The U.S. Food and Drug Administration is expected to authorize the Pfizer-BioNTech COVID-19 vaccine for youngsters 12 to fifteen years antique, a choice that would come by some time early subsequent week. The vaccine is presently authorized best for human beings age 16 and older.
A ruling have to come “shortly,” Pfizer Chairman and CEO Albert Bourla informed investors in a conference call Tuesday morning.
The business enterprise introduced in overdue March that it would ask the FDA to extend its emergency use authorization to allow younger people to get hold of the vaccine, bringing up medical trials that showed the vaccine elicits “a hundred% efficacy and sturdy antibody responses” in youth from 12 to fifteen years vintage.
News of the pending authorization comes as children now represent a growing proportion of new coronavirus instances within the U.S., in which extra than one hundred million adults were absolutely vaccinated against COVID-19.
Children Now Account For 22% Of New U.S. COVID Cases. Why Is That?
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Children Now Account For 22% Of New U.S. COVID Cases. Why Is That?
Pfizer is accomplishing pediatric research to decide the protection and blessings of administering its vaccine to younger kids. The company plans to post two new emergency use authorization requests in September, with one request covering kids from 2 to five years old and a second applying to a long time five to 11. A separate batch of effects and a likely request, for youngsters who’re from 6 months to 2 years antique, are predicted inside the fourth sector.
“We also anticipate to have Phase 2 safety statistics from our ongoing have a look at in pregnant girls through late July/early August,” Bourla stated, in line with his prepared feedback.
Looking similarly into the future, Bourla stated he anticipates “long lasting demand” for the COVID-19 vaccine, much like that for flu vaccines. And he said that later this month, Pfizer will ask the FDA to present complete approval — now not simply emergency authorization — for administering its vaccine to humans a long time sixteen and up. The business enterprise is also reading how a third booster shot could assist protect human beings who have already undergone the two-dose routine.
Pfizer and BioNTech, its accomplice in growing the vaccine, assume so that it will produce at the least 3 billion doses in 2022, the Pfizer chief stated.
The COVID-19 vaccine has already introduced billions of greenbacks to Pfizer; Bourla stated that inside the first zone of 2021 on my own, the vaccine introduced $3.5 billion in international sales. For the yr ordinary, he stated, Pfizer expects to herald round $26 billion primarily based at the vaccine.
The enterprise and BioNTech have shipped some 430 million doses to ninety one countries and territories, Bourla said.