The US drugmaker said on Friday that the Pfizer/BioNTech COVID-19 vaccine showed 90.7% efficacy against the coronavirus in a clinical trial of children aged 5 to 11.
Sixteen children in the trial who received a placebo got COVID-19, while 3 were vaccinated, Pfizer said in briefing documents submitted to the US Food and Drug Administration.
Because more than twice as many children in the 2,268-participant trial were given the vaccine compared to placebo, that equated to better efficacy of over 90%.
Pfizer’s clinical trial in those 5 to 11 years old was not designed primarily to measure efficacy against the virus. Instead, it compared the amount of neutralizing antibodies induced by the vaccine in children to the response of older recipients in their adult trial.
Based on those results, Pfizer and BioNTech said last month that their COVID-19 vaccine induced a strong immune response in children.
The FDA’s external advisors are due to meet on Tuesday to vote on whether the agency should authorize the vaccine for that age group.
The Pfizer/BioNTech vaccine already has US regulatory authorization for people who are at least 12 years old, with full FDA approval in August for people 16 and older.
About 190 million people in the United States have been fully vaccinated, including more than 11 million ages 12 to 17 who have received the Pfizer vaccine.
If the FDA authorizes the vaccine for children ages 5 to 11, a group of advisers from the US Centers for Disease Control and Prevention will meet on November 2 and 3 to make recommendations to the agency about how the shots should be administered. Most states wait for the CDC to begin administering the shots before signing off on recommendations for vaccines.
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