The US Food and Drug Administration yesterday granted full approval to the Pfizer/BioNTech COVID-19 vaccine for people aged 16 and older. This is the first vaccine approved by the FDA, and is expected to open the door to more vaccine mandates.
The vaccine will be marketed as Comirnaty, the FDA said in its announcement yesterday. The Pfizer/BioNTech vaccine has been authorised for emergency use in the United States since mid-December for people aged 16 and older, and in May, the authorisation was extended to those 12 and older.
FDA says it's working as fast as possible to fully approve vaccines, as urgency rises amid the COVID-19 surge. "The vaccine also continues to be available under emergency use authorisation (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals," according to the FDA.
Out of more than 170 million people in the United States fully vaccinated against COVID-19, more than 92 million have received the Pfizer/BioNTech vaccine.
"While this and other vaccines have met the FDA's rigorous scientific standards for emergency use authorisation, as the first FDA approved COVID-19 vaccine, the public can be confident that this vaccine meets the FDA's gold standard for safety, effectiveness and manufacturing quality, FDA acting Commissioner, Dr Janet Woodcock, said during a briefing yesterday.
He called the approval "a pivotal moment" for the United States' fight against the COVID-19 pandemic.
In July, drugmaker Pfizer announced that the FDA granted its vaccine a priority review, and the FDA had been pulling in extra help from across the agency to speed final approval of the vaccine.
The FDA worked around the clock and conducted its own analyses of the vaccine in addition to the companies' analyses, Dr Peter Marks, Director of the FDA's Centre for Biologics Evaluation and Research, said during yesterday's briefing.