The Food and Drug Administration will delay its decision on authorizing Moderna Inc’s vaccine for adolescents while it examines whether it leads to an inflammatory heart condition, the Wall St. Journal has reported.
The move comes after four Nordic countries have taken stronger stances against giving Moderna vaccines to younger adults.
The issue surrounds myocarditis, a condition of heart inflammation. A larger number who received the Moderna vaccination experienced problems, compared to the vaccine from Pfizer, the WSJ said.
Regulators have not yet determined whether there is an elevated risk. The timing for FDA approval is unclear, which could affect the upcoming Los Angeles Unified School District mandates for student vaccinations, and the California statewide call for vaccinations for in-person instruction.
The FDA now plans to further review data before extending the vaccine’s eligibility to younger people.
Gov. Gavin Newsom has detailed two phases for vaccination mandates. The first for ages 7-12 and the second for ages K-6. The mandate applies to private and public schools, elementary and secondary.
The Pfizer vaccine is currently only fully authorized for those aged 16 and up. It is offered under an emergency-use authorization for those aged 12-15. Newsom did not detail the rollout for that group,
Subscribe to Deadline Breaking News Alerts and keep your inbox happy.