Experts weigh in after suing FDA for access to Pfizer trial data

In Dec 2020, the US drug regulator (FDA) granted emergency use authorisation to Pfizer’s Covid-19 mRNA vaccine with limited data from phase III trials. Amid the urgency of the pandemic, the review of the trial data was conducted faster than usual. What would normally take an average of 10 months to review, only took the FDA 108 days.

21 December 2021 By Maryanne Demasi, PhD

Immediately, it raised doubts about the speed with which the agency made its decision.

Fast forward to Aug 2021 and the FDA granted full approval to Pfizer’s (Comirnaty) mRNA vaccine, without releasing the full data set to the public for independent scrutiny.

Experts became concerned that all the publicly available information on a fully licensed product, was limited to journal articles, press releases, and assessments by drug regulators – all of which are subject to conflicts of interest and bias.

Scientists rally for transparency

A group of over 80 public health officers and medical researchers formed an alliance to obtain and disseminate the data upon which the FDA made its decision to license Pfizer’s vaccine.

The non-profit group, called Public Health and Medical Professionals for Transparency (PHMPT) filed a lawsuit in the U.S. District Court, Fort Worth, Texas in September 2021. US-based physician, Dr Aaron Kheriaty, is one of the members leading the charge.

“A group of us were concerned about the trial design, the shortened duration of the clinical trial, and the patchwork system that was in place for the post-marketing surveillance of adverse events,” said Dr Kheriaty.

For example, Pfizer was allowed to terminate its control group after only two months.

“The placebo group was basically eliminated because the vaccine was offered to everyone who had the placebo, so they failed to maintain a control group,” said Dr Kheriaty.

The Freedom of Information Act (FOIA) lawsuit stipulated that, under federal law, the data and information in the documents filed with the FDA should be available for public disclosure unless extraordinary circumstances are shown.

The purpose was to ensure government transparency and accountability.

Prof Tom Jefferson is another member of PHMPT and of the WHO’s Covid-19 Infection Prevention and Control Research Working Group. He says the importance of an independent review of the scientific data cannot be overstated.

“Censorship and lack of transparency have always been the enemies of progress. In the case of Covid-19 vaccines, the importance of transparency in heightened by the mass administration to healthy populations and their unknown long-term effects,” said Prof Jefferson.

“Given the insufficient and hurried testing and the culture of secrecy, it is arguable whether any informed consent is valid, prior to making public all of the documents the FDA has in its possession,” he added.

Pfizer’s vaccine has been the subject of vigorous debate, including claims of under-reporting adverse events, falsification of data, and a lack of efficacy.

FDA asks to delay document release

While the FDA says it’s committed to transparency, the agency proposes to drip feed Pfizer’s documents to the public over several decades.

The Department of Justice (DOJ) lawyers representing the FDA asked the federal judge to allow them 75 years to process the FOIA request, which takes the end date for the final release of documents to 2096.