FDA authorises Pfizer/BioNTech vaccine for adolescents
The FDA has authorised Pfizer/BioNTech’s vaccine for 12- to 15 year-olds under emergency rules.
In a statement the regulator said it had expanded the vaccine’s Emergency Use Authorization to include the new age group.
The vaccine was first approved under the emergency protocols on 11th December, for people aged 16 years of age and older.
The FDA’s acting commissioner Janet Woodcock said this was a “significant step” in the fight against the pandemic.
Woodcock added: “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data.”
The dosing regimen is the same as for the adult jab: two doses, three weeks apart.
The FDA noted that between the period of March 1 2020 until April 30 this year, there have been around 1.5 million COVID-19 cases reported to the Centers for Disease Control and Prevention.
Safety data came from an ongoing trial involving 2,260 people aged 12-15 years old, where 1,131 received the vaccine and the remainder received the placebo.
More than half of participants were followed for safety for at least two months following the second dose.
The EUA follows a mammoth order for the vaccine from the European Union, which has signed a deal for 1.8 billion doses of the vaccine.
It is the biggest contract from the bloc to date and is enough to cover the entire European population and will be administered over the next couple of years.
There are around 450 million people living in the 27 EU member states but the order will cover booster shots and new variants that begin circulation.
Only last month, the EU ordered another 250 million Pfizer-BioNTech doses, which are to be delivered by June.
The EU has not ordered and new AstraZeneca vaccines beyond June following the row with the UK pharma over missed supply deadlines, which has prompted the European Commission to take legal action against the drug maker.
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