FDA's court-mandated release of Pfizer Covid-19 vaccine documents continues to turn over few surprises
A Texas court loss for the FDA has tied up the agency’s FOIA office for months, as it must release hundreds of thousands of documents linked to the FDA’s review of Pfizer’s licensed Covid-19 vaccine. But so far, the releases have been more noise than signal.
The first two document drops from this month and March from the group that won the suit, known as the Public Health and Medical Professionals for Transparency, have offered few new details on the safety or the efficacy of the Pfizer vaccine, as more than 300 million doses have now been administered in the US, according to the CDC.
And although the effectiveness of the vaccine in preventing Covid infections has declined as the dominant circulating variant has shifted to the BA.2 sublineage, the latest documents offer a peek into the extent to which Pfizer analyzed certain adverse event reports received after the trials, and how Pfizer requested a faster review from FDA ahead of the vaccine’s full licensure last August.
While typically confidential, the April document release includes Pfizer’s 17-page priority review request from last May, which may offer competitors a look into how to submit a successful request.
In it, the company again spells out the vaccine’s 90+% efficacy:
In the updated descriptive efficacy analysis (data cutoff date: 13 March 2021), among participants in the evaluable efficacy population without evidence of SARS-CoV-2 infection before and during the vaccination regimen, the estimated VE [vaccine efficacy] against confirmed COVID-19 occurring at least 7 days after Dose 2 was 91.3% (2-sided 95% CI: 89.0%, 93.2%), with 77 cases in the BNT162b2 group and 850 cases in the placebo group.
On the safety side, Pfizer also touted its post-authorization data to explain how, “Aside from addition of anaphylaxis and hypersensitivity, the analyses of cumulative post-authorization safety data, including a review of adverse events of special interest (AESIs), are consistent with the analysis of this pivotal clinical trial. Review of post-authorization data has not revealed any novel safety concerns, except for anaphylaxis, and has confirmed the favorable benefit-risk profile of the vaccine.”
In addition, the PHMPT released a 38-page analysis of the post-authorization adverse event reports through the end of February 2021, as part of the company’s application for full approval.
“The data do not reveal any novel safety concerns or risks requiring label changes and support a favorable benefit risk profile of to the BNT162b2 vaccine,” the analysis concludes. However, the document does lay out the specifics on each category of AESIs, many of which noted that the “cumulative case review does not raise new safety issues. Surveillance will continue.”
And according to a court order from February, the FDA still has a lot to release, including 80,000 pages on or before May 2, June 1, and July 1; 70,000 pages on or before August 1; and then 55,000 pages on or before the first business day of each month thereafter.
Aaron Siri, the lawyer who won the case on behalf of the PHMPT, told Endpoints News, “The FDA moved to modify the schedule. We opposed and after a lot of back and forth entered into what actually will result in an overall quicker production since certain pages cannot be ‘double counted.'”
But as many of the documents released as part of this April drop show, the vast majority of the documents (in terms of pages) released so far have generally included information that’s entirely meaningless to the conversation around the safety and effectiveness of the Pfizer Covid-19 vaccine, including but not limited to:
- 3,100 pages of lists of the demographic characteristics of the unidentified people who were involved in Pfizer’s trials.
- Another document with more than 2,950 pages listing more demographic characteristics.
- 265 pages on the IRBs used by Pfizer in the various countries, as well as the informed consent documents.
- A handful of protocol deviations from its Phase 1 trial.
- Pfizer’s Regulatory Quality Assurance audit certificate list, which includes the listings of 24 audits for the company’s Phase 2/3 vaccine trial sites in the US, Brazil, Argentina, Germany and Turkey, which were performed between April 29, 2020 and March 13, 2021.