Do the briefing documents filed in support of Moderna's application for Food and Drug Administration (FDA) permission for its COVID-19 vaccine say it causes death and autoimmune disease? No, that's not true: The FDA had, as of May 26, 2021, documented no cases in which death or autoimmune disease onset that coincided with Moderna vaccination was caused by the vaccine. Correlation, as scientists often caution, is not causation.
The claim appeared in a May 10 BitChute video (archived here) by Tamika Morrow titled "Brave Nurse Reveals the Pfizer Moderna Adverse Events Cases and FDA Briefing Documents," which opened:
MRNA SHOTS CAUSE AUTOIMMUNE DISEASE
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Brave Nurse Reveals the Pfizer Moderna Adverse Events Cases and FDA Briefing Documents
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Morrow opens the video by claiming an Associated Press fact check of her prior video did not disprove her claims that the Moderna vaccine causes autoimmune disease. She says she knows the contents of mRNA expert Dr. Drew Weissman's research better than he himself does.
In her earlier video, Morrow had cited a 2018 journal article Weissman co-authored in which the authors noted, "A possible concern could be that some mRNA-based vaccine platforms induce potent type I interferon responses, which have been associated not only with inflammation but also potentially with autoimmunity."
But Weissman told the AP in January 2021 that those three-year-old concerns were no longer valid because in 2021, vaccines no longer use that form of mRNA. "There is no data that says an mRNA vaccine can cause an autoimmune disease," he told the AP's fact checker. Lead Stories has reached out to Weissman to update that January comment and will update this fact check, as appropriate, when he replies.
Meanwhile, the FDA has reported no deaths and no autoimmune disease caused by the mRNA vaccines, while carrying out what it says is the most intensive vaccine monitoring program in history:
Over 285 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through May 24, 2021. During this time, VAERS received 4,863 reports of death (0.0017%) among people who received a COVID-19 vaccine. CDC and FDA physicians review each case report of death as soon as notified and CDC requests medical records to further assess reports. A review of available clinical information, including death certificates, autopsy, and medical records has not established a causal link to COVID-19 vaccines.
At 1 minute, 20 seconds, Morrow insists there is data proving mRNA vaccines cause autoimmune diseases, but "it is not being released to the general public." She does not provide the data nor say where it is kept.
At 4 minutes, Morrow begins reading from the publicly available briefing memo the FDA compiled to document the clinical trials and other evidence on which the drug regulator based its approval of Moderna's mRNA vaccine:
Looking at their document ... this is some serious adverse events ... People were dying from the vaccine.
That is not what the FDA memo said.
The FDA has, since before vaccines were released for general use, cautioned the public not to confuse correlation with causation. The death of a person who has been vaccinated cannot automatically be attributed to the vaccine. As the FDA memo points out, some of the deaths were suicides, some were caused by trauma and others were caused by pre-existing health conditions. No link to the vaccine was established:
These deaths in both the vaccine and placebo groups represent events and rates that occur in the general population of individuals of these ages and do not suggest a causal relationship to the vaccine.
