Moderna Asks FDA To Authorize Its Updated Covid Shot
Moderna is ready, it says, to ship the new version of its vaccine in September, hence it's seeking official authorization for the shots, which will target BA.4 and BA.5 subvariants. The FDA request is based on data from a booster targeting an earlier omicron variant rather than new human trials.
The Wall Street Journal:
Moderna Asks FDA To OK Updated Covid-19 Shot
Moderna Inc. has asked U.S. regulators to authorize a new version of its Covid-19 vaccine that targets the latest coronavirus strains. Moderna said on Tuesday that it is ready to ship doses of the new shot in September if it is cleared by the Food and Drug Administration. ... Moderna’s new shot is designed to protect against the original coronavirus strain that emerged in China in late 2019, as well as the Omicron subvariants BA. 4 and BA. 5 that are currently dominant in the U.S. (Walker, 8/23)
The Hill:
Moderna Seeks FDA OK For Updated COVID-19 Booster
Moderna’s vaccine is intended for adults aged 18 and older. Pfizer’s vaccine will be for adults and adolescents aged 12 and older. ... Like Pfizer, Moderna said it does not have clinical trial data for the vaccine. Instead, the request is based on data from a booster targeting an earlier version of omicron, as well as preclinical data from mice. (Weixel, 8/23)
NBC News:
Moderna Asks FDA To Authorize Its Updated Covid Booster Shot
Moderna’s application also includes data on how well the BA.4/BA.5 booster shot performed in animal studies, as studies in humans have yet to be completed. The decision to move forward without complete data from human trials is considered controversial by some scientists, who say it remains unclear whether the new Covid shots will perform any better than the existing vaccines. (Lovelace Jr., 8/23)
