Pfizer and BioNTech include formally submitted a place a question to to the U.S. Food and Drug Administration (FDA) to authorize their COVID-19 vaccine for children ages 5 to 11.
“With novel cases in kids within the U.S. persevering with to be at a excessive level, this submission is a critical step in our ongoing effort against #COVID19,” Pfizer tweeted on Thursday (Oct. 7). “We’re committed to working with the FDA with the final goal of serving to defend kids against this extreme public health threat.”
Closing month, the firms announced that their COVID-19 vaccine become stable and effective for children between the ages of 5 and 11, basically basically based on recordsdata from their most contemporary scientific trial. The young participants got a lower dose of the vaccine than the dose given to older kids and adults, Are living Science previously reported.
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The youthful kids developed an antibody response an analogous to that of folks 16 to 25 years of age. They also tolerated the vaccine effectively, and the aspect effects had been an analogous to those viewed in older age groups, the firms said.
Currently, the FDA has authorized 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 is a ways the handiest vaccine within the U.S. authorized to be given to kids youthful than 18 years of age.
The FDA has tentatively scheduled a gathering of its Vaccines and Connected Biological Merchandise Advisory Committee to debate and overview the knowledge on Oct. 26.
“We know from our immense journey with other pediatric vaccines that kids are now not miniature adults, and we will have the option to conduct a comprehensive overview of scientific trial recordsdata submitted in reduction of the protection and effectiveness of the vaccine frail in a youthful pediatric inhabitants, which could include a clear dosage or formulation from that frail in an older pediatric inhabitants or adults,” Dr. Janet Woodcock, appearing FDA Commissioner, said in a press start on Oct. 1 about the longer term advisory committee assembly.
The Oct. 26 assembly shall be livestreamed right here.
Originally published on Are living Science.
Yasemin is a workers author at Are living Science, masking health, neuroscience and biology. Her work has regarded in Scientific American, Science and the San Jose Mercury Files. She has a bachelor’s level in biomedical engineering from the College of Connecticut and a graduate certificates in science communique from the College of California, Santa Cruz.
