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Pfizer and BioNTech's Comirnaty (BNT162b2) Receives EC's Conditional Marketing Authorization for COVID-19

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Pfizer and BioNTech's Comirnaty (BNT162b2) Receives EC's Conditional Marketing Authorization for COVID-19

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  • 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

 ­ Ref: BusinessWire  | Image: Market Place

Click here to­ read the full press release 

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