Oct 15 (Reuters) - The U.S. health regulator is delaying its
decision on authorizing Moderna Inc's COVID-19 vaccine
for adolescents to check if the shot could increase the risk of
a rare inflammatory heart condition, the Wall Street Journal
reported on Friday.
The U.S. Food and Drug Administration (FDA) has been
inspecting the risk of the condition, myocarditis, among younger
men vaccinated with Moderna's shot, especially versus Pfizer's
vaccine, after certain Nordic countries limited use of the shot,
the report https://on.wsj.com/3p3P5Zp said, citing people
familiar with the matter.
The agency has not yet determined whether there is
heightened risk, and the delay could be several weeks, though
the timing was unclear, the report said.
In June, Moderna filed for U.S. authorization of its vaccine
among adolescents aged 12 through 17. The FDA authorized rival
Pfizer's vaccine for use in children as young as 12 in
The U.S. FDA's review of Moderna's application is ongoing,
an FDA spokesperson told Reuters, adding that while the agency
cannot predict how long the process may take, it is evaluating
the data as expeditiously as possible.
Europe's drug regulator found in July that such inflammatory
conditions could occur in very rare cases following vaccination
with Moderna's vaccine or Pfizer/BioNTech's shot, more
often in younger men after the second dose.
However, the regulator stressed that the benefits of the
shots outweighed any risks.
Earlier this month, Finland, Sweden and Denmark paused the
use of Moderna's shot for younger males due to reports of
myocarditis, though the Danish Health Agency later said the
vaccine was available to under-18s.
Moderna's two-shot vaccine has U.S. authorization for
emergency use in people aged 18 and above.
The FDA in June added a warning https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-adds-warning-about-rare-heart-inflammation-pfizer-moderna-covid-vaccines-2021-06-26
to the literature accompanying Pfizer/BioNTech and Moderna
COVID-19 shots to indicate the rare risk of heart inflammation.
(Reporting by Amruta Khandekar; Editing by Devika Syamnath and