Real-world data supports FDA approval of COMIRNATY® booster for individuals at risk of COVID-19

23 Sep 2021

Written by Darcy Hodge, Editor

COVID-19 Medical devices, pharmaceuticals and vaccines News Real-world evidence

Biotechnology companies Pfizer (NY, USA) and BioNTech (Mainz, Germany) reported that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) have enacted Emergency Use Authorization for a COVID-19 booster dose of COMIRNATY®. The mRNA COVID-19 vaccine has been authorized for individuals at risk of contracting severe COVID-19. Experts involved in VRBPAC advise on regulatory issues such as vaccine safety and efficacy. The data reviewed allowed COMIRNATY to be administrated to those aged 65 years or older and those experiencing occupational exposure to COVID-19. However, approval on the booster was not provided for a general population aged 16 or above. The FDA is expected to decide on this use of COMIRNATY...