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Pfizer may seek EUA for COVID vaccine in children under 5 next spring

December 17, 2021

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Pfizer-BioNTech COVID-19 vaccines for children ages 6 months to 4 years may be a three-dose series and could be available as early as spring.

Pfizer said Friday that trials have evolved to include a third dose and the company also is studying third doses for older children.

“The effectiveness data for three doses of the vaccine in general for people 16 years and older and the early lab data we have seen with delta and other variants of concern including omicron suggest that people vaccinated with three doses of our COVID vaccine may have a higher degree of protection,” Kathrin U. Jansen, Ph.D., Pfizer senior vice president and head of vaccine research and development, said in a call with investors on Friday.

Children under 5 years

After testing several dosages, Pfizer and BioNTech have selected a dose level of 3 micrograms (µg) for children under 5 years, a lower dose than the 10-µg doses used for children ages 5-11 years and 30-µg doses used for those 12 years and older.

“We believe this reflects our commitment to careful dose selection to maximize the benefit-risk profile,” Dr. Jansen said.

She said an immunogenicity analysis found that after two doses, non-inferiority was met for those ages 6 months to 2 years, but not for those ages 2-4 years when compared to a 16- to 25-year-old group. No safety concerns were identified. The results led the companies to initiate a study of a third 3-µg dose given at least two months after the second dose.

If successful, Pfizer said it plans to ask the Food and Drug Administration for emergency use authorization (EUA) for children under 5 years in the second quarter of 2022.


Dr. Jansen said Pfizer would like to have a three-dose series for all ages and has initiated a study of a third dose in about 600 adolescents ages 12-17 years. It is looking at both 10-ug and 30-µg third doses for this group. About 51% of adolescents in this age group are fully vaccinated, according to an AAP analysis of Centers for Disease Control and Prevention (CDC) data.

On Thursday, Pfizer applied for full licensure for its COVID-19 vaccine for ages 12-15 years. This group has been eligible for the vaccine under an EUA since May.

Children 5-11 years

Like adolescents and young children, Pfizer also is studying a third dose of the 10-µg formulation in children ages 5-11 years. This group became eligible for vaccination in early November.

The CDC released new data on Pfizer-BioNTech vaccine safety in ages 5-11 years on Thursday. More than 7 million doses have been given to this age group.

Most reactions reported to the v-safe smartphone monitoring system have been mild to moderate, with about 1% of recipients reporting they sought medical care. There have been 3,233 reports to the Vaccine Adverse Event Reporting System (VAERS), 97% of which have been non-serious.

Two deaths have been reported in young girls, both of whom had complicated medical histories and whom investigators described as fragile. Both cases are still under review.

There have been eight confirmed cases of myocarditis in this age group reported to VAERS and the cases have been mild, according to the CDC.

“This further adds to the strong evidence of the safety of these vaccines for children and should be an encouraging reason for those who are waiting for more data to now feel confident in making the decision to get your child vaccinated,” said CDC Director Rochelle P. Walensky, M.D., M.P.H.



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