The European Medicines Agency (EMA) has begun evaluating an application to extend the use of the Moderna COVID-19 vaccine, Spikevax, to children aged 6 to 11 years.
Spikevax is a vaccine for the prevention of COVID-19, which is currently approved for use in people 12 years of age and older. The EMA’s Committee for Medicinal Products for Human Use (CHMP) will review data on the vaccine, including the results of an ongoing clinical trial involving children aged 6 to 11, to decide whether to propose extending its use.
The timing of any evaluation always depends on the data submitted. The current evaluation schedule provides for an opinion in about 2 months, unless additional information or analysis is required. This is a shortened schedule compared to similar types of non-pandemic assessments.
The Agency will announce the result of its evaluation. The CHMP’s opinion will then be forwarded to the European Commission, which will issue a final decision.
Source: AMPE
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Source From: Capital
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