Pfizer becomes first COVID vaccine to get full FDA approval
pharmafile | August 24, 2021 | News story | Manufacturing and Production |
The FDA has given Pfizer’s COVID-19 vaccine full regulatory approval, making it the first to be officially licensed in the nation.
The two dose vaccine had initially been given emergency use authorisation. It’s now licensed for use in anyone aged 16 and over.
The approval is likely to create a rise in mandatory vaccine rules across the country, and will hopefully reduce vaccine skepticism from those who didn’t want to take a drug that wasn’t fully approved.
In a statement, the FDA said its review for approval included data from approximately 44,000 people.
The vaccine, which will now be marketed as Comirnaty, was found to be 91% effective in preventing the disese.
Acting FDA commissioner Janet Woodcock said that the public “can be very confident” the vaccine meets high safety, effectiveness, and manufacturing quality standards.
It still has emergency use authorisation for children aged 12 to 15.
In a televised address, President Biden spoke directly to the “millions” of Americans he said were waiting for full and final FDA approval.
“The moment you’ve been waiting for is here,” he said. “It’s time for you to go get your vaccination. Get it today.”
This news comes as the UK has ordered 35 million more doses of the Pfizer-BioNTech vaccine, which will be delivered in the second half of 2022.
Health and Social Care Secretary Sajid Javid said the move was intended “to future-proof our vaccine programme”.
It has still not ben decided whether the UK will go ahead with a COVID vaccine booster programme.
The Joint Committee on Vaccination and Immunisation (JCVI) is thought to be waiting for better data on how long protection from the first two doses of the vaccines lasts before making its final decision.
Lilly Subbotin
