FDA Set to Authorize Pfizer COVID-19 Vaccine for Early Teens Next Week, the Times Reports

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Pfizer coronavirus vaccine ampoule, in December
Pfizer coronavirus vaccine ampoule, in DecemberCredit: Emil Salman

The U.S. Food and Drug Administration is preparing to authorize Pfizer Inc. and German partner BioNTech SE's COVID-19 vaccine for adolescents aged between 12 and 15 years by early next week, the New York Times reported on Monday, citing federal officials familiar with the agency's plans.

An approval is highly anticipated after the drugmakers said in March that the vaccine was found to be safe, effective and produced robust antibody responses in 12- to 15-year-olds in a clinical trial.

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Responding to a Reuters request for comment, the FDA said its review of expanding the vaccine's emergency use authorization is ongoing, but did not provide further details.

The vaccine has already been cleared in the United States for people aged 16 and above.

Pfizer declined to comment on the NYT report.

The U.S. Centers for Disease Control (CDC) Director Rochelle Walensky said earlier in April that the vaccine could be approved by mid-May.

If an approval for the 12-15 year olds is granted, the CDC's vaccine advisory panel will likely meet the following day to review the clinical trial data and make recommendations for the vaccine's use in adolescents, the report added. 

A potential approval of the vaccine would boost the country's immunization drive and help allay fears of parents anxious to protect their children from COVID-19.

Moderna Inc and Johnson & Johnson are also testing their vaccines in 12- to 18-year olds, with data from Moderna's trial expected to come soon.

Pfizer and Moderna have also launched trials in even younger children, aged six months to 11 years old. Both companies have said they hope to be able to vaccinate children under 11 as soon as early 2022.

Israel braced

Following Pfizer's clinic trials in March, the Israel Pediatric Association recommended vaccinating this age group as soon as FDA approval is finalized.

"We prepared a list of underlying conditions in children two months ago," the association said. "We urge all parents of children with underlying conditions to call their pediatricians now and find out if their children can be vaccinated."

"Pfizer's announcement is amazing news for the citizens of Israel," Health Minister Yuli Edelstein said. "Nothing is timelier than the acquisition of additional vaccines, so we can immediately begin vaccinating teens once the vaccine receives FDA approval," he added.

With COVID-19 waning in Israel, its public health system is bracing for a new phase in its vaccination campaign against the coronavirus and begin vaccinating the 600,000 young people. It is expected that significant efforts will be expended on public relations appeals to persuade parents. 

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