Did the US FDA know about the many COVID-19 vaccine side effects MONTHS before they were approved?
Take a look at this new claim, and find out what the FACTS really are!
Claim : FDA Leaked Vaccine Side Effects MONTHS Before Approval!
Antivaxxers are now promoting the claim that the US FDA knew about the many COVID-19 vaccine side effects, and accidentally leaked them during a seminar.
Take a look at this claim, that antivaxxers are now sharing on social media and WhatsApp :
The more you know, the less fear you have. This FDA seminar was done on October 22, 2020… 10 MONTHS AGO… Watch to the 2:33:40 mark.
It goes quick, but if you pause fast enough, you will see the slide of side effects from the vaccines they knew about 10 MONTHS AGO… Let that sink in.
www.youtube.com/watch?v=1XTiL9rUpkg
Truth : FDA Did Not Leak Vaccine Side Effects MONTHS Before Approval
The truth is this is more FAKE NEWS on the COVID-19 vaccines that antivaxxers have created, and here are the reasons why…
Fact #1 : It Was A Public US FDA Meeting
The post claims that the slide was leaked in a US FDA seminar. That’s not true.
The truth is it was presented in a public meeting of the US FDA’s Vaccines and Related Biological Products Advisory Committee that ran for over 8 hours!
It is also publicly available for everyone to watch, which wouldn’t happen if they had something to hide.
Fact #2 : The List Was Shown TWICE
Steven Anderson, the US FDA Director for the Office of Biostatistics and Epidemiology, quickly skipped through this slide in his presentation, because it was presented earlier.
“Tom has this list of possible adverse outcomes of interest. I won’t dwell on them, as he has them at the end of his presentation.
At 2:06:29 of the video, Dr. Tom Shimabukuro, MD, MPH, MBA, of the CDC COVID-19 Vaccine Task Force Vaccine Safety Team shared the same list.
Fact #3 : Those Were Possible Safety Outcomes Of Interest
Antivaxxers are claiming that the FDA knew about these adverse events / side effects of the COVID-19 vaccines.
The slide was actually a DRAFT working list of possible adverse event outcomes that the FDA was interested to monitor in the COVID-19 vaccines.
In Dr. Shimabukuro’s version above, it was clearly stated that it was a preliminary list of adverse events of special interest that the CDC would be monitoring.
This early list was created to help pick-up potential adverse events that may register in VAERS (Vaccine Adverse Event Reporting System).
Fact #4 : Those Were NOT Confirmed Adverse Events
The preceding slide actually explained how the FDA planned to monitor 10-20 safety outcomes of interests from the list above.
It confirmed, again, that the FDA had not decided on which safety outcomes were possible adverse events for the COVID-19 vaccines.
Steven Anderson again, stated in the same video :
“We will be coordinating on which of these we might be using in our Rapid Cycle Analysis.“
The FDA monitoring allowed the quick identifications of adverse events like Bell’s palsy (not in the list), anaphylaxis and myocarditis / pericarditis, were confirmed.
On the other hand, most of the other adverse events in the list above did not turn out to be associated with the COVID-19 vaccines.
Fact #5 : Vaccine Adverse Events Have Been Publicly Reported
The US FDA has to be privy to the adverse events and side effects of COVID-19 vaccine submitted to them for approval, but that does not mean they are hiding them from us.
The adverse events and side effects of COVID-19 vaccines observed during the clinical trials have been publicly released in the VRBPAC documents, which you can download from the US FDA :
- Pfizer-BioNTech COMINARTY Briefing Document
- Moderna Spikevax Briefing Document
- J&J Janssen COVID-19 Vaccine Briefing Document
After these vaccines receive their EUA, their safety and efficacy are followed up for several more months before they receive their full FDA approval.
Read more : Full FDA Approval vs. EUA for Vaccines : What’s Different?
Now that you know the truth, please SHARE this fact check with your family and friends, so they won’t get fooled by this fake news.
Please protect yourself and your family – get vaccinated against COVID-19!
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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.
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