4 and BA.5, detected in about 60 countries, together accounted for 34% of virus sequences reported to GISAID, an open-source directory of variants worldwide. Of those, BA.5 appears to have gained ground fastest, accounting for a quarter of sequences, according to the WHO. The rise in prevalence of BA.4 and BA.5 has coincided with an increase in Covid-19 cases in several regions, WHO said in a June 22 report. In some countries, that’s led to a surge in hospitalizations and ICU admissions. Still, available evidence doesn’t indicate they’re associated with a change in severity, the UN agency said.3. What’s the concern?
Omicron viruses are more transmissible than delta, the variant that became dominant worldwide in mid-2021, and each major subvariant appears more infectious still. For instance, BA.2.12.1 appears in the US to be about 25% more transmissible than BA.2, which was already shown to be particularly infectious. Still, their predominance globally has coincided with a marked fall in cases and deaths from a peak in January, according to the WHO. Detailed analysis of omicron and its subvariants by scientists in Japan in late May found BA.2.12.1, BA.4 and BA.5 share a common mutation in the spike protein that’s associated in lab studies with a greater propensity to infect the lower lungs, where the virus can cause more severe disease. The so-called L452 mutation, which was also detected in delta, may make these strains more virulent than a BA.1 or BA.2 infection -- although there’s no evidence yet to indicate that’s the case. A study by scientists in China released ahead of publication in Nature on June 17 found that BA.2.12.1, BA.4 and BA.5 were more adept at evading antibodies than BA.1. They also reduce the neutralizing activity of the monoclonal antibody therapies casirivimab and imdevimab, according to WHO. Still, the monoclonal antibody treatment bebtelovimab and cilgavimab could effectively neutralize, or block, all three.
4. How effective are current vaccines?
Broadly, omicron variants reduce the effectiveness of immunity generated by a primary vaccination series. Booster doses, especially using a mRNA shot from Pfizer Inc./BioNTech SE or Moderna Inc. substantially improve protection against symptomatic disease and infection, though the benefit diminishes over time. More studies are needed to assess the duration of effectiveness of boosters beyond six months, according to the WHO.5. What are the caveats?
Although some of the newer omicron variants have caused local spikes in Covid cases, hospitalizations aren’t going up at nearly the same rate they did during previous waves. This suggests that the immunity generated from prior infections and vaccination is protecting against severe illness in some people, even if they’re at higher risk of infection. Still, even mild infections in vaccinated individuals can lead to long Covid in some cases, which means vaccination alone may not be enough to reduce the long-term health consequences of the pandemic.The Reference Shelf
- Related QuickTakes on whether Covid is becoming endemic, flurona (flu + coronavirus), virus testing, Covid treatments, vaccine mandates, omicron risk to kids, and the risks of flyingamid the spread of omicron.
- The New York Times tracks omicron and other SARS-CoV-2 variants.
- The journal Science focuses on BA.2.
- Bloomberg Intelligence’s Sam Fazeli and Bloomberg Opinion’s Therese Raphael discuss BA.2.
- CDC information on variants.
- The journal Nature provides a guide to the tangled omicron family.
- Omicron’s impact in South Africa is discussed in Science Translational Medicine.
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From JAMA June 2022
Article Information
JAMA. 2022;327(23):2273-2275. doi:10.1001/jama.2022.9367
COVID-19 Resource Center
https://jamanetwork.com/journals/jama/fullarticle/2792030
Seasonal influenza vaccines are updated every year, depending on what strains are circulating globally, leaving many people—especially those who still contracted COVID-19 after 2 booster shots—wondering why vaccines against SARS-CoV-2 haven’t changed as variants have come and gone.
Currently available COVID-19 vaccines are based on the spike protein of Wuhan-Hu-1, the prototype SARS-CoV-2 virus. But the virus has changed significantly since Wuhan-Hu-1 was sequenced in January 2020, with variants of concern ranging from Alpha to Omicron.
Omicron, and especially its subvariants, is so different from Wuhan-Hu-1 that it is most adept at evading the immune response generated by current vaccines. Even so, studies have shown that the prototype COVID-19 vaccines still reduce the risk of serious illness and death from Omicron.
Updating COVID-19 vaccines is easier said than done, and some observers question whether it’s the best way to tackle the unpredictable, ever-changing virus. To help sort out the matter, the US Food and Drug Administration (FDA) convened its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on April 6 to examine general considerations for future COVID-19 vaccine boosters and has scheduled a follow-up meeting on June 28 to discuss the possibility of changing the composition of SARS-CoV-2 vaccines to better protect against variants.
“I don’t think it’s as simple as: ‘There’s a new variant so let’s make a new vaccine,’” Kanta Subbarao, MBBS, MPH, director of the World Health Organization’s (WHO’s) Collaborating Centre for Reference and Research on Influenza in Melbourne, said in an interview.
In a May 2 JAMA Viewpoint, FDA officials called circulating SARS-CoV-2 “the new normal,” likely requiring consideration of annual updates of COVID-19 vaccines, as is done with influenza vaccines. “[A] greater depth and duration of protection might be achieved with a vaccine covering currently circulating variants,” wrote coauthors Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research (CBER); Principal Deputy Commissioner Janet Woodcock, MD; and Commissioner Robert Califf, MD.
But influenza viruses were first isolated in the 1930s, and the first influenza vaccines were licensed in the 1940s, so scientists, vaccine manufacturers, and regulatory agencies have had decades to figure out the immunization strategy for that disease.
“The challenge is we don’t know the rules of how this virus [SARS-CoV-2] behaves. For seasonal flu, we know the rules,” John Beigel, MD, associate director for clinical research in the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases (NIAID), explained in an interview. “Omicron kind of came out of nowhere. A year ago, we wouldn’t have predicted something like Omicron.”
One thing for sure, VRBPAC member Paul Offit, MD, said in an interview, boosting people every 6 months “is not a reasonable public health strategy.” Indeed, as of May 22, only 20% of US adults 50 years of age or older, for whom second boosters are recommended, had received one, according to the US Centers for Disease Control and Prevention (CDC).
COVID-19 Is Not the Flu
The WHO conducts influenza surveillance 24/7 year-round.
Twice annually, in February for the Northern Hemisphere and in September for the Southern Hemisphere, the WHO convenes a panel of experts to review the surveillance data to see whether new influenza strains are circulating and infecting people.
If so, the panel must decide whether current vaccines protect against the new circulating strains and, if not, whether the vaccines need to be updated with antigens that are a better match. About a week after that decision is made, the FDA convenes VRBPAC to make recommendations for the composition of US vaccines for the upcoming flu season.
Determining the composition of the vaccine must be done months in advance of flu season to give manufacturers enough time to produce tens of millions of doses.
When the vaccine is well-matched to circulating viruses, it is approximately 60% effective for the overall population, the FDA’s Jerry Weir, PhD, director of the Division of Viral Products in CBER’s Office of Vaccine Research and Review, told VRBPAC panelists at their April meeting.
Sometimes the vaccine isn’t well-matched, though. For example, preliminary, interim estimates for the 2021-2022 flu season show that the vaccine didn’t reduce the risk of mild or moderate illness from influenza A viruses, according to the CDC.
Reasons vary for why the flu vaccine might not be well-matched, Weir explained at the VRBPAC meeting. Sometimes antigenically distinct viruses emerge after the vaccine composition has been decided, such as the 2009 H1N1 pandemic virus, which required development of a supplemental vaccine against the pandemic strain. Sometimes manufacturing issues can’t be resolved in time to produce a well-matched vaccine, Weir said.
And that’s with a vaccine against a virus that has a long track record.
Updating vaccines against SARS-CoV-2 presents special challenges, Weir noted at the VRBPAC meeting. While most influenza vaccines have similar platforms with similar time frames needed for updating them, that’s not the case with COVID-19 vaccines, he pointed out. Not only do COVID-19 vaccine platforms differ from each other, but there’s been no coordination among manufacturers, who are at various stages in clinical trials with updated vaccines of varying compositions, Weir said.
Although some manufacturers are considering a combination annual vaccine against both COVID-19 and seasonal influenza, “it’s premature to combine them,” Subbarao told JAMA. “We don’t know how often we’ll have to vaccinate against COVID.” Plus, she said, whether SARS-CoV-2 follows the same seasonal pattern as influenza isn’t yet clear. Although transmission has appeared to be greatest during the winter in temperate climates, that could be due to people spending more time indoors, not because more virus is circulating, Subbarao said.
Subbarao chairs the WHO’s recently assembled 18-member Technical Advisory Group on COVID-19 Vaccine Composition; her vice chair is David Wentworth, PhD, chief of the Virology, Surveillance, and Diagnosis Branch of the CDC’s Influenza Division.
The advisory group will recommend methods to assess the impact of variants of concern on COVID-19 vaccines, interpret available evidence on the effects of those variants on vaccines, and provide guidance on whether vaccine composition should be adjusted to protect against variants of concern, Subbarao told VRBPAC members at their April 6 meeting.
If the FDA decides to grant Emergency Use Authorization (EUA) of investigational vaccines that contain antigenic material from SARS-CoV-2 variants, manufacturers may be hard-pressed to manufacture enough doses to meet demand by the fall. (Given the relatively low number of people who’ve received a second booster, just what the demand might be for a third one represents another as-yet unanswered question.)
“It’s not hard to change it,” Beigel said of current COVID-19 vaccines. “It’s hard to scale it and deliver 100 million doses.”
Asking Too Much?
Although he’s 71 and, therefore, eligible for a second booster shot, Offit, chair of vaccinology at the University of Pennsylvania’s Perelman School of Medicine, hasn’t yet opted to get one. He’s healthy, and research has clearly shown that 3 doses would reduce the risk of serious illness if he were to contract COVID-19, he explained.
Offit, citing a lack of evidence showing that an Omicron-based booster would provide more protection than the prototype vaccines do, said, “I don’t understand the thinking behind it.”
By adding a booster against variants to the vaccine arsenal, “What are you really doing for the pandemic: Protecting people who are already protected?” Offit asked. A wiser investment would be to ship the prototype vaccines overseas to vaccinate the unvaccinated, he said.
Protection against serious illness isn’t enough for many people, Offit acknowledged. Concerned about the possibility of long COVID, many people don’t want to get infected with SARS-CoV-2, period, he said, adding that he’d like to see more rigor in defining long COVID.
Offit questioned whether preventing infection completely was an attainable goal for vaccines against SARS-CoV-2.
“Is it realistic to expect that we can protect against all illness with this virus?” Offit asked. “I feel like this is much ado about little. This is not flu. You get a flu vaccine every year because you’re still not protected against serious disease” even if vaccinated the previous year. If the goal is to prevent all SARS-CoV-2 infections, even the mild ones, “I think we’re going to drive ourselves a little crazy,” he said.
Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, is the coinventor of a vaccine to protect against rotavirus, a common cause of severe diarrhea, vomiting, fever, and abdominal pain in infants. Like SARS-CoV-2, rotavirus is a mucosal infection with a short incubation period, giving vaccine-generated immunity a relatively brief window of opportunity to completely block infection.
Infants vaccinated against rotavirus still sometimes get mild disease, just as people vaccinated against SARS-CoV-2 can still get sick with COVID-19, Offit explained. In contrast, measles is a viral infection with an average incubation period of 11 or 12 days—more than twice that of SARS-CoV-2. On top of that, there’s only 1 antigenic type of measles, which has barely changed over time, so vaccine-induced immunity against it is thought to be lifelong.
By expecting the same from COVID-19 vaccines as from measles vaccines, “we’re setting [COVID-19] vaccine up for failure,” Offit said. The wording used to describe SARS-CoV-2 infections in vaccinated and boosted individuals hasn’t helped lower expectations for COVID-19, he added. “We damned it when we used the term ‘breakthrough infection.’”
Still, Subbarao—echoing a March 8 statement from her WHO vaccine composition committee—told VRBPAC members at their April 6 meeting, “We do need to encourage the development of COVID-19 vaccines that will have an impact on prevention of infection and transmission, in addition to protecting against severe illness and death.”
SARS-CoV-2 Vaccine 2.0
Developing variant-based injectable vaccines might seem like a game of whack-a-mole.
Targeting Omicron with a vaccine assumes that there will be an Omicron resurgence, but by the time such a vaccine is ready to be used, the circulating variant could be Beta or Delta, both significantly different from Omicron and Alpha, Beigel told VRBPAC members.
A multivalent COVID-19 vaccine, containing antigens from multiple SARS-CoV-2 variants of concern, would be the next step after a monovalent vaccine, but, as with the quadrivalent seasonal flu vaccines, manufacturers would have to prove that antigens from multiple variants combined were just as immunogenic as each alone, Subbarao said.
To cover as many bases as possible, vaccine makers have set their sights on multivalent COVID-19 vaccines, Robert Johnson, PhD, director of Medical Countermeasure Programs at the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), said in an interview. (BARDA has partnered with companies and funded manufacturing, development, and procurement of 6 COVID-19 vaccines, including the 3 available in the US.)
Multivalent vaccines against numerous varieties of a virus aren’t unprecedented, he noted; human papillomavirus (HPV) vaccines contain antigenic material for multiple HPV strains (for example, human papillomavirus 9-valent vaccine, recombinant, marketed as Gardasil, targets 9 disease-causing HPV strains). However, Johnson pointed out at the April 6 VRBPAC meeting, it will take manufacturers longer to produce a multivalent vaccine than a monovalent vaccine.
Meanwhile, the NIAID is conducting a phase 2 trial, the COVID-19 Variant Immunologic Landscape (COVAIL) study, to compare different vaccine regimens in adults who’ve already received their primary COVID-19 vaccination and a booster.
The open-label COVAIL trial began enrolling participants in early April. As of mid-May, it consisted of 12 groups that are testing, singly and combined, Moderna’s and Pfizer-BioNTech’s prototype messenger RNA vaccines and the companies’ Beta, Delta, and Omicron variant–based investigational vaccines. Researchers will compare the innate, cellular, and humoral immune responses of each group to help figure out how best to cover new variants as they emerge.
The Road Not Taken
Instead of trying to smack down 1 variant just as another pops up, researchers and funders should prioritize creating nasal vaccines and pan–SARS-CoV-2 or even pan-sarbecovirus (the viral subgenus that contains SARS-CoV-2 and SARS-CoV) vaccines, some scientists say. Both types of vaccines are in early clinical trials.
A nasal vaccine could stop SARS-CoV-2 in its tracks, and a pan–SARS-CoV-2 or pan-sarbecovirus vaccine could generate an immune response to current SARS-CoV-2 variants and those yet to come.
“The enemy has evolved, and the world needs next-generation vaccines to respond,” Yale School of Medicine immunology professor Akiko Iwasaki, PhD, who is working on a COVID-19 nasal vaccine, wrote May 16 in the New York Times.
Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine and codirector of the Texas Children’s Hospital Center for Vaccine Development, tweeted May 22 that he has asked the White House COVID-19 team “to explore alternative strategies or technologies to provide longer-lasting protection for years” because, he explained, he thinks public acceptance of another booster in the fall will be “quite low.” (Hotez’s lab developed the technology, which is owned by Baylor, for Corbevax, a low-cost protein subunit COVID-19 vaccine that has received EUA in India.)
Omicron-based boosters are a “done deal,” though, because Moderna and Pfizer-BioNTech have already invested heavily in them, Eric Topol, MD, founder and director of the Scripps Research Translational Institute, said in an email. And yet, he pointed out in a May 15 online column, those boosters are directed against BA.1, the original flavor of Omicron, and might not be as effective against newer Omicron subvariants or other SARS-CoV-2 variants yet to come.
“Before that effort was launched,” Topol told JAMA, referring to the development of Omicron-based boosters, “I do believe strong consideration and priority should have been given to nasal/oral and pan-betacoronavirus vaccines.
“We’ve learned that the time it takes to get a new bivalent vaccine tested and an EUA, no less the resources expended, might, in the future, be directed to variant-proof efforts that are in our reach.”
Challenges of Deciding Whether and How to Update COVID-19 Vaccines to Protect Against Variants
Rita Rubin, MAArticle Information
JAMA. 2022;327(23):2273-2275. doi:10.1001/jama.2022.9367
COVID-19 Resource Center
https://jamanetwork.com/journals/jama/fullarticle/2792030
Seasonal influenza vaccines are updated every year, depending on what strains are circulating globally, leaving many people—especially those who still contracted COVID-19 after 2 booster shots—wondering why vaccines against SARS-CoV-2 haven’t changed as variants have come and gone.
Currently available COVID-19 vaccines are based on the spike protein of Wuhan-Hu-1, the prototype SARS-CoV-2 virus. But the virus has changed significantly since Wuhan-Hu-1 was sequenced in January 2020, with variants of concern ranging from Alpha to Omicron.
Omicron, and especially its subvariants, is so different from Wuhan-Hu-1 that it is most adept at evading the immune response generated by current vaccines. Even so, studies have shown that the prototype COVID-19 vaccines still reduce the risk of serious illness and death from Omicron.
Updating COVID-19 vaccines is easier said than done, and some observers question whether it’s the best way to tackle the unpredictable, ever-changing virus. To help sort out the matter, the US Food and Drug Administration (FDA) convened its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on April 6 to examine general considerations for future COVID-19 vaccine boosters and has scheduled a follow-up meeting on June 28 to discuss the possibility of changing the composition of SARS-CoV-2 vaccines to better protect against variants.
“I don’t think it’s as simple as: ‘There’s a new variant so let’s make a new vaccine,’” Kanta Subbarao, MBBS, MPH, director of the World Health Organization’s (WHO’s) Collaborating Centre for Reference and Research on Influenza in Melbourne, said in an interview.
In a May 2 JAMA Viewpoint, FDA officials called circulating SARS-CoV-2 “the new normal,” likely requiring consideration of annual updates of COVID-19 vaccines, as is done with influenza vaccines. “[A] greater depth and duration of protection might be achieved with a vaccine covering currently circulating variants,” wrote coauthors Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research (CBER); Principal Deputy Commissioner Janet Woodcock, MD; and Commissioner Robert Califf, MD.
But influenza viruses were first isolated in the 1930s, and the first influenza vaccines were licensed in the 1940s, so scientists, vaccine manufacturers, and regulatory agencies have had decades to figure out the immunization strategy for that disease.
“The challenge is we don’t know the rules of how this virus [SARS-CoV-2] behaves. For seasonal flu, we know the rules,” John Beigel, MD, associate director for clinical research in the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases (NIAID), explained in an interview. “Omicron kind of came out of nowhere. A year ago, we wouldn’t have predicted something like Omicron.”
One thing for sure, VRBPAC member Paul Offit, MD, said in an interview, boosting people every 6 months “is not a reasonable public health strategy.” Indeed, as of May 22, only 20% of US adults 50 years of age or older, for whom second boosters are recommended, had received one, according to the US Centers for Disease Control and Prevention (CDC).
COVID-19 Is Not the Flu
The WHO conducts influenza surveillance 24/7 year-round.
Twice annually, in February for the Northern Hemisphere and in September for the Southern Hemisphere, the WHO convenes a panel of experts to review the surveillance data to see whether new influenza strains are circulating and infecting people.
If so, the panel must decide whether current vaccines protect against the new circulating strains and, if not, whether the vaccines need to be updated with antigens that are a better match. About a week after that decision is made, the FDA convenes VRBPAC to make recommendations for the composition of US vaccines for the upcoming flu season.
Determining the composition of the vaccine must be done months in advance of flu season to give manufacturers enough time to produce tens of millions of doses.
When the vaccine is well-matched to circulating viruses, it is approximately 60% effective for the overall population, the FDA’s Jerry Weir, PhD, director of the Division of Viral Products in CBER’s Office of Vaccine Research and Review, told VRBPAC panelists at their April meeting.
Sometimes the vaccine isn’t well-matched, though. For example, preliminary, interim estimates for the 2021-2022 flu season show that the vaccine didn’t reduce the risk of mild or moderate illness from influenza A viruses, according to the CDC.
Reasons vary for why the flu vaccine might not be well-matched, Weir explained at the VRBPAC meeting. Sometimes antigenically distinct viruses emerge after the vaccine composition has been decided, such as the 2009 H1N1 pandemic virus, which required development of a supplemental vaccine against the pandemic strain. Sometimes manufacturing issues can’t be resolved in time to produce a well-matched vaccine, Weir said.
And that’s with a vaccine against a virus that has a long track record.
Updating vaccines against SARS-CoV-2 presents special challenges, Weir noted at the VRBPAC meeting. While most influenza vaccines have similar platforms with similar time frames needed for updating them, that’s not the case with COVID-19 vaccines, he pointed out. Not only do COVID-19 vaccine platforms differ from each other, but there’s been no coordination among manufacturers, who are at various stages in clinical trials with updated vaccines of varying compositions, Weir said.
Although some manufacturers are considering a combination annual vaccine against both COVID-19 and seasonal influenza, “it’s premature to combine them,” Subbarao told JAMA. “We don’t know how often we’ll have to vaccinate against COVID.” Plus, she said, whether SARS-CoV-2 follows the same seasonal pattern as influenza isn’t yet clear. Although transmission has appeared to be greatest during the winter in temperate climates, that could be due to people spending more time indoors, not because more virus is circulating, Subbarao said.
Subbarao chairs the WHO’s recently assembled 18-member Technical Advisory Group on COVID-19 Vaccine Composition; her vice chair is David Wentworth, PhD, chief of the Virology, Surveillance, and Diagnosis Branch of the CDC’s Influenza Division.
The advisory group will recommend methods to assess the impact of variants of concern on COVID-19 vaccines, interpret available evidence on the effects of those variants on vaccines, and provide guidance on whether vaccine composition should be adjusted to protect against variants of concern, Subbarao told VRBPAC members at their April 6 meeting.
If the FDA decides to grant Emergency Use Authorization (EUA) of investigational vaccines that contain antigenic material from SARS-CoV-2 variants, manufacturers may be hard-pressed to manufacture enough doses to meet demand by the fall. (Given the relatively low number of people who’ve received a second booster, just what the demand might be for a third one represents another as-yet unanswered question.)
“It’s not hard to change it,” Beigel said of current COVID-19 vaccines. “It’s hard to scale it and deliver 100 million doses.”
Asking Too Much?
Although he’s 71 and, therefore, eligible for a second booster shot, Offit, chair of vaccinology at the University of Pennsylvania’s Perelman School of Medicine, hasn’t yet opted to get one. He’s healthy, and research has clearly shown that 3 doses would reduce the risk of serious illness if he were to contract COVID-19, he explained.
Offit, citing a lack of evidence showing that an Omicron-based booster would provide more protection than the prototype vaccines do, said, “I don’t understand the thinking behind it.”
By adding a booster against variants to the vaccine arsenal, “What are you really doing for the pandemic: Protecting people who are already protected?” Offit asked. A wiser investment would be to ship the prototype vaccines overseas to vaccinate the unvaccinated, he said.
Protection against serious illness isn’t enough for many people, Offit acknowledged. Concerned about the possibility of long COVID, many people don’t want to get infected with SARS-CoV-2, period, he said, adding that he’d like to see more rigor in defining long COVID.
Offit questioned whether preventing infection completely was an attainable goal for vaccines against SARS-CoV-2.
“Is it realistic to expect that we can protect against all illness with this virus?” Offit asked. “I feel like this is much ado about little. This is not flu. You get a flu vaccine every year because you’re still not protected against serious disease” even if vaccinated the previous year. If the goal is to prevent all SARS-CoV-2 infections, even the mild ones, “I think we’re going to drive ourselves a little crazy,” he said.
Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, is the coinventor of a vaccine to protect against rotavirus, a common cause of severe diarrhea, vomiting, fever, and abdominal pain in infants. Like SARS-CoV-2, rotavirus is a mucosal infection with a short incubation period, giving vaccine-generated immunity a relatively brief window of opportunity to completely block infection.
Infants vaccinated against rotavirus still sometimes get mild disease, just as people vaccinated against SARS-CoV-2 can still get sick with COVID-19, Offit explained. In contrast, measles is a viral infection with an average incubation period of 11 or 12 days—more than twice that of SARS-CoV-2. On top of that, there’s only 1 antigenic type of measles, which has barely changed over time, so vaccine-induced immunity against it is thought to be lifelong.
By expecting the same from COVID-19 vaccines as from measles vaccines, “we’re setting [COVID-19] vaccine up for failure,” Offit said. The wording used to describe SARS-CoV-2 infections in vaccinated and boosted individuals hasn’t helped lower expectations for COVID-19, he added. “We damned it when we used the term ‘breakthrough infection.’”
Still, Subbarao—echoing a March 8 statement from her WHO vaccine composition committee—told VRBPAC members at their April 6 meeting, “We do need to encourage the development of COVID-19 vaccines that will have an impact on prevention of infection and transmission, in addition to protecting against severe illness and death.”
SARS-CoV-2 Vaccine 2.0
Developing variant-based injectable vaccines might seem like a game of whack-a-mole.
Targeting Omicron with a vaccine assumes that there will be an Omicron resurgence, but by the time such a vaccine is ready to be used, the circulating variant could be Beta or Delta, both significantly different from Omicron and Alpha, Beigel told VRBPAC members.
A multivalent COVID-19 vaccine, containing antigens from multiple SARS-CoV-2 variants of concern, would be the next step after a monovalent vaccine, but, as with the quadrivalent seasonal flu vaccines, manufacturers would have to prove that antigens from multiple variants combined were just as immunogenic as each alone, Subbarao said.
To cover as many bases as possible, vaccine makers have set their sights on multivalent COVID-19 vaccines, Robert Johnson, PhD, director of Medical Countermeasure Programs at the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), said in an interview. (BARDA has partnered with companies and funded manufacturing, development, and procurement of 6 COVID-19 vaccines, including the 3 available in the US.)
Multivalent vaccines against numerous varieties of a virus aren’t unprecedented, he noted; human papillomavirus (HPV) vaccines contain antigenic material for multiple HPV strains (for example, human papillomavirus 9-valent vaccine, recombinant, marketed as Gardasil, targets 9 disease-causing HPV strains). However, Johnson pointed out at the April 6 VRBPAC meeting, it will take manufacturers longer to produce a multivalent vaccine than a monovalent vaccine.
Meanwhile, the NIAID is conducting a phase 2 trial, the COVID-19 Variant Immunologic Landscape (COVAIL) study, to compare different vaccine regimens in adults who’ve already received their primary COVID-19 vaccination and a booster.
The open-label COVAIL trial began enrolling participants in early April. As of mid-May, it consisted of 12 groups that are testing, singly and combined, Moderna’s and Pfizer-BioNTech’s prototype messenger RNA vaccines and the companies’ Beta, Delta, and Omicron variant–based investigational vaccines. Researchers will compare the innate, cellular, and humoral immune responses of each group to help figure out how best to cover new variants as they emerge.
The Road Not Taken
Instead of trying to smack down 1 variant just as another pops up, researchers and funders should prioritize creating nasal vaccines and pan–SARS-CoV-2 or even pan-sarbecovirus (the viral subgenus that contains SARS-CoV-2 and SARS-CoV) vaccines, some scientists say. Both types of vaccines are in early clinical trials.
A nasal vaccine could stop SARS-CoV-2 in its tracks, and a pan–SARS-CoV-2 or pan-sarbecovirus vaccine could generate an immune response to current SARS-CoV-2 variants and those yet to come.
“The enemy has evolved, and the world needs next-generation vaccines to respond,” Yale School of Medicine immunology professor Akiko Iwasaki, PhD, who is working on a COVID-19 nasal vaccine, wrote May 16 in the New York Times.
Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine and codirector of the Texas Children’s Hospital Center for Vaccine Development, tweeted May 22 that he has asked the White House COVID-19 team “to explore alternative strategies or technologies to provide longer-lasting protection for years” because, he explained, he thinks public acceptance of another booster in the fall will be “quite low.” (Hotez’s lab developed the technology, which is owned by Baylor, for Corbevax, a low-cost protein subunit COVID-19 vaccine that has received EUA in India.)
Omicron-based boosters are a “done deal,” though, because Moderna and Pfizer-BioNTech have already invested heavily in them, Eric Topol, MD, founder and director of the Scripps Research Translational Institute, said in an email. And yet, he pointed out in a May 15 online column, those boosters are directed against BA.1, the original flavor of Omicron, and might not be as effective against newer Omicron subvariants or other SARS-CoV-2 variants yet to come.
“Before that effort was launched,” Topol told JAMA, referring to the development of Omicron-based boosters, “I do believe strong consideration and priority should have been given to nasal/oral and pan-betacoronavirus vaccines.
“We’ve learned that the time it takes to get a new bivalent vaccine tested and an EUA, no less the resources expended, might, in the future, be directed to variant-proof efforts that are in our reach.”
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GemmaBella
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I've had 4 - they weren't saying anything about the new vaccine when I got my second booster in April, though I probably still would have gone ahead with it. I plan on the new vaccine in Sept/Oct.
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It's a tough decision. I still have not gotten my second booster as I am grappling with this very dilemma. Get it now or wait til the new one is available. I don't want to get a booster every two-three months so not sure what to do now.
Clarity for fall: We're getting an Omicron booster
A critical meeting took place yesterday at the FDA.
yourlocalepidemiologist.substack.com
GemmaBella
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It's a tough decision. I still have not gotten my second booster as I am grappling with this very dilemma. Get it now or wait til the new one is available. I don't want to get a booster every two-three months so not sure what to do now.
Clarity for fall: We're getting an Omicron booster
A critical meeting took place yesterday at the FDA.
Thanks @missy. I appreciate the articles you post so incredibly much. I read everything you post here to stay informed apart from my regular news channels. The articles you post are more thorough and specific to give insight into what I am really curious about.
I share your concern, I am thinking of waiting for the fall to get boosted with an updated version of the vaccine. I do not go out anyway unless it is for medical appointments or the vet (wearing an N95). A family member brings all groceries. Everything else we get delivered. We see extended family outdoors AND masked always. I am criticized for being a recluse while others define Covid as the new common cold. Long Covid is always on my mind. I don't feel like I am doing the wrong thing. I am just in the minority.
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