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Pfizer CEO says chances are ‘very high’ FDA will approve low-dose Covid shots for kids under 5

Pfizer CEO Albert Bourla talks during a press conference with European Commission President after a visit to oversee the production of the Pfizer-BioNtech Covid-19 vaccine at the factory of US pharmaceutical company Pfizer, in Puurs, on April 23, 2021.
John Thys | AFP | Getty Images

Pfizer CEO Albert Bourla on Tuesday said he believes the Food and Drug Administration will authorize the company’s Covid vaccine for children under 5 years old under a fast-track process that allows the agency to review the data as soon as researchers compile it in real time.

“I think the chances are very high for FDA to approve it,” Bourla told CNBC’s Meg Tirrell, while noting that the regulatory process still has to play out. “I think that they will be pleased with the data and they will approve,” he said.

Data on Pfizer and BionTech‘s vaccine for kids under 5 years old is expected on Friday when briefing documents for the FDA’s vaccine advisory committee are published. The committee has a meeting scheduled for Feb. 15 to discuss the shots for young kids.

Pfizer and BioNTech asked the FDA last week to expand the authorization for their vaccine to most kids under 5. The FDA had asked the companies to start submitting data for authorization of the first two-doses of the three-dose vaccine for children six months through 4-years-old.

Pfizer and BioNTech expect kids under 5 will ultimately need three doses for the highest level of protection against the omicron Covid variant and future strains of the virus. The companies said data on the third dose will be finished and submitted to the FDA in the coming months.

Pfizer amended its clinical trial for younger kids in December to study a third shot after the first two doses did not produce an adequate immune response in children 2- to 4-years-old. Younger kids will receive a smaller, three microgram dose compared with the 30 microgram shots that are approved for adults.

Children under 5-years-old are the last age group left in the U.S. that isn’t eligible for vaccination. There has been growing public pressure from many parents and doctors for the FDA to speed up authorization of the vaccine as the omicron variant has lead to an increase in children hospitalized with Covid.

Pfizer and BioNTech said last week that their application for emergency approval came in response to an “urgent public health need” for younger children as omicron has caused an unprecedented wave of infection across the country.

White House chief medical advisor Dr. Anthony Fauci said last month that he expects the vaccine to receive FDA authorization in February.

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