FDA Study Results or a “Working” list of Possible Adverse Events?

22 June, 2021

On June 17, 2021, Facebook user Dato Salukvadze published a post about adverse events of the coronavirus vaccine. The post has a photo attached depicting over 20 severe diseases including stroke, epilepsy, autoimmune diseases, meningitis, and so on. The English version of the listed adverse events is titled as follows: FDA Safety Surveillance of COVID-19 Vaccines: Draft Working List of Possible Adverse Event Outcomes". According to Dato Salukvadze’s claim, the U.S Food and Drug Administration (FDA) revealed the aforesaid adverse events in the studies of coronavirus vaccines.

Dato Salukvadze’s post is a manipulation. The published list is from the slides of the October 2020 meeting of the FDA Advisory Committee, not FDA study on adverse events of vaccines, and comprises those adverse events that FDA has monitored following the vaccination rollout. Currently, three serious adverse events are associated with the vaccines authorized by FDA, however, their rate is extremely low and the benefits of vaccination outweigh the existing risks.

English fragment of the image disseminated by Salukvadze is from the presentation (p.17) of the U.S Food and Drug Administration's (FDA) "Vaccines and Related Biological Products Advisory Committee" meeting, held on October 22, 2020, about plans for monitoring COVID-19 vaccines efficacy and safety. At the time of the meeting, FDA authorized vaccines (Pfizer, Moderna, Janssen) were still undergoing phase 3 clinical trials, thus, FDA was yet to begin studying clinical trial data of vaccines for issuing emergency use authorization.

As read on the 16th slide of the FDA presentation, for COVID-19 vaccine real-time safety surveillance, FDA pre-selected up to 20 possible adverse events per their experience with similar vaccines and planned to carefully investigate the correlation between these adverse events and vaccines if detected in future vaccinated populations. Following the aforesaid slide, we encounter the list of adverse events circulating on social networks, whose title emphasizes the fact that it’s a draft working list and can be subjected to change. According to what Food and Drug Administration explained to Associated Press, the U.S. government has a well-established post-authorization/post-approval vaccine safety monitoring infrastructure that, as a precaution, will include health risks that weren’t detected in the vaccine clinical trials once large-scale vaccination program is launched.

Adverse events and side effects of the FDA-authorized vaccines

The U.S Food and Drug Administration has issued an emergency use authorization for three COVID-19 vaccines so far: Pfizer, Moderna, and Johnson Johnson/Janssen. Pfizer vaccine's efficacy and safety were tested on 43 448 volunteers in phase 3 clinical trials, the aforesaid number was at 30 000 for Moderna vaccine, whereas it was 39 321 people who participated in the Johnson & Johnson vaccine trials. In all three cases, FDA and CDC note that the most common side effects were the pain of different severity/itchiness at the injection site, muscle pain, flu-like symptoms, fever, fatigue, headache, nausea, however, some people might not experience any of the listed side effects after the vaccination.

As for the serious adverse events of the aforesaid vaccines, according to the FDA’s document on the assessment of the Pfizer vaccine safety data, The frequency of serious adverse events in trial participants was very low – 0.5%. In the clinical trials of the Moderna vaccine, only 1% of the volunteers experienced serious side effects, whereas, for Johnson & Johnson vaccine, the aforesaid data amounted to 0.4%. As of June 21, 2021, 318 million doses of the aforesaid vaccines were distributed in the United States. CDC and FDA use various mechanisms to monitor vaccine safety amid ongoing vaccination. According to the information of the U.S. Center for Disease Control, several serious adverse events with confirmed or probable links to the COVID-19 vaccine have been detected: anaphylaxis (severe allergic reaction), a rare form of thrombosis (TTS syndrome), and myocarditis/ pericarditis. All listed adverse events are very rare. According to CDC:

  • Severe Allergic Reaction/anaphylaxis occurs in approximately 2 to 5 people per million vaccinated in the United States. Keep in mind that Severe allergic Reactions can occur after any medication intake and is curable in case of prompt medical aid.
  • The rare form of thrombosis (TTS syndrome) is associated with the Jonson&Jonson vaccine. TTS syndrome was detected in 36 individuals out of 11, 6 million vaccinated people. There is an increased risk of TTS syndrome in women over 50 and that’s why CDC recommended alternative vaccines for this particular group.
  • Myocarditis/ pericarditis are detected in people aged 30 and younger who’ve received RNA vaccines (Pfizer, Moderna). CDC and FDA identified 323 cases of myocarditis and pericarditis in people vaccinated with RNA vaccine, however, CDC is still investigating the cases to determine if it has direct connection to the vaccine.

As for the lethal adverse events of the vaccine, similar to other adverse events, reports of death following the COVID-19 vaccination are extremely rare. Per CDC’s information, out of all death report investigations so far, three cases could have a causal link to the COVID-19 vaccine as a result of TTS syndrome developed after the Jonson & Jonson vaccination.

“Myth Detector” has previously written about the adverse events of COVID-19 vaccines. Read more in the articles:

Prepared by Medea Sulamanidze

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