The Pfizer and BioNTech coronavirus vaccine was approved by the US Food and Drug Administration on Friday (local time), making it the first Covid-19 shot for young children in the country.
Pfizer said that it would begin shipping paediatric vials of vaccine to pharmacies on Saturday. The decision by the regulator is expected to make the shot available to 28 million American children, many of whom are back in school for in-person learning.
It comes after a panel of advisers to the Food and Drug Administration (FDA) voted overwhelmingly to recommend the authorisation on Tuesday.
Only a few other countries, including China, Cuba and the United Arab Emirates, have so far cleared Covid-19 vaccines for children in this age group and younger.
The FDA authorised a 10-microgram dose of Pfizer’s vaccine in young children, lower than the 30 micrograms in the original vaccine for those age 12 and older.
Advisers on the FDA panel said a lower dose could help mitigate some of the rare side effects.
At the meeting, they paid close attention to the rate of heart inflammation, or myocarditis, that has been linked to vaccines from both Pfizer/BioNTech and Moderna, especially in young men.
The regulator said on Friday that known and potential benefits of the Pfizer vaccine in individuals aged between 5 and 11 outweigh the risks.
Many adults who have been hesitant or opposed to the Covid-19 vaccine and even some who were vaccinated themselves, are expected to be more cautious about giving the shot to their children.
An advisory panel to the US Centres for Disease Control and Prevention (CDC) is scheduled to meet next week to consider recommendations on how the vaccine should be used in that age group. The CDC director will have the final say.
Pfizer and BioNTech said their vaccine showed 90.7 percent efficacy against the coronavirus in a clinical trial of children aged 5 to 11.
The United States started administering to the teens between ages 12 and 17 with the vaccine in May. Vaccination coverage among that age group is lower than in older groups, according to the CDC.
Pfizer’s vaccine was the first to be authorised for emergency use in the United States in December last year for those age 16 and older and was granted full US approval in August.
Earlier this week, Moderna reported interim data showing that its vaccine generated a strong immune response in children ages 6 to 11 years. It is awaiting a US regulatory decision on the authorisation for children between ages 12 and 17.