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Coronavirus Files: FDA advisors back Novavax; Moderna claims once-a-year booster

Coronavirus Files: FDA advisors back Novavax; Moderna claims once-a-year booster

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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.

From the Center for Health Journalism

We’re hiring!

The USC Center for Health Journalism at the Annenberg School for Communication and Journalism is seeking two Engagement Editors to serve as thought leaders in one of the most innovative and rewarding arenas in journalism today – “engaged reporting” that puts the community at the center of the reporting process. Learn more about the positions and apply to join our team.

Learn more and apply here.

What we're reading

  • “The everything virus,” by Jon Allsop, Columbia Journalism Review
  • “Are these Cocoa Krispies-loving hamsters a key to cracking long COVID?” by Jason Mast, STAT
  • “Partly cloudy with a 75% chance of COVID exposure,” by Betsy Ladyzhets, FiveThirtyEight
  • “The kids who have never known life without COVID-19,” by Anna North, Vox
  • “How long COVID could change the way we think about disability,” by Frances Stead Sellers, The Washington Post
  • “The U.S. has wasted over 82 million COVID vaccine doses,” by Joshua Eaton, NBC News

Events and Resources

  • June 14–15, 5:30 a.m.–2 p.m. PT: The FDA’s vaccine advisory committee will convene first to discuss Moderna’s application for emergency authorization for ages 6 through 17. Then on June 15, the committee will discuss Moderna’s application for ages 6 months through 5 years, and Pfizer’s application for ages 6 months through 4 years. Click here for livestream links and background materials (available two days before the meeting).
  • June 27–July 31: The Knight Center offers a massive online open course on “Mental Health and Journalism: How journalists can responsibly report on it and take care of themselves.”

Giving Back

Help us continue to serve journalists and policy leaders with new content we are developing on COVID-19. Your tax-deductible contribution to the Center for Health Journalism will advance our mission of helping journalists investigate health challenges and solutions in their communities –serving as a catalyst for change.

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The USC Center for Health Journalism at the Annenberg School for Communication and Journalism is seeking two Engagement Editors to serve as thought leaders in one of the most innovative and rewarding arenas in journalism today – “engaged reporting” that puts the community at the center of the reporting process. Learn more about the positions and apply to join our team. 

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