By Michael Erman
NEW YORK, Oct 22 (Reuters) – The Pfizer / BioNTech vaccine for COVID-19 was 90.7% effective in a clinical trial in children ages 5 to 11, the US drugmaker said on Friday.
Sixteen children in the trial who had received a placebo became infected with COVID-19, compared with 3 who were vaccinated, Pfizer said in information papers filed with the US Food and Drug Administration.
Because more than twice as many children in the 2,268-participant trial received the vaccine rather than placebo, that equates to greater than 90% efficacy.
The Pfizer clinical trial in children ages 5 to 11 was not primarily designed to measure efficacy against the virus. Instead, he compared the amount of vaccine-induced neutralizing antibodies in children with the response of older recipients in his adult trial.
Based on those results, Pfizer and BioNTech said last month that their COVID-19 vaccine induced a robust immune response in children ages 5 to 11. External advisers to the FDA are scheduled to meet Tuesday to vote on whether to recommend that the agency authorize the vaccine for that age group.
The vaccine already has US regulatory clearance for people 12 years and older, including full FDA approval in August for people 16 and older.
About 190 million people in the United States are fully immunized, including more than 11 million children ages 12 to 17 who have received the Pfizer vaccine.
If the FDA clears the vaccine for children ages 5 to 11, a group of advisers from the Centers for Disease Control and Prevention will meet Nov. 2-3 to make recommendations to the agency on how the injections should be given.
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