Pfizer-BioNTech Asks U.S. FDA to Authorize COVID-19 Vaccine for Kids Under Five

Pfizer and BioNTech on Feb. 1 has requested the United States Food and Drug Administration (FDA) to expand the use of its COVID-19 vaccine to children aged six months to four years.

The companies said they applied for the emergency use authorization of a planned three-dose primary series for children under five, the third dose given at least eight weeks after the second dose.

The companies said they expect to complete the submission of the authorization in the coming days, although they also said that they plan to submit data on the third dose to the FDA in the coming months.

The FDA could grant the authorization for the age group by the end of February, a source told NBC News.

The Vaccines and Related Biological Products Advisory Committee of the FDA is scheduled to meet on Feb. 15 to offer guidance on the pediatric doses.

The companies said the request was “in response to the urgent public health need” in the age group.

According to the American Academy of Pediatrics, at least 11.4 million children have tested positive for COVID-19 since the pandemic began.

Children under five are the only group in the U.S. ineligible to receive a COVID-19 vaccine.

“As hospitalizations of children under five due to COVID-19 have soared, our mutual goal with the FDA is to prepare for future variant surges and provide parents with an option to help protect their children from this virus,” Pfizer Chairperson and Chief Executive Officer Albert Bourla said.

The companies also plan to share the data with the European Medicines Agency and other regulatory agencies around the world.


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