Updated: Nov 15, 2020
By Alice Han, Edited by Sami Morse
BNT162b2 is an mRNA-based vaccine candidate being developed as a collaboration between the German, American, and Chinese biotech companies BioNTech, Pfizer, and Fosun Pharma. Like Moderna’s vaccine, the group’s utilization of the cutting-edge and versatile mRNA vaccine technique reduces the cost of goods, shortens time to licensure, and quickens response to disease outbreaks. mRNA vaccines do not contain the entire virus, and therefore pose no risk of infection; instead, they stimulate cells to produce specific viral proteins, triggering our immune system to generate antibodies that, in this case, recognize the SARS-CoV-2 virus and protect against infection. BNT162b2 is an advanced nucleoside-modified messenger RNA (modRNA) encoding the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein. The spike protein is the sole viral membrane protein responsible for cell entry, making it a great vaccine target for immunity.
In May 2020, a hybrid Phase 1 and 2 clinical trial launched with two versions of the vaccine candidate: BNT162b1 and BNT162b2. Both versions successfully caused patients to produce antibodies and T cells (immune cells) to SARS-CoV-2, but BNT162b2 had significantly fewer side effects. Shortly after this study, BNT162b2 successful vaccine candidate was chosen to advance to hybrid Phase 2 and 3 of the clinical trials. On July 27, Phase 3 was launched with 30,000 volunteers enrolled across 120 sites in the U.S, Argentina, Brazil, and Germany. It is also the first vaccine being tested on children.
The Trump administration awarded a $1.9 billion funding contract for 100 million doses to be delivered by December and an option to acquire 500 million more doses further down the line; Japan has secured 120 million doses and the EU has purchased 200 million. In August, Pfizer claimed that their vaccine candidate was on track to seek regulatory review of their vaccine as early as October 2020. If approved, they’re expecting to manufacture over 1.3 billion doses of the vaccine worldwide by the end of 2021.
Results from ongoing research and the current understanding of COVID-19 are constantly evolving. This post contains information that was last updated on October 23, 2020.