Pfizer has cleared the next hurdle in the race to get its Covid-19 vaccine approved for emergency use 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 last month about their coronavirus vaccine based on data showing the two-dose regimen was 95% effective against Covid-19 and had no major safety issues.
The vaccine's efficacy data met its expectations for emergency use authorisation, FDA staff said in documents released ahead of a Thursday meeting of outside experts to the FDA who will discuss whether to recommend the Pfizer shot for people aged 16 and older.