US regulators have fast-tracked Pfizer and BioNTech's novel coronavirus vaccine candidates BNT162b1 and BNT162b2.
The mRNA-based vaccines are being developed to help protect against SARS-CoV-2, the virus that causes COVID-19, and are currently being evaluated in ongoing Phase I/II clinical studies in the US and Germany.
The fast track designation, which should help facilitate the development, and expedite the review, of the vaccines, was granted based on preliminary data from these trials, as well as animal immunogenicity studies.
“The FDA’s decision to grant these two 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,” said Peter Honig, senior vice president, Global Regulatory Affairs, Pfizer.
“We look forward to continue working closely with the FDA throughout the clinical development of this programme, Project Lightspeed, to evaluate the safety and efficacy of these vaccine candidates.”