The companies noted that the clinical results are an important step in stemming the spread of COVID-19 in young children, particularly now at the start of the new school year. File Photo by Debbie Hill/UPI | License Photo
Sept. 20 (UPI) -- Pfizer and BioNTech said Monday that studies show that their COVID-19 vaccine is safe and produces a significant antibody response against the coronavirus disease in children between 5 and 11 years old.
The companies' study is the first based on late-stage clinical data to show that any coronavirus vaccine is safe and effective in young children.
Pfizer and BioNTech said in their announcement that they studied the vaccine's effects in a clinical trial that included more than 2,000 child recipients.
Pfizer said the vaccine was shown to be "safe" and "well-tolerated," and also showed "robust neutralizing antibody responses" in the children who received it.
The Pfizer vaccine, which was the first coronavirus vaccine to be authorized for adults in the United States, has already been studied and approved in the United States for children over the age of 12. Monday's announcement puts the two-dose vaccine regimen on track for approval for children between 5 and 11.
"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 ... as we track the spread of the Delta variant and the substantial threat it poses to children," Pfizer CEO Albert Bourla said in a statement.
"Since July, pediatric cases of COVID-19 have risen by about 240% in the U.S. -- underscoring the public health need for vaccination."
Pfizer said the child recipients received two 10-microgram doses 21 days apart. Children over 12 have been receiving two 30-microgram doses.
"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," Bourla added.
The companies noted that the clinical results are an important step in stemming the spread of COVID-19 in young children, particularly now at the start of the new school year.
"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," said BioNTech CEO Dr. Ugur Sahin.
The companies said they intend to request emergency use authorization, and ultimately full Food and Drug Administration approval, for the vaccine for the 5 to 11 age group.
Pfizer's vaccine has already been given full FDA approval for the vaccine in people over 16 and emergency authorization for children 12 to 16.
Last week, the FDA's advisory panel recommended a third dose of Pfizer's vaccine for Americans over the age of 65 and for people who are particularly vulnerable to COVID-19.
Pfizer's vaccine is one of three that have been approved for use against COVID-19 in the United States. Moderna's is a similar two-dose RNA-based vaccine and Johnson & Johnson produces an adenovirus-based vaccine that requires only one dose for full vaccination.
The Centers for Disease Control and Prevention said on Friday that Moderna's shot has a slight edge over Pfizer's in preventing serious cases of COVID-19.