The Food and Drug Administration in the United States approved the Pfizer-BioNTech COVID-19 vaccine on Monday, marking the first time that a vaccine for the disease caused by the novel coronavirus has been given the full green light from government regulators.
The vaccine, which was previously given emergency FDA authorization in December, will be marketed under the name Comirnaty. The review of the license application included more than 340,000 pages of material, three times the earlier submission for emergency use, which clocked in at 110,000 pages.
"We completed this in about 40% of the normal clock time for a submission of this magnitude," said Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. 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,” stated Acting FDA Commissioner Janet Woodcock.
“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. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.,” she added.
The full authorization process requires that applicants like Pfizer submit more data for approval. Once a drug or vaccine is fully authorized by the FDA, doctors can prescribe it “according to the practice of medicine,” which enables them to prescribe it as they see fit and not simply do so under limited circumstances.
The approval allows the drug to be used for additional applications, should doctors deem it necessary, which could allow doctors to prescribe booster shots for their patients according to individual circumstances.
The Centers for Disease Control and Prevention reports that some 170 million Americans have been fully vaccinated to date, and over 201 million people have received at least a single dose.
Under current guidelines, children between the ages of 12 and 15 do not fall under the new full vaccine approval, meaning that they will continue to only qualify for COVID-19 vaccinations under the existing emergency use authorization program on a case-by-case basis.
USA Today reports:
"It might discourage people from waiting eight months" to get a booster shot, as the administration recommends, said Dr. Jesse Goodman, an infectious disease specialist at the Georgetown University School of Medicine.
And it might make it harder for people who are immunocompromised, who are allowed to get boosters now, to access shots, said Norman Baylor, president and CEO of Biologics Consulting. "It could create a competition for the immunocompromised," he said in a call last week with reporters.
But otherwise, the change will be mostly psychological, he said in an interview.
"Really, there are not major differences," said Baylor, who spent 20 years with the FDA, including running its Office of Vaccines Research and Review.