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The three-dose Pfizer-BioNTech COVID-19 vaccine is safe and 80% effective against symptomatic infection in children ages 6 months to 5 years, according to the manufacturers who released preliminary data today.
The companies plan to submit their data to the Food and Drug Administration (FDA) this week, and an expert panel is expected to review them in mid-June. The summary data announced Monday in a news release have not been formally peer reviewed or published.
“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,” Pfizer Chairman and CEO Albert Bourla said in the release.
The findings are based on clinical trials in 1,678 children under 5 years who received a third dose of the vaccine at least two months after the second dose. Efficacy was 80.3% based on 10 symptomatic cases. However, the trial protocol calls for an analysis to be performed once there are 21 cases. The companies said they would share final efficacy data when they become available.
They conducted an immunogenicity analysis in a subset of children a month after the third dose and found the geometric mean titer ratio and seroresponse rate met noninferiority criteria when compared to a two-dose primary series for people ages 16-25 years.
This vaccine initially was tested as a two-dose series. In December 2021, the manufacturers announced it did not meet noninferiority criteria for those ages 2-4 years, leading the company to study a third dose.
Most adverse events in the three-dose trial were mild or moderate, and no new safety concerns were raised, according to the companies.
Pfizer and BioNTech’s data were released just weeks after Moderna announced its two-dose series in children under 6 years is 51% effective in preventing infection confirmed by polymerase chain reaction test for children ages 6 months through 1 year and 37% effective for children ages 2 through 5 years.
The FDA released revised meeting dates Monday for its Vaccines and Related Biological Products Advisory Committee to review these data. The group will meet June 14 to discuss Moderna’s emergency use authorization (EUA) request for ages 6-17 years. On June 15, it will discuss the EUA requests from Moderna and Pfizer and BioNTech on vaccines in children under 6 years and 5 years, respectively. If the FDA grants an EUA to a vaccine, it will go to the Centers for Disease Control and Prevention (CDC) for consideration.
The CDC has released a guide to help pediatricians prepare to administer COVID-19 vaccines to children under 5 years.