In the second of three phases, the pharmaceutical giants enlisted 2,268 participants ages 5-11 in the United States, Finland, Poland and Spain. While those ages 12 and up have been given 30 µg (microgram) doses, patients in the new study received a 10 µg dose level in a two-dose regimen.
The trial demonstrated strong immune response in the group of children one month after the second dose. That compares well – or was “non-inferior,” the companies said — to the results seen from participants ages 16-25, who were used as the control group for the analysis and were administered a two-dose regimen of 30 µg. The vaccine also was well tolerated in the younger group, with side effects generally comparable to those observed in participants ages 16-2, the companies said.
The study is designed to test for “safety, tolerability and immunogenicity” in kids. The companies plans to share their findings with the U.S. Food and Drug Administration, European Medicines Agency and other regulators as soon as possible.
The news comes as millions of children around the country and the world return to schools for the fall semester.
“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 Albert Bourla, Pfizer’s chairman and CEO. “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 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 Dr. Ugur Sahin, CEO and co-founder of BioNTech: “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. 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.”