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Pfizer plans to request COVID-19 vaccine EUA for ages 2-11 in September

May 4, 2021

Editor’s note:For the latest news on COVID-19, visit http://bit.ly/AAPNewsCOVID19.

Children ages 2-11 could potentially be eligible for a COVID-19 vaccine this fall.

Pfizer Chairman and CEO Albert Bourla, D.V.M., Ph.D., said on a quarterly earnings call Tuesday he expects to request emergency use authorization (EUA) from the Food and Drug Administration (FDA) in September. Under his plan, an EUA request for ages six months to 2 years would follow in the fourth quarter.

Pfizer and its partner BioNTech currently are waiting for an FDA decision on an EUA for adolescents ages 12-15 years. The New York Times reported that approval could come later this week or early next week, giving adolescents the opportunity to be vaccinated before classes begin in the fall. The companies reported in March their vaccine was safe and 100% effective in this age group.

President Joe Biden said Tuesday if the FDA approves, officials will focus on making vaccines available through pediatricians and family physicians. He is challenging states to vaccinate as many adolescents as possible by July 4.

“Parents and their children can talk to their family doctor about it and get their shot from a provider they trust the most. Easy, fast and free,” Biden said. “And if teens are on the move this summer, they can get their first shot in one place and the second shot elsewhere.”

The AAP has continued to push for pediatric vaccine trials in children and adolescents. Last week, children made up 22.4% of new cases, a share that has been growing, according to data from the AAP and Children’s Hospital Association. More than 3.78 million children have been infected with SARS-CoV-2 and at least 303 have died. The pandemic also has taken a toll on children’s mental and emotional health, social well-being and their educational experience.

With adolescent vaccination on the horizon, the AAP has been helping pediatricians prepare to administer the vaccine in their practices. It recently updated its FAQs about COVID-19 vaccines and released new recommendations on how to prepare, how to implement vaccination in pediatric practices and how to get paid for vaccine administration.

In addition to addressing vaccination for children and adolescents on Tuesday, Dr. Bourla said the company plans to apply for full FDA licensure of the Pfizer-BioNTech vaccine by the end of this month for ages 16-85. He also expects to have phase 2 safety data on pregnant women in late July or early August.

Pfizer also is addressing its onerous cold storage requirements and has submitted new data to the FDA that could result in storage at standard refrigerator temperatures for up to four weeks.

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