Oct 30 (Bloomberg) – The US Food and Drug Administration (FDA) has authorised for emergency use the Pfizer-BioNTech Covid-19 vaccine for children 5 through 11 years of age (also referred to as 5 to <12 years) on Saturday. With this, Pfizer-BioNTech’s Comirnaty has become the first Covid-19 vaccine to get FDA’s authorisation in the US for individuals 5 through 11 years of age.
The Covid-19 vaccine manufacturing firms Pfizer and BioNTech said the vaccine would be administered in a two-dose regimen 10-µg doses to the children in 21 days gap.
“Over 6 million children in the U.S. have been diagnosed with COVID-19 since the start of this pandemic, and a high number of young people continue to be infected every week. With this FDA authorization, we have achieved another key marker in our ongoing effort to help protect families and communities, and to get this disease under control,” Albert Bourla, Chairman and Chief Executive Officer, Pfizer said.
However, before children can begin to receive the vaccine, the Centers for Disease Control and Prevention’s immunisation advisory committee will make more detailed recommendations on which youngsters should get vaccinated on Tuesday.
“The rationale here is protect your children so that they can get back towards normal life,” said FDA vaccine chief Dr. Peter Marks. “The tremendous cost of this pandemic has not just been in physical illness, it’s been in the psychological, the social development of children” too.
Nearly 70% of 5- to 11-year-olds were hospitalised for Covid-19 in the US with serious medical conditions, including asthma and obesity, according to federal tracking.
According to Pfizer study of 2,268 schoolchildren found the vaccine was nearly 91% effective at preventing symptomatic coronavirus infections.
The FDA ultimately assessed 3,100 children who received the kid dosage to conclude it was safe. But the study wasn’t large enough to detect any extremely rare side effects, such as the heart inflammation that occasionally occurs after the second full-strength dose, mostly in young men and teen boys. It’s unclear if younger children getting a smaller dose also will face that rare risk. FDA pledged Friday to keep a close watch.
A few countries have begun using other COVID-19 vaccines in children under 12, including China, which just began vaccinations for 3-year-olds.
India’s Bharat Biotech and Zydus Cadila are also working to create a vaccine for children.