The U.S. Food and Drug Administration (FDA) has decided against implementing a “black box” warning for COVID-19 vaccines, according to remarks made by FDA Commissioner Marty Makary in an interview with Bloomberg News. This decision comes despite the recommendations from some agency officials who believed that a boxed warning was warranted.
Makary emphasized that key leaders within the agency, including the FDA’s chief medical and scientific officer, Vinay Prasad, determined that a black box warning was not necessary. This follows previous reports from CNN that suggested plans were underway to impose such a warning, allegedly driven by concerns over side effects associated with the vaccine.
In discussing potential risks, Makary noted a link between receiving two doses of the vaccine within three months and increased instances of side effects like myocarditis among younger individuals; however, he pointed out that the risks may differ with adjusted dosing schedules, such as annual vaccinations.
Additionally, Prasad previously indicated in a memo that COVID-19 vaccines might have played a role in the deaths of at least 10 children due to heart inflammation, prompting further investigation by the FDA into deaths potentially related to the vaccines across various age demographics.
In terms of policy changes, Health Secretary Robert F. Kennedy Jr., known for his critical stance on vaccines, has recently revised guidelines to restrict access to the COVID vaccine for individuals aged 65 and older and those with pre-existing health conditions.
While Moderna has yet to comment on the latest developments, the company has previously maintained that there are no new or undisclosed safety issues with its mRNA-based COVID vaccine, Spikevax, particularly concerning children and pregnant women. Similarly, Pfizer, which collaborates with BioNTech SE on another mRNA vaccine, has reaffirmed its commitment to safety and efficacy.
As the FDA continues to conduct safety reviews, the public remains attentive to updates regarding the vaccines, balancing the need for vaccination with ongoing safety assessments.