FDA Expert Panel Reportedly 'Disappointed' That Moderna Neglected to Present Key Reinfection Data for New COVID Vaccine

AP Photo/Ted Jackson

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Members of the Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee, an external body of vaccine experts that advises the FDA, are expressing anger at Moderna, maker of COVID vaccines and boosters, for being less than candid about their latest product.


According to a report by CNN — yes, this is a negative report on a pharmaceutical company about a COVID vaccine that appeared at CNN; savor that for a moment — there was a “lack of transparency” in the data presented by Moderna to the advisory committee.

“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.


I’m not going to argue about the safety and efficacy of the COVID vaccine.

I’ve had COVID. I’m not getting the vaccine. Ever. I’ll just leave it there.

There are a few observations that can be made here. First, omitting critical data to the FDA advisory committee isn’t an oversight. Moderna’s team either knew the proposed vaccine had nearly double the reinfection rate of the current vaccine and deliberately didn’t flag that data, or they are idiots. It isn’t easy to come up with other alternatives.

The reason they did it is pretty simple. Money. The COVID vaccine earned Moderna over $18 billion last year. It isn’t so much that the product is great; it’s that you have federal, state, and local governments acting as sales representatives and enforcers. When the federal government stops buying the vaccine this year, Moderna plans on a price point of about $130 per shot. Those vaccine mandates will still be in place, but the federal government will no longer be footing the bill.

Just a reminder of where we are with the vaccines and boosters.


In my view, the 800-lb gorilla snoring away in the corner is not so much Moderna playing fast and loose with data presented to the non-employee advisory committee. Instead, the issue is what data did Moderna show the FDA and what conversations did FDA have with Moderna on what data should be briefed to the advisory committee. Unlike Moderna and the FDA, the advisory committee members didn’t have a financial or career stake in the outcome.

The FDA nearly serves as a AAA farm club for Pharma.

The same people who were on point in lying about the COVID vaccine and batting down objections suddenly ended up with very high positions in the drug companies they were supposed to oversee. When your client is your future employer, the government’s — and people’s — interests are not always best served.

Of course, being incensed about Moderna’s deception and $8 will get you a blue check on Twitter. The Moderna vaccine will be issued. No one in either the FDA or Moderna will lose their job. Quite to the contrary, I can easily see where it could be a case of bonuses for everyone. The FDA meets a goal of having a new vaccine to cram down our throats. Moderna has a new product to force people to buy. Win-win.


Never fear, though; Moderna has more vaccines on the way.



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