The US Food and Drug Administration (FDA) plans to put the most serious “black box” warning on coronavirus vaccines, sources familiar with the agency’s plans announced.
The “black box” warning is used when a drug or vaccine carries serious risks to life or health, and the FDA uses it to inform patients and doctors about potential dangers, CNN writes.
The plan is still under consideration and has not been finalized, and it is unclear whether it will apply to all coronavirus vaccines or only to the mRNA versions, used by Pfizer and Moderna.
FDA officials state that vaccine safety is strictly monitored and that a very small number of serious side effects have been reported among the billions of doses distributed worldwide. Moderna and Pfizer reiterated in September that their preparations remain safe and effective, including in children and pregnant women.
However, critics, including former FDA commissioners and public health experts, have expressed concern over the lack of transparency and scientific evidence that would justify such a warning.
They point out that potentially alarming messages could reduce trust in vaccination and lead to deaths.
The FDA has specifically focused on rare side effects such as myocarditis in adolescents and young adults, but data show that most affected patients have fully recovered.
The agency has expanded risk information to a broader age range, while research shows that vaccines have significantly reduced hospitalizations and deaths related to the coronavirus.
FDA officials say they are still collecting data and that every step is carefully considered, while external experts are calling for a public review of the scientific evidence before the warning is released.
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Source: N1; Photo: iStock