Pfizer-BioNTech COVID-19 Vaccine in 5-11 Year Olds Found Safe, Elicits Immune Response

A smaller dosage was used and with their results the two companies plan to submit their data to governmental regulatory agencies around the world.

Pfizer and BioNTech announced their COVID-19 vaccine, BNT162b2 (Comirnaty), provided an immune response and a favorable safety profile in children 5 to 11 years of age using a two-dose regimen of 10 µg administered 21 days apart.

This dosing is smaller than the 30 µg dose that is used for people 12 and older. The antibody responses in the participants given 10 µg doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30 µg doses.

“Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine,” Pfizer CEO Albert Bourla, said. “We are eager to extend the protection afforded by the 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. Since July, pediatric cases of COVID-19 have risen by about 240 percent in the US—underscoring the public health need for vaccination. 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.”

“In the trial, the SARS-CoV-2–neutralizing antibody geometric mean titer (GMT) was 1197.6 (95% confidence interval [CI, 1106.1, 1296.6]), demonstrating strong immune response in this cohort of children one month after the second dose,” the Pfizer company statement reported. “This compares well (was non-inferior) to the GMT of 1146.5 (95% CI: 1045.5, 1257.2) from participants ages 16 to 25 years old, used as the control group for this analysis and who were administered a two-dose regimen of 30 µg.”

The companies said the safety profile was similar to participants in a trial with 16 to 25 years old.

In a previous interview, BioNTech Co-Founder CEO Ugur Sahin, CEO and BioNTech Co-Founder and CMO Ozlem Türeci, MDsaid they expected to seek approval from various government agencies for the 5 to 11 year old population soon, and potentially could see the first doses of the vaccine become available in Europe by mid-October.

With the release of this data, the companies are moving forward with their plan and presenting the information to the FDA, European Medicines Agency, and other international governmental agencies for review and planned submission for approval in that pediatric patient population. 

Results for children under 5 years old are expected later this year, according to the companies.