This positive recommendation comes from the Scientific Committee of the European Medicines Agency (EMA).
The coronavirus vaccine Comirnaty (Pfizer) and Spikevax (Moderna) are approved for use in children from 6 months of age. Research shows that vaccines elicit an immune response against COVID-19 in this target group. Side effects are similar to those seen in older age groups. So the benefits outweigh the risks.
This positive recommendation comes from the Scientific Committee of the European Medicines Agency (EMA). The MEB’s medical authority participates in the evaluation. The European Commission will likely adopt this advice. These manufacturers’ vaccines are already approved for adults and children 5 and 6 years old. This pertains to vaccines targeting the original strain of coronavirus (Wuhan).
Less dose, three shots
The dose of both vaccines is lower for younger age groups. The basic series for children from 6 months to 4 years of age consists of 3 injections (each of 3 micrograms). There should be at least 3 weeks between the first two injections. At least 8 weeks after the second shot, the third shot will follow.
Children 6 months to 5 years of age can receive Spikevax as a basic series of two injections (each of 25 micrograms), 4 weeks apart. The injection is injected into the muscles of the arm or thigh.
Three low-dose (3 mcg) injections of Komernati elicit similar defenses in children 6 months to 4 years of age as two injections of a higher dose (30 mcg) at 16 to 25 years old.
Studies with Spikevax showed that the immune response after two injections of a lower dose (25 mcg) in children 6 months to 5 years of age was similar to that after 2 injections of a higher dose (100 mcg) in 18 to 25 years of age. birthdays.
M. Professor Ton de Boer, Chairman of the Executive Board: The immune system of children and adults works in the same way. The immune response of children is stronger than that of adults, especially in young children. That is why they are satisfied with a smaller amount of children from the age of 5 or 6 years.
The most common side effects for both vaccines were similar to those seen in the older age groups:
- Irritability, drowsiness, loss of appetite, rash, and tenderness at the puncture site were also common adverse reactions in children 6 to 23 months of age with Kommernate.
- Irritability, crying, loss of appetite, and drowsiness were common side effects in children 6 to 36 months of age taking Spikevax.
For both vaccines, side effects were usually mild or moderate and resolved after a few days.
As with all vaccines and age groups, we closely monitor safety and efficacy. This is done through the European Pharmacovigilance System, ongoing studies and additional studies by European manufacturers and authorities.
De Boer: Most children infected with the coronavirus only show mild symptoms. In rare cases, children can become infected with the severe COVID-19 virus. The risk is greater in children with underlying conditions. The original corona vaccines remain effective against serious illness, hospitalization, and death. It is now up to the Board of Health and the Minister of Health to see if and how the vaccine will be used.
Product information for both vaccines contains more information for health care providers, a package leaflet and more information about vaccine approval requirements. The evaluation report will also follow on the EMA website.
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Positive advice about corona vaccines for children from 6 months of age
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