The EU medicines regulator has backed a COVID-19 vaccine for children after a detailed review of evidence on safety and efficacy.
The low-dose vaccine provides a similar immune response to higher doses of the vaccine given to people aged between 16 and 25. Children will be offered 10 µg (compared with 30µg), given as two injections in the upper arm, three weeks apart.
The European Medicines Agency’s Paediatric Committee led the review of data before a recommendation was made by the human medicines committee. The key study reviewed by experts looked at almost 2,000 children who were given either the vaccine or a placebo (a dummy injection).
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. The EMA said that, statistically, the true rate could be between 67.7% and 98.3%.
The most common side effects were similar to those seen in people aged 12 years and older: pain at the injection site, tiredness, headache, redness and swelling at the site of injection, muscle pain and chills. These effects are usually mild or moderate and improve within a few days of vaccination. Safety will be continuously monitored as EU Member States begin rolling the vaccine in the coming weeks and months.
The news comes as governments across Europe are rolling out booster doses to adults amid evidence that immunity falls over time. Governments will now need to balance the complexities of offering third doses to adults and first doses to children. (The vaccine has been available to people aged 12 and older since July.)
At a public meeting on Thursday 25 November, which was live streamed online, the EMA said the benefit of vaccination against COVID outweighs any risk. COVID-19 vaccination programmes are the biggest in history, with more than 7 billion doses administered worldwide in less than one year.
In Europe alone, the vaccines have saved nearly half a million lives in 2021, according to a new study by the WHO and European Centre for Disease Prevention & Control (ECDC).