Pfizer Says FDA Will Soon Authorize COVID-19 Vaccine For 12-15 Age Group : Coronavirus Updates : NPR


The U.S. Food and Drug Administration is anticipated to authorize Pfizer and BioNTech’s COVID-19 vaccine for teenagers ages 12 to fifteen years previous, a call that would come by someday early subsequent week. The vaccine is presently solely licensed for individuals age 16 and older.

A ruling ought to come “shortly,” Pfizer Chairman and CEO Albert Bourla told investors in a convention name Tuesday morning.

The firm introduced in late March that it could ask the FDA to develop its emergency use authorization to permit youthful individuals to obtain the vaccine, citing medical trials that confirmed the vaccine elicits “100% efficacy and robust antibody responses” in adolescents from 12 to fifteen years previous.

News of the pending authorization comes as youngsters have come to signify a rising proportion of recent coronavirus circumstances within the U.S., the place greater than 100 million adults have been absolutely vaccinated towards COVID-19.

Pfizer is conducting pediatric research to find out the security and advantages of administering its vaccine to younger youngsters. The firm plans to submit two new emergency use authorizations in September, with one request overlaying youngsters from 2-5 years previous and a second making use of to ages 5-11. A separate batch of outcomes and a doable request, for youngsters who’re from six months to 2 years previous, are anticipated within the fourth quarter.

“We also expect to have Phase 2 safety data from our ongoing study in pregnant women by late July/early August,” Bourla mentioned, in response to his ready remarks.

Looking additional into the long run, Bourla mentioned he anticipates “durable demand” for the COVID-19 vaccine, just like that for flu vaccines. And he mentioned that later this month, Pfizer will ask the FDA to provide full approval – not simply emergency authorization – for administering its vaccine to individuals ages 16 and up. The firm can be finding out how a 3rd booster shot might assist shield individuals who have already undergone the two-dose routine.

Pfizer and BioNTech, its companion in growing the vaccine, anticipate to have the ability to produce at the very least 3 billion doses in 2022, the Pfizer chief mentioned.

The COVID-19 vaccine has already introduced billions of {dollars} to Pfizer; Bourla mentioned that within the first quarter of 2021 alone, the vaccine added $3.5 billion in international income. For the 12 months total, he mentioned, Pfizer expects to herald round $26 billion based mostly on the vaccine.

The firm and BioNTech have shipped some 430 million doses to 91 international locations and territories, Bourla mentioned.



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