The independent advisers will also discuss at the April 6 meeting the FDA’s role in how future versions of COVID vaccines are created to help fight new variants.
It could be similar to the current process of selecting the composition of the seasonal flu shot, where regulators pick the strain to use for the coming year’s vaccines, FDA staff said in briefing documents ahead of the meeting.
“Implicit in all of this is the notion that we will need further boosters down the road,” said Dr. William Schaffner, infectious disease expert at Vanderbilt University Medical Center in Nashville, Tennessee.
U.S. health officials in late March authorized a second booster dose of the Moderna (MRNA.O) and Pfizer (PFE.N) vaccines for people aged 50 and older, citing data showing waning immunity and the risks posed by Omicron variants of the virus. read more
Roughly 45% of the fully vaccinated in the United States have received a booster dose, according to federal data.
“The greatest concern many of us have is the acceptability of continuing boosters,” Schaffner said.
The FDA’s staff said on Monday that new variants are often more infectious, transmissible and distinct from earlier virus strains.
“The 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,” FDA staff said in briefing documents ahead of the April 6 meeting.
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