Pfizer and BioNTech have officially submitted a request to the U.S. Food and Drug Administration (FDA) to authorize their COVID-19 vaccine for children ages 5 to 11.
“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19,” Pfizer tweeted on Thursday (Oct. 7). “We’re committed to working with the FDA with the ultimate goal of helping protect children against this serious public health threat.”
Last month, the companies announced that their COVID-19 vaccine was safe and effective for children between the ages of 5 and 11, based on data from their latest clinical trial. The young participants were given a lower dose of the vaccine than the dose given to older children and adults, Live Science previously reported.
The younger children developed an antibody response comparable to that of people 16 to 25 years of age. They also tolerated the vaccine well, and the side effects were similar to those seen in older age groups, the companies said.
Currently, the FDA has approved the Pfizer-BioNTech vaccine for those 16 years of age and older and has given an emergency approval for children ages 12 to 15. It’s the only vaccine in the U.S. authorized to be given to children younger than 18 years of age.
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The FDA has tentatively scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee to discuss and review the data on Oct. 26.
“We know from our vast experience with other pediatric vaccines that children are not small adults, and we will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population, which may need a different dosage or formulation from that used in an older pediatric population or adults,” Dr. Janet Woodcock, acting FDA Commissioner, said in a statement on Oct. 1 about the future advisory committee meeting.
The Oct. 26 meeting will be livestreamed here.
Originally published on Live Science.
Yasemin is a staff writer at Live Science, covering health, neuroscience and biology. Her work has appeared in Scientific American, Science and the San Jose Mercury News. She has a bachelor’s degree in biomedical engineering from the University of Connecticut and a graduate certificate in science communication from the University of California, Santa Cruz.
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