EMA recommends approval of Spikevax for 6 to 11 year-olds
The European Medicines Agency’s human medicines committee (CHMP) has recommended granting an extension of indication for Spikevax (COVID-19 Vaccine, mRNA) to include use in children aged six to 11. The vaccine, developed by Moderna (Nasdaq: MRNA), is already approved for use in adults and children aged 12 and above.
The dose of Spikevax in children from six to 11 years of age will be lower than that used in people aged 12 and above (50µg compared with 100µg). As in the older age group, the vaccine is given as two injections in the muscles of the upper arm, four weeks apart.
The evidence indicates that the efficacy and safety of Spikevax in children aged six to 11 are similar to those in adults. The CHMP therefore concluded that the benefits of Spikevax in this age group outweigh the risks, particularly in those with conditions that increase the risk of severe COVID-19.
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