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.
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The vaccine, developed by Moderna, is already approved for use in adults and children aged 12 and above.
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.
Spikevax works by preparing the body to defend itself against COVID-19. It contains a molecule called messenger RNA (mRNA) which has instructions for making the spike protein. This is a protein on the surface of the SARS-CoV-2 virus which the virus needs to enter the body’s cells.
When a person is given the vaccine, some of their cells will read the mRNA instructions and temporarily produce the spike protein. The person’s immune system will then recognise this protein as foreign and produce antibodies and activate T cells (white blood cells) to attack it.
If, later on, the person comes into contact with the SARS-CoV-2 virus, their immune system will recognise it and be ready to defend the body against it.
The mRNA from the vaccine does not stay in the body but is broken down shortly after vaccination. ■