An uproar was felt on social media after the US Food and Drug Administration’s (FDA) Centre for Biologics Evaluation and Research (CBER) authorised public access to the 55 000-page Pfizer documents containing information about the side effects of the vaccine.
Pfizer documents spark outrage on social media
A landmark ruling made by U.S. District Judge Mark T. Pittman back in January 2022, effectively denying the FDA’s attempts to suppress the information contained in the Pfizer documents, has allowed citizens access to data used by the US health regulatory authority to license the release and subsequent use of the Pfizer vaccine.
The matter relates to a lawsuit filed by the Public Health and Medical Professionals for Transparency organisation in September 2021, calling on the FDA to release all COVID-19 vaccine review documents under the Freedom of Information Act (FOIA).
Of course, the US health regulatory authority challenged this request, and in a bid to find a settlement, proposed releasing 500 pages of the Pfizer documents per month for the next 75 years.
This request was denied by the Texas judge and the FDA, despite informing the court of the fact that the branch handling the release of the documents only had 10 employees, was ordered to release 12 000 pages of BioNTech’s vaccine review immediately, and 55 000 pages a month thereafter until the 300 000-page document was fully made public by July 2022.
The FDA is expected to provide an update on its progress in April 2022.
Is the COVID-19 vaccine safe?
According to the US Centres for Disease Control and Prevention (CDC), mRNA vaccines, like Pfizer, are safe and effective against COVID-19.
The BioNTech-manufactured vaccine comes in two shots and is administered in the muscle of the upper arm. The vaccine also contains ingredients like lipids (fats), salts and sugar and mRNA acid, a crucial agent that “provides instructions the body uses to build a harmless piece of a protein from the virus that causes COVID-19.”
“This protein causes an immune response that helps protect the body from getting sick with COVID-19 in the future,” the CDC notes.
In South Africa, more than 24.2 million doses of Pfizer have been administered and, thus far, no cases of deaths related to the vaccine have been reported.
Pfizer documents reveal 1 291 vaccine side effects
It is stated, though, that people with severe allergic reactions, a diagnosed allergy to any of the ingredients listed in the COVID-19 vaccine (such as polyethylene glycol), or issues related to the heart should not get vaccinated.
However, with all the information available about the safety of COVID-19 vaccines, the Pfizer documents have, somehow, sparked outrage on social media.
In particular, commenters have questioned the health regulatory authority’s request to suppress a document that contains information on 1 291 side effects to taking the jab.
Some of the listed side effects include:
- acute kidney injury;
- acute flaccid myelitis;
- anti-sperm antibody positive;
- brain stem embolism;
- brain stem thrombosis;
- cardiac arrest;
- cardiac failure;
- cardiac ventricular thrombosis;
- cardiogenic shock;
- central nervous system vasculitis;
- death neonatal;
- deep vein thrombosis;
- encephalitis brain stem;
- encephalitis hemorrhagic;
- frontal lobe epilepsy;
- foaming at mouth;
- epileptic psychosis;
- facial paralysis;
- fetal distress syndrome;
- gastrointestinal amyloidosis;
- generalised tonic-clonic seizure;
- Hashimoto’s encephalopathy;
- hepatic vascular thrombosis;
- herpes zoster reactivation;
- immune-mediated hepatitis;
- interstitial lung disease;
- jugular vein embolism;
- juvenile myoclonic epilepsy;
- liver injury, low birth weight;
- multisystem inflammatory syndrome in children;
- myocarditis; and
- neonatal seizure, among others
Here is a truncated version of the FDA’s Pfizer approval package.
The Pfizer documents causing an uproar on social media can be accessed here.