Health experts have urged the public not to worry about the Pfizer report, which recently caused a stir on social media, with many people suggesting that Pfizer knew its Covid vaccine was causing more “side effects” than previously stated.
According to epidemiologist Dr. Jo Barnes, Pfizer’s one-year-old 38-page report of post-marketing data does not hide critical information about vaccine side effects. In addition, the number of side effects reported was very low.
“This report is a formal obligation for vaccine manufacturers and addresses adverse reactions that may have been noted following administration of the specific vaccine,” she said.
“It refers to really old data because it covers the period from December 1, 2020 to February 28, 2021 and thus does not include, for example, the time when omicron infections were common.”
Barnes said the vast majority of reported events were not what were termed “adverse reactions of special concern,” or what could be considered serious cases.
However, it was not possible to infer from the data that any particular side effect was caused by the vaccine.
She added: “The event may be due to an underlying illness or other factor, such as a past medical history or concomitant medication.
“Overall, the adverse events recorded in this report were very minor, especially when you consider the number of deaths and the high prevalence of severe symptoms and even the long-term adverse effects of Covid itself.”
Science writer Edward Nirenberg debunked the myths and also explained the difference between side effects, side effects after immunization, and side effects of special concern.
Nirenberg said that what most people thought was a side effect was more formally described as an adverse reaction (ADR) and that for formal purposes the term “adverse reaction” was best avoided.
“Adverse reactions (AE) are monitored whether you get the active ingredient or the placebo in a trial, and that information can be listed in package inserts. Gardasil, for example, has a report on its package insert of gunshot wounds as an AE.
“In a lot of clinical trial designs there is blinding, so you don’t know in advance whether you’re going to get a placebo or an active agent, so you follow everyone,” she said.
“In addition, the placebo group helps you see what is normal for similar people at similar times in similar places.”
Meanwhile, National Health Department spokesman Foster Mohale said they were investigating the report released by the US Food and Drug Administration as part of a recent US court order.
“We also want to confirm that all vaccines are approved by [the SA Health Products Regulatory Authority] for use in South Africa…”