European agency clears Moderna vaccine for children ages 12-17

LONDON — The European Medicines Agency on Friday recommended authorizing Moderna’s COVID-19 vaccine for children ages 12 to 17, the first time the shot has been authorized for people under 18.

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

Until now, the vaccine made by Pfizer and German partner BioNTech has been the only option for children as young as 12 in North America and Europe.

The U.S. Food and Drug Administration is currently considering whether to extend the use of the Moderna vaccine to the same age group.

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.

Hundreds of millions of Moderna doses already have been administered to adults, and the company says the two-dose vaccine is just as protective for adolescents. In a study of more than 3,700 12- to 17-year-olds, the vaccine triggered the same signs of immune protection, and no COVID-19 diagnoses arose in the vaccinated group compared with four cases among those given dummy shots.

Sore arms, headache and fatigue were the most common side effects in the young vaccine recipients, the same ones as for adults.

U.S. and European regulators caution, however, that both the Moderna and Pfizer vaccines appear linked to an extremely rare reaction in teens and young adults — chest pain and heart inflammation.

In the United States, children represent about 14% of the nation’s total coronavirus cases to date. And while the young are far less likely than the old to get seriously ill, at least 344 children have died of COVID-19 in the U.S. alone, according to a tally by the American Academy of Pediatrics.

So far in the U.S., just under half the population is fully vaccinated — with the highest rates, not surprisingly, among older adults.