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EMA recommends approval of vaccination of children aged 5 to 11 with the BioNTech/Pfizer vaccine

The European Medicines Agency (EMA) has recommended that the use of Comirnaty, the COVID-19 vaccine produced by BioNTech/Pfizer, be extended to children aged between 5 and 11, the organisation said on Thursday.

EMA is suggesting using a lower dose of the vaccine for children between the ages of 5 and 11, than the dose used for people aged 12 and above (10 µg compared with 30 µg). The vaccine will be given as two injections, three weeks apart.

According to a study cited by EMA, the immune response to Comirnaty given at a lower dose (10 µg) in the 5 to 11 age group was comparable to that seen with the higher dose (30 µg) in 16 to 25 year olds (as measured by the level of antibodies against SARS-CoV-2).

The efficacy of the vaccines was calculated in almost 2,000 children from 5 to 11 years of age who had no sign of previous infection.

Of the 1,305 children receiving the vaccine, three developed COVID-19 compared with 16 out of the 663 children who received a placebo. This means that, in this study, the vaccine was 90.7% effective at preventing symptomatic COVID-19 (although the true rate could be between 67.7% and 98.3%).

The most common side effects observed in children aged 5 to 11 are similar to those in people aged 12 and above, such as pain, redness or swelling at the injection site, tiredness, headache, muscle pain and chills. These effects are usually mild or moderate and improve within a few days of vaccination.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) therefore concluded that the benefits of Comirnaty in children aged 5 to 11 outweigh the risks, particularly in those with conditions that increase the risk of severe COVID-19.

The EMA notes that the safety and efficacy of the vaccine in both children and adults will continue to be monitored closely as it is used in vaccination campaigns in EU Member States through the EU pharmacovigilance system and ongoing and additional studies.

The CHMP will send its recommendation to the European Commission, which will issue a final decision.

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