An alternative health website that has published articles claiming that vaccines cause autism is now setting its goals for developing the COVID-19 vaccine.
In a December 6 article, GreenMedInfo wrote that a document from the Food and Drug Administration revealed that the government was concerned about a range of possible side effects from coronavirus vaccines. Among them: death.
“Public discussion and documents reveal that the FDA knows that hasty vaccines on the COVID-19 market can cause a wide range of life-threatening side effects, including death,” the article says below a large ad for an alternative health book. .
The article was featured as part of Facebook’s efforts to combat fake news and misinformation in its News Feed. (Read more about our partnership with Facebook.) Beenshte has been distributed thousands of times by Facebook anti-vaccine sites and groups, according to CrowdTangle, a social media knowledge tool.
As U.S. coronavirus cases close to 300,000, public health agencies are developing a strategy to distribute vaccines to millions of Americans by 2021. The first doses may only be a few days away, so we wanted to take a closer look at the claim that they could to cause serious harm.
The article is misleading.
(Photo by GreenMedInfo)
While the FDA is monitoring for possible side effects, it has not discovered that any of the coronavirus vaccines that require approval cause death. And just because COVID-19 vaccines were developed in record time does not mean that they are unsafe.
GreenMedInfo quoted an October 22 presentation given during a meeting of the FDA Vaccine and Related Biological Products Advisory Committees. A one-on-one presentation shows a “working list of possible side effects outcomes” from coronavirus vaccines. Among them are chronic conditions like autoimmune disease and arthritis, as well as stroke and death.
But that does not mean the FDA has reason to believe that coronavirus vaccines pending emergency use authorization could cause death.
“As shown in the slide, this is a description of possible, unknown, unfavorable outcomes that the FDA will monitor while the vaccine is being administered,” a spokesman for PolitiFact said. “As described in the slide, the FDA plans to monitor 10-20 results of interest.”
While vaccines often take 10 to 15 years to develop, some potential COVID-19 vaccines were developed within a few months. There are several reasons for this, including the fact that scientists had previously worked on vaccines for similar coronaviruses, and funding agencies poured billions of dollars into research on COVID-19 vaccines.
The FDA uses emergency use authorizations during public health emergencies such as the coronavirus pandemic. A vaccine that has been given an emergency use authorization is different from an FDA-approved vaccine in that of an emergency authorization, the “set of scientific evidence” should make it “reasonable to believe that the product can be effective.” For official approval, vaccines must show “essential evidence” of efficacy and safety evidence.
Vaccines that are given an authorization for emergency use still go through a rigorous review process, including all stages of clinical trials.
“Clinical trials are evaluating COVID-19 investigative vaccines in tens of thousands of study participants to generate scientific data and other information needed by the FDA to determine safety and effectiveness,” the FDA says on its website. “These clinical trials are being conducted in accordance with the strict standards set by the FDA.”
Deaths during clinical trials
We reached out to GreenMedInfo for a comment. Founder Sayer Ji said the purpose of his website was to “counterbalance the very one-sided promotion of vaccines as” safe and effective “a priori.”
Ji also cited a summary FDA document on the vaccine developed by Pfizer and its partner, BioNTech. The UK on December 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 the 43,448 participants died during clinical trials of the vaccine held from April to November. Two had received the vaccine, and four had received a placebo.
Both participants who received the vaccine and died were older than 55 years; one died of cardiac arrest, the other of 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 noted some minor vaccine-related side effects, including fatigue and headache, it said there were “no specific safety concerns identified that would preclude the issuance” of the emergency use authorization.
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The FDA assessment supports Pfizer’s November 18 announcement that its vaccine was safe and 95% effective in preventing coronavirus. The agency will meet on December 10 to discuss whether to approve the emergency use authorization, after which it will be evaluated by the Advisory Committee of the Centers for Disease Control and Prevention and Immunization Practices and will continue to be studied in clinical trials.
“The FDA would only issue an EUA if the vaccine 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 to have the relevant Phase 3 efficiency results.”
GreenMedInfo was founded in 2008 and has published several articles that falsely claim that there is a link between vaccines and autism. In 2018, Pinterest banned the site for violating its anti-vaccine misinformation policies.
The website statement contains an element of truth but ignores the critical facts that would give a different impression. We rate it mostly false.