No, 331 babies did not die in Pfizer COVID-19 vaccine trials

Context

A video shared on Instagram makes several false claims about the mortality rate of babies participating in trials for the Pfizer COVID-19 vaccine. Captions alongside the video read: "1% of babies survived in Pfizer Trials." The video description reads: "331 babies died in Pfizer vaccine trials."

The video claims that the cited data comes from the United States Food and Drug Administration (FDA). The video captions and description also promote "spike protein detox supplements" for viewers to buy and claim the supplements will help "detox" from so-called "vaccine shedding" or side effects.

In Fact

There is no evidence that babies or children died during the Pfizer COVID-19 vaccine trials. Claims that the COVID-19 vaccines are harmful or toxic have been widely debunked and lack evidence.

Pfizer did hold COVID-19 vaccine trials via a clinical study that initially enrolled up to 4,500 children between the ages of six months and 12 years. The trials took place in the U.S., Finland, Poland, and Spain, and the prosecution was "designed to evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech vaccine on a two-dose schedule." There is no mention in Pfizer's details of the vaccine trials that any children died due to vaccination.

In May 2022, Pfizer asked the FDA to amend the Emergency Use Authorization to expand the use of the COVID-19 vaccine to include a three-dose series in children aged six months to five years. This included data from the controlled clinical study. Both the FDA and CDC state that there were no deaths in this study nor reports of myocarditis, which is the inflammation of the heart muscle. There is no data or evidence that suggests "331 babies" died or suffered serious side effects during these trials. 

A spokesperson from the FDA told Logically Facts that the Instagram video is "an example of ongoing proliferation of misinformation and disinformation about the overall safety of vaccines that results in vaccine hesitancy and lowers vaccine uptake." 

They added: "The totality of the scientific evidence continues to show that the benefits of COVID-19 vaccination for children outweigh the risks."

The Instagram post also utilizes the abovementioned anti-vaccine claims to push supplements claiming to "detox" the user from the side effects of the vaccine, including "vaccine shedding." The term "vaccine shedding" refers to the release of discharge from vaccine components within or outside the body and occurs when a vaccine contains a live, weakened virus. The COVID-19 vaccines used in the U.S. do not shed.

There is no evidence to support the existence of "vaccine shedding" as a phenomenon, nor any to support the claim that supplements are required to "detox" from the effects of the vaccine.

Logically Facts has previously investigated other anti-vaccine claims about the Pfizer vaccine trials, including claims that six people died and 86 percent of children suffered adverse reactions. We found these claims to be false and misleading.

The Verdict

There is no evidence or data to suggest that babies or children died during the Pfizer COVID-19 vaccine trials. Therefore, we have marked this claim as false.