EMA gives green light for Pfizer/BioNTech COVID-19 vaccine in children aged 5-11

25-Nov-2021 - Last updated on 25-Nov-2021 at 16:53 GMT

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The European Medicines Agency’s human medicines committee (CHMP) has recommended granting an extension of indication for the Pfizer/BioNTech COVID-19 vaccine to include use in children aged 5 to 11.

The vaccine, known as Comirnaty in the EU, is already approved for use in adults and children aged 12 and above. It becomes the first COVID-19 vaccine authorized for children in the bloc.

The FDA authorized the vaccine for emergency use in children at the end of last month, followed by the same move from Health Canada last week (with children, the vaccine has been authorized for the same age range and same dosage in these markets).

Reduced dose

In the EU, the CHMP states the dose of Comirnaty in children will be lower than that used in people aged 12 and above (10 µg compared with 30 µg).

As in the older age group, it is given as two injections in the muscles of the upper arm, three weeks apart.

"A study in children aged 5 to 11 showed that the immune response to Comirnaty given at a lower dose (10 µg) in this 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)," notes the EMA.

The efficacy of Comirnaty was calculated in almost 2,000 children from 5 to 11 years of age who had no sign of previous infection. These children received either the vaccine or a placebo. Of the 1,305 children receiving the vaccine, three developed COVID-19 compared with 16 out of the 663 children who received 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%,” continues the agency.

The CHMP 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 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 conducted by the company and by European authorities.

The CHMP will now send its recommendation to the European Commission, which usually issues a final decision in a matter of days.