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Much ado about nothing, here’s why

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

The “confidential report” details several side effects of 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 that the big pharma “wanted to keep it hidden from the public for the next 70 years.”

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

In the video, Wheeler says the report, uploaded to the Internet in February of last year, details side effects that Pfizer “knew” since last year.

Wheeler spends the first few minutes reading a basic disclaimer containing confidential information that you would find on any legal or business document, before telling followers that confidential disclaimers make her more curious than usual.

“Luckily they weren’t allowed to do this (keep the findings confidential), so we get to see the document stamped literally everywhere with large confidential stamps,” Wheeler said. (It is not).

Pfizer Real Data Released by means of Narissa Subramoney on Scribd

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

The report’s authors found that the millions of participants who experienced side effects from mRNA Covid-19 vaccines showed mild symptoms that faded significantly after a day.

“The data reveal no new safety concerns or risks requiring label changes and support a favorable benefit-risk profile of the BNT162b2 vaccine,” the report reads.

The study looked at data from more than 7 million self-reported cases of adverse side effects from mRNA vaccine doses administered between December 2020 and June 2021.

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

Closer to home, the National Institute of Communicable Diseaseswhich successfully manages disease outbreaks in the country, explains that a “post-immunization adverse event” (AEFI) is an adverse health event that occurs after a person receives a vaccine.

A ‘health event’ is a symptom (eg headache or trouble seeing).

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

This concerns, for example, side effects after vaccination: a person receiving a Covid-19 vaccine and then having a stroke, heart attack or death in a car accident.

Each 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 of vaccination, but there is no time limit for reporting an event.

The NICD says all South Africans who experience moderate to severe side effects should report them so they can be investigated.

“If the public understands that all ‘adverse effects after immunization’ are taken seriously and appropriate measures are taken, people will have more confidence that vaccines are safe,” said NICD.

compiled by Narissa Subramoney

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