FDA vaccine advisers ‘disappointed’ and ‘angry’ that early data about new Covid-19 booster shot wasn’t presented for review last year

TL;DR

“I was angry to find out that there was data that was relevant to our decision that we didn’t get to see,” said Dr. Paul Offit, a member of the Vaccines and Related Biological Products Advisory Committee, a group of external advisers that helps the FDA make vaccine decisions.“Decisions that are made for the public have to be made based on all available information – not just some information, but all information.” At a meeting of this FDA advisory group in June and a meeting in September of a panel that advises the US Centers for Disease Control and Prevention, the experts were presented with reams of information indicating that the new vaccine worked better than the one already on shelves, according to a review of videos and transcripts of those meetings and slide presentations made by Moderna, CDC and FDA officials.They are early, but they indicate that we need to look at them and see what their value is.” Dr. Pablo Sanchez, a member of the CDC’s panel, called the Advisory Committee on Immunization Practices, said that if the data “was looked at as part of the study, it should have been presented to the advisers prior to their decision.” The FDA and the CDC convene their advisory board meetings and make presentations to the advisers.Moderna spokesman Christopher Ridley said in an email to CNN that the company shared the infection data with the FDA and posted the study manuscript before the agency’s panel meeting in June “in response to requests that we share an update from the ongoing study.” That study preprint was posted online June 25, three days before the FDA advisers met.Michael Felberbaum, an FDA spokesman, told CNN in an email that “the FDA received the preprint less than a day prior to the advisory committee meeting,” and “the information was therefore not provided in an adequate timeframe for it to be included in the agency’s meeting materials, and generally the FDA only discusses data at advisory committee meetings that the agency has had the opportunity to substantively review.” “Numerous studies support the finding that the COVID-19 vaccines remain the best defense against the most devastating consequences of COVID-19 such as hospitalization and death, and that the updated vaccines may help provide better protection against the currently circulating variants,” Felberbaum wrote."

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