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Pfizer Seeks FDA Authorization for Omicron Vaccine for Children Under 5

AP Photo/Robert F. Bukaty

Pharmaceutical corporation Pfizer and its German partner BioNTech submitted an application to the U.S. Food and Drug Association for Emergency Use Authorization of its COVID-19 omicron vaccine for children under 5.


If approved, children ages six months to 4 years would receive a two-dose primary series of the COVID-19 vaccine followed by a third dose of the Omicron-adapted bivalent vaccine, the companies announced Monday. 

“With the high level of respiratory illnesses currently circulating among children under 5 years of age, updated COVID-19 vaccines may help prevent severe illness and hospitalization,” the companies said in the press release. 

Earlier this year, Townhall covered how the FDA delayed its review of the COVID-19 vaccine for children in this age group. According to the Wall Street Journal, the delay was, in part, because the initial two-dose vaccine regimen was not working well to protect against the Omicron variant. 

Previously, I covered how Pfizer and its partner BioNTech planned to submit a request to the FDA for Emergency Use Authorization (EUA) for their coronavirus vaccine for children 6 months to 5 years old. Sources briefed on the matter told The Washington Post that the FDA urged the companies to submit the application so that vaccine regulators could review the data. However, the data showed “disappointing” vaccine protection results for certain age groups, specifically, children 2 to 5 years of age.


Shortly after, the Florida Department of Health announced it would advise against administering COVID-19 vaccines for “healthy children.” 

“The Florida Department of Health is going to be the first state to officially recommend against the COVID-19 vaccines for healthy children,” the state’s Surgeon General Joseph Ladapo said.

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