Pfizer has announced that its COVID-19 vaccine is safe for use in children aged five to 11.
The company and its partner, BioNTech, revealed the results of a Phase 2/3 clinical trial on September 20, along with plans to seek authorization for the vaccine’s use in the age group.
“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the US –underscoring the public health need for vaccination,” said Albert Bourla, chairman and chief executive officer at Pfizer.
“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.”
- See also:
The Phase 2/3 trial evaluated the safety, tolerability, and immune response of the Pfizer-BioNTech vaccine.
It enrolled approximately 4,500 children aged six months to 11 years in the US, Finland, Poland, and Spain. The kids were split into three age groups: six months to two years, two to five years, and five to 11 years.
Each group received two doses of the vaccine 21 days apart. Those over the age of five received 10-microgram doses, and younger children three-microgram doses.
Individuals aged 12 and over, for whom the vaccine is approved, are given 30-microgram doses. The lower dosage for younger children was “carefully selected” for safety, tolerability, and immunogenicity.
According to Pfizer, the antibody response in participants aged five to 11 was “comparable” to previous studies of people aged 16 to 25.
The children demonstrated a “strong immune response” one month after the second dose, and side effects were similar to older age groups.
Pfizer said it plans to submit data for regulatory approval in several countries, including Canada, the US, and the UK, soon.
A spokesperson for Health Canada told Daily Hive that while they have not yet received a submission, they anticipate data concerning vaccines in children “in the coming months.”
Pfizer said that results for the other age groups included in the trial – children aged six months to two years and two to five years – are expected as soon as the fourth quarter of this year.
“Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine,” 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.”