South African Court Urged to Revoke Authorization of Pfizer’s COVID-19 Vaccine

South African Court Urged to Revoke Authorization of Pfizer’s COVID-19 Vaccine
A man receives a dose of the Pfizer/BioNTech COVID-19 vaccine in Johannesburg, South Africa on Dec. 15, 2021. (Luca Sola/AFP via Getty Images)
Zachary Stieber

A court in South Africa is being urged to revoke the authorization for Pfizer’s COVID-19 vaccine, noting alarming trial data and evidence of side effects.

The High Court of South Africa should set aside the authorization because trial data did not show the vaccine was effective against severe disease or death, which have become the promoted purposes of the vaccine since it performs so poorly against infection as newer variants have emerged, the new filing says.

Six-month data from Pfizer’s trial, for instance, showed that there were 20 deaths among the vaccinated arm and just 14 among the unvaccinated, the Freedom Alliance of South Africa noted in the filing.

The group is asking for a judicial review of the South African Health Products Regulatory Authority’s decision to authorize the vaccine as a primary series and, later, as a booster.

The regulatory authority has promoted the vaccine as safe and effective against infection, transmission, serious illness, and death.

Pfizer’s trial did not test against transmission. It found high efficacy against symptomatic infection but little sign of efficacy against severe illness or death.

The high efficacy can’t be trusted because of problems such as the exclusion of people with underlying health conditions, said the alliance and its experts, including Dr. Aseem Malhotra.

Further, South African regulatory authorities appeared to rely solely on Pfizer’s own data when they authorized the vaccine, the filing states.

The “sole reliance on the very party responsible for commercialization of these vaccines creates a significant conflict of interest,” meaning the authority “could not have exercised its powers under the [law] rationally,” Dr. Herman Jacobus Edeling, a neurosurgeon and mediator who has offered his view as an expert in hundreds of cases, said in the filing.

Attached to the filing are documents including affidavits from medical practitioners and a summary of postmarketing adverse event reports collected by Pfizer that was released after a transparency group successfully sued the U.S. Food and Drug Administration.

The summary showed that 42,086 cases of adverse events after vaccination had been reported through Feb. 28, 2021, just months after the vaccine was first authorized. Of the cases, 1,223 resulted in death and more than 11,300 had not recovered.

Drugs and vaccines have been pulled off the market for much lower numbers of deaths, the filing noted, wondering why Pfizer’s vaccine is still being promoted as “safe and effective” despite “such alarming safety signals.”

The court should, after reviewing the evidence in the petition, revoke the authorization for the shot in South Africa, the alliance said.

Malhotra, a British cardiologist who has called for the Pfizer vaccine to be removed from the market, said he reviewed the filing and that its conclusions are “factually, medically, and scientifically sound.”

“It is highly likely there would have been substantially less deaths and illness in the global population if the vaccine had never been approved in the first place,” Malhotra said in a statement, expressing the hope that the South African court would “lead the way toward a global rectification of a serious injustice.

The South African regulatory authority declined to comment. Pfizer did not return an inquiry.