Coronavirus updates August 2022

[Calliecake]

FYI

@MamaBee and anyone else who is concerned about Covid vaccines regarding when their last vaccine was administered. Our local news just ran a story stating that the new vaccine (once its given authorization) can be administrated as long as its been 2 months since your previous booster. Some here had been concerned there would be a 6 months recommended delay between vaccines. I was relieved to hear thay wasn't the case for the new vaccine that should be available sometime in September, and thought others here may also be glad to hear this. As always, please check with your doctor first to hear what they recommend.

 

[MamaBee]

FYI

@MamaBee and anyone else who is concerned about Covid vaccines regarding when their last vaccine was administered. Our local news just ran a story stating that the new vaccine (once its given authorization) can be administrated as long as its been 2 months since your previous booster. Some here had been concerned there would be a 6 months recommended delay between vaccines. I was relieved to hear thay wasn't the case for the new vaccine that should be available sometime in September, and thought others here may also be glad to hear this. As always, please check with your doctor first to hear what they recommend.

Thank you @Calliecake..I just saw my new doctor last Friday. She told me to get it as soon as it comes out. I had my precious vaccine in May sometime. I never even brought it up to her since I was preoccupied with other issues. She told me it should be available quickly after Labor Day.

 

[missy]

FDA Authorizes Omicron-Targeted Booster Shots​

— Monovalent mRNA shots no longer authorized as boosters in people 12 and up​

by Ingrid Hein, Staff Writer, MedPage Today August 31, 2022

The FDA on Wednesday authorized bivalent COVID-19 booster shots from Pfizer/BioNTech and Moderna that target the original strain along with the Omicron BA.4/BA.5 subvariants.
In an amendment to the emergency use authorizations (EUAs), both shots can be administered starting 2 months following a primary vaccination series or prior booster -- in people 12 and up for Pfizer's shot and in people 18 and up for Moderna's vaccine.

"The FDA has been planning for the possibility that the composition of the COVID-19 vaccines would need to be modified to address circulating variants," Peter Marks, MD, PhD, of FDA's Center for Biologics Evaluation and Research, said in a statement. "We sought input from our outside experts on the inclusion of an omicron component in COVID-19 boosters to provide better protection against COVID-19. We have worked closely with the vaccine manufacturers to ensure the development of these updated boosters was done safely and efficiently."
Of note, clinical data supporting the EUA amendment were derived from studies on bivalent vaccines that targeted the original Omicron strain, but the agency said it considers such data as "relevant and supportive" of the newer BA.4/BA.5-targeted vaccines.
Support for the vaccines' efficacy came in the form of immunogenicity data. The studies for each vaccine involved about 600 fully vaccinated adults who had already received a booster shot as well. Immune responses to BA.1 were superior in individuals receiving either of the companies' bivalent vaccines — which included components targeting the ancestral strain as well as Omicron BA.1 — compared to those that received the original monovalent boosters targeting only the original strain.

This rollout is "similar to situations we've done in the past with influenza strain changes … we don't do clinical studies for them in the United States," Marks said during a press briefing on Wednesday.
"To stave off serious outcomes and symptomatic disease, one needs to refresh the immune system with what is actually circulating," he said. "BA.1 is no longer circulating."
CDC's variant proportions tracker shows that the BA.5 Omicron subvariant makes up 88.7% of cases in the U.S., while BA.4 makes up 3.6% and BA.4.6 makes up 7.5% of cases.
Prior research in individuals infected with BA.4 or BA.5 has demonstrated robust protection against a variety of other variants, including BA.1, Delta, and Beta, Marks noted.
"The hope here is that by increasing the amount of antibodies we have to that particular variant, we will restore the protection we had when these [vaccines] were launched -- that is the goal here," he said.

Safety data for Wednesday's authorization were derived from studies on the BA.1-targeting bivalent vaccines in 800 adults 18 and up for Moderna's shot and in 600 adults 55 and older for Pfizer's. Commonly reported side effects for the vaccines included injection site pain, redness, and swelling, lymph node swelling in the arm of the injection, as well as chills, fever, fatigue, headache, muscle or joint pain, and nausea or vomiting.
"We are confident in the evidence supporting these authorizations," he said.
Monovalent mRNA vaccines that target the original SARS-CoV-2 strain will no longer be authorized as boosters in people 12 and up, the agency said.
Marks said he expects the FDA will authorize bivalent boosters for children in the next month or two.
Before shots can go into arms, the CDC's Advisory Committee on Immunization Practices (ACIP) will need to weigh in with their recommendation; ACIP is scheduled to meet on Thursday and Friday of this week.

 

[AprilBaby]

I’ve had 4 shots and still Covid free. Shot 5 should be available this weekend!

 

[missy]

“
New COVID Omicron Boosters About to Arrive, With Some Controversy

Kathleen Doheny
August 31, 2022
.

Aug. 31, 2022 — COVID-19 booster vaccines targeting the Omicron BA.4 and BA.5 subvariants currently dominating in the United States could be available in the next few days, but their arrival comes with some controversy. .
The FDA granted emergency approval to the mRNA boosters from Pfizer and Moderna today. Next up are 2 days of meetings of the CDC's Advisory Committee on Immunization Practices Thursday and Friday which could pave the way for an official CDC endorsement of the vaccines before the weekend.
The US government has already purchased over 170 million doses of the two vaccines to be ready for use after all approvals are in place (with an additional order of 4 million doses for children should those be approved at a later date).
The expected arrival of the updated vaccines, however, has sparked debate among infectious disease experts and others.



Some have criticized the fact that the new boosters haven't been tested in humans and say they will wait to get the updated booster or skip it altogether. Others worry that the public will view the new vaccines as rushed, increasing an already-reluctant public's hesitation to get another shot.
Still, many experts applaud the speed with which the updated vaccines were developed and say the safety of the COVID-19 vaccines is well established. They say this transition to updating vaccines for COVID-19 is being done much like the US updates its flu vaccine annually, tweaking the formula of an established vaccine platform to combat new viruses or variants expected to be circulating.
The Route to the New Boosters

Earlier this year, vaccine makers submitted data to the FDA on an updated vaccine that targeted BA.1, the previously predominant Omicron variant. But then the FDA asked the companies to update their vaccines to add an Omicron BA.4/5 component, to create a vaccine that is a bivalent booster — meaning it will cover both the original strain of the virus that emerged from China and the newer BA.4 and BA.5 subvariants.
This will be the first update to the mRNA vaccines since they became available in December 2020.
The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met with vaccine makers in late June to review data on Omicron-specific COVID-19 vaccine candidates.
For the new boosters, the FDA did not schedule another meeting of its vaccine advisory panel, according to FDA Commissioner Robert M. Califf, MD. Califf noted on Twitter that "the agency feels confident in the extensive discussion that was held in June."


Evidence on Updated Boosters

At the end of June, Pfizer BioNTech and Moderna presented the FDA with human data on the BA.1 vaccine. The companies also presented lab or animal data on the BA.4 and BA.5 vaccine candidates.
Both companies showed that the BA.1 vaccines triggered antibody responses to BA.4 and BA.5, but lower than those for BA.1.
The companies also presented data that showed the updated shots' side effects were similar to those of the original vaccine, such as soreness at the injection site and fatigue.
In mice studies, presented to the FDA, Pfizer said its new booster increased the antibody responses to all the Omicron variants, including BA.4 and BA.5.
Results from human clinical trials are coming, but not soon. Moderna just completed enrollment of its BA.4 and BA.5 booster clinical trial, with results expected in the fourth quarter of 2022. Pfizer said it plans to start a trial soon.
Peter Marks, MD, director of the FDA's Center for Biologics Evaluation and Research, told NPR that the data from the mouse studies suggest the new vaccines may be about 20 times more protective against Omicron than the original shots.
In response to any concerns about safety data in humans from the new vaccine, CDC Director Rochelle Walensky, MD, recently told CNBC that the new shots involve very small changes in the mRNA sequence and that should not impact safety.
Infectious Disease Experts Weigh In

The lack of convincing neutralizing antibody data against BA.4 and BA.5 in people is a problem, said Paul Offit, MD, infectious disease expert and director of the Vaccine Education Center at Children's Hospital of Philadelphia.

Dr Paul Offit
"At the very least, what I'd like to see is neutralizing antibody data in people who have gotten this BA.4 , BA.5 vaccine as compared to just getting the monovalent vaccine and to see a dramatic increase in neutralizing antibodies, a 4- or 5-fold increase," he says.
Offit also questioned which groups should get the updated vaccine based on benefit and believes the best approach is to target those most at risk of severe COVID-19, such as older adults, those with serious co-existing conditions or the immunocompromised.
"Those are the ones getting hospitalized," he says. He sees the goal of the updated vaccine as preventing serious illness.
Offit, who said he has been vaccinated and boosted, and had a mild COVID-19 infection about 3 months ago, plans to skip this booster.
Eric Topol, MD, executive vice-president of Scripps Research and editor-in-chief of Medscape (WebMD's sister site), applauded the FDA's "aggressive and expedient" approach, with a BA.5 vaccine available for review just 2 months after the FDA meeting asking for such a vaccine.

Dr Eric Topol
He pointed out that mice data is used every year to update the flu vaccine quadrivalent program. "But there's a concern that it's not so easy to extrapolate mouse to human for SARS-CoV-2, a virus that's quite different than influenza," he wrote online in his substack Ground Truths.
Another potential concern, Topol and others said, is something called imprinting, also known by the catchy but potentially misleading term "original antigenic sin," with a person's first exposure to a virus having an effect on a later response to similar viruses. The worry is people may "train" their immune system to remember the response to the first infection and be less able to respond to future ones when faced with different variants, such as those included in the new boosters.
For now, he says, "it's an unknown, the data are mixed."
Will the Public Accept It?

Topol has also expressed concern about public trust in the vaccine and the possibility that people will view the new boosters as a rush job. As he also pointed out, just 32% of the population have had any of the original booster shots.
Topol's personal decision? He is about 8 months out from his fourth shot and said he will wait to see more data. He says that is simply his perspective. "Many will be eager to get the new shot. As I said, that's fine."
Infectious disease expert, William Schaffner, MD, professor of preventive medicine at Vanderbilt University in Nashville, isn't as concerned as others about the lack of human data, citing the need to combat the expected winter surge.

Dr William Schaffner
"If you need a vaccine to combat what some think will be an increase in [cases in] the winter, you won't have an updated vaccine in time if you wait for a clinical trial," he says.
He, too, likens the tweaking of the COVID-19 vaccine to what's done annually with the flu vaccine.
As for safety, "we know a vast amount about the [vaccine's] safety and effectiveness," Schaffner says. "I think the majority of the public health and vaccinology communities are quite content that we are doing these immune-bridging studies that show [updated vaccines] performed similarly to previous vaccines."
As for safety concerns, he noted that the risk of myocarditis, which occurred in some teens and young adults with the second dose of the vaccine, was lower with the booster dose. A reasonable expectation, he says, would be that the updated booster would also carry a lower risk of that side effect.
"These tweaks [with the updated vaccine] are so small, it won't impact safety," said Katelyn Jetelina, PhD, MPH, an epidemiologist and health policy expert who publishes Your Local Epidemiologist, a newsletter translating science for consumers.

Dr Katelyn Jetelina
She recognizes the concern about imprinting. However, "we need to be responsive to the needs of our immune system right now, in the midst of [an expected] surge."
Jetelina acknowledges the unknowns, such as how long the updated vaccine could be effective. Because BA.5 is so new, there hasn't been time to analyze the vaccine in people. In her view, "demanding an effective vaccine and clinical data is simply a fantasy against this rapidly changing virus."
As for experts who want to focus just on those at risk of severe disease, Jetelina says any advance that helps cut down the risk of infection is important: "We cannot stop severe disease and death if we don't stop transmission. Even if we don't stop transmission perfectly, even if it's 50%, that still helps a lot."

She plans to get the updated booster.

“

 

[missy]

Fall Boosters ACIP Meeting: Cliff notes​

https://substack.com/redirect/e5ba7544-5875-41d9-a726-395728667bdc?r=18h82a

Katelyn Jetelina Sep 1

Today ACIP— the external advisory committee to the CDC— met to discuss the bivalent fall boosters in the United States. This committee’s main purpose is to evaluate the safety and effectiveness of vaccines as well as policy recommendations for dissemination (who should get one and when).

This was a much anticipated meeting, as we have seen barely any data on the BA.4/5 bivalent booster. We also had some other burning questions. Here was the agenda for the meeting. Here were the presentations. And here are your cliff notes.

(If you haven’t already, be sure to read my previous post first. I’m picking up from there.)

Safety​

Moderna and Pfizer presented data on the safety of the BA.1 bivalent vaccine among humans. We have data on more than 1,400 adults. While this is not the vaccine being rolled out in the U.S. (we are rolling out the BA.5 bivalent vaccine instead), the differences between BA.1 and BA.5 boosters are minimal. Literally the difference of a few amino acids—like a few letter edits on a Word document. We aren’t changing the number of words in the paper (like dosage of RNA), or the content of the paper, or the platform (like Word to Excel). Because of the minimal change, we are confident that BA.1 bivalent safety data will accurately reflect BA.5 safety.

In general, the rate of side effects from the BA.1 bivalent booster were the same or lower than from the original booster formula or the original series. For example, Moderna found 4% of participants had a fever after the bivalent vaccine (dose 4) compared to 16% who got a fever after the original series (after dose 2). There were two severe adverse events after the bivalent vaccine (prostate cancer and bone fracture), but they were not linked to the vaccine.

​

Moderna Side Effects of Bivalent BA.1 vaccine; Source: Slide here from ACIP meeting

Effectiveness​

We don’t know the effectiveness of the BA.5 fall booster among humans. Given the rapidly evolving virus, we need to triangulate four other data sources:

1. Bivalent BA.1 among humans. Compared to the original formula, the number of neutralizing antibodies (i.e. our first line of defense) induced by the bivalent BA.1 vaccine was better—about 1.22 times better. This isn’t amazing, but it isn’t terrible. This means that we will likely see a slight increase in vaccine effectiveness against infection, but not a huge jump.
2. Bivalent vs. monovalent. Many wonder why we need a bivalent vaccine instead of monovalent (with only the Omicron formula). Pfizer showed us why. If Omicron continues to mutate, we would be okay with monovalent. However, if we get another random variant, say Delta again, the monovalent wouldn’t be as protective as the bivalent. Bivalent is key in providing broader protection taking into account the unpredictability of the future.
   

   ​

   (Pfizer)
3. Bivalent Beta vaccine. We hope that an updated bivalent vaccine will last longer compared to the original vaccine. But we don’t have much data. We have the duration that the bivalent Beta boosters lasted. Moderna showed that bivalent Beta remained durable at 6 months. If this translates to our BA.5 vaccines, this would be great news.
4. BA.4/5 mice data. The only data we have on the bivalent BA.5 fall boosters is from mice. Honestly, there wasn’t much data presented today, but what we did see was promising. Moderna highlighted that the bivalent BA.5 vaccine is particularly better at reducing replicating virus in the lungs than other vaccine variants. This means that the BA.5 bivalent may be similar or even slightly better than the BA.1 bivalent vaccine.
   

   ​

   (Moderna slide)

Benefits and Risks​

CDC followed the vaccine manufacturers’ presentation with their fantastic benefit/harm analysis, as per usual.

Benefits

• Reduce disease. Models show hospitalizations and deaths will increase this winter. How big this wave will be is dependent on viral mutations, booster uptake, behaviors, and a lot of other things. But if we have a booster campaign that matches the influenza vaccination rate, we have the potential to avert 101,000 deaths, 1,028,000 hospitalizations, and 24.9 million infections. That’s a lot. And equates to diverting $62 billion in medical costs.

​

• High interest. I was shocked to see that 72% of Americans in a survey said they will definitely or probably get the updated Omicron vaccine. If this is truly the case, this fall booster will help… a lot.
• Limited imprinting. I need to update my last original antigenic sin post, but we’ve gotten some great news suggesting an improved response after the bivalent vaccine. This suggests bivalent vaccines expand immune response, which is great news.

Risks.

• Myocarditis. We are still seeing a rare, but real, safety signal of myocarditis after a booster among male adolescents and young males. But keep in mind the risk is smaller than after dose 2 (thanks to the longer time period), and the risk of myocarditis after COVID19 infection (compared to vaccination) is 1.8 - 5.6 times higher among young males.

Discussion and vote​

Some voting members voiced uneasiness around the lack of human data for BA.5 boosters, but we rely on similar data and background with flu every year. Ultimately, ACIP voted unanimously for boosters this fall:

• Pfizer: Everyone over the age of 12.
• Moderna: Everyone over the age of 18.

Going forward, CDC will shift away from naming boosters dose 3, 4, 5, etc. From now on, everyone needs the primary series (with the original formula) and bivalent booster. This will equate to being fully vaccinated.

​

(CDC)
The puck now goes to Dr. Walensky at the CDC to sign off. I expect she will do this ASAP. This vaccine should be available to you very soon, depending on the timeliness of delivery to pharmacies and doctors offices.

Bottom line​

Everyone aged 12+ years old should get a booster this fall. It is safe. And we are more confident than not that it will be better than the previous vaccine. It will not be the silver bullet, but will no doubt help greatly on an individual and population level through the winter months. Protect yourself and those around you.

 

[missy]

Are the new booster shots safe?​

Is it safe for older people to get the new Covid booster this fall? Why hasn't it been tested on humans? —Marilyn, Beaverton, Oregon The US Centers for Disease Control and Prevention signed off on updated versions of both the Pfizer and Modern mRNA vaccines this week, and the shots are expected to roll out any day now. Moderna’s shot is intended for use in adults 18 and up, while Pfizer’s is for people 12 and older. Those who haven’t had a dose in at least two months will be eligible. What makes these boosters different from those available in Europe and elsewhere is that that they target the latest versions of omicron, called BA.4 and BA.5, which are now causing most of the world’s cases. While that sounds like a recipe for success, there is at least one issue that’s caused some concern: The revised boosters didn’t go through human clinical trials, and were cleared on the basis of animal data. But Jessica Justman, an infectious diseases specialist and epidemiologist at Columbia University’s Irving Medical Center, points out that “a very close cousin, more like a sibling, of the updated shot, did actually go through two clinical trials in humans.” More than 1,600 people enrolled, most over age 55, in tests of a vaccine that fights an earlier omicron version called BA.1. The trials provided good data on the safety, as well as the efficacy, of the vaccine at several dose levels. Researchers studied a monovalent vaccine that targeted just BA.1 and a bivalent alternative that addresses both BA.1 and the original Wuhan strain that emerged in China. “The safety profile was fine, and the antibody measures for the BA.1 vaccine showed that the boosted antibody levels and antibody function were good,” Justman says. While those BA.1 tests were successful, US regulators recommended that vaccine makers change the design of their vaccines to target the ascending BA.4 and BA.5 variants, hoping that would improve the effectiveness of the shots. But they also said vaccine makers wouldn’t have to test this new version in humans again in order to obtain authorization, because they expected the results to be similar to the shots for BA.1. That strategy actually isn’t all that unusual, Justman points out. Each year “we get a flu shot that has been slightly updated, based on information about closely related versions of the flu virus circulating in other parts of the world,” she says. “This is the same approach that was used to authorize the updated version of the Covid vaccine.” — Kristen V. Brown

 

[dk168]

Waiting for my invitation to have a second booster (4th dose), don't know which one/version I'll be given though and I am not bothered.

Hopefully, I can have my flu jab at the same time, one in each arm.

DK

 

[missy]

Chengdu Locks Down 21.2 Million as Chinese Cities Battle COVID​

By Reuters Staff
September 02, 2022

SHENZHEN, China (Reuters) -The southwestern Chinese metropolis of Chengdu announced a lockdown of its 21.2 million residents as it launched four days of citywide COVID-19 testing, as some of the country's most populous and economically important cities battle outbreaks.
Residents of Chengdu, the capital of Sichuan province, were ordered to stay home from 6 p.m. on Thursday, with households allowed to send one person per day to shop for necessities, the city government said in a statement.
Chengdu, which reported 157 domestically transmitted infections on Wednesday, is the largest Chinese city to be locked down since Shanghai in April and May. It remained unclear whether the lockdown would be lifted after the mass testing ends on Sunday.
Other major cities including Shenzhen in the south and Dalian in the northeast have also stepped up COVID restrictions this week, ranging from work-from-home requirements to the closure of entertainment businesses in some districts.

The moves curtail the activities of tens of millions of people, intensifying the challenges for China to minimise the economic impact of a "dynamic-zero" COVID policy that has kept China's borders mostly shut to international visitors and make it an outlier as other countries try to live with the coronavirus.




Most of the curbs are intended to last a few days for now, although two provincial cities in northern China have extended curbs slightly beyond initial promises.
Chengdu's lockdown sparked panic buying of essentials among residents.
"I am waiting in a very long queue to get in the grocery near my home," 28-year-old engineer Kya Zhang said, adding that she was worried about access to fresh food if the lockdown is extended.

Hwabao Trust economist Nie Wen said that because Chengdu acted quickly to lock down, it was unlikely to see a repeat of Shanghai's two-month ordeal.
Non-essential employees in Chengdu were asked to work from home and residents were urged not to leave the city unless needed. Residents who must leave their residential compounds for hospital visits or other special needs must obtain approval from neighbourhood staffers.
Industrial firms engaged in important manufacturing and able to manage on closed campuses were exempted from work-from-home requirements.
Sweden's Volvo Cars said it would temporarily close its Chengdu plant.

Flights to and from Chengdu were dramatically curtailed, according to Flight Master data. At 10 a.m. local time (0200 GMT) on Thursday, it showed 398 flights had been cancelled at Shuangliu Airport in Chengdu, with a cancellation rate of 62%. At Chengdu's Tianfu Airport, 79%, or 725 flights, were cancelled.

SHENZHEN CURBS

In Shenzhen, which has the third-highest economic output among Chinese cities, the most populous district Baoan and tech hub Nanshan suspended large events and indoor entertainment for a few days and ordered stricter checks of digital health credentials for people entering residential compounds.

Nanshan is home to internet giant Tencent and the world's biggest dronemaker, DJI, among other major Chinese companies.

More than half of Shenzhen's ten districts, home to over 15 million people, have ordered blanket closure of entertainment venues and halted or reduced restaurant dining for a few days, with curbs in two districts initially planned to be lifted by the end of Thursday.

Shenzhen authorities have largely avoided shutting down offices and factories as they did during a week-long lockdown in March.

Data on Thursday showed that Chinese factory activity contracted for the first time in three months in August amid weakening demand, while power shortages and fresh COVID-19 flare-ups disrupted production.

In Shanghai, schools reopened on Thursday after being closed for months.

Mainland China has reported no COVID death since May, leaving the death toll at 5,226.

(Reporting by Roxanne Liu, Ryan Woo, Ellen Zhang, Siyi Liu, Sophie Yu, David Kirton, Liz Lee and Beijing Newsroom; Editing by Christian Schmollinger, Raju Gopalakrishnan and Nick Macfie)

 

[missy]

Waiting for my invitation to have a second booster (4th dose), don't know which one/version I'll be given though and I am not bothered.

Hopefully, I can have my flu jab at the same time, one in each arm.

DK

Yes I am interested to see when the bivalent booster will roll out here. I never got the fourth shot though I was eligible but my husband got the fourth. I wanted him to...but for me though I am at very high risk I listened to my gut and just wanted to wait for the bivalent. I do not believe more is better in that I could have gotten the fourth and two months later the bivalent. No, the more Covid vaccines I get the more risk for my AI conditions to exacerbate or increase so I am trying to judiciously get what I need and not any more than that. Of course, it is an educated guess. All of this. And we are all just doing the best we can.

So when the new booster is available here I am going to get it.
I do have hesitations I won't lie. My good friend got Small Fiber Neuropathy after her second Pfizer vaccine and her doctors/specialists cannot rule out it wasn't due to the vaccine. But I also realize if I get Covid it will most likely be much worse than any reaction I can get from the booster.

 

[missy]

I want to add getting Covid increases one’s risk of small finer neuropathy so really there is no perfect option. I’d rather take my chances with the vaccine because getting Covid in almost most circumstances will be worse. If one has a bad reaction to the vaccine imagine their reaction to the disease.

 

[missy]

White House to Encourage COVID Boosters, Flu Shot This Fall​

Amanda Seitz


WASHINGTON (AP) — The Biden administration hopes to make getting a COVID-19 booster as routine as going in for the yearly flu shot.
That's at the heart of its campaign to sell the newly authorized shot to an American public that has widely rejected COVID-19 boosters since they first became available last fall.
Shots of the updated boosters, specifically designed by Pfizer and Moderna to respond to the omicron strain, could start within days. The U.S. government has purchased 170 million doses and is emphasizing that everyone will have free access to the booster.
White House COVID-19 coordinator Dr. Ashish Jha said this latest round of shots will offer protection during the busy cold and flu season, with the hope of transitioning people to get the vaccine yearly. Typically, at least half of U.S. adults get a flu shot.

"We expect them to provide more durable protection over time," Jha said in an interview Wednesday with The Associated Press. "The goal very much is to get to a point where people get their COVID shot on a regular basis, the way they do their flu shot."


Community health workers in North Carolina, home to the country's lowest COVID-19 booster rate, like the strategy, especially because of confusion among some people about vaccine schedules.
"I believe in keeping things simple," said Marty Stamey, an outreach coordinator for the Mountain Area Health Education Center in western North Carolina. "I've heard a lot of people say, 'I think I'll just wait and try to do it like the flu shots.'"
The White House plan also relies in part of on local health departments, providers and community groups to reach out and encourage people to get the updated booster. Pharmacies, health providers and state or local health departments are preparing to send text messages to millions of people that will encourage them to get a booster this fall, White House officials said.

Jha said he recommends most Americans get the booster by the end of October.
Still, this latest vaccination campaign faces several challenges.
A majority of Americans got their first and second dose of the COVID-19 vaccine when it was released last year but they've been more reluctant to get a booster jab, with less than half getting their first booster since it became available late last year.

Congress also has not moved forward on President Joe Biden's $22.5 billion request earlier this year for the COVID-19 response. Republicans criticized the request, pointing to the $1.9 trillion already spent on responding to the pandemic. Running short on funds, the government announced it would stop shipping COVID-19 tests to people's homes after Friday.

And COVID-19 funding is drying up for many of the community groups that received millions of federal tax dollars to hire workers who spent months reaching deep into neighborhoods with door knocks, mobile vaccine clinics and posters encouraging people to inoculate against COVID-19.

White House officials say those local leaders deserve a lot of credit for stamping out misinformation about the COVID-19 vaccine and convincing many around the country that the shot will protect them.

"Those are the really critical messengers," Jha said.

That on-the-ground work has been crucial to getting people vaccinated in the rural, Spanish- and Haitian-speaking communities that the Migrant Clinicians Network has reached throughout Texas, California and Maryland with its $8.5 million federal grant.


"Simply having the vaccines available is one thing, but getting the shots in the arms is another," said Amy Liebman, a chief program officer for the nonprofit group.

Some of those local health organizations, too, are now stretched as they work to get low vaccination rates among children under 12 up. Only a third of 5- to 11-year-olds received both doses of the COVID-19 vaccine since becoming eligible late last year. Meanwhile, just 7% of children under 5 have gotten a first dose since it was made available this summer.

Dr. Niharika Khanna at the University of Maryland School of Medicine has just started making progress on convincing new mothers that the vaccine is safe and effective for their babies.

Her program, which has hired more than 269 health workers and administered more than 12,000 vaccinations and boosters across Delaware, Maryland, Virginia and West Virginia, isn't quite ready to transition back to pushing COVID-19 boosters.

"All of these people, all of these relationships we've carefully cultivated are at risk for falling apart," Khanna said. "Today if you were to say to me switch to booster, I'd say no. I need another two to three weeks to really get these people going."

AP White House Correspondent Zeke Miller contributed to this report.

 

[Arcadian]

Well my husband finally got it. I'm going to assume its whatever current strain is. He's not being very careful, and I'm sure he got it last week at some dinner shindig he was at (that I wouldn't go to) He's in bed very tired, but he's already started on Paxlovid. I'm still testing negative. I wasn't going to get any boosters until I'm out of the study and will do flue and covid at that point.

He was supposed to go out of town 9/11 but I think he may end up staying home.

 

[missy]

Ugh sorry to read this @Arcadian
I am hoping you remain well and that your husband has a speedy and full recovery.

 

[Lookinagain]

I'm getting the updated booster tomorrow. Pfizer. I'll report back. I have to go to a work function for three days beginning Monday. It will be the first group meeting I've attended since Covid began. So although I know the updated booster hasn't been thoroughly tested, I'm still feeling like it is probably better than being around 150 people who do who knows what every day. I'll still wear a mask (and will probably be only one of a few) and be circumspect about how much I'm around people when i can escape from the meetings. But I do feel a bit better about going knowing I'm getting an updated vaccine. Who knows. I think it's a cr*p shoot one way or the other, but I'll pick the booster over all the careless folks out there who I may be around.

 

[missy]

“

One shot per year? We need to really step up our game then…
Katelyn Jetelina

Yesterday, the White House announced a new plan: one COVID-19 shot per year. The idea is this will decrease public confusion and increase booster uptake by aligning with the flu vaccine campaign. Reading between the lines, I think this is also a political signal to shift out of the SARS-CoV-2 emergency phase.

Will an annual shot plan work? Maybe. But there’s a lot that needs to align beforehand. And I certainly hope this doesn’t mean we are accepting our current state of affairs with vaccines.

Stars need to align

The annual COVID-19 plan largely follows our flu model: evaluate circulating strains and update the vaccine before the flu season. This model works for the flu for three main reasons:

Flu is clearly seasonal. The predictability of the flu allows us to time vaccine recommendations so that vaccine companies can manufacturer and distribute by winter. A 6-month flu season also means that we really only need our flu to cover the winter months. In other words, the vaccine can wane, particularly among older populations.
Flu mutations have direction. As I have written before, the flu mutates in a ladder-like pattern. This allows us to “predict” the direction the flu may be mutating.
Flu has been around for decades, which has allowed us to develop and refine global surveillance systems to identify emerging strains.
SARS-CoV-2 is mutating 4 times faster than the flu. It’s not seasonal nor annual. It’s not mutating in a ladder like form. And we do not have global surveillance systems in place. We expect and hope that COVID-19 will eventually be like the flu but to assume that has already happened is premature. I also think it is a gamble, as the virus continues to surprise us. To pivot the public—again—is risky.

The fall bivalent vaccine is also our first attempt to apply the flu model to SARS-CoV-2. This is our pilot. And we really need to see how the pilot works in the “real world” before making sweeping declarations, like an annual shot. We need the data, the time, and the humility to tell. Let’s first get through winter.

Up our vaccine game

The annual COVID-19 booster plan also means the White House has one goal: prevent severe disease and death. And our first generation vaccines can do this well. In fact, the first generation vaccines saved an estimated 20 million lives across the globe in one year.

However, we can and should do better. This does not mean boosting our way out of the pandemic, but it means leveraging innovation and science to develop next generation vaccines that last longer and/or prevent infection/transmission. This would have immense, positive ripple effects. It would slow transmission. It would slow viral mutations. It would slow morbidity (long COVID-19). It could sunset the pandemic.

Next generation vaccines include:

Mucosal vaccines. Nasal and/or oral vaccines would provide more protection against infection and transmission (i.e., sterilizing immunity). Thirteen nasal vaccines are currently in development. These work very differently from our current vaccines, as they target “mucosal” immunity. Mucosal tissue is all over our body, including our nose and throats. In fact, it’s the largest component of our immune system and is one of the first defenses with the elements in the real world. By providing immunity there (instead of deep within our circulatory system) we can prevent infection in the first place. Clinical trial data is incredibly promising, especially when used as a booster (opposed to the primary series). This week, China approved the world’s first inhaled booster against COVID-19 called Convidecia Air.
Pancoronavirus vaccines. The next best thing to sterilizing immunity would be a variant-proof vaccine that lasts longer. As I’ve written before, there are several in development, but the one winning the race is from the Walter Reed Army Institute of Research using “nanoparticle vaccine technology.” The vaccine presents a protein that looks like a soccer ball with many different faces. Each face presents instructions for a different part or version of a virus. We can include faces on it not just for SARS-CoV-2, but for other coronaviruses, too.
Flu and COVID-19 combo vaccines. At the very least we need one vaccine that contains both the flu and COVID-19 vaccine formula. Earlier this year, Novavax released data on the Phase 1/2 clinical trial of its COVID-Influenza Combination Vaccine. Animal data showed this vaccine worked well, and currently 642 people aged 50-70 years old are in the Phase 1/2 clinical trial. If all goes well, a combo vaccine may be available by 2023 flu season. We need more options in case this one doesn’t make it through clinical trials.
These next generation vaccines are obtainable. We are well on our way, but this cannot be accomplished without investment from Congress. It costs an estimated $1 billion to develop and test a drug or vaccine from start to finish. And it takes risk, as not every vaccine makes it through clinical trials. Money will move mountains in science and research. But we need a push from the public, and a push from the administration. We need an Operation Warp Speed 2.0.

Bottom line

The White House plans to have only one booster per year. This plan may (or may not) be a good one, as the stars would need to align for it to be effective. Regardless, next generation vaccines need to be a part of this conversation, as they are a critical solution for better health. We just need to fight for it.

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[missy]

I'm getting the updated booster tomorrow. Pfizer. I'll report back. I have to go to a work function for three days beginning Monday. It will be the first group meeting I've attended since Covid began. So although I know the updated booster hasn't been thoroughly tested, I'm still feeling like it is probably better than being around 150 people who do who knows what every day. I'll still wear a mask (and will probably be only one of a few) and be circumspect about how much I'm around people when i can escape from the meetings. But I do feel a bit better about going knowing I'm getting an updated vaccine. Who knows. I think it's a cr*p shoot one way or the other, but I'll pick the booster over all the careless folks out there who I may be around.

FYI not sure about the new bivalent booster but generally the vaccines take 14 days to reach maximum effectiveness so behave as if you hadn’t been boosted when you attend the meeting. Yes to masks as you wrote but also physical distancing, no shaking hands, no hugging. Bring an alcohol spray and spray everything down you might have to touch and your hands etc. You cannot be too careful. This prevalent strain is super contagious.

 

[Lookinagain]

FYI not sure about the new bivalent booster but generally the vaccines take 14 days to reach maximum effectiveness so behave as if you hadn’t been boosted when you attend the meeting. Yes to masks as you wrote but also physical distancing, no shaking hands, no hugging. Bring an alcohol spray and spray everything down you might have to touch and your hands etc. You cannot be too careful. This prevalent strain is super contagious.

I agree. I read that the effectiveness begins some right away, but not maximum for one to two weeks. I got the earliest appointment that I could as they just were made available for today. I'll only have 5 days under my belt, but I'm hoping that's better than nothing.

 

[Arcadian]

Ugh sorry to read this @Arcadian
I am hoping you remain well and that your husband has a speedy and full recovery.

I'm still testing negative using rapid testing though I'm feeling a bit crummy. Could be because he's running me ragged...lol

He's doing quite well though he decided he wanted to walk one of the dogs yesterday and that beat the crap out of him.

I went and did a PCR test so will see what that says.

 

[Arcadian]

I did PCR test and I was negative. He still had it as of yesterday. We don't know about today.

We've both had the same amount of shots, though I did have covid way before he did, maybe I still have some immunity left from that.

 

[missy]

I agree. I read that the effectiveness begins some right away, but not maximum for one to two weeks. I got the earliest appointment that I could as they just were made available for today. I'll only have 5 days under my belt, but I'm hoping that's better than nothing.

I think you’ll be well protected. I spoke with my pharmacist who said by day 5 you should be almost at max protection give or take.

I did PCR test and I was negative. He still had it as of yesterday. We don't know about today.

We've both had the same amount of shots, though I did have covid way before he did, maybe I still have some immunity left from that.

Glad you tested negative and hoping you both feel better very soon.

 

[MamaBee]

@Arcadian I’m sorry your husband got it...but glad you are still negative..
Did he use a rapid test at home to find out he had it? How did he get the Paxlovid?

 

[Lookinagain]

I did PCR test and I was negative. He still had it as of yesterday. We don't know about today.

We've both had the same amount of shots, though I did have covid way before he did, maybe I still have some immunity left from that.

A friend of mine had two negative home tests and felt bad, so then went to get a PCR. Also negative. But two days later she had positive tests. So it baffles me because I thought PCRs were always accurate. I'm assuming she just got it too early, but since she had symptoms, you would have thought it would have shown up at that point.

 

[MamaBee]

A friend of mine had two negative home tests and felt bad, so then went to get a PCR. Also negative. But two days later she had positive tests. So it baffles me because I thought PCRs were always accurate. I'm assuming she just got it too early, but since she had symptoms, you would have thought it would have shown up at that point.

I think that happens a lot. My two year old grandson got very sick. He tested negative on the PCR test..My son and daughter in law got it and felt really bad. They also tested negative. It’s possible they all had it but tested negative.

 

[missy]

I think that happens a lot. My two year old grandson got very sick. He tested negative on the PCR test..My son and daughter in law got it and felt really bad. They also tested negative. It’s possible they all had it but tested negative.

This also happened to a friend of mine. He was sick. Rapid tests negative. One pcr negative. A few days later repeated the pcr. Positive.

 

[Arcadian]

A friend of mine had two negative home tests and felt bad, so then went to get a PCR. Also negative. But two days later she had positive tests. So it baffles me because I thought PCRs were always accurate. I'm assuming she just got it too early, but since she had symptoms, you would have thought it would have shown up at that point.

I tested again just to be sure and....negative. And every time he tested, I tested. He always came up positive and me negative. When I caught it we both tested, he did PCR, and I made him leave the house. He stayed negative.

Its strange but I think maybe thats just how it goes. He was pretty convinced he had covid before because he got stupid sick once but kept testing negative even with a PCR.

When he got sick I felt a little ran down for a couple of days but he was also driving me bonkers.

 

[missy]

The latest​

Former “Glee” leading lady and Broadway star Lea Michele has tested positive for the coronavirus. On Sunday, the actress posted on her Instagram stories that she would be taking a 10-day leave from her show, “Funny Girl.” “Unfortunately, I have officially tested positive for covid,” Michele wrote. “Thankfully staying home today and catching this early protected so many members of our company from being exposed. Funny Girl has been and still is tackling a tremendous wave of covid with close to a dozen company members currently out.”

Coinciding with the rollback of Broadway coronavirus protocols, the show, which debuted with Michele on Sept. 6, is one of a few productions that have canceled performances or replaced leading actors with understudies because of covid outbreaks.

In May, Broadway theaters dropped their vaccine requirements; in July, they stopped requiring masks, which has left some theatergoers, actors and production staff concerned about potential outbreaks.

Despite dropping the mask requirement, the Broadway League, Broadway's national trade association, said it still encourages audience members to wear masks.

New Zealand was touted as having some of the world's strictest pandemic protocols. But after 2½ years, the country has finally dropped its coronavirus requirements.

In a news conference Monday, Prime Minister Jacinda Ardern said the government would no longer require masks and would roll back vaccine requirements. “With high vaccination rates now coupled with high numbers of people having had the virus itself, it’s now safe for them to conclude,” she said. Mask-wearing requirements end Monday and vaccine requirements end Sept. 26.

Ardern said the ministry of health would continue offering mask-wearing guidelines. Masks are still encouraged in public places, or left to the discretion of businesses or event organizers.

Effective Monday, travelers entering New Zealand are no longer being asked to show proof of vaccination.

The country, which has a population of about 5 million, has recorded about 1,950 coronavirus deaths. One burden that’s not discussed, Ardern said, is the pandemic’s toll on people’s mental health, and she hopes that the “covid anxiety can start to heal.”

Other important news​

On Monday, Tokyo confirmed 5,654 new cases of the coronavirus. The country has registered a steady decline in cases during the past week.

Lockdowns in China are causing panic in regions where food and medical care have become scarce.

 

[missy]

The Potential Problem(s) With a Once-a-Year COVID Vaccine​

Marcia Frellick

Comments from the White House this week suggesting a once-a-year COVID-19 shot for most Americans, "just like your annual flu shot," were met with backlash from many who say COVID and influenza come from different viruses and need different schedules.

Remarks, from "capitulation" to too little data, hit the airwaves and social media.

Some, however, agree with the White House vision and say that asking people to get one shot in the fall instead of periodic pushes for boosters will raise public confidence and buy-in and reduce consumer confusion.


Health leaders, including Bob Wachter, MD, chair of the Department of Medicine at the University of California San Francisco, say they like the framing of the concept — that people who are not high-risk should plan each year for a COVID shot and a flu shot.





"Doesn't mean we KNOW shot will prevent transmission for a year. DOES mean it'll likely lower odds of SEVERE case for a year & we need strategy to bump uptake," Wachter tweeted this week.


But the numbers of Americans seeking boosters remain low. Only one-third of all eligible people 50 years and older have gotten a second COVID booster, according to the Centers for Disease Control and Prevention (CDC). About half of those who got the original two shots got a first booster.


Meanwhile, the United States is still averaging about 70,000 new COVID cases and more than 300 deaths every day.

The suggested change in approach comes as Pfizer/BioNTech and Moderna rolled out their new boosters that target Omicron subvariants BA.4 and BA.5 after the CDC recommended their use and the US Food and Drug Administration approved emergency use authorization.

"As the virus continues to change, we will now be able to update our vaccines annually to target the dominant variant," President Joe Biden said in a statement promoting the yearly approach.

Some Say Annual Shot Premature​

Other experts say it's too soon to tell whether an annual approach will work.

"We have no data to support that current vaccines, including the new BA.5 booster, will provide durable protection beyond 4 to 6 months. It would be good to aspire to this objective, and much longer duration or protection, but that will likely require next generation and nasal vaccines," said Eric Topol, MD, Medscape's editor-in-chief and founder and director of the Scripps Research Translational Institute.


A report in Nature Reviews Immunology last month states, "Mucosal vaccines offer the potential to trigger robust protective immune responses at the predominant sites of pathogen infection" and potentially "can prevent an infection from becoming established in the first place, rather than only curtailing infection and protecting against the development of disease symptoms."


Topol tweeted after the White House statements, "(An annual vaccine) has the ring of Covid capitulation."




William Schaffner, MD, an infectious disease expert at Vanderbilt University School of Medicine in Nashville, Tennessee, told Medscape Medical News that he cautions against interpreting the White House comments as official policy.


"This is the difficulty of having public health announcements come out of Washington," he said. "They ought to come out of the CDC."





He says there is a reasonable analogy between COVID and influenza, but warns, "don't push the analogy."


They are both serious respiratory viruses that can cause much illness and death in essentially the same populations, he notes. These are the older, frail people, people who have underlying illnesses or are immunocompromised.


Both viruses also mutate. But there the paths diverge.


"We've gotten into a pattern of annually updating the influenza vaccine because it is such a singularly seasonal virus," Schaffner said. "Basically it disappears during the summer. We've had plenty of COVID during the summers."


For COVID, he said, "We will need a periodic booster. Could this be annually? That would certainly make it easier." But it's too soon to tell, he said.


Schaffner noted that several manufacturers are working on a combined flu/COVID vaccine.

Just a "First Step" Toward Annual Shot​

The currently updated COVID vaccine may be the first step toward an annual vaccine, but it's only the first step, Schaffner said. "We haven't committed to further steps yet because we're watching this virus."


Syra Madad, DHSc, MSc, an infectious disease epidemiologist at Harvard University's Belfer Center for Science and International Affairs and the New York City hospital system, told Medscape Medical News that arguments on both sides make sense.


Having a single message once a year can help eliminate the considerable confusion involving people on individual timelines with different levels of immunity and separate campaigns for COVID and flu shots coming at different times of the year.


"Communication around vaccines is very muddled and that shows in our overall vaccination rates, particularly booster rates," she says. "The overall strategy is hopeful and makes sense if we're going to progress that way based on data."


However, she said that the data are just not there yet to show it's time for an annual vaccine. First, scientists will need to see how long protection lasts with the Omicron-specific vaccine and how well and how long it protects against severe disease and death as well as infection.


COVID is less predictable than influenza and the influenza vaccine has been around for decades, Madad noted. With influenza, the patterns are more easily anticipated with their "ladder-like pattern," she said. "COVID-19 is not like that."


What is hopeful, she said, "is that we've been in the Omicron dynasty since November of 2021. I'm hopeful that we'll stick with that particular variant."


Topol, Schaffner, and Madad declared no relevant financial relationships.


Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News, and Nurse.com, and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick.

 

[missy]

Post-COVID Fatigue, Exercise Intolerance
Signal ME/CFS​

Miriam E. Tucker

A new study provides yet more evidence that a significant subset of people who experience persistent fatigue and exercise intolerance following COVID-19 will meet diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).
Data from the prospective observational study of 42 patients with "post-COVID-19 syndrome (PCS)," including persistent fatigue and exercise intolerance, suggest that a large proportion will meet strict diagnostic criteria for ME/CFS, including the hallmark post-exertional malaise (PEM). Still others may experience similar disability but lack duration and/or severity requirements for the diagnosis.
Moreover, disease severity and symptom burden were found similar in those with ME/CFS following COVID-19 and in a group of 19 age- and sex-matched individuals with ME/CFS that wasn't associated with COVID-19.

Dr Carmen Scheibenbogen
"The major finding is that ME/CFS is indeed part of the spectrum of the post-COVID syndrome and very similar to the ME/CFS we know after other infectious triggers," senior author Carmen Scheibenbogen, MD, acting director of the Institute for Medical Immunology at the Charité University Medicine Campus Virchow-Klinikum, Berlin, Germany, told Medscape Medical News.



Importantly, from a clinical standpoint, both diminished hand grip strength (HGS) and orthostatic intolerance were common across all patient groups, as were several laboratory values, Claudia Kedor, MD, and colleagues at Charité report in the paper, published online August 30 in Nature Communications.
Of the 42 with PCS, including persistent fatigue and exercise intolerance lasting at least 6 months, 19 met the rigorous Canadian Consensus Criteria (CCC) for ME/CFS, established in 2003, which require PEM, along with sleep dysfunction, significant persistent fatigue, pain, and several other symptoms from neurological/cognitive, autonomic, neuroendocrine, and immune categories that persist for at least 6 months.
Of the 23 who did not meet the CCC criteria, 18 still experienced PEM but for less than the required 14 hours set by the authors based on recent data. The original CCC had suggested 24 hours as the PEM duration. Eight subjects met all the Canadian criteria except for the neurological/cognitive symptoms. None of the 42 had evidence of severe depression.

The previously widely used 1994 "Fukuda" criteria for ME/CFS are no longer recommended because they don't require PEM, which is now considered a key symptom. The more recent 2015 Institute (now Academy) of Medicine criteria don't define the length of PEM, the authors note in the paper.


Scheibenbogen said, "Post-COVID has a spectrum of syndromes and conditions. We see that a subset of patients have similar symptoms of ME/CFS but don't fulfill the CCC, although they may meet less stringent criteria. We think this is of relevance for both diagnostic markers and development of therapy, because there may be different pathomechanisms between the subsets of post-COVID patients."

She pointed to other studies from her group suggesting that inflammation is present early in post-COVID (not yet published), while in the subset that goes on to ME/CFS, autoantibodies or endothelial dysfunction play a more important role. "At the moment, it's quite complex, and I don't think in the end we will have just one pathomechanism. So I think we'll need to develop various treatment strategies."

Dr Anthony Komaroff
Asked to comment on the new data, Anthony L. Komaroff, MD, professor of medicine at Harvard Medical School, senior physician at Brigham and Women's Hospital in Boston, and editor in chief of the Harvard Health Letter, told Medscape Medical News, "This paper adds to the evidence that an illness with symptoms that meet criteria for ME/CFS can follow COVID-19 in nearly half of those patients who have lingering symptoms. This can occur even in people who initially have only mild symptoms from COVID-19, although it is more likely to happen in the people who are sickest when they first get COVID-19. And those who meet criteria for ME/CFS were seriously impaired in their ability to function, [both] at work and at home."

He pointed to a recent report from the Brookings Institution finding that "long COVID may be a major contributor to the shortage of job applicants plaguing many businesses."

Biomarkers Include Hand Grip Strength, Orthostatic Intolerance, Lab Measures​

Hand grip strength, as assessed by 10 repeat grips at maximum force and repeated after 60 minutes, were lower for all those meeting ME/CFS criteria, compared with the healthy controls. Hand grip strength parameters were also positively correlated with laboratory hemoglobin measures in both PCS groups who did and didn't meet the Canadian ME/CFS criteria.


A total of three patients with PCS who didn't meet ME/CFS criteria and seven with PCS who met ME/CFS criteria had sitting blood pressures of greater than 140 mm Hg systolic and/or greater than 90 mm Hg diastolic. Five patients with PCS — four who met ME/CFS criteria and one who didn't — fulfilled criteria for postural orthostatic tachycardia syndrome. Orthostatic hypotension was diagnosed in a total of seven with PCS, including one who did not meet ME/CFS criteria and the rest who did.

Among significant laboratory findings, mannose binding lectin deficiency, which is associated with increased infection susceptibility and found in only about 6% of historical controls, was found more frequently in both of the PCS cohorts (17% of those with ME/CFS and 23% of those without) than it has been in the past among those with ME/CFS compared with historical controls (15%).


There was only slight elevation in C-reactive protein, the most commonly measured marker of inflammation. However, another marker indicating inflammation within the last 3-4 months, interleukin 8 assessed in erythrocytes, was above normal in 37% with PCS and ME/CFS and in 48% with PCS who did not meet the ME/CFS criteria.


Elevated antinuclear antibodies, anti-thyroid peroxidase antibodies, vitamin Ddeficiencies, and folic acid deficiencies were all seen in small numbers of the PCS patients. Angiotensin converting enzyme 1 (ACE1) levels were below the normal range in 31% of all patients.


"We must anticipate that this pandemic has the potential to dramatically increase the number of ME/CFS patients," Kedor and colleagues write. "At the same time, it offers the unique chance to identify ME/CFS patients in a very early stage of disease and apply interventions such as pacing and coping early with a better therapeutic prognosis. Further, it is an unprecedented opportunity to understand the underlying pathomechanism and characterize targets for specific treatment approaches."


Scheibenbogen and Komaroff reported no relevant financial relationships.





Nature Communications. Published online August 30, 2022. Full text


Miriam E. Tucker is a freelance journalist based in the Washington, DC area. She is a regular contributor to Medscape, with other work appearing in the Washington Post, NPR's Shots blog, and Diabetes Forecast magazine. She is on Twitter @MiriamETucker.
But, Komaroff also cautioned, "the study does not help in determining what fraction of all people who are infected with SARS-CoV-2 go on to develop a condition like ME/CFS, nor how long that condition will last. It is crucial that we get answers to these questions, as the impact on the economy, the healthcare system, and the disability system could be substantial."

 

[missy]

"​

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Don’t let shrill debates keep you from getting a Covid booster​

• 

By Matthew Herper Sept. 12, 2022

Even before the new Covid booster shots arrived, the arguments about them got shrill.

There’s a dizzying kaleidoscope of defensible opinions about the new Covid shots, which are designed to match the BA.5 strain of the virus that currently accounts for 9 in 10 Covid cases in the U.S.

Some argue that the Food and Drug Administration and the Centers for Disease Control and Prevention were too fast to approve the new shots without new human data — yes, these shots really are tested mainly in mice. Some experts worry that instead of being more effective than the primary series of shots they could be less. Still others worry that the vaccine campaign is too broad, and should instead focus only on people at higher risk of severe disease.




And, of course, there are other opinions online that are indefensible — ridiculous and untrue. Vaccines have not been useless in recent variant waves. There is no evidence they’re making the pandemic worse. They are not causing a quarter of children who take them to become too weak to play.




This social media-driven cacophony risks drowning out the most important message about the booster shots: quite simply, that most people should get one right now. Even those who criticize the decision to go with a BA.5-matched booster because of a lack of data say people need at least three shots of the Pfizer or Moderna vaccine to be fully protected. Half of eligible people in the U.S. have not received a booster. A quarter have not been vaccinated at all.




The rest of this article is going to wade through some of the controversies surrounding the new shots, but those who have not had at least three shots of vaccine can stop now and make an appointment. During the spring, death rates among unvaccinated people were eight times higher than among those who had at least three doses of vaccine – down from 20 times higher between January and March. The new BA.5 booster, practically speaking, is what’s available. Not getting a third dose is risking your life to spite the feds. And a fourth shot? We’ll get to that, but many experts think it’s a good idea.

Quickly, what happened with these boosters? Throughout the pandemic, Pfizer and its partner BioNTech as well as Moderna have been conducting small clinical trials to test whether vaccines matched to current strains of the SARS-CoV-2 virus performed better than the original vaccine. Generally speaking, they have at least resulted in antibodies that were more effective at neutralizing the new viral strains in the lab.

The most recent human trials for variant vaccines were for the BA.1 version of the Omicron strain. Trials of both the Pfizer and Moderna vaccines showed that combining vaccine antigen from BA.1 and the original strain resulted in better levels of neutralizing antibodies, which should mean better protection. Some countries, including Canada and those in the European Union, have ordered millions of doses of bivalent vaccine that include BA.1 and the original Wuhan strain. That is, in fact, what the World Health Organization recommends.

But the U.S. has chosen to go its own way. In June, the FDA held a meeting of its expert advisers, and they voted overwhelmingly (19-2) that the agency should ask Pfizer/BioNTech and Moderna to make Omicron-containing vaccines. But the panelists largely seemed to agree that it would be better to have the shot include the BA.5 strain. For the most part, they thought it made more sense to target the current strain than to wait for human data. This is similar to what the U.S. has done when ordering influenza shots for decades.

Here’s where the FDA made a mistake, one that is telling for what has gone wrong with communication throughout the pandemic. While it had the panel vote on whether there should be an Omicron-containing booster, it did not ask for a vote on whether that booster should contain antigen for BA.1 or BA.5 – it simply asked panelists to discuss that topic. That decision gives the agency flexibility, but makes it much harder to communicate the decision to the public. This has been a repeated error by the FDA over the past few years, with the worst example being the decision to approve the Alzheimer’s drug Aduhelm even though an FDA panel was basically screaming that the FDA should not do that. Medicare refused to pay for the drug and its maker decided to all but stop spending money to sell it.

But, again: I watched the panel, and it was very clear that the panelists were planning on a BA.5 booster. Calls that the FDA should have had a second panel are misguided. That was when the decision on which vaccines to order was made; it’s not realistic to expect that Pfizer and Moderna will scrap the vaccine they made for the U.S. over the past few months and make a new batch with a different composition.

Related: Your questions on the new Covid vaccine boosters answered​

Is a fourth shot needed? During the Omicron wave that hit in the spring, CDC data show the risk of death for people over 50 who received two boosters – a total of four shots – was three times lower than those who received three.

Not everyone thinks the benefit of the new shots is clear, though. Paul Offit of the Children’s Hospital of Philadelphia, who for decades has been one of the loudest defenders of childhood vaccination, was one of the FDA panelists who voted no. He’s worried that a vaccine combining smaller amounts of the BA.5 and Wuhan antigens will be less effective than the original shot, and about the paucity of human data on the efficacy of the vaccines. He says he has had a total of three shots of the original vaccine and was recently infected with Covid, and does not plan to get a fourth vaccine.

The other question about the new vaccines is whether their safety will be different from the original versions. This is possible, but unlikely. It’s also not something that would have been detected by the kinds of studies that were being run on new variant vaccines. The serious side effects that have been seen with Covid vaccines have been incredibly rare – think 1 case in 100,000 or 1 million. They emerge only when a vaccine is in wide use. At this point, the mRNA vaccines have been given to billions of people.

This is, incidentally, the mistake made by the Wall Street Journal’s recent op-ed calling out liberals who were worried President Trump would approve vaccines too quickly for not being upset about the BA.5 boosters. Some of them, no doubt, are upset, but there’s a big difference between authorizing a new version of an mRNA vaccine without human data and rushing the first mRNA vaccines ever. Two years ago, we had no idea whether they would prove safe.

The side effect most clearly linked with the mRNA vaccines is a condition called myocarditis, an inflammation of the heart. Serious cases are rare, but seem to occur most often in males in their late teens and early twenties. It’s fair to ask if young men should wait longer between booster doses, and it’s also fair to ask if the Pfizer and Moderna vaccines have different risks here. The FDA and CDC do not believe there is a difference, but some other countries use the Pfizer vaccine preferentially in boys and men in this age group.

But for most people, these issues are quibbles. With many debates during the pandemic — remember the complaints that the FDA wasn’t moving fast enough to approve vaccines? — the answer has turned out to be that a decision had to be made and we had to live with it.

What is true is that we should be getting better explanations of myocarditis and how to prevent it. And someone should be running a good randomized controlled trial so that we know whether the BA.5 boosters are better than the BA.1 boosters or not. Likewise, it seems awfully early to be talking about whether people should get annual boosters from now on.

The problem with a lot of the discussion about the vaccines is that it takes studies, commentaries, or, God forbid, memes, and isolates them from what’s really known. This springs from our social media networks, from our politics, from the increasingly fragmentary nature of our society, from a need to see everything in black and white. The only comfort is that it’s not new.

A hundred years ago, shortly after his pregnant wife became ill during another once-in-a-century pandemic, William Butler Yeats wrote a poem about how everything seemed to be falling apart in the wake of World War I. “Things fall apart; the centre cannot hold,” he wrote. And later: “The best lack all conviction, while the worst are full of passionate intensity.” It felt, literally, like the end of the world. “What rough beast, its hour come at last, slouches toward Bethlehem to be born?”

It wasn’t the end of the world. The center can hold. Less poetically? Even if mistakes were made, we still need these vaccines. Don’t be afraid to roll up your sleeve.

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