Daniel Dvorkin<p>As of today (May 21, 2025) through tomorrow, the <a href="https://qoto.org/tags/FDA" class="mention hashtag" rel="nofollow noopener noreferrer" target="_blank">#<span>FDA</span></a> is taking public <a href="https://qoto.org/tags/comments" class="mention hashtag" rel="nofollow noopener noreferrer" target="_blank">#<span>comments</span></a> on the proposed rule change for <a href="https://qoto.org/tags/covid" class="mention hashtag" rel="nofollow noopener noreferrer" target="_blank">#<span>covid</span></a> <a href="https://qoto.org/tags/vaccine" class="mention hashtag" rel="nofollow noopener noreferrer" target="_blank">#<span>vaccine</span></a> <a href="https://qoto.org/tags/boosters" class="mention hashtag" rel="nofollow noopener noreferrer" target="_blank">#<span>boosters</span></a>. 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 <a href="https://www.regulations.gov/commenton/FDA-2025-N-1146-0001" rel="nofollow noopener noreferrer" target="_blank"><span class="invisible">https://www.</span><span class="ellipsis">regulations.gov/commenton/FDA-</span><span class="invisible">2025-N-1146-0001</span></a></p><p>Note that you have to choose a category for your submission. I picked "<a href="https://qoto.org/tags/Drug" class="mention hashtag" rel="nofollow noopener noreferrer" target="_blank">#<span>Drug</span></a> industry" since that's where most of my work is these days. Those still in patient care should choose "<a href="https://qoto.org/tags/Health" class="mention hashtag" rel="nofollow noopener noreferrer" target="_blank">#<span>Health</span></a> professional. For everyone else, "Individual consumer" is probably appropriate. My letter appears below.</p><p>Good morning, and good luck.</p><p>=== </p><p>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.</p><p>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.</p><p>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.</p><p>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.</p><p>Daniel Dvorkin<br>Ph.D., Bioinformatics, University of Colorado, 2013<br>M.S., Biostatistics, University of Minnesota, 2007<br>Medical Service Technician, United States Air Force, 1989-1997</p>