The US Food and Drug Administration on Friday authorised the Pfizer Inc and BioNTech SE coronavirus vaccine for children aged 5 to 11 years, making it the first Covid-19 shot for young children in the United States.
The shot will not be immediately available to the age group. The US Centers for Disease Control and Prevention still need to make recommendations on how the shot should be administered, which will be decided after a group of outside advisers discuss the plans on Tuesday.
It comes after a panel of advisers to the regulator voted overwhelmingly to recommend the authorisation on Tuesday. 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.
In the United States, around 58% of the population is fully vaccinated, lagging other nations such as the UK and France. "This is a day so many parents, eager to protect their young children from this virus, have been waiting for," Pfizer Chief Executive Albert Bourla said in a statement.
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