Moderna downplays myocarditis concerns in children in FDA briefing doc
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Moderna (NASDAQ:MRNA) said that instances of the rare heart inflammation myocarditis among children after receiving their COVID-19 vaccine are extremely rare and is higher overall in patients that come down with COVID.
Moderna (MRNA) is seeking Emergency Use Authorization of its vaccine in children from six months old to 17 years old.
Myocarditis has been associated with all COVID vaccines, and the highest rates have been seen in young adult males between the ages of 18 and 24.
In a briefing document ahead of a two-day FDA advisory panel meeting on June 14 and 15, data provided by Moderna (MRNA) showed that the rate of myocarditis in the 12-17-year-old age group was 13.3 per million doses in males after the second dose. By comparison, the figure is 42.66 in adult males between 18 and 24, and 14.15 in adults 25 and older.
The company added that all the cases of myocarditis were mild and patients recovered quickly with conservative treatment.
Moderna said that as of April 15, it has received no reports of myocarditis or pericarditis in children.
"The benefits of preventing hospitalizations with mRNA-1273 in these populations outweigh the potential risks, including that of vaccine-associated myocarditis," Moderna (MRNA) wrote.
Moderna (MRNA) also said it has been testing booster shots in some of the young age groups, and will eventually offer the under-6-year-old group ones that are either contain the standard one or one that has an Omicron-containing variant.
The White House has said COVID shots could be administered to children under the age of 5 in a matter of weeks.