Vaccine trials have had a strange week. First, there was the thrilling kickoff of two massive vaccine clinical trials created by Moderna and Pfizer. Each company hopes to recruit 30,000 volunteers to test whether its vaccine is effective and safe. It’s normal.
what do not normal is a group of researchers in Boston who decided to test a DIY coronavirus vaccine themselves. At least 20 people mixed the vaccine and sprayed it in their noses as part of what they call the Rapid Deployment Vaccine Collaborative (Radvac), according to a truly wild group MIT Technology Review story of the publisher Antonio Regalado.
Among those testing the vaccine is Harvard University geneticist George Church. You may know it from other efforts, including recoding the human genome, woolly mammoth revival, and genetic twinning. Church mentored Preston Estep, a geneticist who started Radvac in March.
George Church’s selfie of him taking a DIY coronavirus vaccine. This photo is a classic
It’s the thread that goes with it. pic.twitter.com/7xpb9zs8j6
– Antonio Regalado (@antonioregalado) July 29, 2020
As Regalado notes, this is all happening completely outside of any sort of regulation or oversight.
The Radvac Group does not have FDA clearance to test or use this vaccine.
They claim that because the participants mix the ingredients themselves and self-administer, it is beyond regulatory scope.
I doubt it, but whether they are in trouble can depend on how they talk about it.
– Antonio Regalado (@antonioregalado) July 29, 2020
As you might expect, many bioethicists find this approach to vaccine development … problematic, as Regalado reports:
Arthur Caplan, a bioethicist at New York University’s Langone Medical Center, who saw the white paper, calls Radvac “wacky.” In an email, Caplan says he sees “no wiggle room” for self-experimentation given the importance of vaccine quality control. Instead, he thinks there is a high “potential for harm” and “ill-founded enthusiasm”.
Church disagrees, saying the vaccine’s simple wording means it’s probably safe. “I think the biggest risk is that it is ineffective,” he says.
But there are also other risks that are not directly related to the safety or effectiveness of the DIY vaccine on the patient.
lab rats self-reported research topics. There has been a worrying increase in mistrust of vaccines in recent years, both in the United States and around the world. Today, in the midst of a global pandemic, people are still wary of vaccines, and it is getting worse, thanks to widespread misinformation.
“Since the start of the pandemic, lies about vaccines have multiplied [Facebook]Wrote journalist Erin Brodwin in a recent article on STAT, “And recent research suggests that some of these inaccurate messages are gaining traction among people who were not previously opposed to vaccinations.”
Radvac is not responsible for the current dire state of vaccine attitudes in the United States and around the world. But if you are planning to experiment with high level drugs in the hope of changing the world, you must be fully aware of the world you are experimenting in.
One of the reasons these lies can take hold? People who are already afraid of the pandemic are also quite frightened by the speed at which these vaccines – whether they come from large companies or small experiments – are produced.
“I just feel like there’s a rush to get a vaccine out, so I’m very hesitant,” said Joanne Barnes, a fourth-year retired teacher from Fairbanks, Alaska. Le New York Times earlier this month. Barnes, the Time “, Is someone who” is also always scrupulously up to date to get vaccinated, including shingles, flu and pneumonia. “
The concern felt by people like Barnes is the reason vaccine experts and virologists have repeatedly warned of scientific corners in the search for a vaccine. There are fears that if these experiments go wrong, it could affect people’s desire to get even a safe and approved vaccine in the future.
“A rush for potentially risky vaccines and therapies will betray that trust and discourage work to develop better evaluations. Despite the real need for urgency, the old adage holds: measure twice, cut once, ”wrote Shibo Jiang, professor of virology at Shanghai Fudan University. Nature back in March.
As it stands, Radvac measures and cuts with their own life, betting they can progress and stay small enough to be overlooked by regulatory groups.
“What the FDA really wants to crack down on is something big, making claims or making money. And that’s none of that, ”Church said Technical Review. “As soon as we do any of these things, they would justifiably crack down. Also, things that catch your eye. But we haven’t had one so far.
This is of course changed. What happens next? It is all an experience.
Here’s what was going on this week.
Children can carry coronavirus at high levels, study finds
Children under the age of five who had confirmed cases of COVID-19 had nearly 100 times more virus in their nose and throat than adults with COVID-19. Older children had at least as much virus as adults. “One thing to remember is that we cannot assume that just because children are not sick, or very sick, they are not carrying the virus,” said Taylor Heald-Sargent, lead author of the study. Le New York Times. (Apoorva Mandavilli / Le New York Times)
Coronavirus has infected many children and staff at night camp in Georgia
The CDC released a report on Friday of an outbreak at a night camp in June. About 600 people (staff and campers) were at the camp, and researchers obtained test results for 344 of them. 260 of the tests came back positive, many of them children. “This investigation adds to the body of evidence showing that children of all ages are susceptible to infection with SARS-CoV-2 and, unlike early reports, could play an important role in transmission,” the report says. of the CDC. (Chelsea Janes /Le Washington Post)
Covid-19 infections impact the heart, raising concerns over lasting damage
Two German studies have found disturbing evidence that COVID-19 damages the heart. (Elizabeth Cooney / STAT)
The strange and growing list of symptoms of Covid-19, explained
It is still a relatively new virus, so researchers are still learning a lot about the types of symptoms caused by the disease. (Umair Irfan and Brian Resnick / Vox)
Monkey affairs: The experimental vaccines from Johnson & Johnson and Moderna have been able to protect monkeys from catching the coronavirus, according to a study published this week. This doesn’t mean that vaccines will have the same effect in humans, but that’s good news. “This week has been good – now we have two vaccines that work in monkeys,” said virologist Angela Rasmussen. Le New York Times. “It’s good to be optimistic for a change.” (Carl Zimmer, Denise Grady / Le New York Times)
I like to compare that with the difficult task of simmering milk on the stove. Most of the time it is wrong, as the milk can boil anytime and cause a huge mess. It is just as dangerous to simmer viral infections at a low level.
– Devi Sridhar, Professor of Global Public Health at the University of Edinburgh. Sridhar explains Scotland’s ambitious ‘zero COVID’ policy in a fascinating interview conducted by Veronika Hackenbroch at The mirror.
More than numbers
“Despite less than 5% of the world’s population, nearly a quarter of the 662,000 deaths reported during the pandemic worldwide have occurred in the United States,” NPR reported on Wednesday, when coronavirus deaths in the United States exceeded 150,000. The numbers continue to rise.
At most 17,613,859 people around the world who have tested positive, may your journey to recovery be smooth.
To the families and friends of the 679,986 deceased people around the world – 153,320 of those in the United States – your loved ones are not forgotten.
Stay safe, everyone.