Pfizer seeks full FDA approval of COVID-19 vaccine, awaits OK for adolescents

By Clyde Hughes & Brian Dunleavy
Full approval and licensing from the FDA would allow Pfizer to market its BNT162b2 coronavirus vaccine directly to customers in the United States. File Photo by Debbie Hill/UPI
1 of 5 | Full approval and licensing from the FDA would allow Pfizer to market its BNT162b2 coronavirus vaccine directly to customers in the United States. File Photo by Debbie Hill/UPI | License Photo

May 4 (UPI) -- Drugmaker Pfizer said Tuesday it earned $3.5 billion from sales of its COVID-19 vaccine in the first three months of 2021, and plans to ask federal regulators for full approval of the shot by the end of this month -- and could have an emergency approval to offer it to teens in days.

The authorization for use in adolescents age 12 to 15 is expected in the coming days as states look to start vaccinating children across the country ahead of the summer and 2021-22 academic school year.


The vaccine, developed by Pfizer and BioNTech, received emergency use approval for use in people age 16 years and older from the Food and Drug Administration in December. Full approval and licensing from the FDA would allow the companies to market the BNT162b2 vaccine directly to customers.

"I am extremely proud of the way we have begun 2021," Pfizer CEO Dr. Albert Bourla said in a statement.

Bourla said the company achieving regulatory goals like expanding vaccine use to include younger recipients and receiving approval in more countries will help patients overcome the coronavirus disease.


Overall, Pfizer reported total revenue of more than $14 billion in the first quarter -- a sizable increase over the same period in 2020 ($10.8 billion).

Pfizer said last month that emerging COVID-19 variants may create the need for a second booster shot sometime this year.

The company began studying the safety and effectiveness of a third shot in February, given 6 to 12 months after the second shot, it said Tuesday.

The FDA is expected to authorize the shot for those ages 12 to 15 as soon as next week, according to various media reports Tuesday.

The move would clear the way for millions of middle- and high-school students to get vaccinated against the coronavirus before the start of the 2021-22 academic year, Biden administration officials told NPR and the New York Times.

In a clinical trial of Pfizer's two-dose shot in 12- to 15-year-olds in Israel, the vaccine provided 100% protection against severe illness from infection, based on results released by the company on March 31.

Although children accounted for less than 5% of all coronavirus cases in the United States from most of 2020, that may be starting to change.

From April 22 through April 29, children, teens and young adults ages 0 to 20 years accounted for 22% of all infections nationally, according to an analysis by the American Academy of Pediatrics.


New data on the use of the Moderna two-dose vaccine in adolescents age 12 to 17 is expected to be released in the coming days, with data for children age 6 months to 12 years planned for later this year, the company has said.

Currently, the Moderna shot is approved for adults age 18 years and older, according to the FDA.

Moderna and Johnson & Johnson, the other two vaccines approved for use in the United States, have indicated that they may also produce an additional booster shot.

A year in pandemic: How COVID-19 changed the world

January 31, 2020
National Institutes of Health official Dr. Anthony Fauci (C) speaks about the coronavirus during a press briefing at the White House in Washington, D.C. Health and Human Services Secretary Alexander Azar (L) announced that the United States is declaring the virus a public health emergency and issued a federal quarantine order of 14 days for 195 Americans. Photo by Leigh Vogel/UPI | License Photo

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