FDA Fast Tracks Pair of COVID-19 Vaccine Candidates

The FDA has granted Fast Track designation to 2 of 4 investigational vaccine candidates from Pfizer Inc and BioNTech SE in their BNT162 mRNA-based vaccine program (BNT162b1 and BNT162b2) to protect against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19). BNT162b1 and BNT162b2 are the 2 most advanced candidates in the vaccine program that are currently being evaluated in ongoing phase 1/2 clinical studies in the United States and Germany, according to a press release.

The designation followed preliminary data from the phase 1/2 trials as well as animal immunogenicity studies. The companies released early data from the ongoing clinical trials for BNT162b1 on July 1, 2020, with the manuscript concurrently undergoing scientific peer-review for potential publication. Data from the German trial of BNT162b1 are expected to be released later this month.

“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, Pfizer senior vice president of Global Regulatory Affairs, in a press release. “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.”

The companies’ vaccine program is evaluating at least 4 experimental vaccines that each carry a unique combination of messenger RNA (mRNA) format and target antigen, according to the release. BNT162b1 and BNT162b2 are both nucleoside modified RNAs, formulated in lipid nanoparticles.

“We are pleased to have received Fast Track designation from the FDA for two of our vaccine candidates and look forward to working closely with the FDA, along with our partner Pfizer, to expedite the clinical development path forward,” said Özlem Türeci, chief medical officer at BioNTech, in a press release.

The BNT162 vaccine candidates are undergoing clinical studies and have not been approved for distribution anywhere in the world. Subject to regulatory approval, Pfizer and BioNTech expect to start a phase 2b/3 trial in the immediate future and anticipate enrolling up to 30,000 patients.

If successful in clinical trials and pending regulatory approval, the companies expect to manufacture up to 100 million doses of the vaccine candidate by the end of 2020, with potentially more than 1.2 billion doses by the end of 2021, according to the release.