Wedoany.com Report-Dec.16, The U.S. Food and Drug Administration has no current intention to add a black box warning—the agency's most prominent safety alert—to COVID-19 vaccines, according to FDA Commissioner Marty Makary in comments reported on Monday.

Although certain officials within the agency had suggested including this warning, leadership, including key vaccine oversight personnel such as Vinay Prasad, determined it was not warranted, Makary explained during an interview with Bloomberg News.

A media report the previous week had indicated that the FDA was considering such a label update. The Department of Health and Human Services, which supervises the FDA, did not provide an immediate response to inquiries on the matter.

Makary noted that administering two vaccine doses within a short interval of three months was associated with elevated occurrences of certain side effects, including myocarditis among younger individuals. He added that this pattern might differ with less frequent, annual administration schedules.

The prior month, Prasad informed agency staff through an internal communication that COVID-19 vaccinations were likely linked to heart inflammation cases resulting in the deaths of at least 10 children.

The FDA continues to examine reports of potential vaccine-related fatalities across various age groups as part of ongoing safety monitoring activities.

Recent adjustments to national COVID-19 vaccine recommendations have prioritized availability for individuals aged 65 and older, along with those having specific health conditions.

Moderna has previously stated that no additional or previously undisclosed safety issues have been identified in relation to its mRNA COVID-19 vaccine, Spikevax, particularly concerning pediatric or pregnant populations.

Pfizer, in collaboration with BioNTech on another mRNA-based COVID-19 vaccine, has consistently affirmed the product's established safety and effectiveness profile, supported by comprehensive data.

These developments occur amid continued evaluation of vaccine performance and safety data by regulatory authorities. The FDA's approach emphasizes evidence-based decisions to inform public health guidance while addressing reported adverse events through thorough review processes.

Manufacturers and health officials maintain focus on monitoring real-world outcomes to ensure informed recommendations for vaccination strategies.