The Trump administration is expected to label COVID-19 vaccines with a warning about serious possible side effects.
The Food and Drug Administration will likely put the agency’s most weighty “black box” warning on the vaccines by the end of the year, CNN reported Friday, citing two people familiar with the FDA’s plans. The plan has not been finalized and may still change, according to the outlet.
The black box label is the strictest safety warning issued by the FDA, alerting healthcare providers and patients about serious or life-threatening adverse side effects associated with the product.
The development comes after the Trump administration’s top health officials, led by Health and Human Services Secretary Robert F. Kennedy Jr., who oversees the FDA, have expressed concern over the safety and efficacy of the COVID-19 vaccines.
The risks could include increased vulnerabilities to myocarditis and other heart conditions, as well as pregnancy complications for patients who take them, according to Kennedy, National Institutes of Health Director Jay Bhattacharya, and FDA Commissioner Marty Makary.
Kennedy made an announcement alongside Makary and Bhattacharya in May, revealing the COVID-19 vaccines would no longer be recommended to healthy children and healthy pregnant women.
Accutane, a strong acne treatment, and antidepressants such as SSRIs and SNRIs are among the medications on the FDA’s black box warnings list.
It remains unclear which age groups the FDA’s reported plans for applying the warning to the COVID-19 vaccines would apply to, and whether the warnings would be applied to all COVID-19 vaccines, or only to mRNA vaccines.
The mRNA vaccines, developed by Pfizer and Moderna, have been of particular concern to the Trump administration and some Washington lawmakers.
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A Senate investigations subcommittee over the summer released a report concluding that federal health agencies concealed information from the public about the risks of myocarditis following mRNA COVID-19 vaccination.
The FDA did not respond to the Washington Examiner‘s request for comment.
