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The European Medicines Agency has recommended the extension of indications for the Moderna COVID-19 vaccine Spikevax for use in children aged 6 to 11 years. The EMA also recommends a booster dose of Comirnata in adolescents from the age of 12.

On Thursday, February 24, EMA's Committee for Medicinal Products for Human Use (CHMP) recommended extending the indications for the mRNA vaccine to COVID-19 Spikevax by Moderna for use in children 6 to 11 years of age. The CHMP recommendation will now be sent to the European Commission, which will take a final decision on this matter. This vaccine has so far been approved for use in adults and children over 12 years of age.

The 6-11 year old age group is to use half the dose of the older age group (50 micrograms instead of 100). The method of administration will be the same - two injections into the shoulder four weeks apart.

Dose reduction is based on clinical trials - they showed that the immune response (as measured by anti-SARS-CoV-2 antibodies) to a lower dose of the vaccine in the 6-11 age group was comparable to that seen in those aged 18 -25 years after a dose of 100 micrograms.

In this age group, the most common side effects were similar to those seen in patients 12 years of age and older. These include pain, redness and swelling at the injection site, fatigue, headache, chills, nausea, vomiting, enlarged or tender lymph nodes under the arm, fever, muscle and joint pain. These symptoms were usually mild or moderate and resolved within a few days of vaccination. Therefore, the CHMP assessed that the benefits of the vaccine in the 6-11 year age group are greater than its risks, especially in children with diseases that increase the risk of severe COVID-19.

The CHMP also recommended that children 12 years of age and older may be boosted with Pfizer's COVID-19 mRNA vaccine Comirnata. The final decision on this matter will be issued by the European Commission. Currently, Comirnata is already authorized in the EU as a two-dose primary immunization in adolescents and adults and children from 5 years of age, and the dosebooster is now approved for use from the age of 18.

The Committee emphasizes that the decision to use a booster dose in adolescents from the age of 12 is made by the relevant expert bodies in each EU Member State, taking into account the risks and benefits, including the known risk of side effects, especially rare ones. but a serious complication in the form of myocarditis.

As explained by PAP, the CHMP issued an opinion based on the assessment of preliminary data from a clinical study on the safety and efficacy of a booster dose of the vaccine in people aged 16 years and older, as well as on the basis of published works, confirmed data and evidence from daily practice booster doses in children in Israel.

The Committee considered that the available evidence was sufficient to conclude that the immune response to a booster dose in adolescents is at least as good as in adults. There were no alarming data on adverse effects after the booster dose.

In the coming months, further data on this subject are expected from the ongoing research and analysis.

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