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Pfizer postpones request for FDA to authorize COVID vaccine in kids under 5
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Pfizer and its partner BioNTech on Friday said they are postponing their rolling application to the US Food and Drug Administration to authorize its COVID-19 vaccine for kids ages 6 months to 4 years. The delay means parents hoping to get younger kids vaccinated will have to wait a little longer.
Pfizer said it will wait until it has data from its ongoing clinical trial on a three dose vaccine regimen because they "believe it may provide a higher level of protection in this age group." The data is expected to be available in early April, the companies said.
As a result, the FDA on Friday postponed its advisory committee meeting to discuss whether to authorize the Pfizer-BioNTech vaccine for kids under 5. It was originally scheduled for Feb. 15. The FDA said it will provide updated timing for the committee meting once it receives the additional data from Pfizer's clinical trial.
Children age 5 and up are already eligible for a COVID-19 vaccine.
A previous trial found two doses of the vaccine effective in children 6 months to 2 years, but two shots failed to promote a strong immune response in children age 2 to 4 years. This prompted the company to start testing a three-dose version of the vaccine for children under age 5.
Pfizer's vaccine for children under age 5 is 3 micrograms, or one-tenth the size of the company's vaccine for people 12 and up. The vaccine for kids ages 5 to 11 is one-third the adult size.
CNET's Jessica Rendall contributed to this report.
The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.
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