Pfizer Seeks FDA Authorization for COVID-19 Booster Shots in 16- and 17-Year-Olds

Pfizer Seeks FDA Authorization for COVID-19 Booster Shots in 16- and 17-Year-Olds
A health care worker prepares a dose of the Pfizer-BioNTech COVID-19 vaccine at a UHN COVID-19 vaccine clinic in Toronto on Jan. 7, 2021. (Nathan Denette/The Canadian Press)
Isabel van Brugen

Pfizer CEO and Chairman Albert Bourla on Tuesday announced that the company and its partner BioNTech have submitted a request to the U.S. Food and Drug Administration (FDA) seeking to expand authorization for its COVID-19 booster shot for use in 16- and 17-year-olds.

It comes after U.S. regulators last week expanded the eligibility for a booster dose of Pfizer and BioNTech’s COVID-19 vaccine to all adults 18 and over, to be administered at least six months after receiving the second shot.

If approved, the shot would be the first COVID-19 booster available to people under 18.

Bourla, in announcing the move in a statement on Twitter, cited uncertainty surrounding the Omicron variant of the CCP (Chinese Communist Party) virus.

President Joe Biden on Monday called the variant “a cause for concern, not a cause for panic.”

“It is our hope to provide strong protection for as many people as possible, particularly in light of the new variant,” Bourla wrote.

The White House and the country’s health regulators are currently pushing for wider vaccinations to prevent the spread of the highly infectious Omicron variant, despite a lack of information about its severity. The variant was first detected in Botswana.

Pfizer and BioNTech on Friday said that it could rework its COVID-19 vaccine to counter the Omicron variant in “approximately 100 days,” amid concern from experts that existing vaccines are less effective against the strain due to the high number of mutations on the spike protein.

“We understand the concern of experts and have immediately initiated investigations on variant B.1.1.529,” BioNTech said in a statement.

“We expect more data from the laboratory tests in two weeks at the latest,” it added. “These data will provide more information about whether B.1.1.529 could be an escape variant that may require an adjustment of our vaccine if the variant spreads globally.”

Meanwhile, Moderna CEO Stéphane Bancel suggested in an interview published on Tuesday that new COVID-19 vaccines may be needed to counter the strain.
“There is no world, I think, where [the effectiveness] is the same level … we had with Delta,” Bancel told the Financial Times. “I think it’s going to be a material drop. I just don’t know how much because we need to wait for the data. But all the scientists I’ve talked to … are like ‘this is not going to be good.’

Bancel added that the high number of mutations on the protein spike the virus uses to infect human cells meant it was likely the current crop of vaccines would need to be modified.

He further told the Financial Times that he believes it could be months before pharmaceutical companies can manufacture vaccines at scale specifically to combat the Omicron variant.
The Centers for Disease Control and Prevention (CDC) on Monday urged everyone aged 18 and older to “get a booster shot,” citing the emergence of the Omicron variant.
“CDC is updating its recommendation on [COVID-19] vaccinations: everyone 18 yrs & older should get booster shot,” CDC director Dr. Rochelle Walensky said in a statement. “We have much to learn about [the Omicron variant], but we do know that COVID-19 vaccines are our best tool to avoid serious illness [and] hospitalization.”
Reuters contributed to this report.
Isabel van Brugen is an award-winning journalist. She holds a master's in newspaper journalism from City, University of London.
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