Raising hope of granting emergency use authorisation 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 FDA meet to discuss an emergency use authorisation 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 an EUA (Emergency Use Authorisation),” the agency wrote in documents posted.
Britain has already approved the vaccine for emergency use.
A 90-year-old woman named Margaret Keenan on Tuesday became the first person in the world to receive the Pfizer-BioNTech Covid-19 vaccine as part of the mass vaccination programme being rolled out across the UK.