Professors Say Too Few Reviewers on Pfizer Covid Vaccine
Two university professors say it appears FDA assigned too few reviewers to key elements of the Pfizer/BioNTech Covid-19 vaccine application, possibly as a way to stifle internal dissent. Writing in an online Stat opinion column, University of Maryland School of Pharmacy associate professor Peter Doshi and Dalhousie University law and pharmacology professor Matthew Herder say it appears that only one reviewer was assigned in the clinical and statistical disciplines to do in 22 days the work that typically can take months.
“Unlike its counterparts in other countries,” Doshi and Herder write, “FDA is believed to be the only drug regulator in the world that consistently receives and reviews patient-level data from the clinical trials that underpin drug and vaccine approvals. To perform such rigorous analyses, FDA typically spends around 10 months in an effort that involves reviews by experts representing various scientific disciplines: clinical medicine, statistics, pharmacology, chemistry, pharmacovigilance, and more.”
With just three weeks within which to analyze data from Pfizer’s 44,000 participant Phase 3 trial, the article says, there is a question about why the agency didn’t devote additional reviewers to the work. They say the FDA review memo indicates that some scientific disciplines had multiple reviewers, such as pharmacovigilance. “But,” they write, “the two disciplines tasked with examining the clinical trial data and results, the clinical and statistical reviewers, were seemingly left to do their work solo.”
Doshi and Herder say that without additional reviewers it is hard to understand how the work of several months could be squeezed into 22 days, including weekends. “In-depth review calls for examining patient-level data, a large feat that involves auditing and reviewing individual case records as well as independently running analyses on the raw data,” they say.
While scientific disagreements surfaced during the advisory committee meeting in which four members voted against an emergency use authorization for the vaccine, the authors say, it is unclear whether such disagreements existed within FDA. “By assigning only one clinical, one statistical, and one toxicology scientist to review the Pfizer/BioNTech Covid-19 vaccine, it seems that discussion, let alone disagreement, was curtailed by design,” Doshi and Herder write. “The pressure on these lone FDA reviewers to do their work in record time, and do it without raising serious questions about the data, was likely intense. Having an official second or third reviewer for all core scientific disciplines would have helped. Not making more reviewers available strikes us as an effective way to prevent in-depth assessment of the underlying data and limit the possibility of dissent. Shortcuts in the regulatory process undermine the very purpose of regulation to protect the public.”