- A new paper urges even credentialed researchers not to take ethical and legal risks with homemade vaccines.
- Rushed, unregulated "vaccines" and off-label drug use has eroded public trust in a hypothetical COVID-19 vaccine.
- The New York Times recently shared high-profile examples of homemade vaccine consortia.
Medical researchers and medical legality scholars have joined forces on a new paper debunking homemade kinds of COVID-19 vaccine research. In a regular section in the journal Science reserved for discussing medical policy, these researchers underline the medical and legal risks of different home remedy concoctions.
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Yes, the idea of people inoculating themselves sounds absurd. And thankfully, there’s no reason to automatically think people trying these recipes are very widespread. But part of the point of the paper is to remind people that conducting medical experiments and even ordering certain components from other states can get someone into legal hot water very quickly.
"Just because it’s self-experimentation doesn’t give you carte blanche,” University of Illinois law professor Jacob Sherkow said in a statement. Regulations on everything associated with developing new medications, from the ingredients like chemical reagents all the way to how you handle or distribute any “finished” product, are extremely strict.
That’s on top of strict regulations on approved drugs, like a recent Amazon recall of drugs that were sold in individual packets—normal in office settings where just adults work and don’t require child-safe packaging, but not approved for use in home settings that could include children.
That means someone, for example, concocting a homemade recipe—already sketchy unless they’re a vaccine scientist!—may publish their recipe online without repercussions. And someone trying to buy the ingredients, mix them using chemical processes, and administer them (especially if to others) is liable for a huge number of serious violations of ethics as well as U.S. Food and Drug Administration (FDA) policy.
This paper was likely prompted by a recent New York Times report on people who are developing and giving themselves experimental vaccines. They’re also sharing their conclusions in Facebook groups, for example, some with pat insistence that they consider themselves “immune” to COVID-19 now.
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One entrepreneur had begun selling and administering his homemade vaccine for $400 in April. Another organization, Rapid Deployment Vaccine Collaborative (RaDVaC), is anchored by a Harvard Medical School researcher making vaccines in his own private laboratory.
The big thorn in vaccine regulation is the well-known origin story of modern vaccines, which began with scientists who tested their theories about immune response by rustically inoculating themselves and their families. Even this year, scientists who study vaccines gave public comments about inoculating their families with unneeded, but at least clinically tested and approved, polio vaccines to prompt an immune response that “might” also work on COVID-19.
The off-label, unproven use of hydroxychloroquine to prevent or cure COVID-19 (coronavirus)—which was shown not to work—led to a shortage for people who take the drug safely for established conditions.
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