EMA recommends approval of Comirnaty for children aged five to 11
The European Medicines Agency’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use in children aged five to 11.
The vaccine, developed by Germany’s BioNTech (Nasdaq: BNTX) and US pharma giant Pfizer (NYSE: PFE), is already approved for use in adults and children aged 12 and above, and is notching up record revenues and profits for the companies, with sales this year expected to reach $36 billion.
Pfizer and BioNTech have submitted requests for authorization of their COVID-19 vaccine in this age group to other regulators around the world. The companies expect initial pivotal data from their ongoing clinical trial in two to under five years of age this quarter, and in six month to under two years of age in the first quarter 2022, with full data readouts to follow.
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