The EU’s medicines watchdog on Thursday recommended that Pfizer/BioNTech’s anti-COVID booster vaccine be approved for children aged 12 and older.
The “EMA’s human medicines committee (CHMP) has recommended that a booster dose of the COVID-19 vaccine Comirnaty may be given where appropriate to adolescents from 12 years of age,” the European Medicines Agency said in a statement, using the vaccine’s brand name.
“The committee considered that the available evidence was sufficient to conclude that the immune response to a booster dose in adolescents would be at least equal to that in adults”, it added.
The Amsterdam-based EMA earlier this month said it was evaluating the application to use Comirnaty within the 27-member bloc.
The EMA’s opinion will now be sent to the European Commission “to issue a final decision shortly”, it said.
However, it will be up to each individual member state to decide whether to implement the booster campaign for children this age.
This would be based on factors such as “the spread and likely severity of the disease in younger persons, the known risk of side effects and the existence of other protective measures and restrictions”, the EMA said.
The EMA last October approved Comirnaty booster jabs for all people aged 18 and older, followed by a similar decision to back Moderna’s Spikevax shortly afterwards.
On Thursday it also announced that it has recommended the approval of the Spikevax vaccine for children aged between six and 11.
Comirnaty has already been approved for use in children aged five and older.
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