U.S. Food and Drug Administration ( FDA) experts backed the authorization of the Pfizer Inc and BioNTech SE COVID-19 vaccine for children between the ages of 5 to 11, saying the benefits of vaccination outweigh the risks.
This regulatory step would be important in terms of sending back these kids to schools in a safer environment. With this move, about 28 million children could be inoculated.
In September, the company said its vaccines are safer for children in that age group.
The US is already including its population aged 12 and over.
The decision still needed to be approved by the FDA and the Centers for Disease Control and Prevention (CDC). They are expected to meet on November 2 to make a recommendation on the administration of the vaccine.
The companies have claimed that their vaccines are 90.7% efficacious against the covid-19 amongst the children aged 5 to 11, clinical trials showed that.
While deaths and serious illness are seen less amongst children as compared to adults, though some children do experience difficulties, and infections have been multiplied in unvaccinated children due to the coronavirus’s easily spread Delta version.
“To me, the question is pretty clear,” said Dr. Amanda Cohn, a pediatric vaccine expert at the CDC and a voting member of the panel. “We don’t want children to die of COVID, even if there are far fewer children than adults, and we don’t want them in the ICU.”
Pfizer and BioNTech are vying for the approval of a 10-microgram dosage of the vaccine for children, as opposed to 30 micrograms for people aged 12 and above.
After being certified for individuals 16 and older in December, the shot received permission for children 12-15 since May.
The advisers had certain reservations about the rate of myocarditis, a kind of heart inflammation associated with both the Pfizer/BioNTech and Moderna vaccines, particularly seen in young males.
In most scenarios studied, the hospitalizations averted for COVID-19 would outweigh those prevented for myocarditis if the number of myocarditis cases in the younger age group is equivalent to that in 12- to 15-year-olds, FDA staff reviewers stated in materials prepared ahead of Tuesday’s meeting.