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EMA has started evaluating the Pfizer COVID-19 vaccine for children aged 5 to 11

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EMA has started evaluating an application to extend the use of BioNTech/Pfizer’s COVID-19 vaccine, Comirnaty, to children aged 5 to 11 today (18 October).

Comirnaty is currently authorised for use in people aged 12 and older. A messenger RNA (mRNA) enters the cell and produces a protein, known as the spike protein, which is naturally present in SARS-CoV-2, the virus that causes COVID-19. Pfizer appears to be effective over a longer length of time than the AstraZeneca vaccine, particularly in younger people.

However, the move is not uncontroversial, with a worldwide shortage of vaccines some question the priority given to children when the adult population is already largely vaccinated. On the whole children have proved resilient and unlikely to develop the most severe manifestations of the disease. 

The announcement comes on the day that the European Commission made a statement on its ambition together with the US Biden administration to aim for a global vaccination rate of 70% by next year. 

Background

EMA’s human medicines committee (CHMP) will review the data on the vaccine, including results from an ongoing clinical study involving children aged 5 to 11, in order to decide whether to recommend extending its use. The CHMP’s opinion will then be forwarded to the European Commission, which will issue a final decision.

EMA will communicate on the outcome of its evaluation, which is expected in a couple of months unless supplementary information is needed.

Comirnaty was first authorised in the EU in December 2020. More information about the vaccine is available on the EMA website.

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