Did FDA know a child had died in Moderna's Covid jab clinical trial? If so, what did the agency do about it?

So far, the agency has refused to answer. Beginning Jan. 20, it will have to.

Friday, I reported on the death of a child in Moderna’s key clinical trial for its Covid mRNA vaccine - a death the company failed to admit publicly for years and has even now acknowledged only a single obscure filing in Europe.

But did Moderna tell the Food and Drug Administration, as the company was legally required to do? What steps, if any, did the FDA take in response?

The agency has so far refused to answer. But based on what the FDA said to me on Friday, it seems likely the agency did know about the death - a fact it is trying to hide.

In response to a first round of questions last week, an FDA spokeswoman offered a carefully crafted response that appeared worded to avoid acknowledging the death, without actually denying it. She did not respond to further questions.

The FDA will not be able to stonewall much longer. Sen. Ron Johnson (R-WI) told me he intends to subpoena the agency to find out what it knew as soon as Republicans officially take control of the Senate later this month.

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(Truth. And consequences. Help me get both, for less than 20 cents a day.)

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I have a confession.

When I first contacted the FDA with questions about the death of a pre-school aged child in Moderna’s KidCOVE clinical trial, I didn’t say I had hard information about the death from Moderna’s European report. Instead I wrote:

I'm wondering if the FDA has any information about pediatric deaths in the KidCove trial… I am told that one or possibly two deaths occurred during the trial, which has now been concluded.

This phrasing was accurate (the report refers to the death in two different places), but it no doubt gave the agency the impression I was acting on a tip rather than hard evidence.

Essentially, I wanted to know if the FDA would be honest or try to mislead me with a carefully worded response.

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(And the health of Moderna’s stock price! Don’t forget that!)

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The next day, I had my answer.

An agency spokeswoman responded with a two-paragraph statement.

Nowhere in its 152 words did the FDA - a federal agency that claims its job is “promoting and protecting human health” - acknowledge the death. But the agency also did not make a simple, clean denial by saying no children had died in any trials at any time.

Instead, the agency offered this artful dodge:

For the clinical trials of the Moderna COVID-19 Vaccine that were the basis of the Emergency Use Authorization (EUA), there were no deaths reported in any age group [from 6 months to 17 years old]…

The statement then referred to the “Decision Memorandum” on the data, which is dated July 1, 2022 and signed by Dr. Peter Marks.¹

The FDA’s statement is either intentionally misleading, factually incorrect, or both.

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A child died of “cardio-respiratory arrest” in the Moderna KidCOVE trial, the key trial that formed “the basis” of the authorization.

But Moderna’s report makes clear the child died after the memorandum was issued, during an extension of the trial that began in late 2022 and tested a reformulated version of Moderna’s mRNA Covid shot designed to work better against Omicron.

Thus the FDA is not lying when it says the trial data that form “the basis” for authorizing of the shots for kids at the time of the authorization didn’t include a death - though the agency is wrong to say the trial itself didn’t include that death, since the trial continued.

In any case, the careful wording appears designed to hide rather than inform. It might have succeeded in preventing me from reporting on the death if I had been relying on a tip rather than hard evidence from Moderna itself.

I then followed up with a second round of questions, this time making clear I knew about the death and asking the agency to come clean about what it knew:

I'm sorry, but you have not answered my questions… Did Moderna report any deaths? Can the agency provide any details of possible deaths? And if so, why hasn't the FDA publicly disclosed them?

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(Journalism, up close)

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The agency did not respond to that, or follow-up emails.

To be clear: the FDA’s job is not supposed to encourage² the use of any drug or vaccine, much less to protect the companies that make them. Its job is to license products as safe and effective and give the doctors and patients the information they need.

All the information, even if it might hurt Moderna’s sales.

The death of a child in a vaccine clinical trial - even if the company sponsoring the trial claims the death is unrelated - clearly is an important piece of evidence as to the safety of the vaccine. Physicians and parents have the right to know it.

Why didn’t the FDA tell them?

It doesn’t want to say.

But very soon, it’s not going to be able to hide.

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(If my work matters to you, support it. Please.)

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Original story here (Moderna still hasn’t responded either).

1. Yes, the same Peter Marks who came up with Operation Warp Speed in 2020 - the original sin, as it made him a promoter of the vaccines he would ultimately have to regulate - and then demanded booster Covid jabs on essentially no evidence in 2021, causing two top FDA vaccine regulators to resign.

2. Or discourage - a rule the agency apparently did not believe applied to ivermectin. In March 2024 the FDA agreed to delete its infamous “you are not a horse” tweet to settle a lawsuit from physicians who said the agency had interfered with their ability to prescribe approved medicines as they saw fit. Whatever ivermectin’s merits, the doctors were clearly right that FDA had overreached.