As CBS2’s Dr. Max Gomez reported, the company plans to apply for authorization by the end of the month.
Anxiety has been growing among parents and teachers as children head back to school, and the elementary school age group and their close contacts have not been shielded with a vaccine.
The need is urgent, Gomez reported. Children now account for more than 1 in 5 new cases, and the highly contagious Delta variant has sent more children into hospitals and intensive care units in the past few weeks than any other time during the pandemic.
Pfizer’s clinical trial of more than 2,200 children ages 5 to 11 showed the group developed a strong antibody response.
“It’s effectively the same vaccine that’s being used in adults, but in a lower dose. Pfizer tested multiple doses to find the optimal dose that had the best compromise between reducing the number of vaccine-related side effects, while still providing efficacy that’s on par with what we saw in 16 to 25-year-olds. So this is basically one-third of the dose that’s already approved in adults,” Pfizer board member and former U.S. Food and Drug Administration Commissioner Dr. Scott Gottlieb said.
Gottlieb said even though children rarely become severely ill, if they are unvaccinated, they can spread the virus to family members, teachers and grandparents who are vulnerable to severe disease or death.
Pfizer will shortly apply for emergency use authorization, which could come from the FDA by the end of October. Trial results for children under the age of 5 are not expected until the fourth quarter of the year at the earliest.