Scientists Have Built A Mix-It-Yourself Vaccine And Taken It Themselves Without FDA Approval

There’s a lot in life that you can DIY – a bedside cabinet or shelves, for example – yet one we haven't heard before is assembling your own Covid-19 vaccine. Yet, a group of immunology scientists from Harvard are doing just that.

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A team of highly-esteemed scientists calling themselves the Rapid Deployment Vaccine Collaborative, or Radvac, are attempting to create a simple, readily available vaccine that is delivered by mail and mixed at home before being sprayed into the nose. Without any approval by the FDA, Preston Estep (the designer of the vaccine) and some of his colleagues have gone ahead and administered the experimental DIY vaccine to themselves. The researchers believe the vaccine is safe and that the possible reward of Covid-19 immunity far outweighs the risk.

“I think we are at much bigger risk from Covid considering how many ways you can get it, and how highly variable the consequences are,” Wyss Institute geneticist George Church told MIT Technology Review.

Vaccines attempting to combat the ongoing pandemic are producing some pretty promising results in record time, but Radvac believe they still won’t come fast enough – especially with daily cases increasing rapidly over the past month in the USA. However, whilst they may be jumping hoops to reach the end goal faster, it does come with some costs. The group have conducted no official scientific study, they are currently using other similar vaccines to support their claims, and are in the process of screening its safety. The group will also have a hard time deducing the effectiveness of the vaccine, as they continue to take all the recommended safety precautions. As a result, it's hard to separate immunity gained from the vaccine from protection via masks and social distancing. Since the vaccine is sprayed nasally and not into the blood like a shot, tests used to look for Covid-19 antibodies won't be able to measure mucosal immunity.

Estep, who developed the vaccine, used inexpensive materials and freely-available coronavirus data to design a DIY vaccine kit. The team were inspired by vaccine studies on MERS and SARS, two previous strains of infectious coronavirus, to develop a vaccine that elicits a response against the current strain of Covid-19. Called a "subunit" vaccine, they used fragments of proteins from the virus to signal the immune system to snap into action. The team have released a freely available white paper of their work online.

The vaccine was delivered to 20 volunteers intranasally via two separate doses in the initial testing phase. Since then, they have delivered the vaccine to 70 people. We will not likely know how successful the vaccine is for a while. Currently, no intranasal peptide vaccine exists for Covid-19 (although some studies are underway), but there are intranasal vaccines for influenza.

The scientists’ initiative is perhaps admirable, but Radvac is skirting the legality line with the way they are developing the vaccine. The vaccine is assembled by the user and free, so the FDA technically has no jurisdiction over its regulation. However, it has not been subject to the rigorous testing usually required for regular vaccines, and so problems will not have been ironed out in the usual fashion.

Estep states that users shouldn’t expect to be protected completely and should continue all protective measures currently recommended. “We don’t suggest people change their behavior if they are wearing masks, but it does provide potentially multiple layers of protection,” Estep said.

However, some members of the scientific community have since spoken out against Radvac's efforts. George Siber, the former head of vaccines at Wyeth, told MIT Technology Review that short peptide subunits often don't produce robust immune responses and he is unaware of any subunit vaccine delivered nasally. The team's vaccine simply may not be potent enough to have any effect.

Bioethicist Arthur Caplan called Radvac "off the charts loony" when speaking to MIT Technology Review.

If the vaccine proves effective, it could have implications for the way some vaccines are distributed. Radvac are currently undergoing tests to judge the efficacy of the vaccine.

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