Pfizer vaccine side effects: Much ado about nothing, here’s why

Anti-vaxxers thought they were given an early Christmas present when the US Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER) for the first time allowed the public to access Pfizer data from its clinical trials in support of a Covid-19 vaccine licence.

The ‘confidential report’ details several side effects from the vaccine, sending anti-vaxxers and conspiracy theorists into a frenzy.

American podcaster Liz Wheeler read part of the report to her audience on Twitter, saying the big pharma wanted to “keep it from the public for next 70 years”.

“They wanted the government to allow them to keep it secret from us until we’re all dead,” said Wheeler.

In the video, Wheeler says the report, which was uploaded to the web in February last year, details side effects Pfizer “knew about” since last year.

Wheeler spends the first few minutes reading out a standard confidential information disclaimer that one would find on any legal or company document, before telling followers that confidential disclaimers make her more curious than usual.

“Fortunately they were not allowed to do this (keep the findings confidential) so we are allowed to see the document which is stamped literally everywhere with big confidential stamps,” said Wheeler. (It’s not).

Pfizer Real Data Released by Narissa Subramoney on Scribd

Wheeler’s post was shared widely on Twitter and even made it onto one of our local Twitter influencer’s feeds, A Man’s Not Barry Roux and Dudu Sambudla-Zuma, who supported Wheeler’s less than scientific analysis of the report.

The authors of the report found that the millions of participants that experienced side effects from mRNA Covid-19 vaccines exhibited mild symptoms which faded substantially after one day. 

“The data does not reveal any novel safety concerns or risks requiring label changes and support a favourable benefit-risk profile of to the BNT162b2 vaccine,” reads the report.

The study looked at data from over 7 million self-reported instances of negative side effects from mRNA vaccine doses administered between December 2020 and June 2021. 

Researchers found that pain at the site of injection, fatigue and headache were the most commonly reported side effects. 

Closer to home, the National Institute for Communicable Diseases, which has been successfully managing disease outbreaks in the country, explains that an “adverse event following immunisation” (AEFI) is any detrimental health event that happens after a person receives a vaccine. 

A “health event” is a symptom (for example, a headache or difficulty seeing).

“The health event may or may not be caused by the vaccine,” said the NICD. 

For example, the following are adverse events after immunisation: a person who receives a Covid-19 vaccine and then has a stroke, a heart attack or a death in a motor vehicle accident. 

Any of these events may or may not be associated with vaccination, but all of these events are ‘AEFI’. 

An AEFI usually occurs within 28 days following vaccination, but there is no time limit to reporting an event.

The NICD says all South Africans experiencing moderate to severe side effects must report them so that they can be investigated.

“If the public understands that all ‘adverse effects following immunisation’ are taken seriously, and appropriate action is taken, people will have more trust that vaccines are safe,” said NICD.

Compiled by Narissa Subramoney

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