After almost four months of evaluation, the European Medicines Agency (EMA) has recommended the administration of Moderna’s COVID-19 vaccine in children between the ages of six and 11. Until now, the EMA had only authorized the Pfizer-BioNTech vaccine for children of that age, which is why Spikevax has become the second drug with the green light in children under 11 years of age.
The study submitted for approval showed that Moderna’s vaccine causes an immune response against COVID-19 in children with half the dose of the drug that is injected into adults. For this reason, the EMA indicates that Moderna injections administered in pediatrics will be two doses of 50 micrograms – instead of the 100 used in adults – and they will be given 28 days apart.
Regarding the existing evidence on efficacy and safety, the EMA states that it is similar to that found in research carried out on adults. Common side effects similar to those experienced by those over 12 years of age were seen in children aged 6 to 11 years, including: headache, pain, redness and swelling at the injection site, chills, tiredness, vomiting, nausea, swollen or tender lymph nodes under the arm, fever, and joint or muscle pain.
Moderna’s vaccine for children between the ages of six and 11 will be half the dose (50 micrograms) and 28 days apart between the two injections.
These side effects of vaccines in children are usually mild or moderate and subside within a few days after vaccination. For all these reasons, the EMA Committee for Human Medicines (CHMP) has concluded that the benefits of Spikevax in children between the ages of six and 11 outweigh the risks, especially in those who have conditions that make them vulnerable to severe COVID-19 . The CHMP will now send its recommendation to the European Commission, which will make a final decision on the use of this vaccine.
The EMA also recommends the booster dose from 12 to 18 years
Another of the recent recommendations made known by the EMA is the authorization of the booster dose with the Comirnaty vaccine (Pfizer-bioNTech) from 12 to 18 years of age. In this way, those who have received their complete vaccination schedule will be able to restore protection against SARS-CoV-2 after the time, when it is estimated that the antibodies could decrease.
This recommendation has been made after evaluating interim data regarding the safety and efficacy of a booster dose of the vaccine in those over 16 years of age in a clinical trial, together with the published literature on the subject and post-test data. authorization. As well as real-world evidence of booster dose use in youth in Israel.
“The decision about whether and when to offer boosters in this age group will need to take into account factors such as the spread and likely severity of the disease (especially with the omicron variant) in younger people, the known risk of side effects (particularly the very rare but serious complication of myocarditis) and the existence of other protective measures and restrictions. As with previous decisions on vaccination, it will be up to the experts who guide the vaccination campaign in each Member State to advise on the optimal decision and timing for their country.
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