Earlier this month, the companies released data from a mid- to late-stage study that they say shows a boost in antibodies from a third dose of their COVID-19 vaccine, providing increased protection against COVID-19 and the Omicron variant.
In the trial, 140 children were administered a booster dose approximately six months after receiving the second dose. The vaccine comes in a two-dose primary series.
The children saw a sixfold increase in antibodies against the Wuhan strain of SARS-CoV-2 one month after receiving the booster dose, the companies stated. A subanalysis of 30 participants demonstrated a 36-fold increase in neutralizing antibody titers.
“Data from this study demonstrated a strong immune response in this age group following a booster dose of the Pfizer-BioNTech COVID-19 Vaccine with no new safety signals,” the companies said in a statement.
The data haven’t yet been published on a preprint server or in a journal.
According to data from the Centers for Disease Control and Prevention (CDC), 28 percent of U.S. children aged 5 to 11 years old—about 8.2 million—were fully vaccinated as of April.
There has been some skepticism on the need for boosters in younger children, given the reduced risk of severe infection and hospitalization in the age group.
The primary two-dose COVID-19 vaccine from Pfizer and BioNTech was authorized in the United States for children aged 5 to 11 years old in October 2021.
The FDA authorized in January the use of a booster dose of the Pfizer and BioNTech vaccine for children aged 12 to 15. The agency has also authorized a booster dose for children aged 5 through 11 years old who are immunocompromised.