Legal claims aiming to link Pfizer’s vaccine with a spike in adverse reactions, including disability and death, have been dismissed by scientists, who said the bid to declare the jab authorisation as unlawful were “baseless and misguided”.
Last week, human rights movement Freedom Alliance SA (Fasa) announced it had filed papers in the Gauteng High Court (Pretoria) to set aside the authorisation, claiming it was unsafe and ineffective, reports The Citizen. The aim is to compel judicial scrutiny of the South African Health Products Regulatory Authority’s (Sahpra) approval of the vaccine.
Fasa says global data showed a link between the vaccine and a rise in serious adverse reactions in patients, including disability, foetal abnormalities, aggressive cancers and death.
It added that approval was based on flawed and inaccurate trial data analysis, presented by a heavily conflicted Pfizer, and thus, was legally invalid.
Fasa submitted supporting affidavits from Dr Herman Edeling, a specialist neurosurgeon, and others, and research data from global state authorities and medical journals.
These included Pfizer’s own data and those from the Vaccine Adverse Events Reporting System (VAERS).
FASA also cites VAERS’ case studies from 11 South African patients who experienced serious and sometimes deadly adverse effects after the Pfizer shot.
Challenge baseless and misguided
But Dr Jo Barnes, Stellenbosch University epidemiologist, said there seemed to be little or no regard to vaccine benefit-to-harm ratio in Fasa’s argument.
“One can look at the outcome of vaccination by concentrating on the small number of people with adverse reactions or look at the millions who benefited from the vaccine,” she said.
She said “benefited” can mean either avoiding getting ill at all or, if infected and getting ill, suffering from far less severe illness.
“There seems to (be) little or no regard in their argument for the benefit-to-harm ratio… In other words, how many people benefited (versus) how many people showed adverse effects,” she added.
Dr Glenda Davison, associate professor and head of the Biomedical Sciences Department at Cape Peninsula University of Technology echoed Barnes’ sentiments, saying Fasa’s argument on vaccine dangers was misguided and that all vaccines currently available had undergone extensive clinical trials for both safety and efficacy.
Side effects rare
“In addition, more than 5bn people (>55%) of the world’s population have received at least one dose, with more than 12bn doses being administered in 184 countries.”
In South Africa, 38 717 957 vaccine doses have been administered as of 27 March.
This means the 11 cases presented as evidence of adverse effects comprise a percentage of doses administered so infinitesimally small, they are statistically insignificant.
“The most common vaccines being used are Pfizer and Moderna. Like all vaccines and medication there are always reported side-effects. However, these are very rare and the benefits of vaccination far outweigh the rare risks,” Davison said.
She said reported side effects were usually mild, including pain at the site of the injection, muscle aches, headache and fatigue.
In rare cases, Davison said, people had suffered allergic reactions, which is why, after receiving the vaccine, patients are asked to wait around for 15-20 minutes.
She said in other rare cases, it has been reported that young men have developed myocarditis, which is serious and can cause death, but that this was also extremely rare.
“Despite these rare cases, the overall impact of the vaccine roll-out has been very positive and numerous lives have been saved.”
Neither the Department of Health nor Sahpra has received any legal notifications yet.
The Citizen article – Legal challenge against Covid vaccines ‘baseless and misguided’ (Open access)
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