In preparation for a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC), the FDA has made public the interim results of phase 3 clinical trials for the Pfizer and BioNTech COVID-19 vaccine candidate. This meeting will discuss the Emergency Use Authorisation (EUA) application and determine any recommendations for approval.

Phase 3 clinical trials were spread across the US, Argentina, Brazil, Germany, South Africa and Turkey. The Pfizer and BioNTech vaccine candidate utilises a messenger RNA (mRNA) platform and its’ studies involved participants aged 16 to  85 years. Findings have shown that the vaccine candidate has an acceptable safety profile and following the administration of 2 doses, has an efficacy rate of 95%.

To read the document in full please refer to the link below:

Vaccines and Related Biological Products Advisory Committee: FDA briefing document- Pfizer-BioNTech COVID-19 vaccine