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Pfizer and BioNTech have formally requested that their COVID-19 vaccine be cleared for use amongst younger children.
In a tweet Thursday, Pfizer said the companies submitted their request for an unexpected emergency use authorization (EUA) for their vaccine to the U.S. Foodstuff and Drug Administration. They are seeking clearance for it to be used amongst children ages 5 to 11.
The request for EUA will be evaluated all through an future Vaccines and Associated Organic Products Advisory Committee (VRBPAC) meeting on Oct 26.
“We know from our wide expertise with other pediatric vaccines that children are not smaller grownups, and we will perform a comprehensive analysis of scientific trial facts submitted in help of the security and success of the vaccine used in a youthful pediatric populace, which may possibly will need a distinct dosage or formulation from that used in an more mature pediatric populace or grownups,” Performing Food and drug administration Commissioner Dr. Janet Woodcock said in a assertion.
WHY THIS Matters
The EUA submission arrives as no shock, considering the fact that the companies said they would find regulatory approval “as shortly as probable” past month, when they unveiled vaccine facts for children ages 5 to 11.
The facts confirmed that a smaller dose of Pfizer and BioNTech’s vaccine elicited a equivalent antibody reaction and had equivalent facet outcomes as witnessed in individuals sixteen to 25 many years of age.
As observed in Pfizer’s tweet, COVID-19 instances amongst younger children are on the rise. During the week of September 30, 173,469 little one COVID-19 instances were described, representing 26.seven% of all instances recorded that week, in accordance to the American Academy of Pediatrics.
In the two-week time period prior to September 30, there was a seven% improve in the cumulative variety of little one COVID-19 instances considering the fact that the starting of the pandemic, the AAP found.
“With new instances in children in the U.S. continuing to be at a superior level, this submission is an vital phase in our ongoing hard work versus #COVID19,” Pfizer said in its tweet. “We’re fully commited to doing the job with the Food and drug administration with the supreme objective of aiding shield children versus this really serious community wellbeing menace.”
THE Larger Pattern
In August, Pfizer and BioNTech’s COVID-19 vaccine became the initial to receive whole approval from the Food and drug administration. The vaccine is now promoted as Comirnaty and is authorized for the avoidance of COVID-19 for these sixteen many years previous and more mature.
The companies have also gotten a EUA for a booster shot of Comirnaty amongst specific populations, this sort of as these 65 many years of age and more mature, persons eighteen as a result of 64 at superior danger of intense COVID-19 and these aged eighteen as a result of sixty four whose occupational exposure spots them at superior danger of really serious problems 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 conferences for Oct fourteen and 15 to discuss probable booster shot approvals.
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