The US Food and Drug Administration (FDA) fully approved the Pfizer COVID vaccine – meaning that it is now permanently approved for use in those aged 16 and over
The Pfizer and BioNTech vaccine, which uses mRNA technology, has been given full approval by the FDA as of 23 August.
Dr Peter Marks, Director of FDA’s Center for Biologics Evaluation and Research, said: “Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine.”
“thorough and thoughtful evaluation of this vaccine.”
This means that the COVID vaccine now has a permanent licence for use in people aged 16 and over, while Emergency Use Authorisation (EUA) is a temporary state of legalising drug use in times of urgent need.
However, Pfizer remains in EUA for those aged between 12 and 16 – as more trial data is being created. Currently, the drug is also approved for use in a third booster dose for those with weak immune systems across the US.
“The public can be very confident”, explains FDA Commissioner
Acting FDA Commissioner Janet Woodcock, said: “While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.”
The first EUA for Pfizer was issued on 11 December, 2020, based on an ongoing clinical trial with thousands of participants.
In this recent review of safety data, the FDA looked at updated results from that trial – which included data from over 22,000 individuals who took the vaccine during the experiment.
Based on results, the vaccine was found to be 91% effective in preventing COVID-19. Side effects for the vaccine have been found to be relatively rare, and mild in general.
The updated status of full approval for the Pfizer vaccine will be discussed at a senior FDA meeting, on 30 August.
Commissioner Woodcock further said: “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated.”