Syringes filled with the Pfizer COVID-19 vaccine will be on display at the Christine E. Lynn Rehabilitation Center at Jackson Memorial Hospital in Miami in April. Wilfredo Lee / AP hide caption
Wilfredo Lee / AP
Wilfredo Lee / AP
The U.S. Food and Drug Administration is expected to approve Pfizer and BioNTech’s COVID-19 vaccine for children ages 12-15. That decision could be made early next week. The vaccine is currently only approved for people aged 16 and over.
A decision should come “shortly,” said Pfizer chairman and CEO Albert Bourla said investors in a conference call Tuesday morning.
The Company Announced at the end of March that it would urge the FDA to expand its emergency approval to allow younger people to receive the vaccine, citing clinical studies that showed the vaccine had a “100%” rating in adolescents aged 12-15 ige efficacy and robust antibody responses “.
The news of the pending approval comes when children have come to represent an increasing proportion of new coronavirus cases in the US with more than 100 million adults fully vaccinated against COVID-19.
Pfizer is conducting pediatric studies to determine the safety and benefit of giving its vaccine to young children. The company plans to file two new emergency permits in September, with one application pertaining to children ages 2-5 and a second application pertaining to ages 5-11. A separate set of results and a possible inquiry for children aged six months to two years are expected in the fourth quarter.
“We also expect to have Phase 2 safety data from our ongoing study in pregnant women in late July / early August,” said Bourla, according to his prepared comments.
Looking ahead, Bourla anticipates “sustained demand” for the COVID-19 vaccine, similar to flu vaccines. And he said that later this month Pfizer will ask the FDA for full approval – not just emergency clearance – to give the vaccine to people aged 16 and over. The company is also researching how a third booster shot can help protect people who have already undergone two-dose therapy.
Pfizer and BioNTech, their partner in developing the vaccine, estimate they can produce at least 3 billion doses in 2022, the Pfizer chief executive said.
The COVID-19 vaccine has grossed billions of dollars for Pfizer. Bourla said the vaccine had worldwide sales of $ 3.5 billion in the first quarter of 2021 alone. For the full year, Pfizer expects sales of around US $ 26 billion based on the vaccine.
The company and BioNTech have shipped approximately 430 million cans to 91 countries and territories, Bourla said.