FDA vaccine advisers 'disappointed' and 'angry' that early data about new Covid-19 booster shot wasn't presented for review last year
Key Excerpts from Article on Website of CNN News
Posted: January 22nd, 2023
Some vaccine advisers to the federal government say they're "disappointed" and "angry" that government scientists and 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 the 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. US taxpayers spent nearly $5 billion on the new booster, which has been given to more than 48.2 million people. "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. The data that was not presented to the experts looked at actual infections: who caught Covid-19 and who did not. It found that 1.9% of the study participants who received the original booster became infected. Among those who got the updated bivalent vaccine ... a higher percentage, 3.2%, became infected. A 22-page FDA briefing document given to the advisers did not mention this infection data. Dr. Jerry Weir, director of the Division of Viral Products at the FDA's Office of Vaccines Research and Review, also did not mention the infection data in his presentation to the advisers.