Pfizer asks FDA for authorization for COVID-19 vaccine for young children

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Pfizer and BioNTech have asked the Food and Drug Administration for emergency use authorization for a COVID-19 vaccine for children ages 6 months to 4 years old.

This has been done at the request of the FDA, Pfizer said yesterday.

"With pediatric COVID-19 cases surpassing 10 million and at the request of the FDA, the companies have submitted available data on the safety and efficacy of two 3 µg doses as part of a three-dose primary series for this age group to address the urgent public health need," they said.

The companies plan to submit additional data on a third 3 µg dose in this age group in the coming months.

WHY THIS MATTERS

If authorization is granted, the Pfizer-BioNTech vaccine would be the first COVID-19 vaccine available for pediatric populations under 5 years of age.
This potentially includes protection from future emerging variants of concern.

Pfizer and BioNTech have initiated the rolling submission seeking to amend the emergency use authorization of their COVID-19 vaccine in response to the urgent public health need in this population, Pfizer said.

The companies expect to complete the EUA submission in the coming days. 

This application is for authorization of the first two 3 µg doses of a planned three-dose primary series in this age group.

Data on a third dose given at least eight weeks after completion of the second dose are expected in the coming months and will be submitted to the FDA to support a potential expansion of the requested EUA.

The companies said they plan to share data on safety, tolerability, immunogenicity and available efficacy with the European Medicines Agency and other regulatory agencies around the world.

THE LARGER TREND

Since the pandemic began, more than 10.6 million children have tested positive for COVID-19 in the United States, according to Pfizer data. Children under 4 account for more than 1.6 million of those cases.

Further, reported COVID-19 cases and related hospitalization among children have spiked dramatically across the United States during the Omicron variant surge, Pfizer said.

For the week ending January 22, children under 4 accounted for 3.2% of the total hospitalizations due to COVID-19.

Earlier this month, the FDA authorized the Pfizer-BioNTech booster shot for children 12-to15-years old.

ON THE RECORD

"As hospitalizations of children under 5 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," said Albert Bourla, chairman and CEO of Pfizer. "Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants."

Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com