Researchers test vaccine for COVID-19 on selves
Group posts instructions for other scientists
Scientists in the Boston area have inoculated themselves with an unproven vaccine for COVID-19 and posted a white paper online, offering instructions that would allow others to make and administer the nasal vaccine.
The development, first reported in The MIT Technology Review, follows a history of self-experimentation by scientists, but comes at a time when the practice is highly controversial.
News of the effort met with criticism from officials at the Massachusetts Institute of Technology and Harvard Medical School, where some of the researchers are said to be affiliated. Scientists at other institutions also expressed outrage in interviews with the Milwaukee Journal Sentinel.
“This is like doing science out of your garage,” said William Schaffner, a professor of preventive medicine at Vanderbilt and past president of the National Foundation for Infectious Diseases.
“I’m a big vaccine fan, but I take the vaccine when I know it has gone through the process,” said Maria Elena Bottazzi, a professor of pediatrics at Baylor College of Medicine, and co-developer of another candidate vaccine for COVID-19.
Her vaccine has been tested in mice and is currently undergoing tests in non-human primates in preparation
for human clinical trials. Other vaccines are in latestage clinical trials, and manufacturers predict they could be ready by late this year or early 2021. The process, which usually takes several years or longer, has been accelerated amid the COVID-19 pandemic.
“It doesn’t mean that we cannot improve the process, re-evaluate and learn how to do things better,” Bottazzi said, “but we should definitely not go back to the 1900s mentality.”
George Church, a world-renowned Harvard University geneticist and one of the researchers who have taken the unapproved vaccine, defended the decision, telling the Journal Sentinel, “Many scientists have been taking their own vaccines for many decades.”
Church and the others formed the Rapid Deployment Vaccine Collaborative, which they describe as, “a group of citizen scientists who are concerned about the staggering costs of the current pandemic (and from possible future pandemics).”
As of Friday morning, COVID-19 had killed more than 674,000 people around the world, including more than 152,000 in the U.S.
Church was one of five authors who signed their full names to the 48-page white paper posted online that explains how to make and use the vaccine. Other authors of the paper listed only their initials.
In response to questions from the Journal Sentinel, Church said that posting the white paper online was a way to make the potential vaccine available to the public, and not just a cadre of in-the-know scientists.
“It is important to reduce the perceived exclusivity of that kind of access, while maintaining safety,” Church wrote in an email. “Many smart and careful people previously didn’t have access to sufficiently distilled instruction on how to move forward. (The collaborative) helps citizens to get informed and empowered by engaging in science.
“As part of informed consent we don’t sugar coat the process, don’t make promises and put risk information front and center.”
Asked about the possibility that people may use the posted instructions in an attempt to vaccinate themselves, children and grandparents, Church replied, “What if vaccination saves lives and is relatively harmless? If so, then preventing people from having access to it is the unethical option.”
‘We cannot guarantee safety’
The vaccine itself contains small synthetically produced portions of viral sequences and “is not infectious,” according to the collaborative. It is delivered by small particles of a substance found in the cell walls of fish scales and in the protective exoskeletons of crustaceans and insects.
The collaborative reported that “short-term safety has been demonstrated on a small, scale.” At least 21 researchers, ranging in age from the 20s to the 80s, had taken the vaccine as of mid-July.
When asked what convinced him the vaccine would work, Church answered, “Not ‘would’ but ‘could.’ “He said the nasal inoculation and method of delivery “seemed more likely to succeed than most of the 200 vaccines currently being developed.”
Members of the collaborative state on their website, that “Nasal vaccines have been shown in previous studies to be generally very safe, but we cannot guarantee safety ...The most serious side effect reported in the first few months of vaccine use is a noticeable temporary increase in sinus congestion in the hours after booster doses are administered.”
The self-experimentation and posted do-it-yourself instructions contrast with the usual regulatory process that experimental drugs must undergo. Often, they go through extensive tests in animals, such as mice and non-human primates.
Testing on humans usually requires approval from an Institutional Review Board; universities and hospitals maintain these boards to oversee all research involving human subjects.
Approval for testing in people must come also from the U.S. Food and Drug Administration, which is responsible for ensuring the safety, effectiveness and security of all human and veterinary drugs.
Responding to news of the self-inoculating research group, Schaffner said, “If this happened at Vanderbilt and they were Vanderbilt faculty members, their feet would not just be up to the fire, their feet would be in the fire.”
Although the MIT Technology Review article said many of those who have taken the vaccine are “connected to Harvard University and MIT” both institutions quickly distanced themselves from the group and expressed support for traditional clinical trials.
In a written response to questions from the Journal Sentinel, Maria T. Zuber, MIT vice president for research, said that neither the Institute, nor its board governing the use of humans as experimental subjects, “has reviewed or in any way supports the Rapid Deployment Vaccine Collaborative.”
Zuber went on to say, “we strongly discourage any member of our community from taking an experimental vaccine outside the context of a clinical trial that includes appropriate medical oversight, as well as robust
“(The urgency of a vaccine) doesn’t mean that we cannot improve the process, re-evaluate and learn how to do things better, but we should definitely not go back to the 1900s mentality.” Maria Elena Bottazzi professor of pediatrics at Baylor College of Medicine, co-developer of another candidate vaccine for COVID-19
institutional review and safeguards.”
Harvard University and Harvard Medical School stressed that the rapid deployment group was not affiliated with either institution.
“As an academic medical institution, Harvard Medical School strongly discourages self-experimentation,” said Ekaterina Pesheva, director of science communications and media relations for the medical school. Pesheva made the remark in an emailed response to questions from the Journal Sentinel.
Pesheva added, “The urgency to develop a safe and effective COVID-19 vaccine cannot be overstated, but this urgency should never compromise the integrity of the clinical trials process that functions to generate reliable evidence of vaccine efficacy, while seeking to maximize safety and protect public health.”
Informed of the actions taken by the collaborative, the FDA issued a brief statement: “Consumers are cautioned to make sure that any vaccine they are considering has either been approved or authorized for such use by the FDA, or is being studied under appropriate regulatory oversight.”
Nobel winner drank a beaker of bacterium
Though self-experimentation by scientists is controversial today, it has resulted in seven discoveries awarded Nobel Prizes.
Most recently, Barry J. Marshall won the 2005 prize in medicine for discovering that a bacterium plays a role in gastritis and peptic ulcer disease. Part of his work included drinking a beaker of the bacterium, Helicobacter pylori, and giving himself acute gastritis.
“For some it is evidence of enthusiasm and optimism about their work, though it can slip into hubris at times,” Alta Charo, professor of law and bioethics at the University of Wisconsin-Madison, said of the practice of self-experimentation. “For others, it is about demonstrating their confidence in a vaccine or therapy, so that others may feel comfortable trying it themselves.
“But regardless of the motivation, it is of limited use scientifically. If something is universally lethal, then a test on one person will tell us something.”
“But to know if a vaccine or therapy is effective,” she said, “it is almost always necessary to try it on a group of people, preferably with a ‘control’ arm made up of people getting standard care, but not the experimental (treatment).
“And only with a large group of people can we get a real sense of the range of less-than-lethal adverse effects, as well as a sense of the proper dosing to get maximum effect with minimum risk.”