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Pfizer on Tuesday asked the Food and Drug Administration to grant emergency use authorization to its two-dose COVID-19 vaccine for children under the age of 5 as it continues to study a third shot for the age group.
The company and its partner BioNTech said that the submission was at the request of the FDA, which is an unusual move. Quickly after the announcement, the FDA scheduled a meeting of its vaccine advisory committee for Feb. 15 to discuss the application.
Allowing Pfizer to submit the request now means that, if authorized, “parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose,” according to Pfizer CEO Albert Bourla. Data on the third dose will be submitted to the FDA “in the coming months,” the company said.
“As hospitalizations of children under 5 due to COVID-19 have soared, our mutual goal with the FDA is to prepare for future variant surges and provide parents with an option to help protect their children from this virus,” Bourla said in a statement. “Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants.”
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Coronavirus cases among children have “spiked dramatically” but are down from the peak in January, according to one report. More than 10 million children have tested positive for the coronavirus since the pandemic started.
The request comes after Pfizer reported disappointing results in December that showed that two doses generated a strong immune response in kids under age 2 but not for 2- to 5-year-olds. The company said the shots, which are one-tenth the dosage given to adults, had no safety concerns for kids.
The company said in a press release that “data on a third dose given at least 8 weeks after completion of the second dose are expected in the coming months and will be submitted to the FDA to support a potential expansion of this requested EUA.”