Pfizer is planning to request Emergency Use Authorization (EUA) for its coronavirus vaccine from the US Food and Drug Administration and the European Medicines Agency as soon as possible, the company announced Monday, reporting positive results from its Phase II/III trial.
“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 company CEO Albert Bourla in a release. “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% in the US – underscoring the public health need for vaccination,” Bourla continued. “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.”
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The company is also planning to submit the data from the full Phase III trial to a peer-reviewed scientific journal.
Today, we shared positive topline results from the pivotal trial of our COVID-19 vaccine in children 5 to 11 years of age: https://t.co/jQrvb6MZ6w
This is exciting news for families.— AlbertBourla (@AlbertBourla) September 20, 2021
In Israel, the Health Ministry reported on Monday that 40% of the cases in recent days have been children under the age of 11. Among the Arab population, where schools have been running in full since September 1, the situation is even more acute.
Some 2,268 children between the ages of five and 11 received two doses of 10 micrograms of the company’s coronavirus vaccine, each 21 days apart. Within one month after the second dose, the antibody responses of the participants were comparable to those recorded in previous studies of people ages 16 to 25, the company said. The older cohort, however, received 30 micrograms.
A healthcare worker hands over doses of the Pfizer-BioNTech COVID-19 vaccine to a doctor at Messe Wien Congress Center, which has been set up as coronavirus disease vaccination centre, in Vienna, Austria February 7, 2021. (credit: REUTERS/LISI NIESNER/FILE PHOTO)
“The 10 micrograms dose was carefully selected as the preferred dose for safety, tolerability, and immunogenicity in children 5 to 11 years of age,” Pfizer explained.
It added that the vaccine was “well-tolerated,” with side effects comparable to those experienced by the older cohort.
The company said that it will continue to accumulate the safety and efficacy data required to file for full FDA approval in this age group.
The original Phase I/II/III trial initially enrolled 4,500 kids ages 6 months to 11 years in the US, Finland, Poland and Spain for more than 90 clinical trials. It was designed to evaluate the safety, tolerability, and immunogenicity of the vaccine in three age groups: 5 to 11 years, 2 to 5, and 6 months to 2 years. Topline readouts for the other two age cohorts from the trial are expected as soon as the fourth quarter of this year, Pfizer said.
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