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Pfizer and BioNTech have officially requested that their COVID-19 vaccine be cleared for use among young children.
In a tweet Thursday, Pfizer said the companies submitted their request for an emergency use authorization (EUA) for their vaccine to the U.S. Food and Drug Administration. They are seeking clearance for it to be used among children ages 5 to 11.
The request for EUA will be evaluated during an upcoming Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on October 26.
“We know from our vast experience with other pediatric vaccines that children are not small adults, and we will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population, which may need a different dosage or formulation from that used in an older pediatric population or adults,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement.
WHY THIS MATTERS
The EUA submission comes as no surprise, since the companies said they would seek regulatory approval “as soon as possible” last month, when they released vaccine data for children ages 5 to 11.
The data showed that a smaller dose of Pfizer and BioNTech’s vaccine elicited a similar antibody response and had comparable side effects as seen in people 16 to 25 years of age.
As noted in Pfizer’s tweet, COVID-19 cases among young children are on the rise. During the week of September 30, 173,469 child COVID-19 cases were reported, representing 26.7% of all cases recorded that week, according to the American Academy of Pediatrics.
In the two-week period prior to September 30, there was a 7% increase in the cumulative number of child COVID-19 cases since the beginning of the pandemic, the AAP found.
“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19,” Pfizer said in its tweet. “We’re committed to working with the FDA with the ultimate goal of helping protect children against this serious public health threat.”
THE LARGER TREND
In August, Pfizer and BioNTech’s COVID-19 vaccine became the first to receive full approval from the FDA. The vaccine is now marketed as Comirnaty and is approved for the prevention of COVID-19 for those 16 years old and older.
The companies have also gotten a EUA for a booster shot of Comirnaty among certain populations, such as those 65 years of age and older, individuals 18 through 64 at high risk of severe COVID-19 and those aged 18 through 64 whose occupational exposure places them at high risk of serious complications of COVID-19.
Moderna and Johnson & Johnson have also submitted requests to the FDA for booster shot EUAs. The VRBPAC has scheduled meetings for October 14 and 15 to discuss possible booster shot approvals.
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