The US Food and Drugs Administration approved the Pfizer and BioNTech SE coronavirus vaccine for children aged 5 to 11 years on Friday, making it the first COVID-19 dose for young children in the United States.
The shot will not be provided to the age group right away. The US Centers for Disease Control and Prevention must still recommend how the shot should be given, which will be decided once a group of outside experts meets on Tuesday to debate the plan.
Pfizer announced on Saturday that it will begin distributing kid vaccination vials to pharmacies, paediatricians’ offices and other locations where the doses can be given.
The vaccine is projected to be available to 28 million American children, many of whom are returning to school for offline classes.
COVID-19 vaccinations have been licenced for children in this age range and younger in just a few other countries, including China, Cuba and the United Arab Emirates.
The FDA approved a 10-microgram dose of Pfizer’s vaccination for young children, down from the initial 30 microgram dose for individuals aged 12 and up.
After paying close attention to the rate of heart inflammation or myocarditis, that has been associated to both Pfizer and Moderna vaccinations, especially in young males, advisers on the FDA panel said a lower dose could help alleviate some of the rare side effects.
On Friday, the agency stated that the known and prospective benefits of the Pfizer vaccination in children aged 5 to 11 exceed the risks.
The FDA has approved a new version of the vaccine for children, which employs a new buffer and can be stored in refrigerators for up to 10 weeks.
Around 58 percent of the population in the United States is completely vaccinated, lagging behind other countries such as the United Kingdom and France. Many people who have been hesitant to be vaccinated may be much more hesitant to give their children the shot.
In a clinical trial of children aged 5 to 11, Pfizer and BioNTech stated that their vaccine had 90.7 percent efficacy against the Covid-19 virus.
In May, the vaccination was first given to 12 to 17-year-olds in the United States. According to the CDC, vaccination coverage in this age group is lower than that of older groups.
Pfizer’s vaccine was the first to be approved for emergency use in the United States for a population aged 16 and up in December of last year and it received full approval in August.
Moderna released preliminary findings earlier this week showing that their vaccine elicited a significant immunological response in youngsters aged 6 to 11. It is awaiting a regulatory decision in the United States on the authorization of youngsters aged 12 to 17.
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