Legal challenge against Covid vaccines ‘baseless and misguided’

Scientists have dismissed a legal bid to declare Pfizer’s Covid vaccine authorisation unlawful as “baseless and misguided”, coming just short of slating the case as pure anti-vaccination propaganda.

This week human rights movement Freedom Alliance SA (FASA) announced that it has filed papers in the Pretoria high court in its bid to review and set aside the authorisation of Pfizer’s vaccine products, claiming they were unsafe and ineffective

The lawsuit is largely fanned on the movement’s claim that global data showed a link between Pfizer’s Covid-19 mRNA vaccine products and an unprecedented rise in serious adverse reactions in patients, including disability, foetal abnormalities, aggressive cancers and death.

Judicial scrutiny

The group’s lawyers have explained that FASA’s aim was to subject South African Health Products Regulatory Authority’s (Sahpra) decision to authorise the Pfizer mRNA Covid-19 vaccines to judicial scrutiny.

They argue that the regulator’s decision to approve the vaccine was based on flawed and inaccurate trial data analysis, presented by a heavily conflicted Pfizer, and that it is therefore legally invalid.

The movement said its aim is not only to ensure legal compliance, but to set a precedent requiring a higher level of statutory scrutiny in the case of future vaccine authorisations in the interests of public health.

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In their affidavits supporting the vaccine litigation, FASA said Dr Herman Edeling, a specialist neurosurgeon, and others drew on extensive research data from global state authorities and peer-reviewed medical journals.

According to FASA, these included Pfizer’s own data and that from the Vaccine Adverse Events Reporting System (VAERS) to argue why the approval of Pfrizer’s vaccine products must be urgently reviewed.

FASA also cites VAERS’ case studies from 11 South African patients who experienced serious and sometimes deadly adverse effects following administration of the Pfizer vaccine.

Challenge baseless and misguided

But Dr Jo Barnes, Stellenbosch University epidemiologist, said there seems 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 one can look at the large number of people who benefited from the vaccine,” she said.

According to Barnes “Benefited” can mean either avoiding getting ill at all or, if infected and getting ill, suffering from far less severe illness.

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“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 in Cape Town echoed Barnes’ sentiments, saying FASA’s argument on vaccine dangers was misguided and did not take the full picture into account.

She said all the main Covid-19 vaccines currently available have undergone extensive clinical trials for both safety and efficacy.

Side effects rare

“In addition to that, over 5 billion people (>55%) of the world’s population have received at least one dose, with over 12 billion doses being administered in 184 countries.”

According to government’s statistics, a total of 38 717 957 vaccine doses have been administered in South Africa as of 27 March 2023.

This would mean the 11 cases presented as evidence of vaccine adverse effects make up 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 out way the rare risks,” Davison said.

She explained that there have been reported side effects but said these were usually mild, including pain at the site of the injection, muscle aches, headache and fatigue.

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In rare cases, Davison said, it has been reported that people have suffered allergic reactions and that is the reason why after receiving the vaccine patients are asked to wait around 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 rollout has been very positive and numerous lives have been saved. Since the rollout of the vaccine, the number of hospitalisations has dropped significantly,” Davison said.

Zero chances of success

With a new Omicron variant (XBB 1.5), which is highly contagious, Davison said government was correct in promoting vaccine boosters, as over time the effects of the vaccine will wane.

“The vaccine will also not always prevent serious sickness and death. However, if we look at the full picture it cannot be argued that the vaccine has prevented many deaths and reduced the severity of Covid 19.  I therefore don’t believe that [FASA] will be successful in their bid,” she concluded.

Department of health spokesperson Foster Mohale said Minister of Health Joe Phaahla has not received FASA’s papers and Yuven Gounden, Sahpra spokesperson, said they did not receive any either.

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