Shots:
- The approval is based on P-ll/lll study involve the assessment of Comirnaty (BNT162b2) vs PBO in 44,000 patients aged ≥16 yrs. in the ratio of (1:1) for COVID-19. The approval follows CHMP’s positive opinion to authorize the vaccine
- The P-III demonstrated 95% ER in participants without prior SARS-CoV-2 infection (first primary objective) and in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose
- The CMA is valid in all 27 member states of the EU while the companies are ready to immediately ship initial doses to all the member state
Click here to read full press release/ article | Ref: BusinessWire | Image: Market Place
The post Pfizer and BioNTech’s Comirnaty (BNT162b2) Receives EC’s Conditional Marketing Authorization for COVID-19 first appeared on PharmaShots.
