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Pfizer and BioNTech move one step closer to requesting authorization for young children to receive COVID-19 coronavirus vaccine, submitting data to Food and Drug Administration that shows ‘robust’ antibody response and results “favorable” safety in children aged five to 11 years. who received the two-dose regimen in clinical trials.
The companies plan to submit a formal request for authorization for emergency use of the vaccine for this age group “in the coming weeks,” they said on Tuesday.
The news of the data submission comes a week after Pfizer announced promising results from the trials, which have been closely watched by parents keen to protect their children from the coronavirus. COVID-19 has now killed more than 690,000 people in the United States, and millions more are sick with the disease.
The trial, one of several trials conducted by companies for children of three different age groups, included 2,268 participants.
The children received two 10-microgram doses of the vaccine – notably smaller than the pair of 30-microgram doses used in a previous successful trial, for people aged 16 to 25. The smaller vaccine dose “was carefully selected as the preferred dose for safety, tolerability and immunogenicity,” the companies said.
The results of the two trials are comparable, the companies said when announcing the data submission to the FDA.
In a separate clinical trial for children under 5, participants are given 3 microgram doses of the vaccine. Pharmaceutical companies expect to have test results for children 6 months to 2 years old and 2 to 5 years old “as early as the fourth quarter of this year.”
Copyright 2021 NPR. To learn more, visit https://www.npr.org.
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