COVID-19: Pfizer/BioNTech Say Their Vaccine is Safe and Protective in 5- to 11-Year-Olds

September 20th, 2021 – Earlier today, Pfizer and BioNTech SE announced that their COVID-19 vaccine Comirnaty demonstrated a favorable safety profile and robust neutralizing antibody responses in children ages 5 to 11. The companies said early results from the much-awaited Phase 2/3 trial showed that a two-dose regimen of 10 μg administered 21 days apart was well tolerated in young children.

This dosage is just one-third of the dose used in an earlier study conducted in people between the ages of 16 and 25 years who were immunized with 30 µg. Yet, the antibody responses and side effects were comparable. The 10 µg dose was carefully selected as the preferred dose for safety, tolerability, and immunogenicity in 5- to 11-year-olds.

Data summarized from 2,268 participants between the ages 5 to 11 years showed that the SARS-CoV-2–neutralizing antibody geometric mean titer (GMT) was 1,197.6 (95% confidence interval [CI, 1106.1, 1296.6]), demonstrating a strong immune response one month after the second dose. In comparison, the GMT from the control group, i.e., participants ages 16 to 25 years old who received a two-dose regimen of 30 µg, was 1146.5 (95% CI: 1045.5, 1257.2).

“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,” said Albert Bourla, Chairman and CEO of Pfizer.

“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. – 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.”

Future Plans

The companies are planning to share these data with the FDA, EMA, and other regulators as soon as possible. Additionally, they expect the results from the two other age cohorts of the Phase 1/2/3 trial—children 2-5 years of age and children 6 months to 2 years of age as soon as the fourth quarter of this year.

Reuters reported that the top US health officials believe regulators could make a decision on the vaccine’s safety and efficacy within three weeks of submission. With schools already open nationwide in the US, rapid vaccine approval will help to bring down a potential surge in COVID-19 cases.

Janet Woodcock, the acting commissioner of the FDA, said that once the agency receives the application, its process for determining if the vaccine is safe and effective for children in the younger age group includes verifying the manufacturing processes for lower concentrations of the shot and a study of its safety.

“We’ll look at the clinical data and make sure that children responded to the vaccine the way we would expect,” Ms. Woodcock said.

Pfizer/BioNTech’s Comirnaty is one of the three COVID-19 vaccines currently administered in the US. Just last month, it became the first and only vaccine to receive full approval from the FDA to prevent COVID-19 disease in individuals 16 years of age and older. Besides, it is also authorized under EUA for individuals 12 through 15 years since May.

Notably, last Friday, the FDA advisory panel rejected Pfizer’s plan to administer COVID-19 booster shots for most Americans but approved it for people 65 or older and those with severe disease.

Author

Rajaneesh K. Gopinath