Will COVID-19 Vaccine Booster Shot Restore Full Immunity? Wait For Answer Almost Over
ACIP will discuss possible boosters for immunocompromised people next week. Pfizer’s head of vaccine R&D and BioNTech co-founder and CEO discuss whether neutralizing antibodies are necessary for protection against SARS-CoV-2, indication in children, and the low and high points of their collaboration at Stat summit.
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Agency is pledging to act well ahead of the six-month review deadline in reviewing full applications for COVID 19 vaccines that are already authorized for emergency use. Going too fast may be counterproductive, in more ways than one.
Dosing is capped under emergency use authorizations, but studies show reduced antibody response following primary vaccination series in individuals with compromised immune systems; although BLA approval could allow for off-label prescribing, government officials are exploring other regulatory options for earlier access, including through a study.
US position remains that boosters are not needed yet, but CBER Director Peter Marks says regulators are discussing how to harmonize applications for booster shots.