Coronavirus Files: FDA vaccine committee OKs move to all-bivalent vaccines

Published on
January 30, 2023

Latino teens take the lead in vaccine education

Community health groups are deputizing teenagers to get the word out about COVID vaccines and testing, reports Heidi de Marco at Kaiser Health News.

“Teenagers communicate differently, and they get a great response,” said Sandra Celedon, CEO of Fresno Building Healthy Communities, a nonprofit that helped design an internship program. “During outreach events, people naturally want to talk to the young person.”

More than 84% of Latino and Hispanic adults have completed the primary vaccine series, but fewer than 13% have received the updated bivalent booster, according to CDC data. And de Marco reports that vaccine hesitancy and mistrust remain a challenge in some communities,  particularly for those who speak Spanish at home.

Spanish-speaking advocates and promotoras — non-licensed community health workers that help people access health resources and make good choices — are particularly effective in Latino communities.

Many of the teens in Fresno’s Promotoritos health worker program are children of immigrants, refugees, or immigrants without legal status.

The internships also expose the Hispanic and Latino students to health care career options, where their demographic is underrepresented among physicians, de Marco notes.

FDA advisors look to simpler vaccinations for the future

The FDA is ready to move COVID vaccinations to a flu-like model, in which the agency would release a single booster shot each fall, based on its best guess at what variants will be circulating in winter.

The agency convened its vaccine advisory committee Jan. 26 to discuss the potential shift and the questions it raises.

A key question for the committee was whether the agency should simplify the nation’s vaccine offerings.

Currently, people who get the primary series receive original-formula vaccines, which were designed to match the coronavirus strain that emerged in Wuhan more than three years ago. This fall’s booster, in contrast, is a mix of that vaccine plus one tailored to the omicron strain.

Committee member Dr. David Kim, who directs the Department of Health and Human Services’ National Vaccine Program, noted that the current situation has forced pharmacists and physicians to rely on complex diagrams and flow charts just to pick out the right vial for each patient.

The committee unanimously voted that the FDA should simplify the process by dropping the old vaccine formula and using the current bivalent shot for all vaccinations going forward.

“Bivalent is better, simple is better,” said temporary voting member Dr. Mark Sawyer of UC San Diego.

It’s not clear exactly when the change will take place.

The real-world value of the current bivalent shots remains uncertain, notes Keren Landman, who lays out the latest evidence at Vox.

Experts say it’s not feasible to chase after a vaccine for every new variant, but that improvements to the vaccine over time are still possible.

The FDA floated the idea of picking a new vaccine formula every June, which would give Pfizer and Moderna time to produce new mRNA vaccines by September. Releasing vaccines in early fall would, theoretically, allow the populace to be vaccinated and ready for a winter surge.

But Novavax, which makes a protein-based vaccine, said it would need six months to reformulate its product for a fall campaign. Several committee members urged the FDA not to overlook Novavax, which claims its shots provide broader immunity to variants than the mRNA vaccines.

Committee members also cautioned that the coronavirus is not influenza, and that copying the vaccine design process and schedule from the flu may not be the most appropriate strategy.

Other experts have noted that the coronavirus has yet to settle into a clear seasonal schedule like flu, and that there’s not enough evidence to assume one annual shot is the way to go, as reports Cecelia Smith-Schoenwalder at U.S. News & World Report.

The advisory committee also questioned what the goal of annual vaccination campaigns would be: Are we trying to prevent transmission, severe infection, or deaths?

“The goal is to keep people out of the hospital,” said committee member Dr. Paul Offit of the Children’s Hospital of Philadelphia. Current vaccines, he said, already do that.

Offit echoed his colleagues’ comments when he said the committee needs more data on who’s still dying from the coronavirus to decide “who gets vaccinated, with what, and when.”

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Tripledemic appears to be waning

Americans can breathe easier as COVID, flu, and RSV all seem to be declining. 

“Early waves of respiratory syncytial virus and influenza peaked before the new year,” writes Fenit Nirappil at The Washington Post. “And the expected winter uptick of coronavirus is nowhere close to overwhelming hospitals.”

While it’s difficult to track all infections, a new CDC data dashboard indicates that emergency room visits for all three viruses are at the lowest level in three months, reports Deirdre McPhillips at CNN.

“Being able to look at the proportion of individuals that seek care at an emergency department for these respiratory illness concerns is a really good measure of the respiratory disease season,” said Janet Hamilton, executive director of the Council of State and Territorial Epidemiologists.

But winter isn’t over. “Whether that pattern will hold is still up in the air,” warns McPhillips. Respiratory virus activity remains higher than normal in most parts of the U.S. And in some years the flu has a second winter peak.

The CDC currently lists fewer than 4% of U.S. communities at the “high” level of COVID community transmission, but the highly contagious XBB.1.5 variant continues to spread. That variant now makes up more than half of the nation’s variant pool. And less than 16% of the population is up to date on their COVID vaccines.

 Evusheld is out as COVID prophylactic

The FDA has removed authorization for the antibody combination known as Evusheld, which was previously used to protect immunocompromised people who were unable to generate sufficient antibodies after vaccination on their own.

In response, the CDC has urged people with weak immune systems to wear masks and social distance, reports Spencer Kimball at CNBC.

The move was not unexpected, given the Evusheld antibodies are no longer a good match for the most prevalent strains of the coronavirus. 

“Still, the withdrawal amounts to another blow to the nation’s toolkit for fighting the coronavirus,” writes Andrew Joseph at STAT. “The virus’s evolution has also left the country without any antibody therapies for patients once they’re infected.”

Antivirals such as Paxlovid are still an option.

The FDA advised clinics to hold onto Evusheld supplies in case it proves useful against some future variant.

Drugmakers are working on updated antibody treatments. Evusheld provider AstraZeneca says that if all goes well in its trials, a new prophylactic that works against a broader range of variants could be available later this year.

From the Center for Health Journalism

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What we’re reading

  • “HHS needs better oversight of research that alters pathogens, government watchdog says,” by Rachel Cohrs, STAT

  • “Opinion: The time has come for a major reset at the CDC,” by the editorial board of The Washington Post

  • “Families struggle as pandemic program offering free school meals ends,” by Linda Qiu, The New York Times

  • “6.8 million expected to lose Medicaid when paperwork hurdles return,” by Alan Yu, WHYY/NPR

  • “Wave of rural nursing home closures grows amid staffing crunch,” by Tony Leys, Kaiser Health News

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