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Pfizer and BioNTech have officially asked for that their COVID-19 vaccine be cleared for use among younger little ones.
In a tweet Thursday, Pfizer mentioned the providers submitted their request for an crisis use authorization (EUA) for their vaccine to the U.S. Food stuff and Drug Administration. They are trying to find clearance for it to be made use of among little ones ages 5 to 11.
The request for EUA will be evaluated in the course of an forthcoming Vaccines and Similar Organic Products and solutions Advisory Committee (VRBPAC) assembly on Oct 26.
“We know from our wide knowledge with other pediatric vaccines that little ones are not little grown ups, and we will carry out a detailed analysis of clinical trial data submitted in help of the security and efficiency of the vaccine made use of in a younger pediatric inhabitants, which may perhaps will need a unique dosage or formulation from that made use of in an more mature pediatric inhabitants or grown ups,” Performing Food and drug administration Commissioner Dr. Janet Woodcock mentioned in a assertion.
WHY THIS Issues
The EUA submission will come as no shock, considering the fact that the providers mentioned they would search for regulatory approval “as before long as probable” final thirty day period, when they introduced vaccine data for little ones ages 5 to 11.
The data showed that a smaller sized dose of Pfizer and BioNTech’s vaccine elicited a related antibody response and experienced equivalent facet outcomes as seen in people today 16 to twenty five yrs of age.
As famous in Pfizer’s tweet, COVID-19 situations among younger little ones are on the rise. Throughout the 7 days of September thirty, 173,469 little one COVID-19 situations were being described, representing 26.seven% of all situations recorded that 7 days, according to the American Academy of Pediatrics.
In the two-7 days time period prior to September thirty, there was a seven% boost in the cumulative variety of little one COVID-19 situations considering the fact that the commencing of the pandemic, the AAP discovered.
“With new situations in little ones in the U.S. continuing to be at a large amount, this submission is an critical phase in our ongoing exertion in opposition to #COVID19,” Pfizer mentioned in its tweet. “We’re fully commited to functioning with the Food and drug administration with the final intention of encouraging guard little ones in opposition to this critical public health and fitness menace.”
THE Larger Trend
In August, Pfizer and BioNTech’s COVID-19 vaccine turned the very first to receive whole approval from the Food and drug administration. The vaccine is now marketed as Comirnaty and is authorized for the prevention of COVID-19 for people 16 yrs old and more mature.
The providers have also gotten a EUA for a booster shot of Comirnaty among specific populations, these as people 65 yrs of age and more mature, folks 18 through 64 at large risk of intense COVID-19 and people aged 18 through sixty four whose occupational publicity destinations them at large risk of critical complications of COVID-19.
Moderna and Johnson & Johnson have also submitted requests to the Food and drug administration for booster shot EUAs. The VRBPAC has scheduled meetings for Oct 14 and 15 to explore probable booster shot approvals.
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