COVID-19 Vaccine Second Booster Authorization A ‘Stopgap Measure,’ US FDA’s Marks Says
CBER director says agency understands 'we simply can't be boosting people as frequently as we are,' but wants to give older and immunocompromised individuals extra protection now while FDA considers whether and when formulations should be modified ahead of an expected surge this fall.
You may also be interested in...
US FDA was trying to focus people on a one-booster-per year, updated fall COVID vaccine campaign to address what they perceive as the public’s inoculation exhaustion, but as BA.5 seems to be sending the US into another surge the White House is pushing a summer booster campaign.
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.
Doran Fink says FDA wants to transition the pandemic vaccines to more flu-like labeling under BLAs.