MODERNA COVID-19 VACCINE CLEARED IN EU FOR CHILDREN 12-17

Sun 25 July 2021:

The European Medicines Agency has recommended that Moderna’s COVID-19 vaccine can be used on children and adolescents aged 12 and up.

The EU drug regulator said research in more than 3,700 children aged 12 to 17 showed that the Moderna vaccine — already given the OK for adults across Europe — produced a comparable antibody response.

The European Commission still has to give the green light, but that is considered a formality.

Moderna’s preparation Spikevax would thus be the second COVID-19 vaccine that may also be administered to young people in the bloc. At the end of May, the Pfizer/BioNTech vaccine was also approved for 12-to-17-year-olds.

Just like adults, minors can also be vaccinated with two jabs four weeks apart, the EMA said.

Moderna’s application was based on a study of 2,500 adolescents in the United States. According to the company, the efficacy was 100%. U.S. authorities are still weighing whether to approve the jab for those aged 12 to 17.

The “recommendation of the authorization of our COVID-19 vaccine for use in individuals 12 years of age and older in the European Union is a positive step forward toward authorization of our vaccine in this age group,” said Moderna chief executive Stephane Bancel.

“As we help to combat the pandemic, we hope to be able to help get adolescents safely back to school this fall,” he said in a statement.

Pfizer and Moderna have begun testing in even younger children, from age 11 down to 6 months old. These studies are more complex: Teens receive the same dose as adults, but researchers are testing smaller doses in younger children. The first results from children of elementary school age are expected in September.

With global vaccine supplies still tight, much of the world is struggling to immunize adults. The World Health Organization and other agencies have urged rich countries to donate their doses to the developing world — where fewer than 2% of people have been vaccinated — rather than moving on to inoculate their less vulnerable populations.

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