The vaccine Pfizer /BioNTech for Covid-19 it showed an efficacy of 90.7% in a clinical trial in children between five and 11 years old, the American pharmaceutical company said this Friday morning.
Sixteen children in the trial who had received a placebo became infected with Covid-19, compared to 3 who were vaccinated, said Pfizer in informational documents filed with the US Food and Drug Administration.
Because more than twice as many children in the 2,268-participant trial received the vaccine instead of the placebo, that equates to an efficiency greater than 90 percent.
The clinical trial of Pfizer in children 5 to 11 years of age it 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 They said last month that their Covid-19 vaccine induced a robust immune response in children aged 5 to 11 years. 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.
If the FDA authorizes 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.
Most states wait for the CDC to approve vaccine recommendations before starting to administer them.