Dozens Of Scientists Took A Diy Covid-19 Vaccine With No Proof That It Works

August 26, 2020

The raw material arrives by mail and is prepared by the recipient at home or in a lab. No, it’s not a DIY meal kit, but an unproven COVID-19 vaccine distributed by an organization called the Rapidly Deployable Vaccine Collaborative (RADVAC), and no one knows if it actually works, according to the MIT Technology Review.

The collaborative of more than 20 scientists, technologists, and “science enthusiasts,” some affiliated with Harvard University and MIT, did not seek authorization from the U.S. Food and Drug Administration (FDA) before designing the vaccine, or before squirting it up their noses. The group also did not seek approval from any ethics committee before launching the project and volunteering as their own test subjects in what could potentially be considered an unofficial clinical trial, according to the MIT Technology Review. They also distributed vaccine materials to dozens of people in their social circles.

The FDA did not immediately respond to MIT Technology Review’s questions about whether the initiative could be considered legal. However, Preston Estep, the geneticist who founded RADVAC and serves as its chief scientist, said the FDA has no jurisdiction over the program because participants mixed and injected the vaccine themselves without paying a fee to the partner agency in exchange. It remains to be seen whether the FDA will step in to oversee the program, especially as more people learn about and take the experimental vaccine.

“We’re not recommending that people change their behavior if they’re wearing a mask, but [the vaccine] does offer potentially multiple layers of protection,” Estep told MIT Technology Review. However, RADVAC has no evidence yet that vaccines prompt enough of an immune response to protect. The group has begun conducting studies to answer that question, some of which are being conducted in the Harvard lab of geneticist George Church, who has already taken two doses of the vaccine. (Estep is a former graduate student and current collaborator in Church’s lab.)

“I think the risk we face from COVID [than an experimental vaccine] is much greater, given how many ways you can get it and the highly variable nature of the consequences,” Church told MIT Technology Review.Church added that while he believes the vaccine is safe (in the absence of data proving that’s the case), he believes “the greater risk is that it’s ineffective.” . (Church is also the head of Harvard’s “Mammoth Revival” team, which aims to insert the genes of extinct mammoths into the DNA of Asian elephants).

But whether or not the vaccine gives protection against the coronavirus, there’s always some risk of side effects. As previously reported in Live Science, the more than 30 candidate COVID-19 vaccines undergoing sanctioned clinical trials must undergo several rounds of efficacy and safety testing before they can be approved. In early trials, vaccine developers are on the lookout for acute side effects that occur shortly after the vaccine is administered, which may include swelling, redness and pain at the injection site, and possibly fever. In advanced clinical trials, they can monitor for side effects that may occur when vaccinees are exposed to the virus in the real world.

One possible side effect that can occur after exposure is known as antibody-dependent enhancement (ADE); a rare phenomenon that perversely makes humans more susceptible to serious infection after vaccination, Live Science has reported that it has been observed in animal studies of coronavirus vaccines associated with SARS-CoV-2 (the virus that causes COVID-19).

George Siber, former head of vaccines at Wyeth Pharmaceuticals, told MIT Technology Review that self-experimentation with the RADVAC vaccine “is not the best idea – especially in a situation where you could make things worse by triggering an ADE.” You really need to know what you’re doing here.”

Siber added that given the composition of the vaccine and the route of administration through the nose, he wasn’t sure the vaccine was sufficiently potent, even if it was safe.

RADVAC released a white paper in July detailing the vaccine’s formulation, along with a disclaimer stating that anyone using the information must be a consenting adult, based in the U.S., and agree to “assume full responsibility” for their use of the information, the vaccine, and the materials needed to produce and administer it. In addition, anyone visiting the site must first “acknowledge and agree that any use of this information to develop and self-administer substances is an act of self-experimentation,” the legality of which may vary depending on where you live.

Beneath the paper’s disclaimer, the team describes a vaccine formulation that contains short protein fragments, called peptides, found on coronaviruses. The peptides themselves do not cause COVID-19, but should theoretically be recognized by the immune system and prompt the construction of antibodies that can target and inactivate the virus. Nonetheless, according to MIT Technology Review, Estep called Siber earlier this year to ask about the vaccine, and Siber told him that the short peptides don’t consistently prompt a strong immune response, according to the MIT Technology Review.

According to the white paper, in addition to the peptide, the RADVAC vaccine contains chitosan, a substance found in the shells of crustaceans such as shrimp. The purpose of chitosan is to coat the peptide and facilitate its delivery through the mucosal tissue of the nasal cavity, according to MIT Technology Review.RADVAC developers chose to deliver the vaccine as a nasal spray rather than by injection in an attempt to trigger a strong, localized immune response in the nasal cavity, where COVID-19 infections often take root.

As previously reported in Live Science, mucosal tissues like the nose have their own specialized fleet of immune cells that help protect the somewhat permeable tissues from debris and pathogens. Ideally, an effective COVID-19 vaccine would trigger both this local immune response and a systemic immune response throughout the body. According to the New York Times, some experts agree with RADVAC that a COVID-19 vaccine delivered through the nose would be more protective than an injected vaccine. However, Siber told MIT Technology Review that he is unaware of any existing vaccine that is both peptide-based and delivered through the nose; research is needed to confirm that such a vaccine can reliably trigger a strong immune response.

While the underlying theory may prove correct, the efficacy of an individual vaccine can only be demonstrated through rigorous analysis of the human immune response.RADVAC did not complete such a study.

Without presenting any evidence that the vaccine provides protection against COVID-19, or that it is safe, the researchers have distributed the vaccine material to others in their social circle.

“We’ve sent materials to 70 people,” Estep told MIT Technology Review.” They have to mix it themselves, but we don’t have a full report on how many people have taken it yet.”