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The extension of indications for the COVID-19 vaccine Spikevax – for use in children aged six to 11 years was recommended by the European Medicines Agency (EMA) on Thursday. The agency also recommended a booster dose of Comirnata in adolescents from 12 years of age.
- Spikevax vaccine from Moderna can be used in children from 6 years of age – recommended the European Medicines Agency
- At the same time, the EMA issued a second recommendation on childhood immunization
- Experts decided that patients from the age of 12 can be given a booster. Children can be vaccinated with Pfizera
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Moderny vaccine for children aged 6-11 years
The Committee for Medicinal Products for Human Use (CHMP) recommended the European Medicines Agency on Thursday extension of indications for the mRNA vaccine to COVID-19 called Spikevax by Moderna for use in children from 6 to 11 years of age. The CHMP will send its recommendation to the European Commission, which will issue a final decision on this matter.
So far, the vaccine has been approved for use in adults and children 12 years of age and older.
Children 6-11 years of age will receive half the dose of the vaccine compared to 12 years of age and older (50 micrograms instead of 100 micrograms). The method of administration will be the same – two injections into the shoulder four weeks apart.
A clinical study in a group of children aged 6-11 years showed that the immune response (measured by anti-SARS-CoV-2 antibodies) to the lower dose of the vaccine was comparable to that observed in people aged 18-25 after receiving the 100 microgram dose .
The most common side effects in this group of children 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 generally mild to moderate and they decreased within a few days following vaccination.
Therefore, the CHMP assessed that the benefits of the vaccine in the 6-11 age group are greater than its risks, especially in children with diseases that increase the risk of severe COVID-19.
The safety of the vaccine, both in the group of children and adults, is still to be closely monitored in the Member States of the European Union.
Further part below the video.
A booster dose of COVID-19 vaccines for children over 12 years of age
On Thursday, the CHMP also recommended that children 12 years of age and older be given a booster dose of the mRNA vaccine against COVID-19 called Comirnaty by Pfizer, if appropriate. The final decision on this matter will be issued by the European Commission.
Currently, Comirnaty is approved for use in two doses in children from 5 years of age and in adults, and the booster dose can be – according to registration – used from 18 years of age.
The opinion of the CHMP was based on an assessment of preliminary data from a clinical study on the safety and efficacy of a booster dose of the vaccine in subjects 16 years of age and older, as well as published work and confirmed data and evidence from the daily practice of booster dosing 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 reactions following the booster dose.
Further data on this subject from the ongoing research and analysis are expected in the coming months.
The Committee emphasizes that the decision to use a booster dose in adolescents from the age of 12 will be made by the relevant expert bodies in each EU Member State, after considering the risks and benefits, including the known risk of side effects, especially a rare but serious complication in forms of myocarditis. (PAP)
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