U.S. FDA advisers to weigh on updating initial COVID vaccine doses
FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly PFE -2.78% Add to/Remove from Watchlist Add to Watchlist Add Position
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(Reuters) -The U.S. Food and Drug Administration (FDA) said on Friday it planned to hold a meeting of outside experts next month to discuss whether initial doses of COVID-19 vaccines need to be updated to combat circulating variants.
While updated booster doses from Pfizer (NYSE:PFE) and Moderna (NASDAQ:MRNA) are already approved for adults as well as children as young as five years, the FDA said it was important to weigh in on the composition of both initial and booster doses as new variants spread.
“Since the initial authorizations of these vaccines, we have learned that protection wanes over time, especially as the virus rapidly mutates and new variants and subvariants emerge,” the FDA said in a statement.
The independent advisers, who are scheduled to meet on Jan. 26, are also expected to weigh in on whether the timing or composition of booster doses need to be adjusted.
The U.S. health regulator’s announcement comes after the European Medicines Agency’s (EMA) emergency task force said earlier this month that bivalent COVID-19 shots, which target the original strain and the Omicron BA.4/5 subvariants, may be used in previously unvaccinated children and adults.
EMA’s recommendation was based on data that showed primary vaccination with the adapted bivalent vaccines should give rise to a broad immune response in people who have not yet been exposed to or vaccinated against COVID-19.
In June, advisers to the FDA had recommended a change in the composition of COVID-19 booster shots before fall to combat more recently circulating variants of the coronavirus.
