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Some scientists are taking a DIY coronavirus vaccine, and nobody knows if it’s legal or if it works

coronavirus vaccine mit

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#1 Engadin

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Posted 29 July 2020 - 03:57 PM


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S O U R C E :   M I T Technology Review

 

 

 

 

 

 

SA_radvac_gen6dose3-2_web.jpg

 

 

Famed geneticist George Church and at least 20 others didn’t want to wait for the results of clinical trials: “I think we are at much bigger risk from covid.”

 

 

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.
 
Nearly 200 covid-19 vaccines are in development and some three dozen are at various stages of human testing. But in what appears to be the first “citizen science” vaccine initiative, Estep and at least 20 other researchers, technologists, or science enthusiasts, many connected to Harvard University and MIT, have volunteered as lab rats for a do-it-yourself inoculation against the coronavirus. They say it’s their only chance to become immune without waiting a year or more for a vaccine to be formally approved.
 
Among those who’ve taken the DIY vaccine is George Church, the celebrity geneticist at Harvard University, who took two doses a week apart earlier this month. The doses were dropped in his mailbox and he mixed the ingredients himself.
 
Church believes the vaccine designed by Estep, his former graduate student at Harvard and one of his proteges, is extremely safe. “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,” says Church, who says he has not stepped outside of his house in five months. The US Centers for Disease Control recently reported that as many as one-third of patients who test positive for covid-19 but are never hospitalized battle symptoms for weeks or even months after contracting the virus. “I think that people are highly underestimating this disease,” Church says.
 
Harmless as the experimental vaccine may be, though, whether it will protect anyone who takes it is another question. And the independent researchers who are making and sharing it might be stepping onto thin legal ice, if they aren’t there already.
 
 
A simple formula
 
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.
 
Estep says he quickly gathered volunteers, many of whom had worked previously with the Personal Genome Project (PGP), an open-science initiative founded in 2005 at Church’s lab to sequence people’s DNA and post the results online. “We established a core group, most of them [from] my go-to posse for citizen science, though we have never done anything quite like this,” says Estep, also a cofounder of Veritas Genetics, a DNA sequencing company.
 
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.
 
In early July, Radvac posted a white paper detailing its vaccine for anyone to copy. There are four authors named on the document, as well as a dozen initials of participants who remain anonymous, some in order to avoid media attention and others because they are foreigners in the US on visas.
 
The Radvac vaccine is what’s called a “subunit” vaccine because it consists of fragments of the pathogen—in this case peptides, which are essentially short bits of protein that match part of the coronavirus but can’t cause disease on their own. Subunit vaccines already exist for other diseases such as hepatitis B and human papillomavirus, and some companies are also developing subunits for covid-19, including Novavax, a biotechnology company which this month secured a $1.6 billion contract from Operation Warp Speed.
 
To administer its vaccine, the Radvac group settled on mixing the peptides with chitosan, a substance from shrimp shells, which coats the peptides in a nanoparticle able to pass the mucous membrane. Alex Hoekstra, a data analyst with training in molecular biology who previously volunteered on the PGP staff, and who also squirted the vaccine up his nose, describes the sensation as, “like getting saline up your nose. It’s not the world’s most comfortable feeling.”
 
 
Does it work?
 
A nasal vaccine is easier to administer than one which must be injected and, in Church’s opinion, is an overlooked option in the covid-19 vaccine race. He says only five out of about 199 covid vaccines listed as in development use nasal delivery, even though some researchers think it’s the best approach.
 
A vaccine delivered into the nose could create what’s called mucosal immunity, or immune cells present in the tissues of the airway. Such local immunity may be an important defense against SARS-CoV-2. But unlike antibodies that appear in the blood, where they are easily detected, signs of mucosal immunity might require a biopsy to identify.
 
George Siber, the former head of vaccines at Wyeth, says he told Estep that short, simple peptides often don’t lead to much of an immune response. Moreover, Siber says, he doesn’t know of any subunit vaccine delivered nasally, and he questions whether it would be potent enough to have any effect.
 
When Estep reached out to him earlier this year, Siber also wanted to know if the team had considered a dangerous side-effect, called enhancement, in which a vaccine can actually worsen the disease. “It’s not the best idea—especially in this case, you could make things worse,” Siber says of the effort. “You really need to know what you are doing here.”
 
He isn’t the only skeptic. Arthur Caplan, a bioethicist at New York University Langone Medical Center, who saw the white paper, pans Radvac as “off-the-charts looney.” In an email, Caplan says he sees “no leeway” for self-experimentation given the importance of quality control with vaccines. Instead, he thinks there is a high “potential for harm” and “ill-founded enthusiasm.”
 
Church disagrees, saying the vaccine’s simple formulation means it’s probably safe. “I think the bigger risk is that it is ineffective,” he says.
 

Edited by Engadin, 29 July 2020 - 03:58 PM.

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#2 Daniel Cooper

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Posted 30 July 2020 - 12:50 AM

Probably 50+ years ago this sort of self experimentation was more mainstream amongst researchers.  The guy that did the first heart cath did it on himself under a local.  Jonas Salk famously tested his polio vaccine on himself and his family. 

 

There are a few modern examples. The doctor that theorized that helicobacter pylori caused stomach ulcers (and was soundly ridiculed for it) swallowed h. pylori to see if he would get an ulcer.  He did and then cured himself with a course of antibiotics.  But as drug development and approval has gotten much more .... legalistic .... with the FDA since the 1960s, it has become increasingly rare and we've seemed to just accept it as normal to take a decade or more to test and approve a drug.  It's just the way things are done after all.

 

So I applaud these researchers.  This is getting back to the roots of medical science and hopefully one day this will help break the log jam that has been allowed to occur due to the FDA's bureaucracy.

 

I hope when we get past this and get a working vaccine out in a year or so people will start to ask ..... "Now exactly why did it normally take a decade to develop and approve a vaccine?"

 

 


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#3 geo12the

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Posted 07 August 2020 - 04:48 AM

I would be concerned about antibody mediated enhancement which they briefly mention at the very end. Some antibodies can bind the virus in such a way they enhance infection. I would want to be sure that the vaccine I take does not cause the production of those kinds of antibodies. 

 

https://www.nature.c...1587-020-0577-1


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#4 smithx

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Posted 08 August 2020 - 04:26 AM

I would be concerned about antibody mediated enhancement

 

Yes, that's the main reason I'm not doing this. I know how to fairly easily get all the components but it seems too risky without any trials.


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