EU Medicines Agency approves Pfizer vaccine against Covid for 5-11 year olds

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The European Medicines Agency (EMA) has recommended granting an extension for the use of the Covid-19 vaccine developed by BioNTech and Pfizer to include children aged between 5 to 11. The vaccine is already approved for use in adults and children aged 12 and above.

The EMA has said that for children aged from 5 to 11, the dose would be lower than that used in people aged 12 and above. As with the older age groups, however, two injections would be given, three weeks apart.

A study carried out on children aged 5 to 11 has shown that ‘the immune response to Comirnaty’ [the Pfizer vaccine] ‘given at a lower dose of 10 µg was comparable to that seen with the higher dose (30 µg) in the 16-25 age group’. The study was calculated in almost 2,000 children from 5 to 11 years of age who had no sign of previous infection. The children received 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. The EMA states that ‘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 EMA also state that ‘most common side effects in children aged 5 to 11 are similar to those in people aged 12 and above’. These ‘include pain at the injection site, tiredness, headache, redness and swelling at the site of injection, muscle pain and chills’. The EMA states that ‘these effects are usually mild or moderate and improve within a few days of vaccination’.

The EMA has concluded, therefore, ‘that the benefits of Comirnaty [Pfizer] in children aged 5 to 11 outweigh the risks, particularly in those with conditions that increase the risk of severe Covid-19’.

‼️ EMA recommends approval of BioNTech/Pfizer’s #COVID19vaccine, Comirnaty, for children aged 5 to 11.

In this population, the dose of #Comirnaty will be lower than that used in people aged 12 and above.

Read the full press release: https://t.co/uqqBAklVvl pic.twitter.com/NZQhli4SDl
— EU Medicines Agency (@EMA_News) November 25, 2021