July 26, 2021, 9:58 am | Read time: 4 minutes
Green light for the jab for kids: EMA experts recommend approving the Moderna vaccine for 12- to 17-year-olds. This is likely to increase pressure on German authorities as well.
The EU Medicines Agency EMA has advocated for the approval of Moderna, making it the second COVID-19 vaccine for children and adolescents. According to the EMA recommendation, the U.S. manufacturer’s product can also be administered to 12- to 17-year-olds.
Approval of Moderna Vaccine for Children and Adolescents Just a Formality
Studies have shown that the vaccine is as safe and tolerable as it is for adults, the EMA in Amsterdam announced. According to the studies, the protection against COVID-19 was 100 percent. EMA experts reviewed the data and have now given a positive assessment. The EU Commission still needs to approve the authorization, which is considered a formality.
The Federal Ministry of Health in Berlin welcomed the agency’s decision. On Twitter, the ministry called it good news. “The states can now offer vaccination to children and adolescents who want to be vaccinated even faster.”
BioNTech Vaccine Approved for 12- to 17-Year-Olds Since May
The Moderna product, named Spikevax, would thus be the second COVID-19 vaccine allowed for young people. At the end of May, the BioNTech/Pfizer product was also approved for 12- to 17-year-olds. The Moderna vaccine is already approved for people aged 18 and over in the EU. Like adults, minors can also receive the vaccination with two injections four weeks apart, the EMA stated.
Children and adolescents rarely contract COVID-19. However, according to EMA experts, the benefits of vaccination are still considered higher than potential risks, especially for younger people with pre-existing conditions and therefore increased risk.
Also of interest: BioNTech, Moderna, AstraZeneca, J&J – four COVID-19 vaccines compared
When will the COVID-19 vaccine be available for children under 12 in Germany?
EMA Approves BioNTech Vaccine for Children Aged Five and Up
Moderna as Effective in Children and Adolescents as in Adults
According to the EMA, the effectiveness of Spikevax was examined in a comprehensive study involving more than 3,700 children and adolescents aged 12 to 17. It was found to be as effective as in young adults aged 18 and over. The manufacturer had previously tested the vaccine in the U.S. on about 2,500 adolescents aged 12 to 18. According to the company, the effectiveness was 100 percent.
EMA experts also confirmed that the product is as safe and tolerable as it is for adults. Possible side effects include pain and swelling at the injection site, fatigue, headache, muscle pain, nausea, and fever. However, the symptoms are usually mild and last only a few days.
The very rare side effects observed in adults, such as myocarditis and pericarditis, could not be detected due to the small number of test subjects, according to the experts. However, there is no doubt about the safety of the product. Monitoring for possible side effects will continue permanently, the EU agency explained.
Also of interest: Factors that can affect the COVID-19 vaccination
Pressure on Stiko to Recommend Vaccination for Children and Adolescents Grows
The EMA’s decision could also increase pressure on German authorities. So far, the Standing Committee on Vaccination (Stiko) recommends vaccination only for children and adolescents with pre-existing conditions. But given the rising infection numbers and the rapid spread of the Delta variant, politicians are pushing for an expansion of the recommendation. Bavaria’s Health Minister Klaus Holetschek expressed hope on Friday that Stiko would expand its recommendation. With the expected approval of the Moderna vaccine, “two highly effective products will be on the market, allowing us to expand our vaccination campaign to other population groups that have largely been excluded from vaccination so far.”
Many other countries are already vaccinating 12- to 17-year-olds, also to achieve herd immunity.
With material from dpa