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A new paper in the journal Science has addressed people who may be thinking of using a DIY Covid-19 vaccine, or else creating one themselves, with a strong yet simple message: Please don't, you might end up dead.
Aside from the legal, ethical, and public health issues of self-experimentation when it comes to medical innovations, it's not safe.
“A homemade Covid-19 vaccine is perhaps more dangerous than people would like to believe,” Jacob S. Sherkow, a professor of law at the University of Illinois and co-author of the paper, said in a statement.
“We’re all sympathetic to the notion that people want to inoculate themselves against the virus. But people need to understand that every home remedy is not necessarily going to help, and some may very well be fatal.”
There's a long history of scientists testing ideas on themselves, with good and bad results. In probably the most famous example of a success story, American virologist Jonas Salk discovered a potential vaccine for polio in 1952 and immediately volunteered himself and his entire family as test subjects (important caveat: this was as part of a trial). All of them developed antibodies for the disease, and Salk went on to catapult himself into legendary good guy status by refusing to patent the virus, explaining that it belonged to the people: "There is no patent. Could you patent the Sun?”
On the bad end of the spectrum, there is of course the early 19th-century American doctor Stubbins Ffirth, who believed that yellow fever wasn't an infectious disease, and set out to prove it in the most disgusting manner imaginable.
First, he collected various fluids from the infected. He then made a wound in his arm and poured in some vomit, before pouring it into his eyeballs and then drinking it. After not being infected, he moved on to experimenting with patients' blood, saliva, and urine. Of course, it turned out it was an infectious disease. He didn't get ill, but only because he had collected his fluids from patients in the last stages of the disease, when it was no longer infectious. He had been chugging puke for absolutely no reason at all.
In that tradition, people continue to conduct experiments on themselves today. In what appears to be the first "citizen science vaccine iniative" RaDVaC, a non-profit group of citizen scientists who came together through their associations with Harvard Medical School has created a homemade vaccine for Covid-19, which they have tested on themselves and distributed to friends and colleagues, without going through the usual trials designed to test efficacy and safety. RaDVaC's vaccine, which it says is to provide partial protection until an effective vaccine is found, is made from bits of protein from the virus that are unable to cause the disease. Though it's likely safe because of this, there's no telling how effective it is without rigorous, randomized controlled trials. What's more, taking the vaccine could cause more widespread harm if people act less safely, believing themselves to be immune.
Russia, meanwhile, approved a vaccine against Covid-19 back in August despite just two months of testing (some rumored to be on themselves) and no large scale trial. Despite this, Russian President Vladamir Putin announced that his daughter had been given the vaccine, named “Sputnik V”
The new study warns that as well as potential health consequences from taking untested vaccines, any negative consequences from them could end up undermining the public's (already shaky) trust in vaccines that have gone through the proper trials for safety and efficacy.
“We’re living in an age of vaccine disinformation,” Sherkow said. “It's one of the reasons why we have phased clinical trials for the development of vaccines and medical treatments. It’s not just a matter of figuring out whether something is effective or whether it works. It’s also a matter of figuring out the gross toxicity of the treatment, and if it’s been manufactured in such a way so that it’s not going to harm people.”
The team also adds that there are likely to be legal consequences for those involved in making a DIY vaccine, and that they may not be skirting the law by experimenting on themselves. The team points out that DIY vaccine makers may mistakenly believe that they are not subject to Food and Drug Administration (FDA) regulations or reviews from an Institutional Review Board, but this is legally incorrect.
“People should be aware that just because they’re experimenting on themselves doesn’t make it legal without approval,” Sherkow said. “Some self-experimentation can qualify as human subjects research that is required to undergo ethics review, by law or institutional policy. Just because it’s self-experimentation doesn’t give you carte blanche.”
The way that some vaccines, such as RaDVaC's, are assembled by the user also has ethical and legal implications for the makers. Incorrect preparation or administration of the vaccine could lead lay users to injure themselves, and raises the question whether they can give meaningful consent to the vaccine. The team highlight reports of individuals drinking bleach, for instance, indicating that users might not have the technical know-how to administer the vaccine themselves.
What's more, DIY vaccines may fall under FDA regulations the moment you order it for delivery.
“Taking information that you found in some dark corner of the Internet but using it to develop your own materials and needing to ship materials or reagents across state lines – that is interstate commerce and is what triggers FDA oversight,” Sherkow explained. “At that point, that’s essentially where the FDA can stop you.”
As much as we'd like there to be a quick fix, the best option for you and others is to wait.
[H/T: Futurism]
