"PHILOSOPHICALLY SPEAKING...":

Biohacking and do-it-yourself science have become popular as prices and skills needed for projects have dropped. But is DIY science a useful development to address modern challenges, or is it a dangerous way of evading institutional review boards and the professional ethics they codify? Here's a topical case in point: DIY COVID vaccine development, including inoculation of volunteers.

"Preston Estep was alone in a borrowed laboratory, somewhere in Boston. No big company, no board meetings, no billion-dollar payout from Operation Warp Speed, the US government’s covid-19 vaccine funding program. No animal data. No ethics approval. What he did have: ingredients for a vaccine. And one willing volunteer. Estep swirled together the mixture and spritzed it up his nose. ... The group, calling itself the Rapid Deployment Vaccine Collaborative, or Radvac, formed in March. That’s when Estep sent an email to a circle of acquaintances, noting that US government experts were predicting a vaccine in 12 to 18 months and wondering if a do-it-yourself project could move faster. He believed there was 'already sufficient information' published about the virus to guide an independent project. ... To come up with a vaccine design, the group dug through reports of vaccines against SARS and MERS, two other diseases caused by coronaviruses. Because the group was working in borrowed labs with mail-order ingredients, they wouldn’t make anything too complicated. The goal, says Estep, was to find 'a simple formula that you could make with readily available materials. That narrowed things down to a small number of possibilities.' He says the only equipment he needed was a pipette (a tool to move small amounts of liquid) and a magnetic stirring device. ... Despite the lack of evidence, the Radvac group has offered the vaccine to a widening circle of friends and colleagues, inviting them to mix the ingredients and self-administer the nasal vaccine. Estep has now lost count of exactly how many people have taken the vaccine. 'We have delivered material to 70 people,' he says. 'They have to mix it themselves, but we haven’t had a full reporting on how many have taken it.' One of the Radvac white paper’s co-authors is Ranjan Ahuja, who volunteers as an events manager for a nonprofit foundation that Estep started to study depression. Ahuja has a chronic condition that puts him at heightened risk from covid-19. Although he can’t say whether the two doses he took have given him immunity, he feels it’s his best chance of protection until a vaccine is approved. ... Estep believes Radvac is not subject to oversight because the group’s members mix up and administer the vaccine themselves, and no money changes hands. 'If you are just making it and taking it yourself, the FDA can’t stop you,' says Estep. The FDA did not immediately respond to questions about the legality of the vaccine. ... Whether or not regulators step in, and even if the vaccine proves to be a dud, the DIY covid-19 vaccine is already changing the attitudes of those who’ve taken it. [Alex Hoekstra, a data analyst with an undergraduate degree in biology who previously volunteered with Harvard's Personal Genome Project] says that since twice spraying the formulation into his nose, he moves through an 'unsafe' world differently. 'I am not licking doorknobs,' says Hoekstra, who joined the group after departing his day job due to the shutdown. 'But it’s an amazingly surreal experience knowing that I may have an immunity to this constant danger [and] that my continued existence through this pandemic will be a useful dataset. It lends a level of meaning and purpose.'"
www.technologyreview.com/2020/07/29/1005720/george-church-diy-coronavirus-vaccine