FDA reneges on its promise, grants full approval for Pfizer vaccine without a meeting of its advisory panel
Originally published on Medium 26 August 2021
On 23 August, the FDA announced full approval of Pfizer’s COVID-19 vaccine, reneging on its promise not to grant full approval of this product without a formal meeting of its advisory committee.
The approval was based on the six-month results of a randomized controlled trial bought and paid for by Pfizer. Last December Peter Doshi, professor of Pharmaceutical Health Services Research at the University of Maryland at Baltimore, raised concerns about the trial protocol, which seemed to instruct clinicians to break the blind and not test for cases of covid in the treatment arm. This raises questions about the validity of the trial and its primary endpoint, which was covid infection of any severity.
Moreover, there is no access to the patient-level data for the trial, which means we have to take the company’s word for the safety and efficacy of this product. Pfizer’s past record on this sort of thing is hardly reassuring. In 2009, the company paid out $2.3 billion to settle claims of illegal marketing of its wares, at the time the largest such settlement in history. This is just one of many cash payouts the company has made to settle claims of illegal marketing.
The results Pfizer did report are less than overwhelming. According to the company, barely half of the subjects made it as far as the six-month follow-up. The vaccine is said to have resulted in a one in fifteen hundred reduction in the incidence of severe covid, which was counterbalanced by a one in two hundred increase in all serious adverse events. There was no difference between the treatment arm and the placebo arm in death rates, and no covid deaths in either arm of the trial. There was no endpoint for hospitalizations, transmission, or intubation.
This is all the data we ever will have from RCT’s for this product. Pfizer, which originally had promised the trial would run for two years, has broken that promise and made the vaccine available to all subjects in the placebo arm.
A group of scientists, clinicians, and patient advocates, including the aforementioned Dr. Doshi, had lodged a petition with the FDA asking the agency to delay any consideration of full approval of the covid vaccine. They asked the FDA to require a more thorough assessment of the spike proteins produced by the body after inoculation, a review by independent impartial individuals on all serious adverse events reported to pharmacovigilance systems, and safety data for individuals receiving more than two vaccine doses — something necessitated by current demands for booster shots. They also requested studies on the safety and efficacy of the vaccine for vulnerable populations including children, the elderly, and immunocompromised individuals. Finally, given the novel nature of the Pfizer vaccine platform, they asked the experts in gene therapy be included in the external committee advising the FDA.
All of these requests have been ignored by the FDA.
There were no grounds for rushing through full approval of this product at this time. Hospitals are not overwhelmed with covid patients, and the vaccine was already available to anyone who wanted it. The FDA stamp of approval sets a dangerous precedent, weakening an already largely toothless system for ensuring drug safety and efficacy.
Drug safety advocate Kim Witczak, the only member of the FDA advisory panel who voted against the emergency use authorization of the Pfizer vaccine, was also one of the signatories of the petition. Witczak has first-hand experience with Pfizer’s wares. Her husband Woody, who had no history of depression or suicidality, took Pfizer’s blockbuster drug Zoloft for mild sleeplessness. Two days later he went into the garage and hanged himself. He was thirty-seven years old when he died.