Health

Pfizer submits knowledge on COVID-19 vaccine for kids ages 5-11 to FDA

Pfizer and BioNTech introduced that that they had submitted knowledge to the Meals and Drug Administration displaying that their COVID-19 vaccine was protected and efficient for kids between the ages of 5 and 11.

The vaccine demonstrated a “favorable security profile and elicited sturdy neutralizing antibody response” in youngsters who had acquired two doses, in accordance to the businesses. The scientific trial included 2,268 contributors.

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The FDA has stated it’ll evaluation the info as shortly as potential.

The businesses stated they anticipated to file a request for an emergency use authorization with the FDA to be used of the vaccine in youngsters ages 5-11 within the coming weeks. An EUA permits a vaccine to be administered with out first having to undergo full approval.

Dr. Scott Gottlieb, the previous head of the FDA and now a member of the board of administrators of Pfizer, just lately stated {that a} vaccine could possibly be obtainable for kids ages 5-11 by the top of October or November.

The businesses are additionally testing the vaccine on youngsters beneath the age of 5. The outcomes from these trials are anticipated as quickly because the fourth quarter of this yr.



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