EMA endorses COVID-19 vaccine Comirnaty for children aged 5-11

The European Medicines Agency (EMA) on Thursday recommended the use of COVID-19 vaccine Comirnaty developed by BioNTech and Pfizer for children aged 5 to 11, reported Xinhua.

The vaccine is already approved for use in adults and children aged 12 and above.

In children from 5 to 11 years of age, the dose of Comirnaty will be lower than that used in people aged 12 and above, the drug agency of the European Union (EU) said in a statement, adding that as in the older age group, it is given as two injections in the muscles of the upper arm, three weeks apart.

A main study in children aged 5 to 11 showed that the immune response to Comirnaty given at a lower dose in this age group was comparable to that seen with the higher dose in 16- to 25-year-olds, as measured by the level of antibodies against SARS-CoV-2, the EMA said.

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, it said.

Study showed that the vaccine was 90.7 percent effective at preventing symptomatic COVID-19. The most common side effects in children aged 5 to 11 are similar to those in people aged 12 and above.

They include 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.

The EMA 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 as well as in ongoing and additional studies conducted by the company and by European authorities, it added.