European Medicines Agency evaluates Covid-19 vaccine for young children

The European Medicines Agency is evaluating the administration of the BioNTech / Pfizer covid-19 vaccine to children aged 5 to 11 years.

A Covid-19 vaccine for children aged 5 to 11 years of age may soon be available after the European Medicines Agency (EMA) said it has started evaluating an application to extend the use of BioNTech/Pfizer’s Covid-19 jab today, Monday, October 18.

Currently, there is no Covid-19 vaccine on the market for children under 12.

The EMA’s human medicines committee (CHMP) said it will review the data on the vaccine, including results from an ongoing clinical study involving children aged 5 to 11, in order to decide whether to recommend extending its use.

The two-shot vaccine, based on new mRNA technology, was found to induce a strong immune response in five- to 11-year- olds in a clinical trial of 2,268 participants, the drugmakers said last month. read more

Pfizer and German partner BioNTech submitted data on Comirnaty for young children last week. While children are less susceptible to severe COVID-19, they can spread the coronavirus to others, including those more at risk of severe illness.

Alongside vaccinating children, regulators and drugmakers are also considering booster doses for the vulnerable, underscoring the need to increase production and extend access to protection from the virus to as many people as possible.

The EMA also said on Monday it had approved two more manufacturing sites for producing the vaccine in the Italian cities of Monza and Anagni, while also giving the green light to a ready-to-use formulation of Comirnaty.

The sites would produce up to 85 million additional doses to supply the European Union in 2021, the regulator said. Pfizer and BioNTech are the biggest suppliers of COVID-19 vaccines to the bloc.

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