The vaccines BNT162b1 and BNT162b2, both created jointly by the pharmaceutical company Pfizer and the German company BioNTech, are currently being evaluated and undergoing clinical trials in the United States and Germany.
The FDA in the United Stated granted Fast Track to two of the experimental vaccines created by Pfizer and BioNTech. This step allows to hasten the review, and allow for the development and use of the vaccines when they are shown to be safe for general use in the fight against COVID-19.
Pfizer and BioNTech created an alliance in March of this year to jointly develop a vaccine to combat SARS-CoV-2, developing the BNT162 program. Each of the vaccines represents a unique combination of messenger RNA (RNAm) format and target antigen. Specifically, the BNT162b1 vaccine encodes a SARS-CoV-2 receptor binding antigen, while the BNT162b2 vaccine encodes a complete protein S antigen to SARS-CoV-2.
As well as Pfizer and BioNTech, the company Moderna Inc is also developing a potential vaccine that in May received this same fast-track status from the FDA.
Peter Honig, Pfizer’s senior vice president of global regulatory affairs, stated that they look forward to continuing to work closely with the FDA throughout the clinical development of the Project Lightspeed program, to assess the safety and efficacy of these vaccine candidates.
The Lightspeed project program is the name the company designated for the development of vaccines based on BioNTech’s patented mRNA technology. This project would be hoping to start a trial into a new phase this month, where they would anticipate enrolling up to 30,000 subjects for testing.
Earlier this month, the BNT162b1 vaccine was tested on 24 volunteers where it was identified that they developed a higher number of SARS-CoV-2 antibodies compared to those from infected people.
If everything develops successfully, both companies would expect to manufacture up to 100 million doses by the end of 2020 and more than 1.2 billion doses by the end of 2021.