Latest trial results indicate Pfizer COVID-19 vaccine safe for children five to 11 years old
Published September 20, 2021 at 9:56 am
Pfizer could be expanding eligibility for the COVID-19 vaccine to those under the age of 11.
According to the company, results from Phase 2 of a three-phase trial among children between the ages of five and 11 years old had favourable results using a two-dose regimen of 10 micrograms administered 21 days apart.
The antibody response among trial subjects was similar to the results recorded in a previous Pfizer-BioNTech study in people 16 to 25 years who were administered two 30-microgram doses.
As part of the trial, the pharmaceutical company is monitoring the safety, tolerability, and immunogenicity of the vaccine administered approximately 21 days apart in three age groups—six months to two years old, two to five years old, and five to 11 years old.
Based on the Phase 1 dose-escalation portion of the trial, children ages five to 11 years old received two doses of 10 micrograms each while children under the age of five received a lower, three-microgram dose for each injection.
Participants in the study range in age from six months to 11 years old from the U.S., Finland, Poland, and Spain.
Pfizer and BioNTech intend to share this data with regulators, such as the U.S. Food and Drug Administration, and the European Medicines Agency, as soon as possible.
“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,” Albert Bourla, chairman and CEO of Pfizer, said in a news release.
“These trial results provide a strong foundation for seeking authorization of our vaccine for children five to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”insauga's Editorial Standards and Policies