CAMBRIDGE, Mass. (WBZ NewsRadio) — Moderna says it will try to expand its KidCOVE COVID-19 vaccine study among the youngest members of the population.
Company spokesperson Ray Jordan said conversations with the Centers for Disease Control and the Food and Drug Administration about expanding the trial started last month. The agencies urged Moderna and Pfizer-BioNTech to expand the trials in ages 5 to11. Jordan said the reason for the expansion was to catch rare side effects that only show up on a larger scale.
Moderna's initial adult trials enrolled tens of thousands of people.
"Even there, some side effects would emerge when you got into millions of people," said Jordan. The main side effect the company is concerned with is heart inflammation, which only appears in about 13 of every million people vaccinated. Jordan said the benefits of Moderna's vaccine still vastly outweigh the risks, especially for adolescents.
The children's trial started with about 6,800 participants between the ages of 12 and 6 months back in March.
Moderna said it is still on track to apply for full FDA approval at the end of this year or early next.
WBZ's Jim MacKay (@JimMacKayOnAir) reports: