Photograph by Marko Geber/Getty Visuals
Pfizer and BioNTech have officially asked for that their COVID-19 vaccine be cleared for use among younger youngsters.
In a tweet Thursday, Pfizer stated the organizations submitted their request for an crisis use authorization (EUA) of their vaccine to the U.S. Food and Drug Administration. They are in search of clearance for it to be used among youngsters aged five to eleven years old.
The request for EUA will be evaluated all through an upcoming Vaccines and Related Organic Goods Advisory Committee (VRBPAC) meeting on Oct 26.
“We know from our large expertise with other pediatric vaccines that youngsters are not compact older people, and we will conduct a thorough evaluation of scientific trial facts submitted in help of the safety and performance of the vaccine used in a more youthful pediatric populace, which may possibly will need a distinct dosage or formulation from that used in an older pediatric populace or older people,” Acting Fda Commissioner Dr. Janet Woodcock stated in a assertion.
WHY THIS Matters
The EUA submission will come as no surprise given that the organizations stated they would search for regulatory acceptance “as shortly as achievable” very last month when they introduced vaccine facts among youngsters aged five to eleven.
The facts showed that a smaller dose of Pfizer and BioNTech’s vaccine elicited a very similar antibody reaction and experienced comparable facet consequences as witnessed in folks 16 to 25 years of age.
As observed in Pfizer’s tweet, COVID-19 cases among younger youngsters are on the rise. Through the 7 days of September 30, 173,469 boy or girl COVID-19 cases were being described, representing 26.seven% of all cases recorded that 7 days, according to the American Academy of Pediatrics.
In the two-7 days period prior to September 30, there was a seven% maximize in the cumulative quantity of boy or girl COVID-19 cases given that the beginning of the pandemic, the AAP uncovered.
“With new cases in youngsters in the U.S. continuing to be at a substantial degree, this submission is an vital action in our ongoing effort versus #COVID19,” Pfizer stated in its tweet. “We’re dedicated to performing with the Fda with the supreme aim of helping protect youngsters versus this significant community well being danger.”
THE Greater Craze
In August, Pfizer and BioNTech’s COVID-19 vaccine turned the initially to obtain whole acceptance from the Fda. The vaccine is now marketed as Comirnaty and is accredited for the prevention of COVID-19 for individuals 16 years old and older.
The organizations have also gotten a EUA for a booster shot of Comirnaty among specified populations, this sort of as individuals 65 years of age and older, men and women eighteen by 64 at substantial chance of extreme COVID-19 and individuals aged eighteen by sixty four whose occupational publicity destinations them at substantial chance of significant problems of COVID-19.
Moderna and Johnson & Johnson have also submitted requests to the Fda for booster shot EUAs. The VRBPAC has scheduled conferences for Oct fourteen and 15 to examine achievable booster shot approvals.
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