FDA Panel Backs Shift Toward One-Dose COVID Shot

A panel of advisers to the FDA unanimously supported an effort today to simplify COVID-19 vaccinations, with the aim of developing a one-dose approach — perhaps annually — for the general population.

The FDA is looking to give clearer direction to vaccine makers about future development of COVID-19 vaccines. The plan is to narrow down the current complex landscape of options for vaccinations, and thus help increase use of these shots. 

COVID remains a serious threat, causing about 4000 deaths a week recently, according to the Centers for Disease Control and Prevention (CDC). 

The 21 Members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted “yes” on a single question posed by the FDA:

“Does the committee recommend harmonizing the vaccine strain composition of primary series and booster doses in the US to a single composition, e.g., the composition for all vaccines administered currently would be a bivalent vaccine (Original plus Omicron BA.4/BA.5)?”

In other words, would it be better to have one vaccine potentially combining multiple strains of the virus, instead of multiple vaccines — such as a two-shot primary series followed by a booster containing different combinations of viral strains.

The FDA will consider the panel’s advice as it outlines new strategies for keeping ahead of the evolving virus.

In explaining their support for the FDA plan, panel members said they hoped that a simpler regimen would aid in persuading more people to get COVID vaccines.

Pamela McInnes, DDS, MSc, noted that it’s difficult to explain to many people that the vaccine worked to protect them from more severe illness if they contract COVID after getting vaccinated.

“That is a real challenge,” said McInness, a retired deputy director of the National Center for Advancing Translational Sciences at the National Institutes of Health.

“The message that you would have gotten more sick and landed in the hospital resonates with me, but I’m not sure if it resonates with” many people who become infected, she said.

The Plan

In the briefing document for the meeting, the FDA outlined a plan for transitioning from the current complex landscape of COVID-19 vaccines to a single vaccine-composition for the primary series and booster vaccination.

This would require:

  • Harmonizing the strain composition of all COVID-19 vaccines (mRNA, protein-based)

  • Simplifying the immunization schedule for future vaccination campaigns to administer a two-dose series in certain young children and in older adults and persons with compromised immunity, and only one dose in all other individuals

  • Establishing a process for vaccine strain selection recommendations, similar in many ways to that used for seasonal influenza vaccines, based on prevailing and predicted variants that would take place by June to allow for vaccine production by September.

During the discussion, though, questions arose about the June target date. Given the production schedule for some vaccines, that date might need to shift, said Jerry Weir, PhD, director of the division of viral products at FDA’s Center for Biologics Evaluation and Research.

“We’re all just going to have to maintain flexibility,” Weir said, adding that there is not yet a “good pattern” established for updating these vaccines.

The study was funded by Merck. Smith reports receiving grant funding from Merck. Jones reports no relevant financial relationships.

Kerry Dooley Young is a freelance journalist based in Miami Beach. She earlier covered health policy and the federal budget for Congressional Quarterly/CQ Roll Call and the pharmaceutical industry and the Food and Drug Administration for Bloomberg.  Follow her on Twitter @kdooleyyoung.

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