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EMA recommends approval of Spikevax for children aged 6 to 11

EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Spikevax to include use in children aged 6 to 11.

The vaccine, developed by Moderna, is already approved for use in adults and children aged 12 and above, as previously reported.

The dose of Spikevax in children from 6 to 11 years of age will be lower than that used in people aged 12 and above (50 µg compared with 100 µg). As in the older age group, the vaccine is given as two injections in the muscles of the upper arm, four weeks apart.

A main study in children aged 6 to 11 showed that the immune response to the lower dose of Spikevax (50 µg) was comparable to that seen with the higher dose (100 µg) in 18- to 25-year-olds, as measured by the level of antibodies against SARS-CoV-2.

The most common side effects in children aged 6 to 11 are similar to those in people aged 12 and above. They include pain, redness and swelling at the injection site, tiredness, headache, chills, nausea, vomiting, swollen or tender lymph nodes under the arm, fever and muscle and joint pain. These effects are usually mild or moderate and improve within a few days of vaccination.

The evidence indicates that the efficacy and safety of Spikevax in children aged 6 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.

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.

The CHMP will now send its recommendation to the European Commission, which will issue a final decision.

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