US FDA Bypasses Adcomm In Authorizing Second COVID Booster Because Decision ‘Straight-Forward’
Advisory committee member says FDA's decision to authorize extra shots of Pfizer and Moderna vaccines for those 50 and older was a short-term solution and that VRBPAC should prioritize long-term issues related to the coronavirus.
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FDA Commissioner says the new shots will skip advisory committee review after June meeting on reformulation. ‘As we know from prior experience, strain changes can be made without affecting safety.’
Seeking To Provide ‘The Best Clarity Possible,’ ACIP Votes For COVID Vaccine Booster In Children 5-11
CDC advisory committee recommends Pfizer/BioNTech vaccine booster, but one member votes ‘no,’ citing concern that only 29% of children ages 5 to 11 have received the primary two-dose series and arguing the focus should be on additional vaccinations, not additional doses.
Safety and effectiveness of an mRNA-1273 second booster dose was inferred in large part by extrapolation from reported evidence following use of the Pfizer/BioNTech COVID-19 vaccine in individuals 60 years and older in Israel, FDA review memos show.