On Monday, Pfizer and BioNTech said they plan to submit data to the FDA for emergency use authorization (EUA) after a clinical trial showed their COVID-19 vaccine is safe and effective in children ages 5 to 11.
“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,” said Albert Bourla, Chairman and Chief Executive Officer of Pfizer.
In the trial, the vaccine was administered to children 5 to 11 years of age in two doses (21 days apart) at 10 µg each—a smaller amount than the 30-µg dose approved for those 12 and older. Even with the smaller dose, which Pfizer says was “carefully selected,” the vaccine produced robust antibody responses in the targeted age with minimal side effects and an overall favorable safety profile.
The Phase 2/3 study data is based on 2,268 participants ages 5 to 11 who received both doses. The vaccine demonstrated 95% efficacy one month after the second dose—the same as volunteers ages 16 to 25, who were used as the control group for this analysis.
Most importantly, the vaccine was well tolerated in children aged 5 to 11, with mild side effects comparable to those observed in the 16 to 25-year-old age range.
This Phase 2/3 trial for ages 5 to 11 is part of a larger Phase 1/2/3 trial that enrolled 4,500 children ages 6 months to 11 years across the U.S., Finland, Poland and Spain. The large group was then divided by age into sub-groups: ages 5 to 11 years; ages 2 to 5 years; and ages 6 months to 2 years.
While children aged 5 to 11 received two doses of 10 µg each, those under age 5 have received a lower 3-µg dose for each injection in the Phase 2/3 study. Pfizer says it expects topline readouts for the two younger cohorts by the end of 2021.
Pfizer and BioNTech plan to submit data from the full Phase 3 trial for peer-reviewed publication. In the meantime, the companies expect to file for EUA in the U.S. as soon as possible while they continue to move toward full FDA approval for the 5 to 11-years-old group—following the blueprint they established for adults. A request to the EMA to update the EU Conditional Marketing Authorization is also planned.
With the exception of Cuba and China approving their own vaccines, no countries have given the green light to vaccinate children under the age of 12. However, pediatric cases of COVID-19 as surging as the Delta variant spreads, kids return to school and mask mandates and social distancing measures become voluntary.
For example, the week of Sept. 6.—immediately following Labor Day—over 243,000 COVID-19 cases were recorded, the second highest number of child cases recorded in a week since the pandemic began. According to the District Administration, 13 states have already been forced to shut down at least one school due to COVID-19 since resuming in-person instruction in August/September 2021.
“Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine,” said Bourla. “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.”