By Amber Dance

Omicron boosters authorized

The FDA and CDC have signed off on new mRNA boosters for ages 12 and up, setting the stage for a fall vaccine push to counter an anticipated fall and winter surge. The shots will be available this week.

“The new shots are not likely to provide a huge benefit over the original vaccine,” writes Karen Weintraub at USA Today. “But any boost in protection is worthwhile, potentially preventing death, hospitalization and long COVID-19.”

The shots have been reformulated to target both the original coronavirus and the currently circulating omicron BA.5 strain. Dr. Peter Marks of the FDA said this may boost efficacy that has dwindled as the virus mutated over time.

While human testing of the newest formulas has not been completed, it’s expected they’ll be as safe as previous versions of these mRNA vaccines.

The latest data were revealed at a meeting of the CDC’s vaccine advisory committee. Pfizer’s results illustrated the advantage of a two-part “bivalent” vaccine, writes epidemiologist Katelyn Jetelina at her blog. In mice, the company’s bivalent vaccine targeting original SARS-CoV-2 and the omicron BA.1 strain yielded antibodies that also countered other variants. That crossover protection suggests a bivalent booster could help even if some new, unanticipated variant appears.

A CDC survey, conducted with the University of Iowa in August, suggested that nearly three-quarters of Americans are interested in getting the updated omicron vaccine.

Going forward, the question for individuals will be which booster to get, and when?

People who’ve been recently infected or recently vaccinated have circulating antibodies, and the vaccine won’t be as effective in that case. The FDA authorization says people are eligible once it’s been at least two months since their last vaccine, and the CDC went along with this recommendation.

But some CDC committee members were “uneasy” about that two-month interval, “with the concerns hinging on the fact that the interval may be too short to get maximum benefit from the new shot,” writes Helen Branswell at STAT.

Similarly, there may be value in waiting after a case of COVID. A recent preprint suggests that if people get a booster within two months of infection, it doesn’t do a great job of amplifying long-term immune memory.

As for which booster people should seek, it’s too soon to say, experts told The New York Times’ Noah Weiland and Sharon LaFraniere. “With research in humans just beginning, scientists are at least weeks away from knowing whether one brand offers better protection than the other,” the pair write.

Then there’s Novavax’s protein-based booster waiting in the wings. Novavax applied for authorization of its booster in mid-August. The FDA has promised to review the relevant data quickly, reports Sara Berg, a senior news writer for the American Medical Association, but the agency has not released any updates since. Studies suggest that boosting with Novavax, after a primary mRNA series, doesn’t provide a big benefit.  

The CDC anticipates recommending updated boosters for younger children “in the coming weeks,” according to an agency press release.

Pandemic created unfair burden for people with disabilities

Recent state reports emphasize the challenges people with disabilities faced during the pandemic.

The Arc of Pennsylvania, a nonprofit that promotes the rights of people with disabilities, found that residents with disabilities struggled to access pandemic information as well as testing and vaccinations, leading to a higher risk of severe illness or death from COVID.

“During COVID-19, we were a population that was basically forgotten,” the Arc’s executive director, Sherri Landis, told Scott LaMar at WITF’s Smart Talk radio show.

Health disparities widened further when disabled people were also members of a racial or ethnic minority group or lived in rural areas.

Arizona’s Developmental Disabilities Planning Council also released a literature review detailing the disproportionate impact of the pandemic on people with disabilities, reports Josh Ortega at the Gilbert Sun News.

“This population was very overlooked when it came to the vaccine rollout,” said the report’s author Michelle Thorne, founder and executive director of Care 4 The Caregivers, a nonprofit that supports parents of children with disabilities.

Her report noted that intellectual disability was a major risk factor for COVID-19 diagnosis and death. And Thorne said that the health conditions of children with disabilities continue to make it harder for them to recover from COVID, even as the CDC has loosened restrictions to prevent disease transmission.

The falling of such restrictions, coupled with a return to in-person classes, is also creating worries for college students with disabilities, writes Liann Herder at the publication Diverse: Issues in Higher Education.

Meanwhile, pandemic burnout is contributing to a near-collapse in support systems that serve people with intellectual and developmental disabilities, writes Dan Goldberg at Politico.

Many agencies and facilities, such as group homes, have been forced to turn people away, discontinue programs, or shutter completely. Thousands of Americans are stuck on waitlists.

Despite the challenges, Landis in Pennsylvania expressed optimism. The Arc suggests three main solutions: designating people with disabilities as a vulnerable population; ensuring people with disabilities have a voice in the health care and health policy communities; and ensuring medical personnel are trained in disability issues.

“We want to make sure that this never happens again,” Landis said.

Government funding for COVID shots and drugs running dry

The federal government is no longer distributing free COVID tests by post. The Biden administration blamed the change, which took effect Sept. 2, on a lack of funding from Congress.

The move will help the government maintain its stockpile in the event of a fall surge, report Monica Alba and Dennis Romero at NBC News. Additional funding could allow the program to restart.

Tests can still be covered by government or private insurance.

Republicans, in denying the White House’s requests for additional COVID funds, have suggested the administration repurpose other funds, writes Maureen Groppe at USA Today. “Democrats now hope to include emergency coronavirus funding in the package of pending bills needed to fund the government after September,” she reports.

This move heralds a broader shift that will move COVID vaccines and treatments out of the federal purview and into the commercial sector. The Department of Health and Human Services says the supply of free vaccines and treatments will end in 2023, reports Ahmed Aboulenein at Reuters.

Funds to purchase and distribute vaccines will probably run out by January, making the upcoming fall booster push likely the final freebie. There is already less money to support outreach and distribution of the shots than during past efforts, reports Benjamin Mueller at The New York Times.

Federal supplies of the antiviral drug Paxlovid are expected to last until the middle of 2023, but other treatments could run out sooner.

“Once that transition happens, it means products to fight the pandemic will be subject to all the problems evident in other disease areas — like possible price gaming by drugmakers or inequitable access to potentially lifesaving treatments,” writes Rachel Cohrs at STAT. “It’s unclear what might happen in the future if an uninsured person wanted a COVID-19 vaccine but couldn’t pay.”

For example, Moderna has been selling the U.S. its vaccine for $16.50 per dose, but the future reimbursement from Medicare could rise to $60 per shot.

The fact that companies can’t sell their products until they obtain full FDA approval, not just emergency authorization, could also complication the transition.

Some argue the federal government should continue to pay for COVID vaccines and treatments.

“The private market isn’t going to get it right,” said Jonathan Gruber, an economist at MIT.

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U.S. health advisers on Thursday endorsed new COVID-19 boosters that target today’s most common omicron strains, saying if enough people roll up their sleeves, the updated shots could blunt a winter surge.

The tweaked shots made by Pfizer and rival Moderna promise Americans a chance at their most up-to-date protection at yet another critical period in the pandemic. They’re combination or “bivalent” shots, half the original vaccine and half protection against the BA.4 and BA.5 omicron versions now causing nearly all COVID-19 infections.

Advisers to the Centers for Disease Control and Prevention struggled with who should get the new booster and when — because only a similarly tweaked vaccine, not the exact recipe, has been studied in people so far.

But ultimately the panel deemed it the best option considering the U.S. still is experiencing tens of thousands of COVID-19 cases and about 500 deaths every day — even before an expected new winter wave.

“I think they’re going to be an effective tool for disease prevention this fall and into the winter,” said CDC adviser Dr. Matthew Daley of Kaiser Permanente Colorado.

Comparing the tweak that has been studied in people and the one the U.S. actually will use, “it is the same scaffolding, part of the same roof, we’re just putting in some dormers and windows,” said Dr. Sarah Long of Drexel University.

The CDC is expected to adopt that recommendation soon, the last step before shots can begin. Millions of doses are expected to reach vaccination sites nationwide by Labor Day, CDC officials said.

The original COVID-19 vaccines still offer strong protection against severe illness and death, especially among younger and healthier people who’ve gotten at least one booster.

But those vaccines were designed to target the virus strain that circulated in early 2020. Effectiveness drops as new mutants emerge and the longer it’s been since someone’s last shot. Since April, hospitalization rates in people over age 65 have jumped, the CDC said.

The new updated shots are only for use as a booster, not for someone’s first-ever vaccinations. The Food and Drug Administration cleared Pfizer’s bivalent option for people 12 and older while Moderna’s is for adults only.

A big unknown: Exactly how much benefit people will get from one of those extra shots.

The CDC said more than 1,400 people have been included in studies of a prior tweak to the vaccine recipe — targeting an earlier omicron strain named BA.1. That omicron-targeting combo shot proved safe and able to rev up virus-fighting antibodies — and European regulators on Thursday recommended using that type of booster.

In the U.S., the Food and Drug Administration wanted fall boosters to target the currently circulating omicron strains — and rather than waiting until possibly November for more human studies to be finished, the agency accepted mouse testing that showed the newer tweak sparked a similarly good immune response.

That’s how flu vaccines are updated every year, the CDC noted.

Still, several CDC advisers said that to get the maximum benefit, people will need to wait longer between their last vaccination and getting the new booster than the two months that the FDA set as the minimum. Waiting at least three months would be better, from the last shot or if someone had recently recovered from COVID-19, they said.

Before this new COVID-19 booster update, people 50 and older already were urged to get a second booster of the original vaccine — and those who did saw some extra protection especially the longer it had been since their last shot, said CDC’s Dr. Ruth Link-Gelles.

The new combination booster “should provide at least similar or better protection against omicron since it’ll be a better match” to today’s virus strains, she told the panel.

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By Amber Dance

CDC plans overhaul amid critiques of latest loosened recommendations 

After more than two years of a bungled U.S. COVID response, the CDC is acknowledging its mistakes and pledging to improve.

“In our big moment, our performance did not reliably meet expectations,” said agency director Dr. Rochelle Walensky on Aug. 17. She promised a new agency culture with a stronger focus on action for public health.

The changes are Walensky’s response to a report based on interviews with about 120 CDC employees. The report said it “takes too long for CDC to publish its data and science” and that the guidance is “confusing and overwhelming,” according to Sasha Pezenik at ABC News.

Part of the overhaul includes restructuring the communications office and updating the website with simpler language.

The slow release of CDC research findings stemmed, in part, from a promotion system that incentivized publication in the agency’s Morbidity and Mortality Weekly Report, report Lena H. Sun and Dan Diamond at The Washington Post. The CDC now plans to release more data by preprint, which is faster.

One of the problems has been a focus on research rather than public health management, reports Joyce Frieden at MedPage Today. “CDC is a great organization, but it has always functioned like a big academic health system and not an emergency response entity,” Dr. Georges Benjamin, executive director of the American Public Health Association, told her.

Another problem was that the staff in charge of outbreaks changed every few months, creating a disjointed response and confusion about who was in charge. According to The Post, Walensky is considering a minimum six-month rotation for staffers charged with handling outbreaks.

The shakeup comes on the heels of criticism over CDC’s latest loosening of COVID-19 guidelines. Notably, the agency eliminated the recommendation for people exposed to COVID-19 to quarantine. It continues to recommend isolation for at least five days for people who have symptoms or test positive.

Some experts noted the agency seems to be ”leading from behind,” acknowledging what people are already doing rather than recommending what they should do.

The latest guidelines are “leaving decision-making mainly to individuals and local officials who lack public health training,” opine professors Wendy Netter Epstein and Daniel Goldberg in the Los Angeles Times. Putting the onus on individuals to avoid illness disproportionately harms low-income communities and people of color, they write.

Meanwhile, the U.S. seems to be repeating its public health missteps with monkeypox. The nation has more cases than any other country in the world.

Outsiders praised Walensky’s plans to fix the CDC, but noted Congressional approval and funding will be needed for some changes — and that it will be difficult to change the agency’s culture, as Helen Branswell reported at STAT.

“It’s an agency run by geeks. It’s run by doctors and Ph.D.s,” Dr. Jay Varma, director of the Cornell Center for Pandemic Prevention and Response and a former CDC employee told Branswell. “They’re really good at hypothesis-driven research and analyzing information and making predictions about what might happen. What they’re really bad at is managing people in an effective way.”

Study finds COVID-related discrimination on AirBnb

Pandemic scapegoating led to a 12% reduction in AirBnb bookings for hosts with Asian-sounding names, according to a new Harvard Business School working paper.

The researchers based their study on data from New York City in 2019 and 2020, using the quantity of reviews as a proxy for bookings.

The authors suggest the platform could minimize racism by hiding host names and photos until a reservation is made. AirBnb is eager to counter discrimination and looking into the research, reports Anissa Gardizy at The Boston Globe.

This latest finding is an example of discrimination against members of the Asian American and Pacific Islander (AAPI) community that has, at times, been much more sinister, even violent, during the pandemic. The latest report from Stop AAPI Hate documented nearly 11,500 hate incidents through March 2022 — mostly harassment but also physical assault and shunning.

“If you’re only watching the news, you aren’t getting the full picture of what AAPIs are experiencing,” the organization’s co-founder Russell Jeung told Michelle De Pacina at Yahoo! News.

White House promises new boosters by September

White House COVID coordinator Dr. Ashish Jha has predicted that updated booster shots could be available for adults within a couple of weeks, assuming the FDA and CDC give the new formulations their approval, reports Cheyenne Haslett at ABC News.

Jha also expressed hope that the government would be able to buy enough doses for everyone in the U.S., but the Biden administration is waiting for Congress to open its purse. So far, it’s only been able to afford a contract for 171 million doses from Pfizer and Moderna.

That might be enough — after all, only 108 million people got their first booster shot.

A recent poll from the University of Michigan found that among adults over 50 who have already received at least one vaccine dose, 61% are very likely to seek the new booster.

These new mRNA vaccines, which target the omicron BA.4/5 spike protein as well as the original spike, will be authorized based not on human trials, but on their performance in mice, explains Rob Stein at NPR. Data from human trials aren’t expected until mid-autumn.

The United Kingdom has already approved a new booster from Moderna, but that one targets the original omicron variant, for which human data are already available. U.S. regulators chose to take aim at the more recently circulating variants.

Last week Novavax requested authorization for its booster shot — a protein-based vaccine tailored to the original coronavirus strain. At an FDA meeting earlier this summer, the company said this shot generated significant antibodies against omicron BA.5 without needing any change to the formula.

If Novavax is authorized alongside mRNA boosters, it could set up a debate over which type of booster is the best to maximize Americans’ immunity before the upcoming winter, when COVID is expected to surge yet again.

Experts are also likely to be debating the best time for people to get a COVID booster, because earlier isn’t always better.

“The concern is that someone who gets a shot in, say, September, may lose a chunk of their protection if the peak of the season is going to be in February,” writes Andrew Joseph at STAT. “Complicating the process is that scientists don’t have a sense yet — after only two winters with SARS-CoV-2 — about just when the virus might peak.”

Jha also said that the White House may soon stop purchasing COVID-19 vaccines, tests and treatments on behalf of Americans, reports Brenda Goodman at CNN.

“My hope is that in 2023, you’re going to see the commercialization of almost all of these products,” Jha said at a U.S. Chamber of Commerce Foundation event. “Some of that is actually going to begin this fall.”

Neurological consequences of COVID may linger for years

Brain fog can persist for at least two years following a bout with COVID-19, according to a new study in The Lancet Psychiatry.

Risks for other neurological conditions, such as dementia and psychosis, also remains heightened for years, and at rates higher than those for other respiratory infections.

The study was based on the medical records of about 1.25 million people who were diagnosed with COVID, mostly in the U.S.

It found that the risk for mood disorders, such as anxiety and depression, was higher in the months immediately following illness but dropped quickly.

Children who had COVID were less likely to suffer neurological consequences than adults, but still had higher risk for seizures and psychiatric disorders than kids recovering from other infections.

The study authors, from the University of Oxford, characterized the absolute risk for neurological consequences as relatively low overall, but “nontrivial,” reports Elizabeth Cooney at STAT.

The study had several caveats. For example, some neurological symptoms may go unrecorded by providers.

“This is only pickup up very blunt stuff,” said Dr. Steven Deeks of UCSF, who was not involved in the study. “At the end of the day, it provides additional proof that long COVID is real, that some people can have profound symptoms, and that they can persist for a couple of years.”

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By Amber Dance

Biden extends pandemic rescue funds for affordable housing

The Treasury Department released new guidelines that will make it easier for state and local governments to apply COVID relief funds to affordable housing projects, reports Joey Garrison at USA Today.

Cities and states have already spent $12.9 billion from 2021’s $350 billion American Rescue Plan on housing.

Now, there will be fewer restrictions on governments’ use of additional relief dollars for loans to nonprofits and developers building affordable housing.

The move also allows governments to direct relief funds to several federal housing programs, such as low-income housing credits and housing for people who are elderly or disabled.

“This is a major win for increasing housing stock and lowering the cost of housing for thousands of Americans,” said Rep. Alma Adams (D-N.C.), who co-sponsored legislation to allow this change.

Fall booster push moved up to September

Pfizer and Moderna have now promised to deliver millions of improved, ómicron-targeting vaccines to the United States by September, a month earlier than previously expected.

With an expectation of boosters in hand so soon, the Biden administration has scrapped plans to release a summer booster with the original vaccine formula. It wouldn’t be effective to get two boosters in such close proximity, and doing so might even raise the risk of myocarditis, an inflammation of the heart, as a side effect.

“Officials agreed on the goal of strengthening everyone’s immunity in the fall with what is hoped will be a more effective booster, ahead of a possible winter surge,” write Noah Weiland and Sharon LaFraniere at The New York Times.

The pair report that all adults will be eligible for the new boosters, and children might be eligible as well.

The Biden administration has purchased 105 million doses of Pfizer’s vaccine, and 66 million Moderna doses. The U.S. has an option to purchase more — enough for all 330 Americans — but would require additional money from Congress to do so, reports Naomi Thomas at CNN.

The updated boosters would still require FDA authorization and CDC recommendation before use. 

Summit plans for future COVID vaccines, but where’s the money?

The first generation of coronavirus vaccines has saved 20 million lives worldwide, but the White House thinks it can be improved upon.

The Biden administration convened an optimistic “Summit on the Future of COVID-19 Vaccines” last Tuesday. It was “likely the largest indoor gathering of U.S. public health leaders since the pandemic began,” quips Lev Facher at STAT.

Next-gen vaccines might be delivered to the nose with an inhaled mist, triggering antibodies that stop the virus right where it attempts to enter the body. Or they might be needle-free, coming via a skin patch covered in tiny, painless micro-spikes.

They might even create immunity against future, unknown variants.

Conference attendees were upbeat about these prospects, Facher reports, but admitted none of it would happen with billions of dollars from a Congress that has been reluctant to release more money to combat the pandemic. 

The current vaccines resulted in great part from the Trump administration’s Operation Warp Speed, which spent $18 billion on COVID vaccines.

One official told Facher a funding request for as much as $12 billion is being prepared.

“We need vaccines that are durable,” said White House COVID coordinator Dr. Ashish Jha. “We need vaccines that are broader and offer longer-lasting protection. We need a vaccine that can stand up to multiple variants. Ultimately, we need vaccines that can protect us no matter what Mother Nature throws at us.” 

These new vaccines could take three to five years, or longer, to develop, writes Cheyenne Haslett at ABC News. Jha expressed hope that timeline could be cut drastically if a large government investment were made.

Few families choose vaccination for youngest children

Just one month into vaccine eligibility for children younger than 5, the last group to be granted access, interest has already begun to wane, according to an analysis by the Kaiser Family Foundation.

By July 20, about 544,000 children under age 5 had started the vaccine series — just 2.8% of the 19 million newly eligible kids. The number of children getting vaccinated has been dropping since the beginning of July.

For comparison, 18.5% of children ages 5 through 11 had received their first dose one month after they became eligible. Eight months in, only 30% have completed a vaccination course. 

The District of Columbia has the highest uptake, with 14.4% of young kids starting vaccination, while Mississippi had the lowest share at 0.4%. In Florida, the only state not to pre-order vaccines from the government, 1% of young children have received their first dose.

KFF analysts attributed the low uptake, in part, to fewer locations where young kids can be vaccinated. Washington Post columnist Alyssa Rosenberg notes that D.C. set up vaccination clinics all over the city, with weekend and late hours, making access easy.

“Public health officials should make sure logistics aren’t keeping kids from getting vaccinated,” she writes. 

Another issue is parental caution about trying the shots, especially since many parents perceive the pandemic as less of an emergency now than it was when vaccines arrived for adults and older kids.

KFF’s latest Vaccine Monitor survey found that 53% of parents of kids younger than 5 viewed the vaccine as a greater threat to their child’s health than the virus itself. 

Many Black parents reported it would be difficult to take time off work to get the vaccine and deal with potential side effects, notes James Lopilato at MedPage Today. Hispanic parents were concerned about finding a trustworthy vaccination site and the potential cost of the vaccine. (The vaccines are free.)

Health experts were alarmed by the results, reports Jan Hoffman at The New York Times. Patricia A. Stinchfield, president of the National Foundation for Infectious Diseases, noted that “some kids get very, very ill from [the virus] and some die.”

Long-lasting symptoms can also occur in children. A recent study found that 5.8% of kids had problems like fatigue or cough 90 days following COVID infection, reports Elizabeth Short at MedPage Today.

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WASHINGTON (AP) — The Biden administration is calling on people to exercise renewed caution about COVID-19, emphasizing the importance of getting booster shots for those who are eligible and wearing masks indoors as two new highly transmissible variants are spreading rapidly across the country.

The new variants, labeled BA.4 and BA.5, are offshoots of the omicron strain that has been been responsible for nearly all of the virus spread in the U.S. and are even more contagious than their predecessors. White House doctors stressed the importance of getting booster doses, even if you have recently been infected.

“Currently, many Americans are under-vaccinated, meaning they are not up to date on their COVID-19 vaccines,” said Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention. “Staying up to date on your COVID-19 vaccines provides the best protection against severe outcomes.”

Walensky said the U.S. has seen a doubling in the number of hospitalizations due to COVID-19 since April, reflecting the spread of the new subvariants, though deaths remain steady around 300 per day.

Dr. Anthony Fauci, the nation’s top infectious disease expert, said while the new variants are concerning, with boosters, indoor masking and treatments the country has the tools to keep them from being disruptive.

“We should not let it disrupt our lives,” he said, “but we cannot deny that it is a reality that we need to deal with.”

He added that even if someone recently had COVID-19, they should get a booster.

“Immunity wanes, so it is critical to stay up to date with COVID 19 vaccines,” he said.

All Americans age 5 and over should get a booster five months after their initial primary series, according to the CDC, and those age 50 and over — or those who are immunocompromised — should get a second booster four months after their first. According to CDC, tens of millions of eligible Americans haven’t received their first booster, and of those over 50 who got their first booster, only 28% have received their second.

“If you’re over 50 and you haven’t gotten the shot this year, you should go get a shot,” said White House COVID-19 coordinator Dr. Ashish Jha. “It’s going to save your life.”

Jha and Fauci said the U.S. is regularly discussing expanding eligibility for a second booster shot to all adults, but that no decision has been made yet.

“It’s a regulatory decision on the part of the FDA,” Fauci said.

Jha said people who are eligible for a booster but haven’t received one shouldn’t wait for forthcoming vaccines targeted at the omicron strain in addition to the original form of the coronavirus. The U.S. has ordered 105 million of those updated shots, which studies show provide better protection against omicron variants, but they won’t be available until the fall.

“Let me be clear, if you get vaccinated today, you’re not going to be ineligible to get the variants specific vaccine, as we get into the later part of fall and winter,” Jha said. “So, this is not a tradeoff, we’ve got plenty. It’s a great way to protect yourself.”

Added Fauci, “The threat to you is now.”

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Pandemic slashed Native American life expectancy

An updated preprint finds that American Indian and Alaska Native populations took the biggest hit to life expectancy of any American race during the pandemic.

An earlier version of the study found steep dips for Black and Hispanic populations between 2019 and 2021, but the drop of 4.71 years for Native American populations is even worse.

“We were horrified to see how large [the change] was,” said study author Dr. Steven Woolf of Virginia Commonwealth University.

As for the reason behind racial disparities, Woolf pointed to inequities not only in health care but also in social factors that contribute to health, including access to education, housing, and jobs that pay a living wage.

A recent CDC report, focusing on Alaska, delineates how AI/AN people in the state are at increased risk for COVID-19. Their risk for illness, hospitalization or death between March 2020 and December 2021 was more than double that for white residents.

Potential causes for the disparities include structural racism and inhabiting remote, rural areas where health care is limited and getting to providers often requires lengthy journeys.

The agency called for “culturally competent public health efforts that are designed in collaboration with AI/AN persons and communities” to combat the problem.

Moderna’s omicron formula boosts antibodies

Moderna’s top candidate for a fall COVID booster is a one-two punch that delivers mRNA for the original coronavirus spike protein plus the omicron version. The company announced Wednesday that this approach increased antibodies against omicron and could have long-lasting effects.

On average, the 437 adults in the trial had their blood’s ability to block the omicron variant rise by a factor of eight compared to their pre-boosted levels.

Based on that eightfold amplification, Moderna’s chief medical officer Dr. Paul Burton thinks the booster’s effects might last for a year, reports Ian Sample at The Guardian.

“For the first time, we could really be looking at the potential for just once-yearly boosting,” said Burton, “because we can get people to such a high level that they will take longer to decay.”

There’s another way to look at Moderna’s data, comparing those omicron-boosted people to 377 subjects who received the original-formula booster. In that case, the new bivalent shot led to a more modest increase in antibodies that worked against omicron, by a factor of 1.75.

There’s a caveat: Moderna’s new formula uses the genetic code for the BA.1 omicron variant, which is no longer the dominant variant of concern. In the U.S., BA.4 and BA.5 are rapidly gaining ground.

“Many experts worry that the virus is evolving so quickly that it is outpacing the ability to modify vaccines,” writes Sharon LaFraniere at The New York Times.

Moderna president Dr. Stephen Hoge said that in a very small dataset, it looked like the new booster still generated enough antibodies that worked against BA.4 and BA.5, albeit at a lower level than it countered BA.1.

Burton told The Guardian, “I feel confident it would hold up against the [omicron] family now.”

The only way to catch vaccines up with viral evolution, writes LaFraniere, would be to skip human trials for each booster. This is what’s done for the yearly influenza shot, and it’s an approach many health care professionals would be comfortable with, according to virologist John Moore of Weill Cornell Medicine in New York.

The FDA’s vaccine advisory committee will meet on June 28 to discuss booster formulas for fall. Pfizer is also testing booster that targets omicron.

The shot could be available to adults as soon as late summer, said Moderna CEO Stéphane Bancel in a press release.

Moderna plans to study the updated booster in children, but it’s possible the FDA could authorize an omicron-specific booster for all ages without those studies, reports Alexander Tin at CBS News.

FDA committee greenlights Novavax shot

A group of outside experts convened by the FDA voted on June 7 that the benefits of Novavax’s protein-based coronavirus vaccine, in a two-dose series, outweigh the risks.

The vote was 21-0, with one abstention. The abstainer, Dr. Bruce Gellin of the Rockefeller foundation, characterized his vote as a “conditional yes.” He was satisfied with the company’s data on their vaccine’s 90.4% efficacy against the viruses circulating in late 2020 and early 2021, but he wondered how it would hold up against omicron.

Novavax is already testing an omicron-specific booster in a trial in Australia, report Jacqueline Howard and Nadia Kounang at CNN.

The vote came 18 months after emergency authorization of the first coronavirus vaccine, and Moderna’s and Pfizer’s shots for adults are now fully approved. Some panelists questioned whether the adding another kind of vaccine merited the emergency authorization Novavax requested. In nations where the Novavax vaccine is already authorized, uptake has been low.

The FDA’s Dr. Peter Marks countered that this vaccine, based on viral protein instead of mRNA, might be more palatable to some vaccine-hesitant Americans.

“Anything we can do to get people more comfortable to be able to accept these potentially lifesaving medical produces is something that we feel we are compelled to do,” said Marks.

Martha Dawson, president of the National Black Nurses Association, told the panel that some patients would be more comfortable with the traditional, protein-based formula.

People who are allergic to ingredients in the mRNA vaccines might be able to tolerate the Novavax shot.

Its higher stability at refrigerator temperatures is also an advantage over the mRNA shots.

But the FDA did raise a red flag over five cases of inflammation in or around the heart, mostly in young men, that occurred shortly after vaccination.

Novavax argued that this rate, 0.007%, wasn’t significantly different from the 0.005% rate of heart inflammation among subjects who received a placebo shot.

The vaccine is not shipping to pharmacies yet. The final decision is still up to the FDA, which is resolving concerns about the manufacturing process.

The vaccine is made at the Serum Institute of India, and the FDA wants confirmation that the Serum product is a match in quality for the shots used in the clinical trials.

The CDC’s vaccine committee would then likely weigh in on whether that agency should recommend the shots. The committee has meetings scheduled later in June, but the CDC has not yet posted detailed agendas.

Should the vaccine be authorized by FDA and recommended by CDC, the Biden administration has plans to purchase “a limited quantity,” report Carl Zimmer and Rebecca Robbins at The New York Times.

But slow and steady could still be a winning strategy: Novavax hopes the vaccine will find a place in ongoing booster regimens.

WH shuffles funds to pay for vaccines, treatments

The Biden administration, still waiting for Congress to release more funding to counter the pandemic, will move money around to pay for vaccines and treatments in the coming months, reports Tony Romm at The Washington Post.

The funds, about $10 billion, will be pulled from programs focused on testing and stockpiling of personal protective equipment and ventilators, an anonymous official told Romm.

The move could also mean cuts to further research on vaccines and treatments.

On Wednesday, the White House shared preliminary plans for distributing vaccines to children younger than 5. Authorization for this age group is widely expected after FDA and CDC advisory committee meetings on June 15 and June 18, respectively. June 21 is the earliest the shots could be available.

The vaccine will be free at pharmacies, but the administration also hopes to put it on offer at physician’s offices and health clinics as well as libraries and children’s museums.

Five million kid-sized doses from both Moderna and Pfizer are already available for pre-order, with millions more expected to be released within weeks. So far, states have ordered fewer than half of those doses, with Pfizer proving more popular.

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By Amber Dance

Pandemic response neglected poor Americans

Communities in lower-income U.S. counties suffered twice the COVID-19 death rate of wealthier American counties according to a new Poor People’s Pandemic Report, writes Ed Pilkington at The Guardian. 

The gap was even worse during major surges, rising to a three-fold difference in deaths between the poorest and richest 10% of counties during the omicron winter wave.

Because CDC has not been tracking income distribution alongside death rates, the report fills an important hole in the national pandemic picture, writes Pilkington. The Poor People’s Pandemic data, from more than 3,000 U.S. counties, are accessible online.

Vaccination rates didn’t explain the disparities, the authors found, but the large number of people in poor counties who don’t have health insurance was a likely contributor.

“The findings of this report reveal neglect and sometimes intentional decisions not to focus on the poor,” said Bishop William Barber, co-chair of the Poor People’s Campaign, which produced the report in collaboration with the UN Sustainable Development Solutions Network.

Counties with high death rates included those largely comprising communities of color (such as Hancock, Georgia) as well as some with primarily white populations (Robertson, Kentucky).

New report outlines COVID’s impact on ‘Black America’

Race continues to be a major factor in pandemic impact. A new report from the Black Coalition Against COVID notes that hospitalization rates for Black people was much higher than other populations during the omicron surge, Usha Lee McFarling reports for STAT.

“The juxtaposition — that for some, the pandemic is over, yet the hospitalization rate for Black people is higher than it’s ever been — is stark,” said Dr. Marcella Nunez-Smith of Yale University’s School of Medicine.

The report also details higher rates of children being orphaned, children missing time in the classroom, food insecurity, and pandemic-linked anxiety, depression, and substance use disorders among Black people, compared to white Americans.

All of this is a “predictable result of structural and social realities,” the report says, rather than any biological or genetic factors related to race.

Researchers are also studying how media reports of racial disparities influenced attitudes during the early pandemic, and a recent study in the journal Social Science & Medicine reached a “disturbing conclusion,” writes Ed Pilkington at The Guardian.

The study found that when white U.S. residents were made aware of racial disparities through media reports, they were less afraid of the virus, felt less empathetic towards vulnerable populations, and were less supportive of safety precautions.

That leads the study’s authors to the unsettling suggestion that publicizing racial disparities could, paradoxically, contribute to a “vicious cycle wherein raising awareness reduces support for the very policies that could protect public health and reduce disparities.”

COVID boosters could become annual affair

The FDA’s vaccine advisory committee met last week to discuss a path forward for COVID-19 booster shots, leading to a new FDA plan to seek annual vaccines with at least 80% efficacy against severe disease and death, reports Poynter’s Al Tompkins in his Covering COVID-19 newsletter.

The challenge is to design a booster by spring to defend against the most likely prevailing variant in the coming fall. Trevor Bedford of the Fred Hutchinson Cancer Research Center told the panel that a dangerous new variant like omicron could emerge as often as every 18 months, or as rarely as once a decade.

Ultimately, the committee found there was no existing framework in place to choose when to offer a COVID-19 booster, and which variant to target, writes Andrew Joseph in STAT’s play-by-play of the meeting.

“We’re in uncharted territory,” said acting committee chair Dr. Arnold Monto of the University of Michigan.

Pfizer and Moderna are both trialing omicron-specific vaccine formulas, the effects of which could inform future decisions. The committee will likely convene again in May or June to make more specific plans for fall boosters, reports Scott Hensley at NPR.

Committee members also questioned the FDA’s recent move, made without their input, to authorize second booster shots for Americans 50 and older now. That decision has sown considerable confusion, as Yasmeen Abutaleb and Lena H. Sun report at The Washington Post, because the agency didn’t go so far as to recommend older adults get the shots.

That call was based in part on data from Israel, where second boosters were made available to elderly individuals and health care workers months ago. Two studies from Israel indicated that a fourth dose, compared to three shots, increased protection against severe disease by 73% and death by 78%, reports Yaron Kelner at Haaretz.

However, in one of the studies, fewer than 1% of people in either the three-dose or four-dose group experienced severe symptoms. And the added protection against infection from the additional dose quickly fizzled, dropping to just 29% within 10 weeks.

The European Medicine Agency, relying on the same Israeli data, decided against authorizing a fourth dose, Tompkins notes.

The FDA’s Dr. Peter Marks clarified that the recently authorized additional booster was intended as a stopgap to protect vulnerable groups, and not a signal of an ongoing booster strategy.

Marks also said that once the FDA makes the switch to vaccines targeting a new variant, all vaccines would be changed, including those for the initial series of shots. That means Americans won’t be forced to deliberate the merits of protection from different variants when choosing a booster shot.

According to a STAT-Harris Poll, 60% of U.S. adults would get a second booster if it was recommended, and an additional 22% would do so if there were a new variant or surge in their area.

COVID spending bill hits another snag

Early last week, the Senate appeared poised to approve $10 billion in funds for COVID-19 vaccines, therapeutics and research, only to hit another roadblock over the Biden administration’s plan to relax pandemic-era immigration restrictions.

The bipartisan deal was already for much less than the $22.5 billion the White House had requested. It cut $5 billion in funding for global aid, which many experts say is crucial to block development of new variants that could impact U.S. citizens. The deal also eliminated support for tests, vaccination and treatment of uninsured people.

The $10 billion left in the bill would send $9.25 billion to the Biomedical Advanced Research and Development Authority, including at least $5 billion to purchase therapeutics. This budget would also be used to purchase tests and vaccines.

The remaining $750 million was earmarked for the Public Health and Social Services Emergency Fund to cover research, development, and manufacturing of new vaccines.

The purse was based entirely on unspent funds from previous measures, including unused money originally funneled towards grants for shuttered entertainment venues, small business loans, and other sources. Katie Lobosco and Tami Luhby at CNN have all the details.

The Senate initially planned to pass the bill quickly, which would require unanimous agreement to proceed to a vote.

But the Biden administration announced on April 1 that it planned to lift border restrictions known as Title 42 that, for the past two years, have allowed border agents to expel migrants to prevent COVID-19 spread.

Several Democrats had pushed the White House to make the change, especially in light of the rollback of travel restrictions, write Caroline Simon and Suzanne Monyak at Roll Call.

The reduced restrictions, expected to take place in late May, are expected to lead to a large influx of migrants and asylum-seekers.

Some Democrats as well as Republicans were displeased with the announcement. Several GOP senators said on April 5 that they wouldn’t vote to proceed on the COVID relief funds without progress toward a vote on border restrictions as well.

Lawmakers cited “mixed messages from the Biden administration as it seeks to remove a pandemic mitigation measure while simultaneously demanding billions of dollars to address the continuing spread of the virus,” report Mike DeBonis and Rachel Roubein at The Washington Post.

Senate Republican leader Mitch McConnell said, “There will have to be an amendment on Title 42 in order to move the bill.”

COVID-19 plus diabetes hits harder

People with diabetes are very vulnerable to the coronavirus but haven’t received much attention during the pandemic, writes reporter Andrew Jacobs at The New York Times.

Jacobs cites studies suggesting that 30% to 40% of COVID deaths in the U.S. were among people with diabetes, but this “sobering figure has been subsumed by other grim data from a public health disaster that is on track to claim a million American lives sometime this month.”

More than 37 million people in the U.S. have diabetes, according to the CDC, with 20% of those unaware they have it.

Diabetes impairs both the immune system and the cardiovascular system, putting people at higher risk for COVID complications.

“It’s hard to overstate just how devastating the pandemic has been for Americans with diabetes,” said Dr. Giuseppina Imperatore of the CDC.

The disease also contributes to COVID’s racial disparities. Uncontrolled diabetes, which seems to create the greatest danger, is more prevalent among people of color, Jacobs notes.

Researchers and clinicians hope the pandemic’s toll will bring more attention to the disease.

Sadly, the pandemic may also swell the ranks of people with diabetes, writes Clare Watson at Nature.

A study of more than 180,000 U.S. veterans who survived COVID found that their risk of developing type 2 diabetes within the year following infection went up by 40%.

Post-COVID diabetes occurred even in people with no other risk factors for the disease and a mild case of COVID, though more severe COVID-19 amplified the diabetes risk.

It’s not clear how COVID-19 influences diabetes risk. Some researchers have suggested that the virus could damage the pancreas, leading to impaired insulin production. But a lab study failed to substantiate that idea, writes Watson.

The veterans in the study were mainly older, white men, so it’s not certain the results will apply to other populations. It’s also not yet known if the diabetes risk continues beyond one year.

From the Center for Health Journalism

4/20 Webinar: Making Mental Health Care More Equitable: What Works?

We’ll hear from a leading international researcher of mental health access about challenges for immigrants and communities of color. Dr. Sergio Aguilar-Gaxiola of the University of California, Davis, will share a model of innovative community-based approaches to make it easier for Latino, Filipino and LGBTQ+ clients to benefit from mental health care.

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Many Americans now can get a second COVID-19 booster, but it’s hard to tell who really needs another shot right now and who could wait.

The Food and Drug Administration authorized extra Pfizer or Moderna shots for anyone 50 or older and for some younger people with severely weakened immune systems. It’s an effort to get ahead of a possible next coronavirus surge.

With COVID-19 cases low in the U.S., it’s easy to ignore calls for another dose — or for those who aren’t yet vaccinated or boosted to get up to date, said Dr. Erica Johnson, an infectious disease specialist at the American Board of Internal Medicine.

Her advice: If you’re on the fence, use this lull to talk with your doctor about how protected you really are — and need to be.

WHO IS ELIGIBLE FOR A SECOND BOOSTER?

Anyone 50 and older can get the extra dose at least four months after their last vaccination. So can severely immune-compromised patients, such as organ transplant recipients, as young as 12.

Adults can choose either the Pfizer or the Moderna vaccine for their extra shot, but Pfizer is the only option for children.

WHAT ABOUT PEOPLE WHO GOT JOHNSON & JOHNSON?

Adults who received J&J’s single-dose vaccine already were eligible for a booster of any kind — and the Centers for Disease Control and Prevention recommends only some of them get another.

A new study found a Moderna or Pfizer second shot was superior to getting a second J&J dose. So the advice is anyone who got a second J&J shot now can choose a Moderna or Pfizer dose.

But if they already had one of those other boosters, the CDC says only those who meet the newest criteria — age or weak immune system — qualify for another.

WHAT PROMPTED THE MOVE?

Vaccines still offer strong protection against severe illness and death, but effectiveness against milder infections wanes months later. The shots also don’t work as well against new variants like the super-contagious omicron mutant as they did earlier in the pandemic.

That’s why everyone 12 and older, regardless of their health, already was urged to get a first booster for the best chance at fending off omicron. Only about half of those eligible have.

With an omicron sibling causing spikes in infections in other countries, officials are nervous the U.S. is next, prompting efforts to offer extra protection to the most vulnerable.

WHAT’S THE EVIDENCE FOR ANOTHER BOOSTER?

Many scientists say it’s limited, leaving public health officials to use their best judgment.

During the U.S. omicron wave, two Pfizer or Moderna doses plus a booster were 94% effective against death or needing a ventilator, according to a recent CDC study. That protection was lowest — 74% — in immune-compromised people, although most hadn’t gotten the already recommended third dose.

Israel began offering people 60 and older a second booster during its omicron surge. Preliminary findings posted online last week show there were fewer deaths among people who chose another booster compared to those who skipped the fourth dose.

The FDA decided to set the age limit at 50 instead of 60 because that’s when chronic illnesses like heart disease or diabetes become more common, leaving people more vulnerable to serious COVID-19.

WHO REALLY NEEDS A SECOND BOOSTER?

The CDC says an extra shot is an option — but those most likely to benefit are those most vulnerable to severe disease, including people 65 and older and 50-somethings who have multiple health problems.

WHEN SHOULD I GET IT?

Again, experts have differing opinions, partly because it’s not clear how long any extra benefit lasts.

“We can never really perfectly time when the next wave is, or when someone might encounter infection,” said Johnson, who sees patients at Johns Hopkins Bayview Medical Center in Baltimore. “To be as ready as possible, I think everyone just needs to stay as up to date as possible with their vaccines.”

Another dose now may make sense for older people and the immune-compromised, but “there’s less urgency in an otherwise healthy person,” said University of Pennsylvania immunologist E. John Wherry.

At 50, Wherry said he’s healthy enough to watch if cases rise enough to prompt another booster, but he’d prefer to wait until fall. That’s because going longer between vaccinations allows the immune response to better mature and strengthen.

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By Amber Dance

Omicron hospitalized record number of Black adults

Recent data indicates that during the winter surge, non-Hispanic Black adults were hospitalized at higher rates than any other ethnic group, at any time in the pandemic, according to a new report from the Centers for Disease Control and Prevention.

Black adults were four times as likely as white adults to be hospitalized during the winter omicron wave.

Part of the reason is likely lower immunization rates, writes Akilah Johnson at The Washington Post. Black people made up 31% of all hospitalized, unvaccinated patients during the omicron surge. Fewer than 40% of Black Americans had receive two vaccine shots by Jan. 26, according to the CDC report.

Unequal access to health care and racism in the health care industry have driven disparities throughout the pandemic, notes Noah Y. Kim at Mother Jones.

Hospitalization rates also increased over the winter for Asian and Pacific Islander adults. Rates fell in American Indian, Alaska Native and Latino populations, the CDC reported.

Vaccines block severe illness from omicron BA.1, BA.2 too

The CDC also reported that COVID-19 vaccines did their job during the omicron BA.1 outbreak, despite the variant’s highly contagious nature, reports Katie Shepherd at The Washington Post.

Vaccines from Moderna and Pfizer, both based on mRNA technology, protected people from the worst outcomes of needing a ventilator to breathe or death. “Receiving two or three doses of an mRNA COVID-19 vaccine was associated with a 90% reduction in risk for COVID-19–associated invasive mechanical ventilation or death,” the report states.

Getting a booster enhanced protection against serious illness. Among people who contracted COVID, unvaccinated people were nine times more likely to die than people who received the initial two-dose vaccine course, and 21 times more likely to die than those who’d been boosted as well, writes Shepherd.

The mRNA vaccines’ efficacy against milder illness has been shown to wane, dropping to 78% protection against hospitalization within four months of a booster.

And the Johnson & Johnson vaccine, despite its lesser reputation, now seems to be working about as well as the mRNA formulas against infection, hospitalization and death — even among those who haven’t sought a booster shot — reports Apoorva Mandavilli at The New York Times. Not everyone is convinced this is true, she adds, and it’s not clear why it now appears more effective.

The next big test for the vaccines will be omicron BA.2, now dominating the globe and making up just over a third of U.S. cases.

While several nations are currently facing omicron outbreaks, fueled in large part by the BA.2 variant, U.S. case rates remain low. Hospitalizations are the lowest they’ve been since last summer.

Experts now predict a rise in U.S. cases due to BA.2, but nothing like winter’s surge. “Hopefully, we won’t see a surge,” the NIH’s Dr. Anthony Fauci said last week. “I don’t think we will.”

One preprint study from Qatar, not yet peer reviewed, suggests the mRNA vaccines work as well against BA.2 as they did against BA.1, though the protection afforded by boosters still wanes within months, reports Saima May Sidik at Nature.

Moderna tees up to vaccinate youngest children

Moderna announced last week that its clinical trial of two COVID-19 vaccine doses for children between 6 months and 5 years were successful, writes Molly Walker at MedPage Today: The shots were safe, and they induced antibody levels equivalent to those of vaccinated adults.

But the vaccine’s real-world efficacy against omicron, at first glance, seems less than stellar: during the winter surge, the shots were 37.5% effective against illness, which the company defined as a positive COVID-19 test plus at least one symptom, for children ages 2 to 5. For those under 2, efficacy was just slightly higher at 43.7%.

Since the trial wasn’t specifically designed to measure efficacy, those numbers aren’t statistically certain, but Moderna said efficacy was definitely more than zero, reports Carolyn Y. Johnson at The Washington Post.

The FDA originally sought vaccine efficacy levels against infection of 50% or higher, but that was before the omicron variant. Moderna said these numbers from the pediatric vaccine were comparable to the protection that two doses of its vaccine gave adults during omicron.

And children have proven comparatively resilient to coronavirus, which means there may have been less room for improvement. No children in either of the trial’s vaccinated or placebo groups became ill enough to require hospitalization, so it’s impossible to say for certain if the vaccine protected against severe disease or death, or by how much.

As for safety, while more than one in 10 of the children 5 and younger had a fever after vaccination, these were generally mild. There were no cases of heart inflammation (myocarditis) or death after the vaccination.

“40% with adequate safety data could be very meaningful, especially to higher risk individuals,” former FDA chief scientist Luciana Borio told STAT.

Moderna is also testing a third, booster shot in children of all ages, and planning to apply for authorization of the vaccine in children aged 6 to 11. The company’s vaccine authorization for teens has been stalled over concerns about a risk for myocarditis, which is less common in younger kids.

Several other nations have already authorized the Moderna vaccine for teens and kids as young as 6.

This move means Moderna could leapfrog Pfizer in the race to vaccinate younger children. Despite enthusiasm from regulators eager to protect these children, the only age group still ineligible for vaccination, Pfizer’s application was put on hold after two doses didn’t generate the level of antibody response seen in teens and adults. Pfizer is also testing a third dose, with results expected in April.

The different results from the two companies may lie in the doses used. Pfizer’s dose for the youngest children is 3 micrograms of the active ingredient, while Moderna’s is 25 micrograms.

Expiry of pandemic relief imperils school meal programs

Millions of children rely on the National School Lunch Program, which received additional funding during the pandemic. That funding is now set to expire at the end of June.

Loosened rules that allowed programs more flexibility, such as waiving the requirement that children eat together in groups, are also coming to an end.

During the pandemic, school programs could spend the extra money on fruits and veggies. Going back to the old ways will mean less funding, higher expenses and less healthy meals, reports NPR’s Allison Aubry.

For example, for students to eat as a group during the summer break, some rural districts must send busses around so the kids who qualify for school meals can eat together, on the bus. With prices rising for gas as well as food, doing so will mean less money for decent meals on the roving cafeteria.

The decision to extend the waivers lies with Congress, and thus far lobbying by nutrition advocates and school food directors has been unsuccessful.

As a result, kids could miss more than 95 million meals over the summer of 2022, said Lisa Davis, head of the national No Kid Hungry campaign.

Ending the flexible programs would have real consequences for children’s health, notes Aubry. Poor nutrition is linked to chronic conditions such as diabetes and obesity, which in turn increase the risk for severe COVID disease.

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By Amber Dance

Society is woefully unprepared for the wave of people disabled by long COVID

Some commentators see a return to normal just around the corner at last and the CDC is reportedly preparing looser mask guidelines. But life may never go back to normal for a growing group of people left with lingering health problems from the coronavirus.

“Two years in, the debilitating tail of the pandemic has revealed itself in the form of tens of millions of people living with long COVID,” writes Laura Spinney at Nature.

There were 1.2 million more people with disabilities in the U.S. in 2021 than 2020, notes the Center for American Progress (CAP). At least some of those people are suffering from long COVID, which the federal government has labeled a disability.

But policymakers and employers are underprepared. And people with long COVID may not know they’re eligible for accommodations, struggle to prove those needs amid skepticism, and face stigma. 

It may be particularly difficult to get long-term disability benefits for self-reported, difficult to measure problems such as brain fog, writes Allen Smith at the Society for Human Resource Management. Responsibility to prove disability falls on the person making a claim for benefits, not their employer or insurer.

Solid data on long COVID remains scarce, and researchers have few answers on the long-term prognosis of those afflicted. But recent estimates cited by Spinney “indicate that disability is likely to account for the lion’s share of COVID-19’s burden, and might disproportionately affect women, especially those who were infected young.”

Notes CAP, “People who are disabled and are also members of another marginalized group — such as disabled LGBTQI+ people — often bear the brunt of barriers to economic security.”

Since COVID-19 infections have been more prevalent in populations of color, long COVID is likely to follow a similar pattern. Vulnerable groups face ongoing barriers in accessing care and affording specialized treatments.  

New antibody treatment approved, but treatment disparities remain

The FDA authorized a new monoclonal antibody treatment, bebtelovimab, to protect high-risk patients from severe COVID, including the omicron variant, reports Andrew Joseph at STAT. Its maker, Eli Lilly, expects to ship 300,000 courses of treatment in February. 

There are currently more than 100,000 U.S. cases on average being diagnosed every day, though not all have the risk factors that would warrant antibody treatment. 

The new treatment should help assuage the fact that two other antibody treatments have failed against omicron, while compensating for shortages of a third that does work.

These treatments are in addition to the three authorized antivirals, paxlovid, molnupiravir and remdesivir, which have held up against omicron.

Access and equity remain a problem, writes Phil McCausland at NBC News. Antibody treatments have more often gone to white patients than people of color.

The antiviral pills, paxlovid and molnupiravir, are free and easy to use, but require a physician’s prescription. That doctor’s visit must be scheduled quickly for the drugs to help, and the appointment can be too expensive — or just unavailable — for low-income or uninsured people.

“I got 500 bottles of molnupiravir just sitting there in my pharmacy,” pharmacist Pete Nagel told NBC. “I’ve had four or five different patients die from COVID when I’ve had the pills to help them and couldn’t give it to them.”

Pharmacists are allowed to order and administer the antibodies, via four injections. Some advocates say they should be able to prescribe antiviral pills as well.

The pills are in short supply, and the FDA says those prescriptions should be in doctor’s hands so physicians can assess patients’ risk for severe COVID and for potential drug interactions or side effects.

Booster protection wanes, and other vaccine news

About 28% of the U.S. population is fully vaccinated and boosted, but fewer people than ever are getting boosted, reports Jacqueline Howard at CNN. 

Those who have received an mRNA booster — from Pfizer or Moderna — can’t expect the extra protection to last for long, according to new CDC data. As with the initial series of two shots, protection against the need for doctor visits or hospitalization started high and waned within about four months of receiving the booster. 

“How long that third shot’s protection lasts is a critical question facing public health officials because many people received their third dose months ago,” notes Lena H. Sun in The Washington Post. The NIH’s Dr. Anthony Fauci said a fourth dose down the line might be necessary, perhaps based on people’s age or other risk factors.

The boosters people got in recent months did seem to hold up against the latest variants, which is good news because omicron-specific boosters didn’t work any better than the original formulations in early animal studies, reports Emily Waltz at Nature. 

Nevertheless, human trials with omicron-specific shots are underway, with results expected within months.

Meanwhile, even the first doses of vaccine for children younger than 5 remain in limbo; Pfizer’s data show the company’s dose for young kids is less effective against the omicron variant, report Jared S. Hopkins and Stephanie Armour at The Wall Street Journal.

But recent CDC data suggest that when expectant mothers get vaccinated, their babies are protected after birth. 

Another change in vaccine guidelines may be coming. The CDC is considering extending the time between the first and second doses of the mRNA vaccines to eight weeks, writes Julia Ries at Healthline. 

While maximizing protection within just a few weeks made sense during vaccine trials and the early rollout, the longer interval may boost efficacy while reducing risk for the heart condition known as myocarditis.

Other nations have already extended the interval between shots. While such a change would be a “seismic policy shift” in the U.S., write Drs. Michael Daignault and Monica Gandhi in MedPage Today, they say the change is “long overdue.”

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