FDA Panel Says New Boosters Should Protect Against Omicron Variant

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On Tuesday, an advisory panel of the Food and Drug Administration met to discuss what the next generation of COVID-19 boosters might look like this fall. And Thursday the panel agreed they should include protection against the BA.4 and BA.5 omicron subvariants.

All of the COVID-19 vaccines and boosters we have now were developed to target the original strain of the virus from 2019. But since then, we’ve seen how different variants emerge and take over — even with 67% of the population fully vaccinated and 47% of eligible people having received at least one booster dose, according to data from the Centers for Disease Control and Prevention.

So the FDA’s Vaccines and Related Biological Products Advisory Committee was tasked with figuring out whether or not it’s time to start updating the vaccines to protect against more coronavirus strains.

Earlier this week, that panel voted to recommend including some type of omicron-specific protection in the next set of COVID-19 boosters. But questions remained after the initial vote about which omicron subvariant the boosters should target and whether the shots should include protection against more than one strain.

Thursday's update provides more clarity: After the vote and using the best evidence that's available now, the FDA advised manufacturers to develop modified vaccines that target BA.4 and BA.5 omicron subvariants in addition to the original strain, Dr. Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, wrote in a statement.

The decision directs manufacturers to "create a two component (bivalent) booster vaccine, so that the modified vaccines can potentially be used starting in early to mid-fall 2022," wrote Marks. "As we move into the fall and winter, it is critical that we have safe and effective vaccine boosters that can provide protection against circulating and emerging variants to prevent the most severe consequences of COVID-19."

However, the FDA did not direct the manufacturers to update the primary vaccine series.

Of course, no one can guarantee exactly which variants we'll be facing in the fall. But the FDA made the calculated decision to target BA.4 and BA.5, which are accounting for an increasing number of COVID-19 cases in the U.S. right now. Together, BA.4 and BA.5 are responsible for about 52% of COVID-19 cases in the U.S., according to the most recent available CDC data. Another subvariant, BA.2.12.1, accounts for 42% of cases while BA.2 now accounts for less than 6%.

Making these decisions quickly is important because, as some panel members noted, they need to give manufacturers enough time to produce the doses with the recommended specifications in time for the fall.

Both Pfizer and Moderna already have COVID-19 vaccines in development that target the omicron variant, as well as the original strain. During the meeting this week, the panel heard from those two companies, as well as Novavax, which developed a different type of COVID-19 vaccine that it hopes will provide broader protection than the other shots.

The panel also discussed changes in severity and death rates as the coronavirus variants wax and wane and the potential for those variants to evade the protection of the current slate of vaccines.

Experts told TODAY previously that there's a good chance that future variants will also likely be related to omicron. So an omicron-specific booster would likely help protect against coronavirus infections from omicron and its subvariants significantly more than the vaccines we have now.

Regular boosters may continue to be necessary if the virus evolves in such a way that our current vaccines are no longer effective at protecting against it, or if the protection from our current vaccines and boosters doesn't last very long, experts said previously. And with the rise of omicron and its subvariants, we may be in one or both of those scenarios this fall, the FDA panel's discussion indicated.

Earlier this week, a World Health Organization panel made a similar determination and recommended including the omicron variant in future COVID-19 booster doses. The WHO panel also concluded that it "may be prudent" to consider updating the primary series of COVID-19 vaccines to include omicron protection.

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