> The U.S. Food and Drug Administration (FDA) is preparing to add a “black box” warning, its strongest type of safety alert, to COVID-19 vaccines, according to a CNN report citing people familiar with agency deliberations. A black box warning appears prominently in prescribing information and is used to highlight risks of serious or life-threatening side effects or to indicate that a product should be used only in certain populations.
>
> The move is being driven by Dr. Vinay Prasad, the FDA’s chief medical and scientific officer and director of the Center for Biologics Evaluation and Research, though the plan has not been finalized and could change before an expected rollout by the end of the year. It is not yet clear whether the warning would apply to all COVID-19 vaccines or only to certain types, such as mRNA vaccines from Pfizer/BioNTech and Moderna, and whether it would apply to all age groups.
This is a very bad move, obviously politically motivated and pushed by RFK Jr., and will continue to erode the public health system in the US, because the crux of the issue is that there’s no evidence of the vaccine being harmful, and there are plenty of studies, one recently by the CDC, saying how the vaccine reduced deaths and illnesses.
I suggest reading the actual article and not relying on the AI summary or my brief statement; it took me about 10 minutes while I ate lunch.
rahmza on
Astounding how they’re willing to let this lunacy stain an industry where the US is actually the world leader.
gnurdette on
Remember when RFK Jr. testified to Congress, under oath, that he wasn’t anti-vaxx?
3 Comments
Chat GPT summary statement:
> The U.S. Food and Drug Administration (FDA) is preparing to add a “black box” warning, its strongest type of safety alert, to COVID-19 vaccines, according to a CNN report citing people familiar with agency deliberations. A black box warning appears prominently in prescribing information and is used to highlight risks of serious or life-threatening side effects or to indicate that a product should be used only in certain populations.
>
> The move is being driven by Dr. Vinay Prasad, the FDA’s chief medical and scientific officer and director of the Center for Biologics Evaluation and Research, though the plan has not been finalized and could change before an expected rollout by the end of the year. It is not yet clear whether the warning would apply to all COVID-19 vaccines or only to certain types, such as mRNA vaccines from Pfizer/BioNTech and Moderna, and whether it would apply to all age groups.
This is a very bad move, obviously politically motivated and pushed by RFK Jr., and will continue to erode the public health system in the US, because the crux of the issue is that there’s no evidence of the vaccine being harmful, and there are plenty of studies, one recently by the CDC, saying how the vaccine reduced deaths and illnesses.
I suggest reading the actual article and not relying on the AI summary or my brief statement; it took me about 10 minutes while I ate lunch.
Astounding how they’re willing to let this lunacy stain an industry where the US is actually the world leader.
Remember when RFK Jr. testified to Congress, under oath, that he wasn’t anti-vaxx?