Pfizer and BioNTech announced Tuesday they are requesting emergency use authorization for their two-dose COVID-19 vaccine for children 6 months through 4 years of age.
Food and Drug Administration authorization could come as soon as late February, making the Pfizer-BioNTech vaccine the first authorized COVID-19 vaccine for that age group, the New York Times reported. But data released in December indicate that it might not produce an adequate immune response for most of the age group.
NOVAVAX REQUESTS FDA AUTHORIZE ‘MORE TRADITIONAL’ COVID-19 VACCINE
“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,” Pfizer CEO Albert Bourla said. “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.”
The companies have previously said they plan to pursue a third dose for the age group after receiving authorization for the first two doses. They said they expect the third dose will receive approval in the first half of 2022 if data show it is successful.
The vaccine produced an immune response in children ages 6 months to 2 years old that was similar to the response in fully vaccinated people ages 16 to 25, data released in December indicated. However, children ages 2–5 did not produce an adequate response.
The company said it did not detect adverse effects during its study. It used about a tenth of adult doses in its vaccine for children under 5.
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The FDA issued an emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine for children ages 5-11 last October, meaning children under 5 are the last remaining group that does not have an authorized COVID-19 vaccine in the United States.
COVID-19 cases in children under 18 climbed dramatically in January during the omicron wave. Last week, there were over 800,000 COVID-19 cases reported among children, according to data from the American Academy of Pediatrics. This is down from the peak of about 1.2 million cases reported the week prior. Currently, about 20% of children ages 5-11 and 66% of teenagers ages 12-17 are vaccinated with at least one dose of the COVID-19 vaccine, according to AAP.
