(Bloomberg) -- An all-star panel of Covid experts is gathering Wednesday to hash out how and when vaccines should be updated to address future variants as the virus continues to rapidly mutate.
The meeting of U.S. Food and Drug Administration advisers should provide some of the first hints of its strategy to map out a more proactive plan for developing strain-specific boosters. Until now, the process has been led by drugmakers such as Moderna Inc. and Pfizer Inc., which have gained approval for boosters for specific populations.
This is likely just the beginning. Many researchers believe the vaccines will need to be periodically updated to counteract new strains, just like annual flu shots. A key portion of the coronavirus' spike, the protein it uses to enter cells, evolved at a rate of roughly 12 mutations per year, far faster than the flu virus's annual rate of change, according to slides posted ahead of a presentation at the meeting by Trevor Bedford of the Fred Hutchinson Cancer Research Center.
Chances are roughly 20% that there will be another “omicron-like” event this year, where emergence of a wildly different variant abruptly causes another big wave of infections, according to Bedford's slides. A more likely scenario is that the virus continues to evolve from the current BA.2 subvariant, leading to less dramatic seasonal waves.
The FDA is asking the advisory committee to ponder two major unanswered questions: How often should the vaccine's makeup be assessed to see if it needs to be revised to combat new variants? And what conditions would warrant retooling the vaccine to better match a new strain?
No Vote Planned
Slides published ahead of the meeting by the agency laid out proposed plans for making such changes. The FDA would routinely review the epidemiology of currently circulating variants in the U.S. and consult with advisers while working closely with drug manufacturers and public health agencies to provide clinical data, according to the proposed plan. Any recommendations from the World Health Organization would also be discussed by the FDA and its advisers to evaluate use in the U.S.
The experts will also will review on Wednesday who could be eligible for additional boosters, the timing between doses and whether the agency's role in updating vaccines would mimic the current process for flu shots. No vote is planned at the advisory meeting and there will be no discussion of specific regulatory applications from drug companies.
Nonetheless, the stakes are high for both Moderna and Pfizer, as the meeting could help begin to set broad contours for when vaccines should be updated. Both companies are working on omicron-specific boosters as well as shots that combine existing vaccines with the variant-specific formulation. If Covid shots end up being revised annually, that could lead to billions of dollars of additional sales for both companies.
There is still much to learn about how emerging variants impact vaccine effectiveness, FDA staff said in a briefing document published Monday. “Accumulating data suggest that the composition of vaccines may need to be updated at some point to ensure the high level of efficacy demonstrated in the early vaccine clinical trials,” the staff said.
The early portion of the panel will focus on the latest data on what the virus may hold in store and how best to prepare future iterations of the vaccine.
Israel Data
Researchers from Israel will present data from the country's fourth-shot campaign using Pfizer's booster. The rate of severe illness among people who received a fourth dose of Pfizer's vaccine was about three times lower than those who got only three, according to an Israeli study published Wednesday in the New England Journal of Medicine. The study of data from around 1.2 million people 60 and older also found that people who received three doses reported twice as many infections as those with additional boosters.
More booster-related information will come from Centers for Disease Control and Prevention scientists explaining the latest epidemiology on variants. Kanta Subbarao, a Melbourne-based virologist who chairs the World Health Organization panel devising criteria for vaccine updates, will also provide that agency's perspective on variant-specific shots.
After a public comment period, much of the afternoon session will feature a discussion among panel members about what to do next. The group, called the Vaccines and Related Biological Products Advisory Committee, advises the FDA on immunizations. The agency isn't obligated to follow the recommendations of the panel, though it typically does.
The omicron BA.2 strain has become dominant in the U.S., leading to concerns about a resurgence of cases and the need for additional safeguards. In the U.K., researchers have recently found a potentially more transmissible hybrid strain called XE. In the U.S., booster doses are becoming an increasingly relied-upon tool in the fight against Covid, especially as states and companies cut back on precautions such as masking and working from home.
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