Biologics

Vaccine Advisors Angry at Lack of Transparency

David McFarland

— 2 min read
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Some members of FDA and Centers for Disease Control vaccine advisory committees are “angry” and “disappointed” that neither the government nor Moderna presented some Moderna Covid-19 booster shot infection data when the advisors considered at meetings in 6/2022 and 9/2022 whether the booster should be authorized and made available to the public. CNN reports the data that weren’t presented were early and had many limitations, even as it showed that the updated Moderna booster might not be any more effective at preventing Covid-19 infections than the original shots.

The article quotes FDA Vaccines and Related Biological Products Advisory Committee member Paul Offit as being “angry to find out that there was data that was relevant to our decision that we didn’t get to see. Decisions that are made for the public have to be made based on all available information, not just some information but all information.”

While the committees were given immunogenicity data, CNN says, they did not receive data that looked at actual infections.

The six FDA and CDC advisors CNN interviewed said the data would not have changed now they voted, because of the data’s limitations, but it still should have been presented.

“There should always be full transparency,” said FDA committee acting chair Arnold Monto. “These data should not be dismissed. They are early, but they indicate the need to look at them and see what their value is.”

The advisors told CNN there are three main reasons why it matters that they did not receive the infection data:

  • the potential impact on their decision;
  • the fact that advisory committee meetings are streamed worldwide and other regulatory agencies use the information that is presented to help make their own decisions; and
  • the need to be transparent.

Former FDA Office of Vaccine Research and Review deputy director Philip Krause told CNN there’s no excuse for excluding the information. “The company’s failure to present this information and the omission of a discussion about the data at the meeting raises questions about the ability of the process to provide a full and transparent review of the data,” he said. Krause resigned from his position in 10/2021.

He said that preserving or regaining public trust in FDA was the most important thing. “FDA’s objective review of the data is what is providing the great, great value to the American people because they know that somebody who doesn’t have a stake in the outcome has looked at the deepest possible level at these data.”

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