Claim that the FDA found that coronavirus vaccines awaiting approval could cause death is majorly misleading

 Newswise
10-Dec-2020 2:30 PM EST, by Newswise

Fact Check By: Craig Jones, Newswise

Truthfulness: Mostly False

Claim:

The FDA knows that rushed-to-market COVID-19 vaccines may cause a wide range of life-threatening side effects, including death

Claim Publisher and Date: GreenMedInfo on 2020-12-06

GreenMedInfo, an alternative health website that has published articles claiming vaccines cause autism, published an article on December 6th warning about the adverse side effects of the coronavirus vaccines, including death. The article has been shared thousands of times by anti-vaccine Facebook pages and groups. We rate this article as mostly false and misleading. 

Although the vaccines were developed in record time, it doesn’t mean they’re unsafe. The FDA is still monitoring for potential adverse side effects from the vaccines in development. So far, it has not found that any of the COVID-19 vaccines seeking approval cause death.

As reported by Daniel Funke on Politifact...

We reached out to GreenMedInfo for a comment. Founder Sayer Ji said his website’s intention was "to counterbalance the highly biased promotion of vaccines as ‘safe and effective’ a priori."

Ji also cited an FDA briefing document on the vaccine developed by Pfizer and its partner, BioNTech. The United Kingdom on Dec. 8 became the first country to start distributing the vaccine, and Canada approved it the next day.

In the document, the FDA reported that six of 43,448 participants died during clinical trials of the vaccine held from April to November. Two had been given the vaccine, and four had received a placebo. 

Both participants who received the vaccine and died were older than 55; one died from cardiac arrest, the other from arteriosclerosis. The vaccine was not listed among the causes of their deaths, which the FDA said were characteristic of their age groups. 

Although the agency did note some minor side effects associated with the vaccine, including fatigue and headache, it said there were "no specific safety concerns identified that would preclude issuance" of emergency use authorization.

The FDA’s assessment supports Pfizer’s Nov. 18 announcement that its vaccine was safe and 95% effective at preventing the coronavirus. The agency will meet Dec. 10 to discuss whether to approve the emergency-use authorization, after which it will be assessed by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices and continue to be studied in clinical trials.

"The FDA would only issue an EUA if the vaccine has demonstrated clear and compelling efficacy in a large well-designed phase 3 clinical trial," the FDA told PolitiFact. "If an EUA is issued, the process will not be rushed, and no shortcuts will be taken around having the relevant phase 3 efficacy results."

GreenMedInfo was created in 2008 and has published several articles that falsely claim there’s a link between vaccines and autism. In 2018, Pinterest banned the site for violating its policies against anti-vaccine misinformation. 

The website’s statement contains an element of truth but ignores critical facts that would give a different impression. We rate it Mostly False.

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Claim that the FDA found that coronavirus vaccines awaiting approval could cause death is majorly misleading
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GreenMedInfo, an alternative health website that has published articles claiming vaccines cause autism, published an article on December 6th warning about the adverse side effects of the coronavirus vaccines, including death. We rate this article as mostly false and misleading.

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