In April, more than three months before any coronavirus vaccine would enter large clinical trials, the mayor of a picturesque island town in the Pacific Northwest invited a microbiologist friend to vaccinate him.
The exchange occurred on the mayor’s Facebook page, to the horror of several Friday Harbor residents following it.
“Should I pop up and get your vaccine started?????,” wrote Johnny Stine, who runs North Coast Biologics, a Seattle biotech company with a focus on antibodies. “Don’t worry — I’m immune — I have boosted myself five times with my vaccine.”
“Sounds good,” Farhad Ghatan, the mayor, wrote after a few follow-up questions.
Several residents interjected skepticism in the exchange. They were swatted down by the mayor, who defended his friend of 25 years as a “pharmaceutical scientist on the forefront.” When residents raised additional concerns — about Mr. Stine’s credentials and the unfairness of encouraging him to visit San Juan Island despite travel restrictions — Mr. Stine lobbed back vulgar insults. (The geekiest and least R-rated: “I hope your lung epithelial cells over express ACE2 so you die more expeditiously from nCoV19.”)
Several residents reported all of this to a variety of law enforcement and regulatory agencies. In June, the Washington attorney general filed a lawsuit against Mr. Stine not only for pitching the mayor with unsupported claims, but also for administering his unproven vaccine to about 30 people, charging each $400. In May, the Food and Drug Administration sent a letter warning Mr. Stine to stop “misleadingly” representing his product.
Although his promotional tactics were unusual, Mr. Stine was far from the only scientist creating experimental coronavirus vaccines for themselves, family, friends and other interested parties. Dozens of scientists around the world have done it, with wildly varying methods, affiliations and claims.
The most impressively credentialed effort is the Rapid Deployment Vaccine Collaborative, or RaDVaC, which boasts the famous Harvard geneticist George Church among its 23 listed collaborators. (The research, however, is not happening on Harvard’s campus: “While professor Church’s lab works on a number of Covid-19 research projects, he has assured Harvard Medical School that work related to the RaDVaC vaccine is not being done in his lab,” a spokeswoman for Harvard Medical School said.)
Among the most tight-lipped projects is CoroNope, which refuses to name anyone involved because, according to the person responding to messages sent to the group’s anonymous email account, the “less than half a dozen” biologists don’t want to risk getting in trouble with the F.D.A. or with their employers.
Each D.I.Y. effort is motivated, at least in part, by the same idea: Exceptional times demand exceptional actions. If scientists have the skills and gumption to assemble a vaccine on their own, the logic goes, they should do it. Defenders say that as long as they are measured about their claims and transparent about their process, we could all benefit from what they learn.
But critics say that no matter how well-intentioned, these scientists aren’t likely to learn anything useful because their vaccines are not being put to the true test of randomized and placebo-controlled studies. What’s more, taking these vaccines could cause harm — whether from serious immune reactions and other side effects, or offering a false sense of protection.
“Take it yourself and there is not much anyone can or should do,” said Jeffrey Kahn, the director of the Johns Hopkins Berman Institute of Bioethics. But once a person starts encouraging other people to try an unproven vaccine, “you’re headed right back to the days of patent medicine and quackery,” he said, referring to a time when remedies were widely sold with colorful but misleading promises.
‘We are the animals’
The RaDVac vaccine effort, first reported on by MIT Technology Review, is different from Mr. Stine’s project in two important ways. No one involved plans to charge for the vaccine. And unlike Mr. Stine’s expletive-laden Facebook rants, RaDVaC has a 59-page scientific document to explain how it works and to guide others who might want to mix up the vaccine formulation on their own.
“The white paper is quite impressive,” said Avery August, an immunologist at Cornell University in Ithaca, N.Y., who is not involved with RaDVaC.
But the impetus of both projects is similar. In March, as Preston Estep, a genome scientist who lives in the Boston area, was reading about people dying amid the pandemic, he vowed not to sit complacently on the sidelines. He emailed some chemists, biologists, professors and doctors he knew to see whether any were interested in creating their own vaccine. Soon they had devised a formula for a peptide vaccine that could be administered through a spritz in the nose.
“It’s very simple,” Dr. Estep said. “It…