Last
week, vaccine advisers to the US Food and Drug Administration debated what
kind of detailed information the agency would need to consider
authorizing the use of coronavirus vaccines in children younger than 12 years
old. While a
few advisers said it's too soon to rush the use of vaccines in children
because kids are at such low risk from the virus, most argued that it's
important to have authorizations on hand should there be a resurgence of the
virus in the fall and winter. And a
top FDA official reminded committee members that Covid-19 can and does kill
children. Currently,
only Pfizer/BioNTech's vaccine is authorized for use in people as young as
age 12. Moderna's vaccine is authorized for people 18 and older, although the
company has asked FDA to authorize its use in children as young as 12. The
one other FDA-authorized vaccine is the Johnson & Johnson vaccine, used
in the people 18 years and older. While
the vaccines have been shown to be highly safe and effective in older age
groups, the advisers were concerned about preliminary reports of an
inflammatory heart condition called myocarditis that could potentially be
linked to the vaccine. According
to data from the US Centers for Disease Control and Prevention, while there
are "very few" reports of myocarditis or pericarditis in 12-15-year
olds who have been given coronavirus vaccines, the data does show that there
has been a higher-than-expected number of cases of heart inflammation among
young people who have recently received their second doses of the
Pfizer/BioNTech and Moderna coronavirus vaccines. Most of
the cases are among older teens, among 16- and 17-year-olds. Through May 31,
nearly 2.3 million doses of the vaccines were administered and 79 cases of
myocarditis and pericarditis were reported. The CDC noted the expected rate
-- the rate that is typical among people this age -- is between two and 19
cases. The CDC
data also showed that among 18-24-year-olds, nearly 9.8 million doses were
administered, and there were 196 reports of myocarditis and pericarditis. The
expected rate is between eight and 83 cases. The
CDC’s vaccine advisory group is meeting on Friday to discuss the benefits and
risks of vaccinating young people, with specific discussion about the heart
inflammation issue. |
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