The FDA has amended emergency use authorizations (EUAs) for the bivalent COVID-19 vaccine boosters from Moderna (Nasdaq:MRNA) and Pfizer (NYSE:PFE) to allow their use in children at least five years old. FDA authorized a single dose of either bivalent vaccine in younger age groups at least two months after completion of primary or booster vaccination.…
Pfizer and BioNTech file for FDA authorization of COVID-19 vaccine boosters for all adults
Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) have filed paperwork with FDA to authorize their COVID-19 vaccine for all adults 18 and older. The two companies had filed a supplemental Biologics License Application for a booster dose of the COVID-19 vaccine in adults at least 16 years old. FDA did not accept the supplemental Biologics License…
Why COVID-19 booster criteria will remain complicated for now
The FDA has authorized COVID-19 vaccine boosters for many people who are fully vaccinated. Individuals seeking boosters must currently navigate a sort of checklist to confirm their eligibility. The criteria for the Janssen vaccine are the simplest: Anyone who has received a single dose of that vaccine can receive an additional dose two months or…
FDA appears to be lukewarm on Moderna COVID-19 vaccine boosters
To date, FDA has been cautious in its consideration of COVID-19 vaccine boosters. Now, the agency seems to be staying the course. In a recently published document summarizing its current view of Moderna’s booster application, the agency concluded that Moderna had not met all of its criteria for authorization. Rather than taking a position, the…
Moderna submits initial data to FDA for COVID-19 vaccine booster
Moderna (NSDQ:MRNA) announced that it initiated its submission to the FDA for a booster dose of its COVID-19 vaccine. Cambridge, Massachusetts–based Moderna expects to submit data to the European Medicines Agency and other regulatory authorities around the world in addition to the FDA in the coming days for the booster shot at a 50 µg…
COVID-19 vaccine booster questions remain
While the question of when the vaccinated public will require a COVID-19 booster remains unclear, some long-term care advocates are pushing for guidance to avoid a potential resurgence in infections in the fall and winter. Nursing home residents were among the first to receive COVID-19 vaccines. Providing boosters to the demographic is vital to prevent…