Pfizer and BioNTech request EUA for COVID-19 vaccine in young children

Pfizer and BioNTech have formally requested that their COVID-19 vaccine be cleared for use amongst young little ones.

In a tweet Thursday, Pfizer mentioned the businesses submitted their ask for for an emergency use authorization (EUA) of their vaccine to the U.S. Foodstuff and Drug Administration. They are looking for clearance for it to be utilised amongst little ones aged 5 to eleven decades old.

The ask for for EUA will be evaluated through an impending Vaccines and Connected Biological Solutions Advisory Committee (VRBPAC) meeting on Oct 26.

“We know from our extensive experience with other pediatric vaccines that little ones are not tiny grown ups, and we will carry out a extensive analysis of medical demo knowledge submitted in support of the safety and usefulness of the vaccine utilised in a youthful pediatric population, which could will need a different dosage or formulation from that utilised in an older pediatric population or grown ups,” Acting Fda Commissioner Dr. Janet Woodcock mentioned in a statement.

WHY THIS Issues

The EUA submission comes as no surprise since the businesses mentioned they would find regulatory acceptance “as before long as doable” last thirty day period when they introduced vaccine knowledge amongst little ones aged 5 to eleven.

The knowledge confirmed that a smaller sized dose of Pfizer and BioNTech’s vaccine elicited a identical antibody reaction and had similar side outcomes as observed in individuals sixteen to 25 decades of age.

As mentioned in Pfizer’s tweet, COVID-19 scenarios amongst young little ones are on the rise. In the course of the 7 days of September 30, 173,469 youngster COVID-19 scenarios ended up reported, symbolizing 26.7% of all scenarios recorded that 7 days, according to the American Academy of Pediatrics.

In the two-7 days period of time prior to September 30, there was a 7% raise in the cumulative quantity of youngster COVID-19 scenarios since the beginning of the pandemic, the AAP found.

“With new scenarios in little ones in the U.S. continuing to be at a substantial degree, this submission is an essential step in our ongoing work in opposition to #COVID19,” Pfizer mentioned in its tweet. “We’re fully commited to doing work with the Fda with the supreme target of helping safeguard little ones in opposition to this severe public wellness menace.”

THE Larger Pattern

In August, Pfizer and BioNTech’s COVID-19 vaccine grew to become the very first to obtain comprehensive acceptance from the Fda. The vaccine is now marketed as Comirnaty and is accredited for the avoidance of COVID-19 for those sixteen decades old and older.

The businesses have also gotten a EUA for a booster shot of Comirnaty amongst certain populations, these kinds of as those 65 decades of age and older, men and women eighteen by means of 64  at substantial hazard of significant COVID-19 and those aged eighteen by means of sixty four whose occupational publicity places them at substantial hazard of severe issues of COVID-19.

Moderna and Johnson & Johnson have also submitted requests to the Fda for booster shot EUAs. The VRBPAC has scheduled meetings for Oct fourteen and fifteen to go over doable booster shot approvals.

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