FDA Vaccine Advisers 'Disappointed' and 'Angry' That Early Data About New Covid-19 Booster Shot Wasn't Presented For Review Last Year (cnn.com) 168
The pharmaceutical company Moderna didn't present a set of infection data on the company's new Covid-19 booster during meetings last year when [FDA] advisers discussed whether the shot should be authorized and made available to the public
That data suggested the possibility that the updated booster might not be any more effective at preventing Covid-19 infections than the original shots. The data was early and had many limitations, but several advisers told CNN that they were concerned about a lack of transparency.
Specifically, Moderna hid data on actual infection rates among patients who were administered the original booster and those who got the bivalent vaccine. The data showed that the original booster resulted in slightly fewer infections than the bivalent version - though CNN points out that "the primary purpose of the study was not to study infection rates but to do immunogenicity analyses, taking blood from participants and examining their antibody responses to the vaccine."
CNN reports that Moderna "shared the infection data with the FDA and posted the study manuscript before the agency's panel meeting in June," but with an FDA spokesperson complaining that they received the preprint less than a day prior to the advisory committee meeting, and "therefore not provided in an adequate timeframe for it to be included in the agency's meeting materials..."
1.9% of the study participants who received the original booster became infected. Among those who got the updated bivalent vaccine -- the one that scientists hoped would work better -- a higher percentage, 3.2%, became infected.
Both versions of the shot were found to be safe. This infection data was far from complete. The number of study subjects who became infected was very small, and both the patients and the researchers were aware of who was getting the original shot and who was getting the new booster.... [S]ix FDA and CDC advisers interviewed by CNN said that this infection data wouldn't have changed how they voted, because the data had such limitations, but it still should have been presented to them.
Research released by the New England Journal of Medicine found that "boosting with new bivalent mRNA vaccines targeting both the BA.4-BA.5 variant and the D614G strain did not elicit a discernibly superior virus-neutralizing peak antibody response as compared with boosting with the original monovalent vaccines. Limitations of our study include the small sample size and follow-up period of our groups. We also note that the between-group comparisons were not controlled for factors such as age, vaccine type, and health status, which may have had an effect on antibody responses. These findings may be indicative of immunologic imprinting, although follow-up studies are needed to determine whether antibody responses will deviate over time, including after the administration of a second bivalent booster."