Pfizer expects to ask for emergency vaccine authorization for children in September

Pfizer expects to request emergency use authorization for its COVID-19 vaccine to be given to children ages 2 to 11 in September as vaccine manufacturers work to get approval to administer doses to minors. 

The company told reporters on a Tuesday call that it expects to have completed trials for children ages 2 to 5 and 5 to 11 in the fall, allowing Pfizer and its German partner BioNTech to apply to the Food and Drug Administration (FDA) for emergency use authorization for those age groups.

The FDA granted the Pfizer-BioNTech vaccine emergency use authorization for those 16 and older in December, the first vaccine given such approval in the U.S. The New York Times reported on Monday that the FDA is getting ready to give emergency approval for the vaccine to be given to adolescents ages 12 to 15 by early next week.

The FDA can issue emergency use authorizations, which are designed to be temporary, during a public health emergency after conducting clinical trials.

Pfizer and BioNTech plans to also seek the FDA’s full approval for the shot to be given to those 16 to 85, which would allow the vaccine to be administered after the public health emergency is declared over. The companies expect to apply for full approval later this month. 

Data on the vaccine’s safety in pregnant women is expected to be released by August. 

Ahead of its Tuesday call, Pfizer also declared that it earned $3.5 billion from the COVID-19 vaccine in the first three months of this year, amounting to almost a quarter of its revenue. 

More than 131 million doses of the Pfizer-BioNTech vaccine have been administered across the U.S. since September, making up more than half of the administered doses, according to Centers for Disease Control and Prevention data.  

The White House said it was ready to distribute and administer vaccines to those ages 12 to 15 once the FDA grants emergency authorization.

“The FDA and the FDA alone will make that decision,” President Biden said in an address on Tuesday.

“Today I want American parents to know that if that announcement comes we are ready to move immediately — immediately move to make about 20,000 pharmacy sites across the country ready to vaccinate those adolescents as soon as the FDA grants its OK,” he added.