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FDA approves Pfizer vaccine for children in the 5-11 age group

By on October 30, 2021

The Food and Drug Administration on Friday authorized Pfizer and BioNTech’s coronavirus vaccine for children five to 11 years old. All that’s needed for the vaccines to reach American children is a CDC approval on Tuesday.

Earlier this week, the US FDA Vaccines and Related Biological Products Advisory Committee voted to recommend the Pfizer-BioNTech coronavirus vaccine for children in the five to 11 age group.

Using the clinical data collected by Pfizer from a trial test involving over 2,200 children, the US drug manufacturer said the vaccine efficacy against COVID-19 was 90.7 percent at least seven days after a second dose. It reported that there were no short-term safety concerns found after the children were  vaccinated.

Based on the analysis for the said age group, FDA says the risk of hospitalization is higher than the risk of adverse effects after vaccination. The benefits outweighing the risks led to an overwhelming ‘yes’ vote by the committee members.

Following the results, children in the United States as young as 5 may be eligible to get a shot as soon as next week after final approval by FDA.

Parents in Japan may have to wait longer. Japan requires clinical data to approve the vaccine. Pfizer said it is talking with regulatory authorities in Japan.

 

 

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