The European Medicines Agency has recommended approving Moderna’s COVID-19 vaccine for children ages 12 to 17, marking the first time the shot has been authorized for people under 18.
LONDON — The European Medicines Agency has recommended that Moderna’s COVID-19 vaccine be authorized for children aged 12 to 17 years, marking the first time the shot has been authorized for people under the age of 18.
In a decision on Friday, the European Union’s drug regulator said research in more than 3,700 children aged 12 to 17 years showed that the Moderna vaccine – already given OK to adults across Europe – is a Produces comparable antibody response.
Until now, the vaccine, made by Pfizer and its German partner BioNTech, has been the only option for children under 12 in North America and Europe.
The US Food and Drug Administration is currently considering whether to extend the use of Moderna Vaccine to the same age group.
Global vaccine supplies are still tight, much of the world is still struggling to vaccinate adults, and agencies including the World Health Organization have urged wealthy countries to donate their doses to the developing world – where 2% fewer people have been vaccinated – rather than proceed to vaccinate their less vulnerable populations.
Millions of doses of Moderna have already been administered to adults, and the company says the two-dose vaccine is only protective in adolescence. In a study of more than 3,700 12- to 17-year-olds, the vaccine triggered symptoms similar to immune protection — and there was no COVID-19 diagnosis in the vaccinated group, compared with four cases given dummy shots.
Pain in the extremities, headache, and fatigue were the most common side effects, as in adults.
In the US, children so far represent about 14% of the country’s total coronavirus cases. According to a tally by the American Academy of Pediatrics, while young people are much less likely than the elderly to become seriously ill, at least 344 children have died from COVID-19 in the US alone.
So far in the US, less than half the population has been fully vaccinated – with the highest rates, not surprisingly, among older adults. According to the Centers for Disease Control and Prevention, just a quarter of 12 to 15-year-olds who have access to Pfizer’s vaccine starting in May have received their second dose. About 37% of those 16 and 17 of them are fully vaccinated.
Pfizer and Moderna have both started trials in children as young as 6 months old as young as 11 years old. These studies are more complex: Adolescents receive the same dose as adults, but researchers are testing smaller doses in younger children. The first results for primary school-aged children are expected in September.
The EU drug regulator said it would continue to monitor the safety and efficacy of Moderna Vaccine in children as it is used in European member states.
Although some countries have authorized Pfizer-BioEntech’s vaccine for children under the age of 18, not all have decided to start using it, given that children face the least exposure to the coronavirus. have to do. For example, in the UK, health officials have so far refused to recommend that children under the age of 18 be vaccinated unless they have a medical condition that requires it.
Neergaard reported from Alexandria, Virginia.
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