Pfizer and BioNTech have actually formally sent a demand to the U.S. Food and Drug Administration (FDA) to license their COVID-19 vaccine for kids ages 5 to 11.
” With brand-new cases in kids in the U.S. continuing to be at a high level, this submission is a crucial action in our continuous effort versus #COVID19,” Pfizer tweeted on Thursday (Oct. 7). “We’re dedicated to dealing with the FDA with the supreme objective of assisting secure kids versus this major public health hazard.”
Last month, the business revealed that their COVID-19 vaccine was safe and efficient for kids in between the ages of 5 and 11, based upon information from their newest scientific trial. The young individuals were offered a lower dosage of the vaccine than the dosage provided to older kids and grownups, Live Science formerly reported.
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The more youthful kids established an antibody reaction equivalent to that of individuals 16 to 25 years of age. They likewise endured the vaccine well, and the negative effects resembled those seen in older age, the business stated.
Currently, the FDA has actually authorized the Pfizer-BioNTech vaccine for those 16 years of age and older and has actually provided an emergency situation approval for kids ages 12 to15 It’s the only vaccine in the U.S. licensed to be provided to kids more youthful than 18 years of age.
The FDA has actually tentatively arranged a conference of its Vaccines and Related Biological Products Advisory Committee to talk about and examine the information on Oct. 26.
” We understand from our large experience with other pediatric vaccines that kids are not little grownups, and we will carry out an extensive assessment of scientific trial information sent in assistance of the security and efficiency of the vaccine utilized in a more youthful pediatric population, which might require a various dose or formula from that utilized in an older pediatric population or grownups,” Dr. Janet Woodcock, acting FDA Commissioner, stated in a declaration on Oct. 1 about the future advisory committee conference.
The Oct. 26 conference will be livestreamed here.
Originally released on Live Science.
Yasemin is a personnel author at Live Science, covering health, neuroscience and biology. Her work has actually 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 interaction from the University of California, Santa Cruz.