U.S. FDA staff says Moderna did not meet all criteria for COVID-19 boosters
[quote] (Reuters) - Scientists at the U.S. Food and Drug Administration said on Tuesday that Moderna Inc (MRNA.O) had not met all of the agency's criteria to support use of booster doses of its COVID-19 vaccine, possibly because the efficacy of the shot's first two doses has remained strong.
[quote] FDA staff said in documents that data for Moderna's vaccine showed that a booster does increase protective antibodies, but the difference in antibody levels before and after the shot was not wide enough, particularly in those whose levels had remained high.
[quote] "There was boosting, sure. Was it enough boosting? Who knows? There’s no standard amount of boosting that is known to be needed, and nor is it clear how much boosting happened in the study,” John Moore, a professor of microbiology and immunology at Weill Cornell Medical College in New York, said in an email.
Another article characterizes the FDA's response as
[quote] FDA scientists neutral on Moderna Covid-19 vaccine booster ahead of key meeting
The administration will make the decision on the boosters and may or may note take the FDA's advice.
One university professor characterized the strongest case for boosters this way: The people were promised cake, and so we shall have cake.
Yet DL fav Eric Topol said this about the Moderna booster-
[quote] The evidence for Moderna's booster appears to have "a lot of holes," said Dr. Eric Topol, a professor of molecular medicine and director of the Scripps Research Translational Institute in La Jolla, California, noting that the data provided was limited and offers no insight into how the boosters actually perform in people.
[quote] "That is fairly short of what Pfizer had from Israel, where they had the full restoration of the vaccine effectiveness from the booster," Topol said.