A spokesperson for the Commission told us it completed the authorization procedure for the extension of the use of the shot, now branded as Spikevax, for children on Friday July 23, the same day it received the opinion from the European Medicines Agency (EMA).
The decision was published in the Union registry, making the Moderna vaccine the second COVID-19 jab authorized for young people in the EU. May saw the EMA give the green light for the use of the Pfizer-BioNTech COVID-19 vaccine in teenagers.
Trial data
Like with adults, Spikevax will be given in two injections, each four weeks apart.
The effects of Spikevax have been studied among 3,732 children aged 12 to 17 years, the EMA said. That ongoing study is being carried out in accordance with Spikevax’s pediatric investigation plan (PIP), which was agreed by EMA's Pediatric Committee (PDCO).
The study showed that Spikevax produced a comparable antibody response in 12- to 17-year-olds to that seen in young adults aged 18 to 25 years, as measured by the level of antibodies against SARS-CoV-2. In addition, none of 2,163 children receiving the vaccine developed COVID-19 compared with four of 1,073 children given a dummy injection. These results, said the EMA, allowed it to conclude that the efficacy of Spikevax in 12- to 17-year-olds is similar to that in adults.
However, the trial's small size meant uncommon side-effects, such as the risk of heart inflammation, could not be assessed among the 12-17 age group. But the agency maintains that the benefits of vaccination with the Moderna shot outweigh any risks.
The EMA said the safety and efficacy of the vaccine in both children and adults will continue to be monitored closely as it is rolled out in vaccination campaigns across the member states.
Moderna is also conducting a Phase 2/3 study, called the KidCOVE study, of its COVID-19 vaccine in children ages 6 months to less than 12 years.
Vaccinate adults elsewhere first, says WHO
Some EU countries have extended the use of Pfizer-BioNTech’s vaccine for children under 18.
The US Food and Drug Administration (FDA) is currently considering whether to allow the use of the Moderna vaccine in adolescents.
Many commentators, however, argue that it is ethically and morally wrong to be vaccinating adolescents in wealthy countries when the vaccination rate in most of Asia and Africa is far lower than in the regions such as North America and the EU.
The World Health Organization (WHO) has repeatedly urged developed countries to donate COVID-19 vaccines to poorer nations instead of vaccinating their children.
Children and adolescents tend to have milder disease compared to adults, so unless they are part of a group at higher risk of severe COVID-19, it is less urgent to vaccinate them than older people, those with chronic health conditions and health workers, argues the WHO.
Meanwhile, last week saw the EU Commission announce that Team Europe - the EU, its institutions and all 27 member states - is on track to share 200 million doses of COVID-19 shots with the countries that need them most, by the end of 2021. Those doses will reach their destination countries, mainly through COVAX, by that deadline, said the EU executive body.
