FDA Grants Fast Track Designation for 2 MRNA-Based COVID-19 Vaccine Candidates

Two vaccine candidates from Pfizer Inc and BioNTech SE being developed to protect against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) received Fast Track designation from the FDA, which will allow the companies to begin phase 2b/3 safety and efficacy studies for the vaccines.¹

The 2 candidates, BNT162b1 and BNT162b2, are part of the join BNT162 program that was being evaluated in ongoing phase 1/2 clinical studies in both the United States and Germany. They were part of a group of 4 candidates and are considered the most advanced in the program.¹

Each candidate in the program represented a unique combination of messenger RNA (mRNA) and target antigen. BNT162b1 and BNT162b2, both nucleoside-modified RNAs, are encoded respectively with an optimized SARS-CoV-2 receptor-binding domain (RBD) antigen and a SARS-CoV-2 full-length spike protein antigen.¹

The Fast Track designation was based on preliminary data from phase 1/2 studies released in the United States on July 1, 2020 for BNT162b1, with the German trial data expected to release soon. Pfizer and BioNTech hope to start phase 2b/3 trials later in July with an anticipated enrollment of 30,000 subjects. Assuming the current studies are successful, and that the candidates receive regulatory approval, both companies hope to develop 100 million doses for the novel coronavirus 2019 (COVID-19) by the end of 2020, and possibly 1.2 billion doses or more at the end of 2021.¹

“The FDA’s decision to grant these 2 COVID-19 vaccine candidates Fast Track designation signifies an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2,” Peter Honig, senior vice president, global regulatory affairs, Pfizer, said in a statement. “We look forward to continue working closely with the FDA throughout the clinical development of this program, Project Lightspeed, to evaluate the safety and efficacy of these vaccine candidates.”¹

References

1. Pfizer and BioNTech Granted FDA Fast Track Designation for Two Investigational mRNA-based Vaccine Candidates Against SARS-CoV-2. News Release Pfizer; July 13, 2020. Accessed July 15, 2020. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-granted-fda-fast-track-designation-two.