Pfizer: COVID shot effective for youngest children

Pfizer and BioNTech announced Monday that a third dose of their mRNA vaccine against COVID-19 was found to elicit a strong immune response for children 6 months to 5 years old.

The company said that 1,678 children received a third dose at least two months after the second dose at a time when Omicron was the predominant variant. The third dose of the COVID-19 vaccine was well tolerated in this age group, and no new safety signals were identified.

The company said that 10 symptomatic COVID-19 cases were identified from seven days after the third dose and accrued as of April 29. The vaccine efficacy was found to be 80.3 percent.

"Our COVID-19 vaccine has been studied in thousands of children and adolescents, and we are pleased that our formulation for the youngest children, which we carefully selected to be one-tenth of the dose strength for adults, was well tolerated and produced a strong immune response," Albert Bourla, chairman and CEO of Pfizer, said in a statement.

"We are preparing the relevant documents and expect completing the submission process to the FDA (Food and Drug Administration) this week, with submissions to EMA (European Medicines Agency) and other regulatory agencies to follow within the coming weeks," Ugur Sahin, CEO and co-founder of BioNTech, said in the statement.

On Monday, the FDA announced that its advisory committee of external experts will meet on June 15 to review Moderna's EUA (emergency use authorization) request for 6 months through 5 years old and Pfizer-BioNTech's EUA request for 6 months through 4 years old.

The youngest population of 6 months to 5-year-olds is the only group that hasn't been authorized to be fully vaccinated against COVID-19. Roughly 19 million children fall into that age group.

The FDA advisory committee also will convene its advisory committee of external experts on June 14 to discuss Moderna's EUA request for ages 6-17. The Pfizer-BioNTech vaccine has already been approved for this age group.

"We know parents are anxious for us to determine if these vaccines are safe and effective," the FDA said on Twitter. "We are working as quickly as possible to carefully review all the data." The agency also said that it will complete the review of both EUA requests within days of one another.

Although COVID-19 is normally less severe in children, hospitalizations of those under age 5 were five times higher during the Omicron wave than the previous Delta surge, according to the Centers for Disease Control and Prevention (CDC).

A recent study in UK and US theorized that the recent surge in pediatric acute hepatitis cases happening in the US, Europe, Japan and Israel might be a result of an unnoticed COVID-19 infection.