The U.S. Food and Drug Administration is expected to authorize the Pfizer-BioNTech COVID-19 vaccine for children 12 to 15 years old, a decision that could come by some time early next week. The vaccine is currently authorized only for people age 16 and older.
A ruling should come “shortly,” Pfizer Chairman and CEO Albert Bourla told investors in a conference call Tuesday morning.
The company announced in late March that it would ask the FDA to expand its emergency use authorization to allow younger people to receive the vaccine, citing clinical trials that showed the vaccine elicits “100% efficacy and robust antibody responses” in adolescents from 12 to 15 years old.
News of the pending authorization comes as children now represent a rising proportion of new coronavirus cases in the U.S., where more than 100 million adults have been fully vaccinated against COVID-19.
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Pfizer is conducting pediatric studies to determine the safety and benefits of administering its vaccine to young children. The company plans to submit two new emergency use authorization requests in September, with one request covering children from 2 to 5 years old and a second applying to ages 5 to 11. A separate batch of results and a possible request, for children who are from 6 months to 2 years old, are expected in 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 said, according to his prepared remarks.
Looking further into the future, Bourla said he anticipates “durable demand” for the COVID-19 vaccine, similar to that for flu vaccines. And he said that later this month, Pfizer will ask the FDA to give full approval — not just emergency authorization — for administering its vaccine to people ages 16 and up. The company is also studying how a third booster shot could help protect people who have already undergone the two-dose regimen.
Pfizer and BioNTech, its partner in developing the vaccine, expect to be able to produce at least 3 billion doses in 2022, the Pfizer chief said.
The COVID-19 vaccine has already brought billions of dollars to Pfizer; Bourla said that in the first quarter of 2021 alone, the vaccine added $3.5 billion in global revenue. For the year overall, he said, Pfizer expects to bring in around $26 billion based on the vaccine.
The company and BioNTech have shipped some 430 million doses to 91 countries and territories, Bourla said.
