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EMA authorises Pfizer/BioNTech’s COVID-19 vaccine for children aged 12 to 15

Clinical trial data recently showed that the vaccine is safe and effective in individuals in this age group

Pfizer and BioNTech’s mRNA-based COVID-19 vaccine has been approved for children aged 12 to 15 in the European Union (EU).

The European Medicines Agency (EMA) has authorised the vaccine for this younger age group after data recently showed that it is safe and effective in individuals aged 12 to 15.

The vaccine, which is authorised in the EU under the brand name Comirnaty, was found in a clinical trial to produce an immune response in this age group that was comparable to the immune response seen in the 16 to 25 year age group.

The most common side effects in children aged 12 to 15 are similar to those observed in people aged 16 and above, the EMA said in a statement.

This includes pain at the injection site, tiredness, headache, muscle and joint pain, chills and fever. These are typically mild or moderate and improve ‘within a few days’.

"From a safety perspective, the vaccine was well tolerated and the side effects in this age group were very much similar to what we have seen in young adults and not raising major concerns at this point in time,” said Marco Cavaleri, head of vaccine strategy at the EMA.

The US Food and Drug Administration (FDA) has already expanded its emergency use authorisation (EUA) for the Pfizer/BioNTech vaccine in 12- to 15-year-olds, and Canada has also approved the jab in this age group.

A spokesman for Pfizer previously confirmed that the company has submitted data for the vaccine in 12- to 15-year-olds to the UK Medicines and Healthcare products Regulatory Agency (MHRA).

NHS England created contingency plans last month for vaccination of children of secondary school age later this year. This proposal is to be included in ‘core planning scenario’ documents showing that a single dose of the jab could be offered to children aged 12 and over at the start of the autumn term.

“It is very important to enable [children] to get back to everyday school life and to meet friends and family while protecting them and their loved ones,” said  Ugur Sahin, chief executive officer and co-founder of BioNTech.

Article by
Lucy Parsons

1st June 2021

From: Regulatory

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