FDA gives early safety assurance on Pfizer-BioNTech vaccine data
The vaccine’s efficacy data met expectations for emergency use authorisation, but it has yet to be decided if it is suitable for people aged over 16
08 December 2020 - 16:41
Bengaluru/New York — Pfizer cleared the next hurdle in the race to get its Covid-19 vaccine approved for emergency use on Tuesday after the US Food and Drug Administration (FDA) released documents that raised no new issues about its safety or efficacy.
Pfizer and German partner BioNTech submitted data to the FDA in November about their coronavirus vaccine based on data showing the two-dose regimen was 95% effective against Covid-19 and had no major safety issues...
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