For the first time, children from six months through five years of age can receive the COVID-19 vaccine. Parents and caregivers can now get their young children vaccinated with the Pfizer-BioNTech or Moderna vaccines to better protect them from COVID-19. All children, the Centers for Disease Control and Prevention (CDC) says, including children who have already had COVID-19, should get vaccinated.

“We know millions of parents and caregivers are eager to get their young children vaccinated, and with today’s decision, they can,” noted Rochelle Walensky, MD, director of the CDC. “I encourage parents and caregivers with questions to talk to their doctor, nurse, or local pharmacist to learn more about the benefits of vaccinations and the importance of protecting their children by getting them vaccinated.”

Distribution of pediatric vaccinations for these younger children has already started across the country, and will be available at thousands of pediatric practices, pharmacies, Federally Qualified Health Centers, local health departments, clinics, and other locations this week.

This move comes after regulatory approvals that were made throughout the weekend. On Friday, June 15, clinical trial results were reviewed by the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) who voted unanimously to recommend authorization.

After the Pfizer-BioNTech COVID-19 vaccine was granted emergency use authorization (EUA) by FDA on Friday, the CDC moved swiftly. Saturday saw both a unanimous recommendation made by Advisory Committee on Immunization Practices’ (ACIP) and the director’s endorsement—the last hurdle the vaccine needed to get over before entering into childrens’ arms. 

The EUA for this age is for a three 3-µg dose series. The EUA is based on data from a Phase II/III randomized, controlled trial that included 4,526 children. In the trial, children received the third 3-µg dose at least two months after the second dose at a time when Omicron was the predominant variant. Following a third dose in this age group, the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo.

No new safety signals were identified, and the frequency of adverse reactions observed in children six months through four years were generally lower than in children five through 11 years. Reactogenicity events were mostly mild to moderate and short-lived for both age groups with systemic events comparable to placebo. Reactions were comparable after dose 1, 2, and 3.

In the trial, the SARS-CoV-2-neutralizing antibody geometric mean titer (GMT) one month after the third dose was 1,535.2 (95% CI, 1,388.2, 1,697.8) in children two through four years of age and 1,406.5 (95% CI, 1,211.3, 1,633.1) in infants six through 23 months. The antibody responses in both age groups were comparable to those recorded in people 16 to 25 years of age immunized with two 30-µg doses.

Three 3-µg doses of the Pfizer-BioNTech COVID-19 vaccine demonstrated a favorable safety and tolerability profile comparable to placebo in young children ages six months through four years in the Phase II/III clinical trial. The 3-µg dose was carefully selected as the preferred dose for children under five years of age based on safety, tolerability, and immunogenicity data.

“Tens of millions of older children across the globe have already been vaccinated with our COVID-19 vaccine, helping to prevent symptomatic, severe disease and hospitalization,” said Albert Bourla, DVM, PhD, chairman and CEO, Pfizer. “We know many parents in the U.S. have been eagerly awaiting an authorized vaccine for their children under five and we are proud to now offer them a vaccine option with a favorable safety profile.”

The companies plan to submit requests for authorization of their COVID-19 vaccine in this age group to other regulators around the world, including the European Medicines Agency in early July.