Pfizer and BioNTech Expand Pivotal Phase 3 Trial of COVID-19 Vaccine Candidate BNT162b2 to Enhance Diversity and Increase Enrollment

Pfizer and BioNTech recently announced that they have submitted an amendment to the U.S. FDA, proposing to increase the enrollment size of the pivotal Phase 3 clinical trial of their candidate COVID-19 vaccine, BNT162b2, from 30,000 to up to 44,000 participants. The amendment will also allow for the recruitment of new participant populations.

The BNT162 development program, jointly conducted by Pfizer and BioNTech, initially included four different mRNA vaccines. BNT162b2, the candidate that entered Phase 2/3 clinical trials, is an mRNA vaccine encoding the full-length spike protein of SARS-CoV-2 and was granted Fast Track designation by the U.S. FDA.

The Phase 3 clinical trial of BNT162b2 was launched on July 28 and is expected to reach the initial target of enrolling 30,000 participants next week. This amended protocol will allow for further increased diversity among the study population, including adolescents aged 16 years and older, as well as individuals with chronic, stable HIV, hepatitis C, or hepatitis B infections. It will also provide additional safety and efficacy data.

This pivotal trial evaluates the vaccine based on the number of events, and many variables may affect the timing of the final data report. The press release noted that, based on current infection rates, the two companies continue to expect conclusive efficacy data by the end of October.

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