Pfizer applies for EUA for COVID-19 vaccine candidate
Pfizer Inc. today announced it will request emergency use authorization from the Food and Drug Administration for its BNT162b2 mRNA vaccine candidate against SARS-CoV-2. The drug maker, in conjunction with BioNTech SE, said it is basing the application on a 95% vaccine efficacy rate, which is supported by solicited safety data in which no serious concerns have been observed to date. The companies said their combined manufacturing network has the potential to supply up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses by the end of 2021. The FDA has scheduled a Dec. 10 meeting of its Vaccines and Related Biological Products Advisory Committee to discuss the request.
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