covid vaccine
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.

The data was early and had many limitations, but several advisers told CNN that they were concerned about a lack of transparency.

US taxpayers spent nearly $5 billion on the new booster, which has been given to more than 48.2 million people in the US.

"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.

That data - called immunogenicity data - was based on blood work done on study participants to assess how well each vaccine elicited antibodies that fight off the Omicron strain of the virus that causes Covid-19.

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 - 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.

Despite these imperfections, the data was included in a preprint study that was posted online in June, again in September in an FDA document and then later that month in a top medical journal - and advisers to the FDA and the CDC said the data should have been shared with them, too.

"It's not a group of children. We understand how to interpret these results," said Dr. Eric Rubin, a member of the FDA vaccine advisory committee.

The six 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.

"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."

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. At last year's meetings, Moderna executives made presentations, as well. The advisers then make their recommendations to the agencies, and the agencies decide whether to authorize the shots and recommend them to the public.

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.

He added that "throughout the pandemic, the FDA has remained as transparent as possible regarding its processes and decision-making regarding the COVID-19 vaccines" and that Moderna could have chosen to present the data at the FDA advisory committee meeting.

Kristen Nordlund, a CDC spokeswoman, said that "due to the many limitations involving this clinical data, it was not featured" in the CDC's advisory committee discussion.

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