Wilfredo Lee / AP
The US Food and Drug Administration is expected to approve the Pfizer-BioNTech COVID-19 vaccine for children aged 12 to 15, a decision that may be made some time early next week. Currently, the vaccine is only allowed for people aged 16 and over.
A decision should come “soon,” Pfizer chairman and CEO Albert Burla told investors in a conference call Tuesday morning.
In late March, the company announced it would ask the FDA to extend its emergency use permit to allow younger people to receive the vaccine, citing clinical studies that show the vaccine causes “100% efficacy and stable responses to antibodies “in adolescents 12 to 15 years of age.
News of the impending authorization comes as children now account for a growing share of new coronavirus cases in the United States, where more than 100 million adults have been fully vaccinated against COVID-19.
Pfizer is conducting pediatric studies to determine the safety and benefits of the vaccine in young children. The company plans to submit two new applications for an emergency use permit in September, with one application covering children aged 2 to 5 and a second covering children aged 5 to 11. From 6 months to 2 years are expected in the fourth quarter.
“We also expect to have safety data in phase 2 of our ongoing study in pregnant women by the end of July / beginning of August,” Burla said, according to his comments.
Looking ahead, Burla said he expects a “permanent demand” for the COVID-19 vaccine, similar to that for influenza vaccines. And he said that later this month, Pfizer would ask the FDA to give full approval – not just emergency authorization – for the vaccine to people aged 16 and over. The company is also exploring how a third booster shot can help protect people who have already gone on a two-dose regimen.
Pfizer and BioNTech, its partner in vaccine development, expect to be able to produce at least 3 billion doses by 2022, the Pfizer chief said.
The COVID-19 vaccine has already brought billions of dollars to Pfizer; Burla said that in the first quarter of 2021 alone, the vaccine added $ 3.5 billion in global revenue. For the full year, he said, Pfizer expects to bring in about $ 26 billion based on the vaccine.
The company and BioNTech have shipped about 430 million doses to 91 countries and territories, Burla said.