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EMA Recommends Approval For Pfizer's COVID-19 Vaccine Comirnaty For Kids Aged 5 To 11

European Medicines Agency or EMA's medicines committee (CHMP) on Thursday recommended the use of COVID-19 vaccine Comirnaty in children aged 5 to 11.

The vaccine, developed by BioNTech and Pfizer, 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.

A main study in children aged 5 to 11 showed that the immune response to Comirnaty given at a lower dose (10 mcg) in this age group was comparable to that seen with the higher dose (30 mcg) in 16- to 25-year-olds. The vaccine showed 90.7% efficacy at preventing symptomatic COVID-19.

"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 said.

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.

In addition, the CHMP noted that it will now send its recommendation to the European Commission, which will issue a final decision.

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