Pfizer-BioNTech on Monday announced that its COVID-19 vaccine has been proven safe and effective in Phase 2/3 clinical trials for children ages 5 to 11.
The trial used a two-dose regimen of 10 µg administered 21 days apart, a smaller dose than the 30 µg dose 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. The 10 µg dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age. These are the first results from a pivotal trial of a COVID-19 vaccine in this age group.
"Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine. 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 Chief Executive Officer, Pfizer.
"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."
"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 Dr. Ugur Sahin, CEO and co-founder of BioNTech. "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 data summarized from this Phase 2/3 study, which is enrolling children 6 months to 11 years of age, was for 2,268 participants who were 5 to 11 years of age and received a 10 µg dose level in a two-dose regimen. In the trial, the SARS-CoV-2–neutralizing antibody geometric mean titer (GMT) was 1,197.6 (95% confidence interval [CI, 1106.1, 1296.6]), demonstrating strong immune response in this cohort of children one month after the second dose. 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. Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age.
Pfizer and BioNTech plan to share these data with the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulators as soon as possible, the companies said in a statement.
For the United States, the companies expect to include the data in a near-term submission for Emergency Use Authorization (EUA) as they continue to accumulate the safety and efficacy data required to file for full FDA approval in this age group. A request to the EMA to update the EU Conditional Marketing Authorization is also planned.
Topline readouts for the other two age cohorts from the trial – children 2-5 years of age and children 6 months to 2 years of age – are expected as soon as the fourth quarter of this year.
Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-reviewed publication.
Earlier this week, the FDA approved a booster dose of the Pfizer-BioNTech vaccine only for those who are over age 65 or otherwise determined to be high risk, despite Israeli data showing that the third dose provides 10 times more protection than the first two alone.
Last month, it was reported that over 500 Israeli children ages 5-11 had received the Pfizer-BioNTech vaccine, despite the fact that it was not approved for their age group.
These children were in high-risk categories and been specially approved by the Health Ministry to receive the vaccine. As of the reporting, no unusual side effects had been reported; the only side effects were the usual light symptoms expected after receiving a vaccination.