The drug has proven effective in patients between 5 and 11 years old, according to Pfizer.
Pfizer is seeking emergency use authorization (EUA) for their COVID-19 vaccine to be administered to young children.
According to a tweet from the company, Pfizer has officially submitted an application to the Food and Drug Administration (FDA) seeking EUA for COVID-19 vaccine Comirnaty to be administered to children between age 5 and 11.
The New York Times reports that the FDA has promised to work quickly on the application and has set a tentative meeting date to discuss the submission for Oct. 26.
As previously reported, results of the phase 2/3 trial showed a robust neutralizing antibody response to the 2-dose regimen of 10 µg administered 21 days apart—a dose smaller than the 30-µg given to people aged ≥12 years. The antibody responses among the younger volunteers were comparable to that seen in trials of the vaccine in those aged 16 to 25 years, according to the company. Side effects, too, were comparable to those seen in the older cohort.
“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 press statement.
Last month, the Centers for Disease Control and Prevention (CDC) recommended booster doses of the Pfizer COVID-19 for members of some populations.
The agency’s Advisory Committee on Immunization Practices’ recommends booster doses of the vaccine Comirnaty for those over 65 and those at high risk of severe COVID-19 due to an underlying condition. CDC Director Rochelle Walensky went a step further and recommended the extra shots for those in high-risk occupations or institutions.
Previously, the FDA authorized the additional shot to be administered at least six months after the primary doses in patients 65 years of age and older, patients between 18 and 64 who are at high risk of severe COVID-19, and in patients who work in close proximity to the virus which leaves them at risk for severe COVID-19.
On Aug. 23, the FDA fully approved the Pfizer COVID-19 vaccine for use in people age 16 and older, the first COVID vaccine to receive such approval.