The EMA experts recommend the approval of a certain vaccine for 12 to 17 year olds as well.
That should also increase the pressure on the German authorities.
Amsterdam - The EU Medicines Agency EMA has spoken out in favor of the approval of a second corona vaccine for children and adolescents.
According to the EMA recommendation, the preparation from the US manufacturer Moderna * can also be
injected into
12 to 17 year olds
.
Studies have shown that the vaccine is just as safe and well tolerated as in adults, said the EMA in Amsterdam.
The protection against Covid disease in the studies was therefore 100 percent
.
The EMA experts had checked the data and now rated it positively.
The EU Commission still has to approve the approval, which is a matter of form.
The Federal Ministry of Health in Berlin welcomed the authority's decision.
The ministry called her
good news
on Twitter
.
"The federal states can offer children and young people who want to be vaccinated a vaccination even faster."
Two mRNA vaccines approved for children
Moderna's preparation called Spikevax would be the second corona vaccine that can also be administered to young people.
At the end of May, the preparation from Pfizer / Biontech was also approved for 12 to 17 year olds.
Moderna's vaccine is already approved in the EU for people aged 18 and over. Just like adults, minors can also be vaccinated with two injections four weeks apart, the EMA said.
Children and adolescents contract Covid-19 relatively rarely. But in the opinion of the EMA experts, the benefits of vaccination are still to be rated higher than possible risks, especially for younger people with previous illnesses and therefore increased risk.
According to the EMA, the effectiveness of Spikevax had been examined in an extensive study with more than 3,700 children and adolescents aged 12 to 17 years.
This makes it clear that the preparation is just as effective as it is in young adults aged 18 and over. The manufacturer itself had previously tested the vaccine in around 2,500 adolescents between the ages of 12 and 18 in the United States. According to the company, the effectiveness was 100 percent.
The EMA experts have now also confirmed that the preparation is just as
safe and tolerable
as it is in adults.
Possible side effects included pain and swelling at the injection site, fatigue, headache and muscle pain, nausea, and fever.
The symptoms are mostly mild and only last a few days.
Covid-19: Increasing numbers of infections also among younger people
The very rare side effects found in adults, such as inflammation of the heart muscle and inflammation of the pericardium, could not be determined, according to the experts, given the small number of test persons.
But there is no doubt about the safety of the preparation.
The control for possible side effects will be continued permanently, said the EU authority.
The EMA's decision could also increase the pressure on German authorities. So far, the Standing Vaccination Commission (Stiko) recommends vaccination only for children and adolescents with previous illnesses. But in view of the increasing number of infections and the rapid spread of the delta variant, politicians are pushing for the recommendation to be expanded. Bavaria's Health Minister Klaus Holetschek expressed the hope on Friday that the Stiko would expand its recommendation. With the expected approval of the Moderna vaccine, "
two highly effective preparations will be on the market
with which we can expand our vaccination campaign to other groups of the population who have previously been largely excluded from vaccination." Many other countries are already vaccinating 12 to 17-year-olds, also to achieve herd immunity.
(dpa)
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