Raising hope of granting emergency use authorization to drugmakers Pfizer and BioNTech’s experimental Covid-19 vaccine, the US Food and Drug Administration (FDA) said on Tuesday that data from 38,000 trial participants involved in testing the vaccine suggest a “favourable safety profile”.
The data on the vaccine showed no “specific safety concerns,” the FDA said in a document.
The report comes two days before a group of experts from the FDA meets to discuss an emergency use authorization request for a Covid-19 vaccine.
Pfizer and BioNTech submitted a request for emergency use authorisation of its investigational Covid-19 vaccine to US FDA on November 20.
“As such, FDA has determined that the sponsor has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under a EUA (Emergency Use Authorisation),” the agency wrote in documents posted.
Britain has already approved the vaccine for emergency use.