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The US Food and Drug Administration (FDA) has granted full approval for the Pfizer-BioNTech COVID-19 vaccine.
It is the first COVID-19 vaccine to be fully licensed in the US. It will be marketed under the trade name Comirnaty.
The approval applies to individuals ages 16 and older. The vaccine is still available for emergency use for those ages 12 through 15.
The FDA's official sign-off is somewhat anticlimactic, following months of real-world use and millions of doses doled out to the general population. It comes after months of scrutiny by the agency of the clinical trial data.
Still, the approval puts the vaccines on firmer legal footing and is expected to spur a raft of new vaccination requirements by employers, schools, and universities.
"The FDA approval is the gold standard," said President Joe Biden in remarks from the White House. "Those who have been waiting for full approval should go and get your shot now."
"It could save your life or the lives of those you love," he said.
Biden also called on businesses to mandate COVID vaccines for their employees.
Indeed, soon after the approval was announced, Defense Secretary Lloyd Austin said the vaccines would be required for all 1.4 million active duty service members.
"Will Persuade Some"
Public health advocates have seen full approval as an important tool to increase vaccination rates in the US and had criticized the FDA for taking so long to grant the license.
In a press briefing on the approval, Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, said the agency had not dragged its feet.
Marks noted that his team had reviewed tens of thousands of pages of clinical trial data — down to the level of individual patients. They also inspected clinical trial sites and manufacturing facilities, and reviewed information gathered after the vaccines were authorized for use.
"It's been 97 days since Pfizer completed the rollout of its BLA [biologics license application] and the clock started, which means that we completed this in about 40% of the normal clock time for a submission of this magnitude," he said. "People worked day and night."
The agency resisted pressure to speed up its process, saying a thorough review was necessary to ensure public confidence.
"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 US," said Acting FDA Commissioner Janet Woodcock in a news release.
Experts agreed the move could increase public confidence.
"I don't expect a big line outside of vaccination sites this afternoon or tomorrow morning, but it will persuade some," said William Schaffner, MD, a professor of infectious diseases at Vanderbilt University in Nashville, Tennessee.
A recent Kaiser Family Foundation poll found that 3 in 10 unvaccinated adults said they would be more likely to get vaccinated if the vaccines were given full approval.
More importantly, Schaffner said, the FDA's approval would lay the groundwork for vaccine mandates. "I think those kinds of mandates are going to be necessary to get us up over 80% vaccinated."
In granting the approval, the agency reviewed a record amount of data from more than 40,000 clinical trial participants. About 12,000 recipients have been followed for at least 6 months, the agency said.
The FDA also reviewed safety data collected since it issued its emergency use authorization for the shots in December.
Based on the results from the clinical trial, the vaccine was 91% effective at preventing COVID-19 disease. That estimate was derived from data collected before the Delta variant became widespread, however.
The most commonly reported side effects in the clinical trial were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever.
The FDA said the vaccine is effective in preventing COVID-19 and potentially serious outcomes, including hospitalization and death.
Based on safety data reviewed since the two-dose vaccine was approved, the FDA said the data demonstrate an increased risk for heart inflammation — clinically known as myocarditis or pericarditis — especially within 7 days after the second dose of the shots. The risk is highest for men under age 40 compared with women and older men.
The prescription information includes information on these risks. The FDA said the manufacturers must continue to study the risks and long-term effects on people who develop myocarditis following vaccination.
The rapid deployment of COVID-19 vaccines in the US happened less than a year after the first COVID-19 cases were detected in this country, and is widely considered to be a historic scientific achievement.
A recent study by Yale University and The Commonwealth Fund estimated that the COVID-19 vaccines had saved nearly 280,000 lives and averted 1.25 million hospitalizations in the US by the end of June 2021.
Not for Young Children, Yet
Traditionally, once the FDA approves a drug or therapy, doctors are free to prescribe it as they see fit. Some have worried that freedom would allow prescribers to offer the vaccines to children.
Woodcock said the COVID vaccines have been purchased by the government and are made available to providers only after they sign an agreement with the CDC. The agreement requires providers to adhere to certain requirements for use.
"That would be a great concern — that people would vaccinate children because we don't have the proper dose. We don't have the safety data, nor do we have the efficacy data," she said in a press briefing, noting that those studies are ongoing.
"We are not recommending that children younger than age 12 be vaccinated with this vaccine. It would not be appropriate."
The American Academy of Pediatrics quickly issued a statement discouraging the idea.
"We know parents are eager to be able to give their children the protection of this vaccine, and the American Academy of Pediatrics shares that feeling of urgency," said AAP President Lee Savio Beers, MD, in a statement.
"The Delta variant has led to significant increases in the number of children and adults infected with the virus. While we wait for a vaccine to be authorized for younger children, it's important that everyone who is eligible now get the vaccine. That will help reduced the spread of the virus and protect those who are too young to be vaccinated."
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Cite this: FDA Fully Approves Pfizer's COVID Vaccine, Paves Way for Mandates - Medscape - Aug 23, 2021.