EMA gave the green light for boosters with Pfizer from the age of twelve

by time news

The EU medicines agency EMA has given the green light for the booster vaccination of children from the age of twelve with the corona vaccine from the manufacturers Pfizer and Biontech. The EMA announced this on Thursday in Amsterdam. In Austria this was already possible off-label. The EMA experts now also agree to the basic vaccination of children from six to eleven years with the vaccine from the manufacturer Moderna. The final approval is made by the EU Commission, which is considered a formality.

The EMA emphasized that the EU member states themselves decide whether a booster vaccination should be offered to children. In Austria, a third-party vaccination with the mRNA vaccines from Pfizer/Biontech and Moderna was already possible without approval under the age of 18. Because of the omicron wave, the National Vaccination Committee (NIG) had also recommended the booster for children and adolescents between the ages of twelve and 17 from six months after the second vaccination. According to the currently valid application recommendation of the NIG, this is also possible after four months if requested and after a doctor’s decision.

The Pfizer vaccine is already approved as a two-dose basic vaccination for people aged five and over. However, the approval for a booster vaccination was previously only available from the age of 18. The Moderna vaccine is now also to be approved for children aged six to eleven. The effectiveness and safety of the preparation is just as high as in adults. For children, the dose should be reduced by 50 percent, as the EMA announced. Studies have shown that the immune protection in children is as high as in adolescents aged 18 to 25 with the high dose. Possible side effects include pain and redness at the injection site, fatigue, headache, nausea, fever and joint pain.

Based on international safety reports on an increased occurrence of myocarditis and pericarditis, mainly in younger people, the NIG currently only recommends vaccinations with Moderna from the age of 30 as a precaution. According to the approval, the vaccine can also be used in people under 30 years of age if expressly requested, the NIG’s recommendation for use emphasizes.

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