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Coronavirus updates August 2023

missy

missy

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www.medscape.com

Gilead Quarterly Profit Falls on COVID Sales Drop

Gilead Sciences reported lower second-quarter profit as costs from a legal settlement and sharply lower sales of its COVID-19 treatment offset another strong performance by HIV drugs.
www.medscape.com

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Gilead Quarterly Profit Falls on COVID Sales Drop, Legal Settlement Charge
By Michael Erman
August 04, 2023


(Reuters) - Gilead Sciences on Thursday reported lower second-quarter profit as costs from a legal settlement and sharply lower sales of its COVID-19 treatment offset another strong performance by HIV drugs.

The drugmaker raised its full-year revenue forecast, even as it trimmed its estimate for COVID antiviral Veklury due to lower pandemic-related hospitalizations.
The company said it now expects sales of Veklury, known generically as remdesivir, to total $1.7 billion this year, down from its previous estimate of around $2 billion.
Second-quarter sales of the hospital-administered drug fell 43% from a year ago to $256 million, well below analysts' forecasts of $351 million.
Gilead reported second-quarter earnings of $1.34 per share excluding items, on total revenue of $6.6 billion, down from $1.58 a share and revenue of $6.26 billion in the year-ago quarter.



Wall Street analysts had expected an adjusted profit of $1.64 per share on revenue of $6.44 billion, according to Refinitiv data.
The company said earnings were hurt by a $525 million, or 32 cents a share, charge related to HIV antitrust litigation settlements.
Research & development costs also increased year-over-year, rising more than 25% to $1.4 billion.
Chief Medical Officer Merdad Parsey said the increase was due to the culmination of multi-year plans to diversify Gilead's pipeline, resulting in 21 late-stage trials ongoing simultaneously.
"We are going to be really disciplined about where we go from here ... looking at our portfolio and making some tough decisions around what keeps going and what doesn't," Parsey said in an interview.
Gilead cut its full-year adjusted earnings forecast to a range of $6.45 to $6.80 per share, from $6.60 to $7.00. The California-based company raised the low end of its 2023 revenue forecast range to $26.3 billion from $26.0 billion, but kept the high end at $26.7 billion.
Its shares rose 0.6% in after hours trading to $76.
Product sales excluding Veklury rose 11% to $6.31 billion in the quarter due to the strength of the company's HIV treatments and cell therapy for cancer.

Sales of Gilead's HIV portfolio rose 9% to $4.63 billion, with Biktarvy bringing in $2.98 billion, compared with Wall Street estimates of $2.85 billion.
(Reporting By Michael Erman, additional reporting by Deena Beasley; Editing by Bill Berkrot)

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www.nbcnews.com

Updated Covid boosters could be authorized by end of month, Pfizer says

The drugmaker's prediction comes as Covid hospitalizations are once again on the rise.
www.nbcnews.com www.nbcnews.com

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Updated Covid boosters could be authorized by end of month, Pfizer says


The drugmaker's prediction comes as Covid hospitalizations are once again on the rise.
Image: A health worker administers a Covid-19 vaccine in Reading, Pa., in February.

A health worker administers a Covid vaccine in Reading, Pa., in February.Matt Rourke / AP file


Aug. 1, 2023, 1:25 PM EDT
By Berkeley Lovelace Jr.
The Food and Drug Administration could authorize Pfizer's updated Covid boosters by the end of August, Pfizer CEO Albert Bourla said during an investor call Tuesday.

The drugmaker asked the FDA in June to authorize an updated version of its Covid booster that is designed to target the XBB.1.5 subvariant, a coronavirus strain that began circulating widely last winter. Moderna made a similar request that same month.


The requests came days after the FDA advised the drugmakers to update the shots to target XBB.1.5 ahead of a fall Covid booster campaign.

XBB.1.5 is no longer the predominant strain, only making up 12.3% of all new Covid cases through the week ending July 22, according to the Centers for Disease Control and Prevention. It's been edged out by XBB.1.16, which accounts for about 15% of all new cases. (Experts said during a June meeting of FDA advisers that they don’t expect that will hurt vaccine effectiveness too much, as the XBB strains aren’t too genetically different from one another.)

Bourla’s prediction on the availability of new boosters comes as Covid hospitalizations are rising in the U.S., though they still remain lower than at any point during the pandemic.

During the call, Bourla said the company expects Covid cases and hospitalizations will continue to pick up heading into the colder months.


“We expect a new Covid wave to start in the U.S. this fall,” Bourla said.

The FDA did not immediately respond to a request for comment on Bourla’s remarks about booster authorization.


It’s unclear if the Covid boosters will be recommended for everyone in the U.S. That decision will be left up to the CDC, which isn’t expected to make a recommendation until after the FDA authorizes the shots.

The FDA is not expected to convene its advisory committee, known as the Vaccines and Related Biological Products Advisory Committee, before making the decision, according to two sources familiar with the agency’s plans.

That committee met in June, voting unanimously in support of updating the shots to target an XBB strain, as well as dropping the original coronavirus strain from the formulation.

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Covid is in the news recently in UK about a new strain that is causing concerns, with cases going up etc...

I believe another round of vaccine is on the card for autumn, and am hoping it will be available at the same time as the annual flu vaccine, with one arm for Covid and the other for flu.

DK :))
 

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Scientists develop breath test that rapidly detects COVID-19 virus
Published August 2, 2023 | Originally published on MedicalXpress Breaking News-and-Events
Scientists at Washington University in St. Louis have developed a breath test that quickly identifies those who are infected with the virus that causes COVID-19. The device requires only one or two breaths and provides results in less than a minute.

The study is has been published online in the journal ACS Sensors. The same group of researchers recently published a paper in the journal Nature Communications about an air monitor they had built to detect airborne SARS-CoV-2—the virus that causes COVID-19—within about five minutes in hospitals, schools and other public places.

The new study is about a breath test that could become a tool for use in doctors' offices to quickly diagnose people infected with the virus. If and when new strains of COVID-19 or other airborne pathogenic diseases arise, such devices also could be used to screen people at public events. The researchers said the breath test also has potential to help prevent outbreaks in situations where many people live or interact in close quarters—for example aboard ships, in nursing homes, in residence halls at colleges and universities or on military bases.

"With this test, there are no nasal swabs and no waiting 15 minutes for results, as with home tests," said co-corresponding author Rajan K. Chakrabarty, the Harold D. Jolley Career Development Associate Professor of Energy, Environment & Chemical Engineering at the McKelvey School of Engineering. "A person simply blows into a tube in the device, and an electrochemical biosensor detects whether the virus is there. Results are available in about a minute."

The biosensor used in the device was adapted from an Alzheimer's disease-related technology developed by scientists at Washington University School of Medicine in St. Louis to detect amyloid beta and other Alzheimer's disease-related proteins in the brains of mice. The School of Medicine's John R. Cirrito, a professor of neurology, and Carla M. Yuede, an associate professor of psychiatry—both also co-corresponding authors on the study—used a nanobody, specifically an antibody from llamas, to detect the virus that causes COVID-19.

Chakrabarty and Cirrito said the breath test could be modified to simultaneously detect other viruses, including influenza and respiratory syncytial virus (RSV). They also believe they can develop a biodetector for any newly emerging pathogen within two weeks of receiving samples of it.

"It's a bit like a breathalyzer test that an impaired driver might be given," Cirrito said. "And, for example, if people are in line to enter a hospital, a sports arena or the White House Situation Room, 15-minute nasal swab tests aren't practical, and PCR tests take even longer. Plus, home tests are about 60% to 70% accurate, and they produce a lot of false negatives. This device will have diagnostic accuracy."

The researchers began working on the breath test device—made with 3D printers—after receiving a grant from the National Institutes of Health (NIH) in August 2020, during the first year of the pandemic. Since receiving the grant, they've tested prototypes in the laboratory and in the Washington University Infectious Diseases Clinical Research Unit. The team continues to test the device, to further improve its efficacy at detecting the virus in people.

For the study, the research team tested COVID-positive individuals, each of whom exhaled into the device two, four or eight times. The breath test produced no false negatives and gave accurate reads after two breaths from each person tested. The clinical study is ongoing to test COVID-positive and -negative individuals to further test and optimize the device.

The researchers also found that the breath test successfully detected several different strains of SARS-CoV-2, including the original strain and the omicron variant, and their clinical studies are measuring active strains in the St. Louis area.

To conduct the breath test, the researchers insert a straw into the device. A patient blows into the straw, and then aerosols from the person's breath collect on a biosensor inside the device. The device then is plugged into a small machine that reads signals from the biosensor, and in less than a minute, the machine reveals a positive or negative finding of COVID-19.

Clinical studies are continuing, and the researchers soon plan to employ the device in clinics beyond Washington University's Infectious Diseases Clinical Research Unit. In addition, Y2X Life Sciences, a New York-based company, has an exclusive option to license the technology. That company has consulted with the research team from the beginning of the project and during the device's design stages to facilitate possible commercialization of the test in the future.

This article was originally published on MedicalXpress Breaking News-and-Events.

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Thanks missy for the updates as always.

DK :))
 
That sounds really interesting @missy, thanks for the update.
 
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It May Be Time to Pay Attention to COVID Again​

Kara Grant; Damian McNamara, MA
DISCLOSURES | August 11, 2023


More than 3 years into the COVID-19 era, most Americans have settled back into their pre-pandemic lifestyles. But a new dominant variant and rising hospitalization numbers may give way to another summer surge.

Since April, a new COVID variant has cropped up. According to recent CDC data, EG.5 — from the Omicron family — now makes up 17% of all cases in the U.S., up from 7.5% in the first week of July.

A summary from the Center for Infectious Disease Research and Policy at the University of Minnesota says that EG.5, nicknamed "Eris" by health trackers, is nearly the same as its parent strain, XBB.1.9.2, but has one extra spike mutation.


Along with the news of EG.5's growing prevalence, COVID-related hospitalization rates have increased by 12.5% in the last week — the most significant uptick since December. Still, no connection has been made between the new variant and rising hospital admissions. And so far, experts have found no difference in the severity of illness or symptoms between Eris and the strains that came before it.

Cause for Concern?​

The COVID virus has a great tendency to mutate, says William Schaffner, MD, a professor of infectious diseases at Vanderbilt University in Nashville.

"Fortunately, these are relatively minor mutations." Even so, SARS-CoV-2, the virus that causes COVID-19, continues to be highly contagious. "There isn't any doubt that it's spreading — but it's not more serious."


So, Schaffner doesn't think it's time to panic. He prefers calling it an "uptick" in cases instead of a "surge," because a surge "sounds too big."
While the numbers are still low compared to last year's summer surge, experts still urge people to stay aware of changes in the virus. "I do not think that there is any cause for alarm," agreed Bernard Camins, MD, an infectious disease specialist at Mount Sinai Hospital in New York City.


So why the higher number of cases? "There has been an increase in COVID cases this summer, probably related to travel, socializing, and dwindling masking," said Anne Liu, MD, an allergy, immunology, and infectious disease specialist at Stanford University. Even so, she said, "because of an existing level of immunity from vaccination and prior infections, it has been limited and case severity has been lower than in prior surges."

What the Official Numbers Say​

The CDC no longer updates its COVID Data Tracker Weekly Review. They stopped in May 2023 when the federal public health emergency ended.
But the agency continues to track COVID-19 cases, hospitalizations, emergency department visits, and deaths in different ways. The key takeaways as of this week include 9,056 new hospitalizations reported for the week ending July 29, 2023. That is relatively low, compared to July 30, 2022, when the weekly new hospitalization numbers topped 44,000.

"Last year, we saw a summer wave with cases peaking around mid-July. In that sense, our summer wave is coming a bit later than last year," said Pavitra Roychoudhury, PhD, an assistant professor and researcher at the University of Washington School of Medicine's Vaccine and Infectious Disease Division.
"It's unclear how high the peak will be during this current wave. Levels of SARS-CoV-2 in wastewater, as well as the number of hospitalizations, are currently lower than this time last year."

For part of the pandemic, the CDC recommended people monitor COVID numbers in their own communities. But the agency's local guidance on COVID is tied to hospital admission levels, which are currently low for more than 99% of the country, even if they are increasing.
So, while it's good news that hospitalization numbers are smaller, it means the agency's ability to identify local outbreaks or hot spots of SARS-CoV-2 is now more limited.
It's not just an uptick in hospitalizations nationwide, as other COVID-19 indicators, including emergency room visits, positive tests, and wastewater levels, are increasing across the United States.

In terms of other metrics:
  • On June 19, 0.47% of ER visits resulted in a positive COVID diagnosis. On Aug. 4, that rate had more than doubled to 1.1%.
  • On July 29, 8.9% of people who took a COVID test reported a positive result. The positivity rate has been increasing since June 10, when 4.1% of tests came back positive. This figure only includes test results reported to the CDC. Results of home testing remain largely unknown.
  • The weekly percentage of deaths related to COVID-19 was 1% as of July 29. That's low, compared to previous rates. For example, for the week ending July 30, 2022, it was 5.8%.

What About New COVID Vaccines?​

As long as you continue to make informed decisions and get the new Omicron vaccine or booster once it's available, experts predict lower hospitalization rates this winter.
"Everyone should get the Omicron booster when it becomes available," recommended Dean Winslow, MD, a professor of medicine at Stanford University in California.
In the meantime, "It is important to emphasize that COVID-19 is going to be with us for the foreseeable future," he said. Since the symptoms linked to these newer Omicron subvariants are generally milder than with earlier variants, "if one has even mild cold symptoms, it is a good idea to test yourself for COVID-19 and start treatment early if one is elderly or otherwise at high risk for severe disease."

Schaffner remains optimistic for now. "We anticipate that the vaccines we currently have available, and certainly the vaccine that is being developed for this fall, will continue to prevent severe disease associated with this virus."
Although it's difficult to predict an exact timeline, Schaffner said they could be available by the end of September.
His predictions assume "that we don't have a new nasty variant that crops up somewhere in the world," he said. "[If] things continue to move the way they have been, we anticipate that this vaccine…will be really effective and help us keep out of the hospital during this winter, when we expect more of an increase of COVID once again."

Asked for his outlook on vaccine recommendations, Camins was less certain. "It is too soon to tell." Guidance on COVID shots will be based on results of ongoing studies, he said. "It would be prudent, however, for everyone to plan on getting the flu shot in September."

Stay Alert and Stay Realistic​

Cautious optimism and a call to remain vigilant seem like the consensus at the moment. While the numbers remain low so far and the uptick in new cases and hospitalizations are relatively small, compared to past scenarios, "It makes sense to boost our anti-Omicron antibody levels with immunizations before fall and winter," Liu said.
"It's just advisable for everyone — especially those who are at higher risk for hospitalization or death — to be aware," Camins said, "so they can form their own decisions to participate in activities that may put them at risk for contracting COVID-19."

We have to remind ourselves that whether they're for the flu, COVID, or even RSV, these respiratory virus vaccines work best at keeping us out of the hospital. They're not as good at preventing milder infections.
Schaffner said, "So if we don't expect perfection, we won't be so disappointed."
Sources:
CDC: "Monitoring Variant Proportions anchor link," "United States COVID-19 Hospitalizations, Deaths, Emergency Department (ED) Visits, and Test Positivity by Geographic Area."
Center for Infectious Disease Research and Policy: "WHO adds Omicron EG.5 to variant monitoring as global COVID markers decline further."

William Schaffner, MD, professor of infectious diseases, Vanderbilt University, Nashville.

Bernard Camins, MD, infectious disease specialist, Mount Sinai Hospital, New York City.

Anne Liu, MD, clinical associate professor, Department of Medicine, Division of Infectious Diseases, Stanford University, Palo Alto, CA.

Pavitra Roychoudhury, PhD, assistant professor, researcher, Vaccine and Infectious Disease Division, School of Medicine, University of Washington, Seattle.


Dean Winslow, MD, professor of medicine, Stanford University, Palo Alto, CA.


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Children and Long COVID: How Many Are Affected?​

Tinker Ready
August 11, 2023


Long COVID most often strikes seniors and adults, but children are also affected, even though they get less attention, new research shows.
Experts noted that the disease poses particular challenges for children and the doctors who treat them.
Parents and doctors need to be on the lookout for symptoms of long COVID in children and teens that might be easily missed or misdiagnosed, according to physicians and family groups.

Children are at lower risk for contracting COVID and often experience milder symptoms. But the virus is now widespread, and a recent study found that around 16% of pediatric patients with COVID go on to develop symptoms that last more than 3 months — the working definition of long COVID.




Parents and doctors are calling for more studies and more awareness.
Diane Sheehan, who lives outside Charlotte, North Carolina, says she was an active person and is now permanently disabled from long COVID. Her teenage son has it too and is still recovering.
He contracted COVID after a school event, she said. He had a mild case, but then he started experiencing dizziness and would even experience loss of consciousness when he stood up suddenly. After he contracted the virus a second time, he was bedridden for 8 months.

The staff at Hackensack Meridian Health, a pediatric long COVID clinic in New Jersey, has been working with area schools to help teachers and school nurses recognize possible long COVID in children and young people. The clinic is one of about a dozen in the US that specializes in pediatric cases.
Katherine Clouser, MD, a pediatric hospital medicine specialist, has been with the clinic since it opened in 2021, and she's seen a steady flow of patients. Some get better, but she sees a few new cases each week.
"We are seeing children who are having a difficult time returning to school and sports," she said.
The clinic is having success with a mix of approaches, including intensive rehabilitation, talk therapy, and some off-label use of nirmatrelvir (Paxlovid), an antiviral now being studied as a treatment for long COVID through a National Institutes of Health clinical trials initiative that was announced last month.

Treatment depends on symptoms and is determined on a case-by-case basis, Clouser said.

Families of her patients are grateful, she said.

"We hear a lot of parents who were desperate for someone to believe them ― or someone who knows about it," she said.

A recent review of more than 30 studies with about 15,000 participants concluded that 16.2% (95% CI, 8.5% to 28.6%) of the pediatric participants experienced one or more persistent symptoms of long COVID at least 3 months after acute infection.

Estimates of the number of children and youth with long COVID have varied widely. A 2022 study put the number at more than 25% of cases, but the American Academy of Pediatrics notes that estimates of the percentage of children infected with SARS-CoV-2 who go on to have long COVID range from 2% to 66%.


The federal Recover Initiative has enrolled more than 10,0000 children and youth ― a number it plans to double ― and studies of electronic health records are underway. The Recover pediatric team is also setting up a cohortthat they plan to follow into 2025.


Some clinics are having luck treating young people with approaches ranging from special diets to off-label medication.


David W. Miller, MD, who runs the long COVID clinic at the UH Rainbow Babies and Children's Hospital in Cleveland, Ohio, said he's seen about 250 patients.


A warning sign of long COVID in children is profound fatigue, he said.





"It's the most common symptom," Miller said. "They feel like they have the fluall the time."


Many also experience orthostatic hypotension on standing, triggering dizziness.


He said his team targets symptom groups. Initial management consists of a diet without sugar or refined carbohydrates. Skipping pasta and sweets can be hard for young people, but Miller said sometimes the diet alone helps.

Many have vitamin D and iron deficiencies. Others need help getting a good night's sleep. He's treated 50 with off-label low-dose naltrexone.

Some people with long COVID ― both young and old ― complain about being misdiagnosed as having depression. Miller says he see a lot of anxiety ― some situational and some biochemical ― in pediatric patients. But he cautions doctors not to treat their illness solely as a mental health problem.

His advice: If a young person or child experiences a major change in his or her regular level of functioning or has multiple COVID symptoms that don't go away after several months, parents and doctors should consider long COVID as a possible cause.

Miller said most of his patients get better over time with some treatments: "We see improvement in the majority of kids who can stick to the regimen," such as a sugar-free diet, supplements, and adequate sleep. Recovery has been slow and incomplete for Diane Sheehan and her son. She was training as a permanent make-up artist, she said, but now has hand tremors that make work impossible.

She has found doctors who treat some of her symptoms with antihistamines, and her son has benefited from physical therapy.

But for now, her son is passing on a scholarship he was awarded to attend North Carolina State University this year. Instead, he's living at home and going to a local college.

Sheehan urges parents to be on the alert for signs that their children might have long COVID, which can be confused with many other conditions.
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Should I wait for a fall booster?
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To boost or to wait to boost?​

Some doctors are telling patients that it’s time for another Covid booster. The newer variant booster will be available relatively soon. So, should one wait a month or two and get the new one, or just get the current one now? Judy, Newport News, Virginia
With extreme heat contributing to a spike in Covid cases across the nation, the virus is once again on many people’s minds. Just the other day, I was reading about the 125% jump in cases last month in New York, where I live, and thinking “Not again!”

It’s hard to believe that three years after the pandemic started, Covid still poses a threat. That’s especially true for those at risk of getting extremely ill, such as older people and the immune compromised.

In April, the Food and Drug Administration recommended an extra dose of the bivalent booster that debuted last fall for those most at risk. This shot was specially formulated to tackle the omicron variants most commonly circulating. Shockingly, just 17% of eligible Americans have received this shot.
This fall, again, we’ll get a new version of the vaccine tailored to the strains of Covid now in circulation.

“The Covid-19 vaccine booster shot is now expected to be an annual fall ritual, along with the seasonal flu vaccine,” says Katrine Wallace, an epidemiologist at University of Illinois at Chicago. “As they say, an ounce of prevention is worth a pound of cure.”

Wallace says there will be two major changes with this fall’s booster: a new formulation and a simplified schedule.

The unvaccinated can get one shot of the new fall vaccine and be up to date. “The rationale for this is that we have a lot of population immunity now with people having had one or more cases of Covid,” she says.

The new booster will also only include the XBB.1.5 variant that has been dominant for most of the spring and summer of 2023. (Last year’s booster contained 50% of the wild type strain plus 50% of omicron BA4/BA5 strains.)

As for the question of whether to vaxx now or later, Wallace says at this point in the year, it probably makes sense to wait for the new shot.

“The updated vaccine is expected to produce broadened immunity,” she says. Effectiveness data for the new vaccine has not yet been released by either Pfizer or Moderna.

“While the fall booster will be helpful to boost everyone’s immunity to the virus, it is especially important for vulnerable groups to get it,” Wallace says. — Kristen V. Brown

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A guide to Fall vaccine options​

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KATELYN JETELINA AND CAITLIN RIVERS
AUG 17
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It’s the first time we have vaccines for all three fall respiratory viruses that hospitalize and kill hundreds of thousands annually. This is a big deal, that is, if we utilize them. So, we thought collecting information about them in one place would be helpful. This is the what, who, and when for each.
At the bottom, we include a one-page PDF summary. (Many physician offices and health departments have previously found it helpful to print these.)

Seasonal influenza (flu)​

What: The vaccine covers four strains of seasonal flu offered by fourpharmaceutical companies. Selecting vaccine strains for rapidly changing viruses, like flu and COVID-19, is both an art and a science, so the vaccine formula doesn’t always align perfectly with the circulating virus. We are optimistic that this year’s is a good match because the vaccine composition matches flu strains that recently circulated in Australia (which is a good predictor of the upcoming Northern Hemisphere season). During the years when the vaccine does match, it can reduce the risk of needing to go to the doctor by 40% to 60%.
Who: Everyone ages 6 months and older. There are special formulations to provide added protection to older adults. Children should get two shots during their first flu season.
When: Protection wanes throughout a season. For most people, October is the best time to get vaccinated so that you’re fully protected before a flu wave. The complete list of timing recommendations for specific populations (pregnant people, older adults, young children) is available here.

COVID-19 vaccine​

What: The fall Covid-19 vaccine has an updated formula targeting XBB.1.5, which should be a good match to the currently circulating Omicron subvariant. Moderna, Pfizer, and Novavax all plan to have boosters on the market this fall.
Who: We don’t know yet but should know in mid-to-late September. Why the delay? The CDC only determines who is eligible after the FDA fully approves the vaccine. The FDA can only fully approve it once the pharma companies submit data showing the vaccines are safe after manufacturing. We are waiting for this process to play out.
Last year, though, eligibility was dependent on the manufacturer, and it will likely be the same this year:
When: Guidance will be provided by the CDC soon. (Hopefully, they will guide recently infected people, too.) For protection against severe disease, you can get the vaccine when it becomes available because this kind of protection lasts longer. For protection against infection, though, keep in mind that protection wanes in a few months, so it’s best to get vaccinated right before a wave. Of course, this can be challenging to time.
More info: To understand why we need an updated vaccine and what clinical trials found, go to this previous YLE post.

RSV vaccine for older adults​

What: For the first time, an RSV vaccine is available and from two manufacturers— GSK and Pfizer. Both effectively protect against severe illness, with 82-86% efficacy. The two vaccines are slightly different in design, but only at a microscopic level. And side effects like fever and body aches are uncommon.
Who: People ages 60 and older “may” get the vaccine in the U.S. In the U.K., those over 75 years “should” get the vaccine. People with underlying health conditions (like heart or lung disease or diabetes) and those living in long-term care facilities should strongly consider the vaccine.
When: They are available now. RSV vaccines do not wane as quickly as flu and COVID-19 vaccines, so getting one now should protect you throughout the entire season (and maybe even next season).
More info: For a breakdown of the clinical trial findings, go to this previous YLE post.

RSV vaccine for pregnancy​

What: Pfizer is actively pursuing approvals for an RSV vaccine given to pregnant people. The protection will pass from mother to baby so that the baby is protected in the first 6 months of life, which is the riskiest time for severe RSV. Clinical trials showed 82% efficacy in preventing hospitalization during the first 3 months of life, and 69% efficacy at 6 months.
Who: If approved, the vaccine would be given between 24 to 36 weeks of pregnancy.
When: This vaccine is not yet available. It is still going through review by the FDA and CDC. We may have a decision this month. If so, it may become available this fall, but the timing is uncertain.

RSV medication for infants​

What: AstraZeneca has a new monoclonal antibody called Beyfortus, which protects against severe RSV in infants. This is not a vaccine (i.e., doesn’t teach the body to make antibodies) but rather a medication (it provides antibodies). In clinical trials, it reduced the risk of hospitalization and healthcare visits by ~80%.
Who: All infants under 8 months should get it for their first RSV season. High-risk children between 8 months to 19 months should also get it. High-risk categories include:
  • Chronic lung disease of prematurity
  • Severe immunocompromise
  • Cystic fibrosis
  • American Indian and Alaska Native children
When: Beyfortus is not available yet, but the manufacturer has committed to making it available for this RSV season. The protection lasts about 4-6 months, so get this as soon as it’s available.

Summary​

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Bottom line​

Get protected! It is one of the best things you can do this fall and winter to stay healthy and minimize disruption.

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I have received a notification and have booked my flu jab; however, still no mention of a Covid booster for this autumn.

I'll have it if it is on offer.

There was a piece of news article about the vaccine being available to buy privately for those who are not eligible to have it for free in UK, estimated to be priced at 130 GBP per injection.

I should be eligible to have it for free as I am over 50 with an underlying health condition.

DK :))
 
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A new variant: BA.2.86​

KATELYN JETELINA
AUG 22

We have a new COVID-19 variant—BA.2.86—turning heads even among the calm, cool, and collected scientists.

This is what we know, what we don’t know, and what’s likely next.

What is happening?​

SARS-CoV-2 continues to mutate.

This is expected, as this is what viruses do to survive. There was ~20% possibility of another “Omicron-like event” in 2023. Since Omicron arrived on the scene in November 2021, we’ve only seen incremental changes, which have created a ladder-like pattern (see panel A below). This is a good thing—we wanted Omicron to mutate because then we can predict where it’s going (for vaccines and our immunity, for example).

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However, BA.2.86 doesn’t follow the ladder-like pattern. It has so many changes at once that it seems to come out of nowhere (see Panel B above). The virus likely mutated over time in one immunocompromised individual and then jumped to others.

Why is there concern?​

As of now, we’ve only seen 7 cases in 4 countries. Usually, this isn’t enough to warrant concern, but some details are noteworthy:

  • Mutations. The new variant has 35 mutations on the spike protein relative to what is currently circulating. (We pay attention to the spike protein because it’s the key to our cells.) This is an insane amount of change at once; it’s as big of an evolutionary jump as Wuhan → Omicron.
    Image​
    (Raj Rajnarayanan)
  • Community-level transmission. 6 cases are without travel history (and 1 U.S. case was a traveler from Japan). There is vast geographical distribution of the cases identified (Israel, the U.S., Denmark, and the U.K.). And we are seeing BA.2.86 in country-level wastewater samples (without corresponding reported cases). All of these point to undetected community transmission—it’s spreading.
    ​
    (Marc Johnson)
  • Rapid spread. The 7 sequences are very similar, which means this variant hasn’t had time to change. In other words, it’s spreading quickly.

What do we not know?​

A lot.

Genetic surveillance is down 90%. Only 9,757 COVID-19 sequences were uploaded to the public database last week, compared to 137,878 for Omicron’s first week. In other words, we are searching in the dark.

On an immunologic level, it will take weeks to understand what these new mutations mean or, more importantly, what the combination of mutations means. Some labs, like those in Denmark, are already at work. In the meantime, we have a few educated guesses:

  • Immune escape. One U.S. lab found that BA.2.86 has 16 known mutations that significantly escape our front-line immunity—antibodies. In other words, this will likely infect many people, regardless of prior immunity.
  • Severity. We don’t know if this is more severe than Omicron or Delta, but it’s probably about the same severity level. This is because SARS-CoV-2 has historically evolved to escape antibodies (first line of defense) rather than T-cells (second line of defense) that primarily protect us from severe disease.
  • Transmissibility. There’s a ceiling to contagiousness. It’s hard to imagine BA.2.86 spreading much better than Omicron, but nothing is ruled out yet.
Epidemiologically, we don’t know whether this will cause a wave yet; it may be a dud. But with more cases, it becomes more likely. Again, we are flying blind. We don’t have testing or case data like we did 2 years ago.

There is good news.​

  • This is still COVID-19. We aren’t returning to March 2020; our immune systems will still recognize the highly mutated variant, albeit suboptimally. This will protect a lot of us from severe disease.
  • We can detect BA.2.86 on a PCR. Usually a swab has to go to a special lab for genome sequencing to know which variant caused the infection. However, BA.2.86 has a unique signal on the PCR directly—when positive, it lights up two channels instead of three. This is fantastic news because it means we can track this virus much easier and more quickly worldwide. CDC is doing this right now.
  • Scientists are on top of it. While much of the public has moved on, public health is still working just as hard. WHO and CDC announced last week that they are monitoring this variant. U.K. came out with a fantastic risk assessment on Friday.

What’s next?​

We are at the mercy of time to see what this variant does. Like a hurricane, we don’t know if it will fizzle away, become a category 5 disaster, or somewhere in between.

Regardless, our next moves include:

  • WHO will determine if this is a new variant of concern—the highest risk classification. If so, it will be assigned a Greek name; next in line is “Pi.”
  • Scientists are actively trying to understand how our immune systems react to BA.2.86 and if this impacts “real world” patterns. Their results should be coming in a few weeks.
  • Companies will confirm (or deny) whether our tools (like the vaccines, Paxlovid, and antigen tests) work against BA.2.86.

Bottom line​

We have a new variant on the horizon. We are in a lull now, waiting for the virus’s next move and for science to answer some key questions. Things should become more clear in the next two weeks.

"
 
"

CDC Tracking New COVID Strain​

Ralph Ellis
August 21, 2023




The CDC is tracking a newly discovered strain of COVID-19 called BA.2.86.
On Thursday, the agency posted on X, formerly known as Twitter, that the lineage has been detected in the United States, Denmark, and Israel.
"As we learn more about BA.2.86, CDC's advice on protecting yourself from COVID-19 remains the same," the CDC said on X.
A case of BA.2.86 was detected at a laboratory at the University of Michigan, CBS News reported. It's not clear how the university obtained the sample that was sequenced. A case was also detected in the United Kingdom, the news outlet said.

The World Health Organization is also tracking BA.2.86 and has classified it as a "variant under monitoring."




"More data are needed to understand this #COVID19 variant and the extent of its spread, but the number of mutations warrants attention. WHO will update countries and the public as we learn more," the WHO said on X.
The strain is so new that scientists don't know if BA.2.86 is more easily spread, causes more severe symptoms than existing strains, or will be more resistant to vaccines and natural immunity developed over the last few years.
Early research indicates BA.2.86 "will have equal or greater escape than XBB.1.5 from antibodies elicited by pre-Omicron and first-generation Omicron variants," Jesse Bloom, PhD, a virologist at the Fred Hutchinson Cancer Center, said in a slide deck published Thursday. (XBB.1.5 is the Omicron subvariant that is targeted in the updated COVID booster shot to be released soon.)

Still, Bloom noted that "even if a highly mutated new variant like BA.2.86 starts to spread, we will be in a far better place than we were in 2020 and 2021, since most people have some immunity to SARS-CoV-2 now."

Sources​

X, formerly known as Twitter: @CDCgov, Aug. 17, 2023; @WHO, Aug. 17, 2023.
CBS News: "CDC tracking new COVID variant BA.2.86 after highly-mutated strain reported in Michigan."

Fred Hutchinson Cancer Center: "Phenotypic assessment of spike mutations in BA.2.86 (new highly mutated BA.2 variant)."

"
 
News articles appeared in the past couple of days with regard to another variant of concern named Pirola.

Without sending a sample for testing, I shall never know which variant I caught back in July 2023 when I was travelling back from Amsterdam.

LFTs well-stocked at home so that I can at least test at home if I become ill with flu-like symptoms.

DK :))
 
So many people around my area are coming down with Covid. One group of friends went to Cape Cod for a week of holiday. All 8 of the group came down with it. I have neighbors, colleagues and friends with it now. I don’t know what strain(s) they have but definitely it is on the upswing.
 
"

NYC Health Chief Aims to Redefine Public Health Post-COVID​

— Ashwin Vasan, MD, PhD, is making agency changes based on COVID lessons and the city's needs​

by Kristina Fiore, Director of Enterprise & Investigative Reporting, MedPage Today August 22, 2023


A photo of Ashwin Vasan, MD, PhD

Public health has endured a very public critique during the acute crisis of the COVID-19 pandemic and its aftermath.
Now, public health leaders are tasked with the difficult challenge of digesting those lessons and shaping the field into a new and improved version of itself.
Among them is Ashwin Vasan, MD, PhD, Commissioner of the New York City Department of Health and Mental Hygiene (DOHMH), who took the helm almost 18 months ago and has already started making changes at the agency, aimed at setting up the city for future public health success.

"We've always been a city that celebrates and supports public health," Vasan told MedPage Today in a recent interview. "But the issues are similar [to what's going on across the country]: community engagement and trust building, getting out of the ivory tower ... and into the community."
Vasan discussed those challenges, and his plans for addressing them, in a conversation with MedPage Today in mid-August. He says he's looking externally at the city's public health needs to inform any internal changes.
"We're trying to bring the external focus and the internal focus into alignment because we know we can't achieve [our external goals] if we don't reform internally," Vasan said.
Modernizing Public Health
During the first year of his tenure, Vasan and his teams identified external public health issues to inform the best internal structure for the agency going forward.
The key statistic that stood out to him was the significant drop in life expectancy in the city.

"We lost nearly 5 years of life expectancy in 2020, and in 2021 we gained about half back, but it's not inevitable that we'll just get back on track and be at our pre-COVID levels," Vasan noted. "We're seeing rates of excess death, premature death, and death in vulnerable populations ... worsen."
He said the key question informing his approach is, "How do we organize our strategy around getting back those life-years and ensuring equity?"
Part of that process is developing a population health agenda for the city that establishes numerical goals for each of the leading causes of death in those three categories, to improve those rates by 2030 and beyond, Vasan said.
Several internal changes are needed to make that happen, he explained, highlighting five key areas. These include investing in a stronger workforce, both for current workers and for recruiting new workers.
Another, he said, is ensuring that equity is baked into the infrastructure, making it a "part of every single program at the agency."

It's also about improving communications and external affairs, he added. "How do we really engage people? How do we build that trust? How do we get out of our offices and into communities to build relationships -- and understand that this simple act can pay off for a long time, especially when you're asking something of communities, like wearing a mask or taking a vaccine? If you've never spent any time with people, it's much harder."
It also requires building data systems that can deliver important information sustainably, Vasan said.
"We did incredible things during COVID around data dashboards, but when you look at the work it took underneath, it's not sustainable," he noted. "It's highly manual and highly circumstantial. And a lot of it was highly funded by emergency federal dollars that are now disappearing."
Perhaps one of the biggest changes Vasan has made is creating a Chief Program Officer position, tasked with unifying the department's many division and subject matter experts.

"Most health departments are organized in a fairly flat way, and we decided we need a unifying body that's thinking interdisciplinarily across subject matter divisions," he said.
The intention is to think of the work as shared services, and it's been called "one DOHMH" to note the need to work as one entity, he continued. He's also created an executive leadership team that focuses more on these big agency questions.
Culture Change
Vasan wants to bring more of a crisis-management mindset to the department's daily work structure. When health departments face an emergency, they create an incident command structure "and they pull people from all over the agency into a new command structure to work on the crisis," he explained.
Crisis times also usually mean people are more comfortable working "quickly with imperfect information," he added, and there's less fear of failure.
"How do we start working more like that in non-crisis times?" he asked. "We've shown what we can do when we draw upon the strengths of this whole beautiful agency. Why can't we do that day-to-day?"

"There are sensible things we can do to create new structures which beget smart functions and ways of working that benefit all of us," he pointed out.
Vasan said there's also a scholastic or academic focus on public health, "but we have to remember that we are public servants first."
"The academic-driven culture of public health has to evolve," he said. "That's not to say we stop publishing or doing great research, but we have to put it in the right place. Taxpayers pay us, and we have a responsibility to the public, so we have to think about programs first, results first, and accountability first. With that, you'll have plenty of opportunities to write, be thought leaders, and advance the science."
"Scholasticism is not an end in-and-of-itself, but a byproduct of great work serving people," he added.
It's not necessarily easy to implement such culture change at a large bureaucracy -- the department has 7,500 employees and a $2 billion budget -- but Vasan called it a work in progress.

Part of selling the changes involves "coming up with examples of where better communication, better collaboration, better awareness and visibility can improve the product," he said. A goal is to have employees trust that working differently is "helping us elevate their work in a more strategic way."
City public health employees are "smart enough to know that public health has been under a lot of stress," he noted, "and it's time to pivot, to evolve, to take the next step forward and redefine public health for this new era."
  • author['full_name']

    Kristina Fiore leads MedPage’s enterprise & investigative reporting team. She’s been a medical journalist for more than a decade and her work has been recognized by Barlett & Steele, AHCJ, SABEW, and others. Send story tips to [email protected]. Follow

  • "



 
"

What will this fall/winter look like? ​

KATELYN JETELINA
AUG 24
​
​
The fall/winter season always means more respiratory sickness—the weather changes, people head inside, and social networks change (school starts, holiday celebrations occur). But the last four years have resulted in veryunusual patterns.
This makes predicting this season a fool’s game. But I’ll take the bait and give it a shot.

What makes predicting challenging?​

Three main factors:
  1. Many scientists agree that SARS-CoV-2 still hasn’t settled into a predictable, seasonal pattern. BA.2.86 is an excellent example.
  2. Changing human behavior: The changing immune landscape, new and improved tools, and pandemic fatigue have meant that human behavior has changed drastically from season to season, as I outlined in a rough table below. Human behavior plays into viral patterns.
    ​
  3. Perplexing viral behavior: Other viruses’ timing seems to be off. One hypothesis is viral-to-viral interaction—one virus takes over, then subsides, and another virus wave begins due to population-level immunity to the first virus. For example, last year, we were concerned about a triple-demic—all three viruses peaking simultaneously and flooding our hospital systems. Interestingly, they didn’t, which helped immensely. (Viral-to-viral interaction?Maybe—we’ll see what happens this year.)
    ​
    (Hospitalizations per 100,000 for RSV (green), flu (blue), and COVID-19 (red). Source: CDC
But I think this season will be the first time we have a repeat in behavior (except for the RSV vaccine availability) and all three viruses present.
So, my guess: this year’s patterns will broadly mirror last year’s.

So what happened last year?​

RSV arrived earlier than usual (peaking in early November) and with a vengeance, particularly among children under 5. Our pediatric hospitals were overwhelmed, to say the least.
​
(CDC)
Flu also came earlier than usual, peaking around mid-November. (Pre-pandemic it peaked in mid-January.) But last year’s wave was about the same height as pre-pandemic.
​
(CDC)
COVID-19 had a middle-of-the-road year. In other words, hospitalizations weren’t as bad as before but still had a sizeable impact.
​
(CDC)
Of course, BA.2.86 on the scene complicates fall/winter predictions. The COVID-19 Modeling Hub—8 academic teams across the U.S.—made projections before BA.2.86 was identified but took this kind of scenario into account:
  • If BA.2.86 explodes, we likely see closer to scenario F
  • If BA.2.86 fizzles, we likely see scenario E
This means we should expect to lose 55,000 (optimistic model) to 450,000Americans (pessimistic model) over the next two years.
​
Scenario Modeling Hub projections for COVID-19 deaths across four scenarios

What happened in the Southern Hemisphere?​

The Northern Hemisphere has an advantage in predicting upcoming seasons—Southern Hemisphere data. Their respiratory season occurs before ours, so we can look to their winter season to predict ours.
This year’s Southern Hemisphere respiratory season looked a whole lot like last year's:
  • In South America, RSV made huge waves, just as high as last year.
    ​
    Respiratory Syncytial virus distribution and percent positivity by subregion, 2015-2023, Region of the Americas
  • Flu hospitalizations in Australia were as early and about as high as 2022.
​
Number of influenza hospitalizations at sentinel hospitals, from April to October, 2016 to 2023 by year and week of diagnosis. Source here.
  • Excess deaths in Australia continue to tick up from pre-pandemic levels.
​
The all-cause death rate per 100,000 population, all ages, 2017 to 18 June 2023. Source here.

Bottom line​

I wouldn’t be surprised if the Northern Hemisphere saw a repeat of last year: an early RSV wave, followed by an early flu wave, and COVID-19 finishing us off. But of course, predicting patterns only 4 years into a novel virus is a fool’s game.
Regardless, we know viruses are coming. Their wave height depends heavily on how we utilize our tools, like vaccines, ventilation, medications, and masks. Let’s consider using them.

"
 
DH had it over a month ago, none of the rest of us got it. Then I got a completely different flavor two weeks after him, no one else got that one. It's a wild card that's for sure.
 
oops. posted in the wrong thread yesterday. Mutlitasking error sorry

missy said:
"

Your top 7 questions about fall vaccines answered​

KATELYN JETELINA
AUG 29
​
​
Thank you for all of your questions! You’re keeping us busy here at YLE. Here are answers to the top 7 that I’ve received in my inbox.

When will we know about the COVID-19 vaccine?​

The ACIP meeting is now scheduled for September 12. This will be a huge meeting, as we will find out:
  • Who is eligible for a COVID-19 vaccine and why.
  • Cost-effectiveness, given this vaccine is now privatized. In other words, we will get an answer to the question: Do the benefits of a vaccine outweigh the costs for all age groups?
  • Updated myocarditis data for younger males (I hope).
I will be in attendance and provide cliff notes.
Then, vaccines should be available mid-to-late September.

Can I get the vaccines (flu, RSV, and/or COVID-19) at once?​

There is no combined shot (some companies are working on it, but will not be available for years). This means that, if you’re eligible, you will need three shots to protect against the three viruses this fall.
You can get them all at once. But it may not be ideal. It just depends on your situation and your comfort with unknown risks:
  • Benefits to getting all at once: Going to the doctor/pharmacy multiple times can be a pain for many people, including grandparents. Or some people may tend to forget to go. Getting all three at once may be the best option in this situation.
  • Benefits to staggering: The optimal timing of vaccines is different for all three viruses. Also, we don’t know the safety risks of getting all three simultaneously. It hasn’t been studied. In other words, there are unknown risks. This is what we do know:

Should I wait for the fall COVID-19 vaccine?​

I’m telling my family and friends to wait (as opposed to getting last year’s vaccine formula). Of course, there is some risk to waiting, but there are two benefits, too:
  1. While we are in a wave now, we expect a larger wave in winter. Getting it closer to this wave will better prevent infection;
  2. Recent preprint shows that two shots of last year’s vaccine formula resulted in imprinting. This isn’t necessarily dangerous, but it means our antibody factory line (i.e. B-cells) wasn’t updated—it doesn’t broaden protection. Getting an updated vaccine formula will be more helpful against currently circulating variants.

Novavax vs. mRNA COVID-19 vaccine?​

Both are great shots. And the data pool to draw on is so narrow I’m uncomfortable saying one is immunologically better than the other. But we’ve had some studies (here, here, here, and here), and they’ve shown many similarities and some subtle differences:
Similarities
  • Both provide a solid first line of defense (i.e., neutralizing antibodies).
  • Both strengthen a solid second line of defense (i.e., T-cells).
Differences
  1. Negative: Novavax produced significantly lower levels of a specific antibody called IgG.
  2. Positive: Novavax had a more durable response over time (waned less quickly).
  3. Positive: Novavax has fewer side effects, like pain and muscle aches. For this reason alone, I will be getting Novavax this fall.
​
Side effects from varying combinations of COVID-19 vaccines. Figure from the Lancet, with YLE annotations. Original source here.

The new RSV vaccines aren’t covered by insurance?​

Medicare Part D covers the RSV vaccine, but some private health insurance plans don’t. In other words, some older adults must pay ~$330 for their RSV vaccine. This is because of two factors:
  1. The adult RSV vaccine is not yet included in the CDC’s annual vaccine schedule, which should be updated in 2024.
  2. CDC’s official recommendation for RSV vaccines is that older adults “may” get the vaccine rather than “should.” Private companies use this language as justification not to cover expenses.

Aren’t there neurological side effects to the adult RSV vaccine?​

Clinical trials found a possible safety signal. For more details, see this previous YLE post.
TLDR: Because the number of events was so small, it’s hard to know whether these are coincidental events or reflect a real safety issue. Future data will clarify this, but it will take time for real-world data to accumulate.

When will the maternal RSV vaccine be available?​

It will still be a while. While the FDA has officially approved the vaccine, the CDC is not meeting until October 25-27 to determine policy.

Bottom line​

A lot is going on this fall. Keep sending us your questions. I hope this helps!

"
Click to expand...
 
From Bloomberg.com

"

What makes a virus seasonal?
Since the pandemic’s early days, people have been waiting for Covid to behave in a way that feels familiar — to eventually fade from our daily existence and behave more like, say, influenza, which only bothers us once a year.

But years after the start of the pandemic, Covid cases are still present year-round. Experts agree it cannot be considered seasonal – at least not yet. This begs the question, what makes a virus seasonal? Like so many things Covid, this, too, doesn’t exactly have a straightforward answer.

When I asked Vanderbilt infectious disease specialist William Schaffner to define seasonality, he actually laughed.

“If I could give you a definitive answer to that, somebody would put me on the list as a possible Nobel Laureate,” he said. “It is remarkable, still in 2023, how little we can understand these seasonal behaviors.”

Seasonality is determined by patterns in case data. Flu cases, for instance, start to spike in late October in the Northern Hemisphere, reach a peak at the end of December and fall to nearly zero by late February. By contrast, using hospitalizations as a proxy for cases, Covid appears to have some dips throughout the year, but also surges in both the winter and summer.

As for what actually causes a virus to fall into a seasonal pattern, the answer ranges from environmental factors to human behavior. Respiratory illnesses like the flu spike in the winter because the dry air allows the virus to linger in the air for a longer time, Schaffner says. On top of that, people congregate indoors in the winter for holiday gatherings and to escape the cold, increasing exposure.

Although it is also a respiratory virus, scientists still don’t know all the reasons why Covid can thrive in the summer as well as winter. At least some of it may have to do with human behavior. This year, for example, experts suggest that extreme heat waves driving people inside along with summer travel may have led to Covid surges in July and August.

Because Covid is relatively new to the human population, it may just take more time for it to fall into a seasonal pattern. And that pattern matters. It helps public health better plan for and respond to outbreaks. If Covid isn’t seasonal, for example, it may call into question our current annual fall booster strategy, as I detail in a story out today.

“Whether it will continue to have two peaks or just a single winter peak, we can’t predict that,” says John Vanchiere, a pediatrician and infectious disease specialist at Louisiana State University Health Shreveport. “We probably won’t see a once-a-year peak until 5 to 10 years from now.” —Cailley LaPara

"
 
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