WHAT YOU NEED TO KNOW:
- FDA vaccine advisers were reportedly “disappointed” and “angry” that data on Moderna’s updated Covid-19 booster shot was not presented during meetings last year.
- The data not presented suggested that the new booster shot might not be any more effective at preventing infections than the original shots.
- Advisers told CNN that they raised concerns about a lack of transparency.
Some FDA vaccine advisers say they’re “disappointed” and “angry” that several scientists and the pharmaceutical company Moderna didn’t present a set of data on the updated COVID-19 booster during meetings last year. The meetings were about the discussion of whether the booster should be authorized and made available to the public.
The particular data suggested that the new Moderna booster might not be any more effective than the original shots in preventing COVID-19 infections.
Though data was early and had many limitations, several advisers told CNN that it raised an issue about a lack of transparency.
Nearly $5 billion was spent on the new booster using US taxpayers’ money. It has been administered to more than 48.2 million people in the United States.
“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 aids the FDA to make decisions about vaccines. “Decisions that are made for the public have to be made based on all available information – not just some information, but all information.”
In a meeting in June and September of last year, this FDA advisory group advises the U.S. Centers for Disease Control and Prevention (CDC), they were presented with data indicating that the updated vaccine was more efficient than the original one. The panel reviewed videos and transcripts of those meetings and slide presentations made by Moderna, CDC, and FDA officials.
That data not presented to the experts was called immunogenicity data – based on blood work done on study participants to assess how well each vaccine-elicited antibodies fight off the Omicron strain of the virus.
The data that was not presented to the experts: who caught COVID-19 and who did not.
The FDA and CDC advisers told CNN that this infection data wouldn’t make a difference in how they voted due to limitations, but the fact remains that it still should have been presented to them.
“There should always be full transparency,” said Dr. Arnold Monto, a professor of epidemiology at the University of Michigan School of Public Health and acting chair of the FDA advisers’ group. “These data should not be dismissed. They are early, but they indicate that we need to look at them and see what their value is.”
CNN received an email from Moderna spokesman Christopher Ridley, insisting that the pharmaceutical company shared the infection data with the FDA. He added that the study manuscript was released before the FDA’s panel meeting in June “in response to requests that we share an update from the ongoing study.”