Drug Developers Granted Fast Track Designation for 2 COVID-19 Vaccine Candidates

Officials with the FDA have granted Fast Track designation for 2 investigational messenger RNA(mRNA)-based SARS-CoV-2 vaccine candidates, according to drug developer Pfizer. SARS- Cov- 2 is the virus that causes the coronavirus disease 2019 (COVID-19).

The FDA’s Fast Track designation is designed to facilitate the development and expedite the review of new drugs and vaccines. This designation was granted to 2 of 4 Pfizer and BioNTech vaccine candidates: BNT162B1 and BNT162B2. The designation was granted based on results from BNT162 program Phase 1/2 clinical studies in the United States and Germany, according to Pfizer.

In the BNT162 program, each candidate has a unique combination of mRNA format and target antigen. Both candidates granted Fast Track Designation are nucleoside modified RNA’s, formulated in lipid nanoparticles, according to Pfizer.

BNTI62b1 encodes an optimized SARS- CoV-2 receptor-binding domain antigen, according to Pfizer. BNT162b2 differs slightly in the fact it encodes an optimized SARS-CoV-2 full-length spike protein antigen.

The BNT162 vaccine candidates are undergoing clinical studies and are not currently approved for distribution anywhere in the world, according to Pfizer. Subject to regulatory approval, Pfizer and BioNTech are anticipating a start to a Phase 2b/3 trial as early as late July 2020, with to 30,000 subjects enrolled. Depending on the outcome of ongoing research, the companies could have up to 100 million doses by the end of 2020, and potentially more than 1.2 billion doses by the end of 2021, according to Pfizer

REFERENCE

PFIZER AND BIONTECH GRANTED FDA FAST TRACK DESIGNATION FOR TWO INVESTIGATIONAL MRNA-BASED VACCINE CANDIDATES AGAINST SARS-COV-2 [News Release]. New York, NY; July 13, 2020: Pfizer website. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-granted-fda-fast-track-designation-two Accessed July 13, 2020