As of today (May 21, 2025) through tomorrow, the #FDA is taking public #comments on the proposed rule change for #covid #vaccine #boosters. I have no idea who will read these comments or if they'll do any good. But it seems like we have to try. Please add your voice at https://www.regulations.gov/commenton/FDA-2025-N-1146-0001
Note that you have to choose a category for your submission. I picked "#Drug industry" since that's where most of my work is these days. Those still in patient care should choose "#Health professional. For everyone else, "Individual consumer" is probably appropriate. My letter appears below.
Good morning, and good luck.
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Recently announced plans to change the covid vaccination approval process will, if implemented in their current form, make it difficult to impossible for people under aged 65 without serious medical conditions to receive vaccine boosters.
This proposed change seems to be rooted in the idea that covid is a serious threat only to certain groups. Nothing could be further from the truth. Of course older people, and those with underlying medical conditions, are at greater risk of morbidity and mortality from covid infection. However, healthy younger people do can and do die from the disease.
Consider that as of July 2022, about 8,000 people in the US aged 18 to 30 had died of the disease. This is greater than the number of US military deaths in the Afghanistan and Iraq wars, over a much shorter period: two and a half years for covid, vs. eight years for Iraq and twenty for Afghanistan.
The idea that vaccination and boosters should be restricted is a lethal myth. As a biomedical researcher and former military medic, I consider this change deeply unwise, and urge the FDA to continue using current approval protocols.
Daniel Dvorkin
Ph.D., Bioinformatics, University of Colorado, 2013
M.S., Biostatistics, University of Minnesota, 2007
Medical Service Technician, United States Air Force, 1989-1997
@BrianAllbee thank you!
@medigoth @BrianAllbee my comment:
Known efficacious and safe vaccines must be available to those who need them, or want to protect themselves and their extended social groups from the preventable disease. Reducing vaccine availability to healthy, low-risk individuals allows them to become infected and expose those around them, including high-risk individuals, to the pathogen.
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This increases the spread of disease and the negative effects on public health, individual finances, and the nation's economy. COVID is a threat to known high-risk groups. It is also a threat to UNKNOWN high-risk individuals whose risk level would only be known after their infection, disability, and/or mortality.
The minimum standard for public health would be to keep the COVID vaccines available to all, based on individual choice.
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A higher standard to protect public health and the nation's economy would include mandatory vaccinations for all debilitating or lethal pathogens where a safe, effective vaccine exists, such as the COVID vaccines previously approved for use in the United States.
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In my comment, I mention the economy, not that it's the point, but because the audience may be devoid of empathy so an economic argument may resonate where an appeal to personal or national health falls on deaf ears.
@Jirikiha I think you're spot-on about the economic argument.
@medigoth Done. Less credentialed than yours, but done anyway.