In April, more than three months before a coronavirus vaccine entered large clinical trials, the mayor of a quaint island town in the Pacific Northwest invited a friend of a microbiologist to vaccinate him.
The exchange took place on the Mayor's Facebook page, to the dismay of several Friday Harbor residents.
"Should I show up and get your vaccine up and running?" Wrote Johnny Stine, who runs North Coast Biologics, a Seattle biotech company focused on antibodies. "Don't worry – I'm immune – I got five times better with my vaccine."
"Sounds good," wrote Farhad Ghatan, the mayor, after a few follow-up questions.
Several residents threw skepticism in exchange. They were put down by the mayor, who defended his 25-year-old friend as a "frontline pharmacist". When residents raised additional concerns – about Mr. Stine's IDs and the injustice in encouraging him to visit San Juan Island despite travel restrictions – Mr. Stine returned vulgar insults. (The geekeste and least R-rated: "I hope your lung epithelial cells overexpress ACE2 so you die faster from nCoV19.")
Several local 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 indicting the mayor with unsupported allegations, but also for administering his unproven vaccine to about 30 people, $ 400 each in Have been billed. In May, the Food and Drug Administration sent a letter warning Mr. Stine not to discontinue "misleading" displays of his product.
Although his promotional tactics were unusual, Mr. Stine was far from being the only scientist who made experimental coronavirus vaccines for himself, his family, friends, and other interested parties. Dozens of scientists around the world have done this using very different methods, affiliations, and claims.
The most impressive achievement is the Rapid Deployment Vaccine Collaborative (RaDVaC), in which the famous Harvard geneticist George Church is represented among its 23 employees. (The research does not take place on the Harvard campus, however: “While Professor Church's laboratory is working on a number of Covid-19 research projects, he has assured Harvard Medical School that his laboratory is not doing any work related to the RaDVaC – Vaccine to be carried out. ”Said a Harvard Medical School spokeswoman.)
One of the closest projects is CoroNope, which refuses to name everyone involved because, according to the person who responds to messages sent to the group's anonymous email account, the "less than half a dozen" biologists do not want to risk getting into trouble with the FDA or with their employers.
Every D.I.Y. Efforts are motivated, at least in part, by the same idea: Extraordinary times require extraordinary measures. If scientists have the skills and the wits to put together a vaccine themselves, then logically they should. Defenders say we could all benefit from what they learn as long as they are measured against their claims and transparent about their process.
However, critics say that no matter how well-intentioned, these scientists are unlikely to learn anything useful because their vaccines are not put to the test in randomized and placebo-controlled trials. In addition, taking these vaccines can lead to damage – be it through severe immune reactions and other side effects, or through a false sense of protection.
"Take it for yourself and there isn't much anyone can or should do," said Jeffrey Kahn, director of the Johns Hopkins Berman Institute of Bioethics. But as soon as a person encourages other people to try an unproven vaccine, "you go back to the days of patent medicine and quackery," he said, referring to a time when remedies with colorful but misleading promises were widespread .
"We are the animals"
The RaDVac vaccine effort, first reported by MIT Technology Review, differs from Mr. Stine's project in two important ways. Nobody had any plans to bill for the vaccine. And unlike Mr. Stine's explosive Facebook rants, RaDVaC has a 59-page scientific paper that explains how it works and to guide others who might want to confuse the vaccine formulation themselves.
"The white paper is pretty impressive," said Avery August, an immunologist at Cornell University in Ithaca, New York who is not involved in RaDVaC.
However, the impulses of both projects are similar. When Preston Estep, a genome scientist who lives in the Boston area, read about people dying amid the pandemic in March, he vowed not to sit on the sidelines complacent. He emailed a few chemists, biologists, professors, and doctors who he knew were interested in developing their own vaccine. Soon they had developed a formula for a peptide vaccine that could be administered through an injection in the nose.
"It's very simple," said Dr. Estep. "It consists of five ingredients that you can mix together in a doctor's office."
The main ingredient: tiny pieces of viral proteins or peptides that the scientists ordered online. If all went well, the peptides trained the immune system to defend itself against the coronavirus, even when no actual virus was present.
At the end of April, Dr. Estep told several workers in a laboratory when they stirred the preparation and sprayed it into their nostrils. Dr. Church, a longtime mentor to Dr. Estep said he took it to his bathroom by himself to take social precautions.
Dr. Estep soon gave the vaccine to his 23-year-old son, and other staff members also shared it with their family members. So far, no one has reported anything worse than a stuffy nose and mild headache, said Dr. Estep. He also refined the recipe, removing and adding peptides as new coronavirus research surfaced. So far he has sprayed eight versions in his nose.
A traditional drug development workflow begins with mouse or other animal studies. For RaDVaC, Dr. Estep: "We are the animals."
But without rigorous clinical trials, said Dr. August, there is no reliable way to determine if it is safe or effective. He feared that the scientists' reputable credentials might imply otherwise.
Dr. Church said that he respects the traditional assessment process, but that there should also be room for "preliminary research" and that most of what he has been involved in throughout his career – including manipulating genes in human cells – has been viewed as "marginal" " first.
According to Dr. Estep had taken the vaccine to around 30 people in the US, Sweden, Germany, China and the UK last week. He said a university professor in Brazil told him he was considering making it in his laboratory and giving it away for free.
Vaccine via Facebook
There is a long history of scientists openly testing vaccines on themselves and their children, but in recent decades this has become less common, according to Susan E. Lederer, a medical historian at the University of Wisconsin-Madison. What is ethically and legally acceptable for testing and distributing your own medical device varies by facility and country.
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frequently asked Questions
Updated August 27, 2020
What do I have to consider when choosing a mask?
- There are a few basic things to keep in mind. Does it have at least two layers? Well. If you hold it up to the light, can you see through it? Bad. Can you blow a candle through your mask Bad. Do you feel okay most of the time wearing it for hours? Well. The most important thing after finding a mask that fits well with no gaps is finding a mask that you will wear. Take some time to choose your mask and find something that suits your personal style. You should always wear it when out in public for the foreseeable future. Read more: What is the best material for a mask?
What are the symptoms of the coronavirus?
- In the beginning, the coronavirus appeared to be primarily a respiratory illness – many patients had fevers and chills, were weak and tired, and coughed a lot, although some people don't show many symptoms at all. Those who seemed the sickest had pneumonia or acute respiratory distress syndrome and were given supplemental oxygen. By now, doctors have identified many more symptoms and syndromes. In April the C.D.C. added to list of early signs of sore throat, fever, chills, and muscle pain. Gastrointestinal disorders such as diarrhea and nausea have also been observed. Another tell-tale sign of infection can be a sudden, profound decrease in your sense of smell and taste. In some cases, teenagers and young adults have developed painful red and purple lesions on their fingers and toes – nicknamed "Covid Toe" – but few other serious symptoms.
Why does it help to stand three feet away from others?
- The coronavirus spreads mainly through droplets from your mouth and nose, especially when you cough or sneeze. The C.D.C., one of the organizations using this measure, bases its six-foot recommendation on the idea that most of the large droplets that people make when they cough or sneeze fall within six feet of the ground. But six feet has never been a magical number that guarantees complete protection. For example, sneezing, according to a recent study, can trigger droplets that are much farther than two meters away. It's a rule of thumb: it is safest to stand six feet apart, especially when it's windy. But always wear a mask even if you think they are far enough apart.
I have antibodies. Am i immune now?
- As of now, this seems likely for at least a few months. There have been scary reports of people appearing to be suffering from a second attack of Covid-19. However, experts say these patients may have a protracted course of infection, with the virus taking a slow toll weeks to months after initial exposure. People infected with the coronavirus typically produce immune molecules called antibodies, which are protective proteins made in response to an infection. These antibodies may only last in the body for two to three months, which may seem worrying, but that's perfectly normal after an acute infection subsides, said Dr. Michael Mina, an immunologist at Harvard University. It may be possible to get the coronavirus again, but it is highly unlikely to be possible in a short window of time after the initial infection or make people sick the second time.
I am a small business owner. Can I get relief?
- The stimulus packages passed in March provide help to millions of American small businesses. Eligible are companies and non-profit organizations with fewer than 500 employees, including sole proprietorships, independent contractors and freelancers. Some larger companies in some industries are also eligible. The assistance offered, administered by the Small Business Administration, includes the Paycheck Protection Program and the Economic Injury Disaster Loan Program. But a lot of people haven't seen any payouts yet. Even those who have received help are confused: the rules are draconian and some are stuck with money they cannot use. Many small business owners get less than expected or hear nothing at all.
What are my rights if I am worried about going back to work?
In August, the Scientific Research Institute for Biosafety Problems, a government institution in Kazakhstan, announced that seven employees were the first to try the Covid-19 vaccine they had developed. Russian and Chinese scientists associated with government and academic institutions have made similar statements in the context of the pandemic.
The problem with Mr. Stine's product, according to Washington Attorney General Bob Ferguson, isn't that he took it. It is that he "sold this so-called vaccine to people in Washington who are afraid and more inclined to look for a miracle cure amid a global pandemic," Ferguson said in a statement. In the lawsuit, Mr. Stine's unsupported security and effectiveness claims are also cited.
In March, several months after he said he had vaccinated himself and his two teenage sons, he posted an ad on the North Coast Biologics Facebook page. After working with antibodies for decades, Mr. Stine said in an interview, he knew that making a vaccine should be "damn easy".
He described a job that sounded a bit like writing Hollywood scripts that never became films. He makes antibodies that could be used against various pathogens and sells them to companies that could, but probably not, use them to develop drugs. According to the Washington Attorney General's lawsuit, Mr. Stine's company was administratively dissolved in 2012.
To make his vaccine, he used a genetic sequence for the spike protein on the outside of the coronavirus to make a synthetic version. He put it in a saline solution, injected himself just under the surface of the skin on his upper arm, and then did a titer test to look for antibodies in his bloodstream. "It took me 12 days from sequence download to positive titer," he said.
In his Facebook ad, he claimed it made him immune to the virus and given "prospects" the opportunity to "pay $ 400 per person."
Under an agreement that Mr Stine eventually made with prosecutors, he must reimburse all 30 people who took his vaccine.
Mr. Stine appeared to be amused by this and insisted that few people would likely ask for a refund. His fee, he said, barely covered travel expenses and often didn't.
A man in his sixties in Montana who wanted to remain anonymous on privacy concerns said he had flown Mr. Stine out to vaccinate him and his family. Now, he said, they could return to “normal behavior” such as having lunch with friends, whose work poses a high risk to them. The man even came to see Mr. Stine to visit a friend of a Washington state police officer who was diagnosed with Covid-19 and who was "at the door of death." According to all three present, no one was wearing a mask. And Mr. Stine was sitting in a closed room near the sick officer when he was treating him.
According to Stine, his vaccine is similar to a recombinant vaccine being developed by the University of Pittsburgh in Pennsylvania. He also claims that a shot not only protects people from the virus, but treats those who have it as well. Dr. Louis Falo, a senior researcher in the University of Pittsburgh's efforts, said he was skeptical that Mr Stine's vaccine could be safe or effective because of its composition. Even if it did, he said, it is unlikely to help sick people.
In the 1990s, Mr. Stine worked for Patrick Gray, a molecular biologist who helped discover a hepatitis B vaccine and who is now the director of a biotech company.
Dr. Gray said in an interview that the science that Mr. Stine published at Icos, the biotech company they worked for, was "healthy," but that the young scientist had a penchant for making too much with too little . "Johnny was in a hurry to get his work out and get his career moving," he said. "We have often insisted on more confirmation and more controls."
"In relation to his current scientific endeavors, I don't think Johnny is a 'cheater' but he has FDA regulations that are required for drug development," he wrote in an email. "For a person like Johnny it is just not possible to develop a viable vaccine. "
The Mayor of Friday Harbor said he regretted not responding privately but responding to Mr. Stine's message on his Facebook wall. But he doesn't see why he should apologize for accepting his friend's phrase for free. "I would rather have the chance to have some protection than no protection at all and wait and wait," said Ghatan.
However, the controversy has derailed their plans for the meeting, he said. But if there was another opportunity to get the push, he said, "I would."