Pfizer, BioNTech seek FDA EUA status for Covid-19 vaccine
The companies have submitted a request to the FDA to secure FDA EUA status for BNT162b2 mRNA vaccine candidate against SARS-CoV-2. The Covid-19 vaccine is expected to be
The data analysis showed a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection (primary infection), as well as in participants with and without prior SARS-CoV-2
The status was based on efficacy and safety results from HPTN 083 phase IIb/III randomised, multicentre, double-blind and clinical trial. The study compared long-acting and injectable cabotegravir to
As part of single target research collaboration, both companies will conduct research activities to select a pre-clinical candidate after which Roche will focus on further development and global