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

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

Fact Check By: Craig Jones, Newswise

Truthfulness: Mostly False


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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The First Dose of the Pfizer Vaccine Gives About 50% COVID Protection, Not 91% Claimed by Those Who Want to Speed Up Immunization

The NEJM paper actually states that the efficacy between the first and second doses was found to be 52 percent when given 21 days apart. After the second dose, the efficacy raises to 95 percent.

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Released: 10-Dec-2020 2:30 PM EST
Claim that the FDA found that coronavirus vaccines awaiting approval could cause death is majorly misleading

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.

Released: 9-Dec-2020 5:05 PM EST
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Released: 3-Dec-2020 2:30 PM EST
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On November 17, U.S. Sentator Rand Paul of Kentucky compared the effectiveness of the Moderna and Pfizer vaccines with "naturally acquired COVID-19" on Twitter. He folllowed-up by asking, "Why does the left accept immune theory when it comes to vaccines, but not when discussing naturally acquired immunity?" Besides ignoring the point of vaccines, which is to protect the public BEFORE they get sick, the comparison of natural COVID-19 infection and vaccine efficacy is inacurate. Reinfections have not been confirmed and the efficacy of naturally-acquired immunity is still not understood.

Released: 1-Dec-2020 2:40 PM EST
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Released: 17-Nov-2020 2:30 PM EST
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Released: 30-Oct-2020 12:10 PM EDT
Are a third of the excess deaths this year not linked to COVID-19? Yes. Are they directly linked to the lockdown? It's complicated.

The article accurately sites a study published in the Journal of the American Medical Association which examined the number of excess deaths in the U.S from March to August, which claimed a 20% increase. Nearly a third of that increase did not have the coronavirus as the underlying cause. However there is no scientific evidence that the deaths were a direct result of lockdown measures.

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