The results are the first from a pivotal trial of any COVID-19 vaccine in children under 12 years of age, with results in children under 5 years of age expected as soon as later this year.
Pivotal trial results have found that Pfizer and BioNTech’s COVID-19 vaccine was safe, well tolerated, and showed robust neutralizing antibody responses in all trial participants between 5 and 11 years of age, according to a press release.
The results are the first from a pivotal trial of any COVID-19 vaccine in children under 12 years of age, with results in children under 5 years of age expected as soon as later this year. Officials at Pfizer and BioNTech plan to submit these data to the FDA and other regulatory agencies around the world as soon as possible.
“We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season,” said Ugur Sahin, MD, CEO and co-founder of BioNTech, in the press release. “The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose.”
The trial used a 2-dose regimen of 10 µg administered 21 days apart, which is a smaller dose than the 30-µg dose given to patients 12 years of age and older. According to the press release, the antibody responses in the younger patients given the 10-µg dose were comparable to the responses recorded in an earlier study among individuals 16 to 25 years of age. The 10-µg dose was selected as the preferred dose based on safety, tolerability, and immunogenicity in children 5 to 11 years of age.
These data come from the phase 2/3 study, which is enrolling children between the ages of 6 months and 11 years, including 2268 participants between 5 and 11 years of age. According to the press release, the SARS-CoV-2 neutralizing antibody geometric mean titer was 1197.6, demonstrating a strong immune response 1 month after the second dose.
These findings compared well to the geometric mean titer of 1146.5 among patients 16 to 25 years of age, who received a 30-µg dose and were used as the control group for this analysis, according to the study authors. Furthermore, the vaccine was well tolerated in participants 5 to 11 years of age and adverse effects were generally comparable to those observed in older patients.
“Over the past 9 months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine,” said Albert Bourla, DVM, PhD, chairman and CEO of Pfizer, in the press release. “We are eager to extend the protection afforded by this vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children.”
The phase 1/2/3 trial has enrolled up to 4500 children in the United States, Finland, Poland, and Spain between the ages of 6 months and 11 years. The participants are being evaluated in 3 groups: ages 5 to 11 years, ages 2 to 5 years, and ages 6 months to 2 years. The trial enrolled children with or without prior evidence of SARS-CoV-2 infection.
“Since July, pediatric cases of COVID-19 have risen by about 240% in the US—underscoring the public health need for vaccination,” Bourla said in the press release. “These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”
Pfizer and BioNTech Announce Positive Topline Results from Pivotal Trial of COVID-19 Vaccine in Children 5 to 11 Years. News release. Pfizer; September 20, 2021. Accessed September 20, 2021. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-positive-topline-results