Two of the four experimental COVID-19 vaccines developed by Pfizer Inc and BioNTech using the BNT162 mRNA-based vaccine program received Fast Track designation from the US Food and Drug Administration (USFDA). The two most advanced vaccine candidates, BNT162b1 and BNT162b2, are currently being tested in ongoing Phase 1/2 clinical studies in Germany and the US.
Fast Track is a process designed to facilitate the development of vaccines and new drugs to prevent or treat any serious conditions and to expedite their review. The COVID-19 vaccines by Pfizer and BioNTech were granted fast track based on the Phase 1/2 studies going on in Germany and the United States as well as the studies conducted in animals.
On July 1, 2020, the data from Phase 1/2 study of the vaccine candidate BNT162b1 was released by the company. The online preprint server medRxiv published the manuscript, which is undergoing scientific peer-review now. Early data from the trial will be released in July.
Each of the four experimental vaccines being evaluated now represents a unique combination of messenger RNA (mRNA) format and target antigen. BNT162b1 and BNT162b2 are formulated in lipid nanoparticles, and both are nucleoside modified RNAs. BNT162b2 encodes an optimized SARS-CoV-2 full-length spike protein antigen while BNT162b1 encodes an optimized SARS-CoV-2 receptor-binding domain (RBD) antigen.
Peter Honig, Senior Vice President, Global Regulatory Affairs, Pfizer, said that granting Fast Track designation to these two COVID-19 vaccine candidates is a significant milestone to develop an effective and safe vaccine against the novel coronavirus. Throughout the clinical development of this program, the researchers are planning to work closely with the FDA to ensure the efficacy and safety of the vaccine candidates.
The Project Lightspeed vaccine development program is supported by Pfizer’s global vaccine development capabilities and is based on BioNTech’s proprietary mRNA-based technology platforms. The vaccines are not currently approved for distribution anywhere in the world, as the clinical studies are still undergoing. Pfizer and BioNTech are expecting to start a Phase 2b/3 trial of COVID-19 vaccine later this month, which is subjected to regulatory approval, and they are planning to enroll up to 30,000 subjects. The company expects to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021, provided the studies are successful and receive USFDA approval.