A Food and Drug Administration official said that the makers of the COVID-19 vaccines will not have to conduct new clinical trials to get approval for booster vaccines they are updating for the newer Omicron variants. Dr. Peter Marks, who directs the FDA’s Center for Biologics Evaluation and Research, told Reuters the agency would use data from vaccine trials targeting BA.1, the Omicron variant that caused a huge spike in infections last winter – as well as producing vaccine evaluation data. Safety data and preclinical data from animal studies may also be used.
This week, the FDA asked vaccine makers to modify the booster shots to target the Omicron BA.4 and BA.5 variants in addition to the original strain of the virus. The agency hopes to have the updated boosters ready by fall. “It’s going to be really critical as we move into this fall where we’ve seen that evolution to BA.4/5 where we can see further evolution to try to get as many people up to speed as possible,” Marks said.
The Centers for Disease Control and Prevention says BA.1 is no longer circulating in the U.S., but BA.4 and BA.5 now account for more than 52 percent of the country’s COVID-19 infections. Combined, they accounted for just 0.5 percent of U.S. cases at the end of April.
Pfizer and Moderna released clinical trial data this week suggesting that versions of their injections targeting BA.1 offer a stronger immune response than the original COVID-19 vaccines. These boosters didn’t do so well against the BA.4 and BA.5. However, the data show that the immune response is still strong.
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