Reporting Positive Vaccine Results, Pfizer, BioNTech May Seek FDA Approval in October


The vaccine candidate, BNT162b2, was well-tolerated and phase 3 enrollment is more than one-third complete.

“Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review of BNT162b2 as early as October 2020 and, if regulatory authorization or approval is obtained, currently plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021,” written in a Pfizer statement released last night.

This statement could not be more clear. The collaborative efforts of these two companies are moving its COVID-19 vaccine candidate, BNT162b2, towards an FDA review as early as October—just weeks away potentially.

“We are especially pleased to offer these early data showing our vaccine candidate’s promising safety and immunogenicity profile from the U.S. trial and we look forward to sharing T cell immune response data from the German trial in the near future,” Kathrin Jansen, PhD, senior vice president and Head of Vaccine Research & Development, Pfizer, said.

A newly released manuscript describes key safety and immunogenicity data from the US phase 1 trial for the BNT162b2 vaccine candidate, which at30μg recorded 7 days after the second dose elicited SARS-CoV-2-neutralizing geometric mean titers (GMTs) in younger adults (18-55 years of age) that were 3.8 times the GMT of a panel of 38 sera of SARS-CoV2 convalescent patients, and in older adults (65-85 years of age) the vaccine candidate elicited a neutralizing GMT 1.6 times the GMT of the same panel, demonstrating strong immunogenicity in younger and older adults.

In addition, BNT162b2 administration was well tolerated with mild to moderate fever in fewer than 20% of the participants.

These data informed the companies’ decision to advance a 2-dose regimen of the 30µg dose level of BNT162b2, which encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S), into a Phase 2/3 evaluation. The data from the study is under scientific review for publication. It can be reviewed here.

These results informed the selection of the BNT162b2 candidate for the pivotal Phase 2/3 global study in up to 30,000 participants that started in July 2020, which has to date enrolled more than 11,000 participants, including in areas with significant SARS-CoV-2 transmission.

BNT162b2 remains under clinical study and is not currently approved for distribution anywhere in the world.

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