Scientists, under pressure, try to balance speed and safety on coronavirus vaccine research
S E E D E D C O N T E N T
For researchers working on possible coronavirus treatments, time is short.
More than 100 clinical trials of dozens of potential coronavirus treatments are already underway around the world, a mobilization of global medical resources rarely seen before in human history.
But science can be slow and indirect. And despite the sheer number of scientists involved in these efforts, the scientific method requires a rigor that can only be sped up so much.
Experts have said that it could take at least 12 to 18 months before a vaccine is commercially available to administer widely — a timeline already seen as aggressive. And with international attention focused on coronavirus efforts, some researchers are warning about the potential pitfalls of accelerating scientific research and the risks of overpromising what science can deliver in a short time.
In an essay published Monday in the journal Science , the publication’s editor-in-chief H. Holden Thorp, a chemist and a former provost at Washington University in St. Louis, voiced concerns about the unusual nature of relying on science to find a swift solution to a problem with still many unknowns that is unfolding in real time.
The scientific method, Thorp wrote, inherently takes time, and involves basic research to first identify the problem and subsequently applying that research to test and build on scientists’ understanding.
“Now, scientists are trying to do both at the same time,” he wrote. “This is not just fixing a plane while it’s flying — it’s fixing a plane that’s flying while its blueprints are still being drawn.”
As new coronavirus cases multiply in many countries and fatalities rise, the scientific community is under enormous scrutiny and pressure to identify potential treatments.
The proposed timeline of 12-18 months for a vaccine is already exceptionally fast given the normal pace of vaccine development and trials, according to Walter Orenstein, a professor at the Emory University School of Medicine and the former director of the United States’ National Immunization Program at the Centers for Disease Control and Prevention.
“It often takes 10 years for a new vaccine to make it through all the steps and all the tests necessary,” Orenstein said. “The public health urgency of this is definitely moving things faster than would generally be done.”
Part of the challenge of working at such an accelerated pace is ensuring that safety is not compromised.
Typically, clinical trials are made up of three main stages. Most of the trials currently underway are in the first phase, which is designed to test whether the experimental drug of a vaccine candidate is safe to give to humans.
“Phase one is about basic safety — does it make people get violently ill, or are there other extreme consequences?” said Jeremy Block, a biochemist and co-founder of Medaptive Health, a New York-based company that develops tools to help scientists conduct clinical studies and trials. “This step is not necessarily to see if the drug even does what you want it to do.”
Once safety is established, the drug moves into phase two, which is designed to test its effectiveness and the specificity of the treatment.
“If you give somebody a drug and it does a good job of killing the invading cells, but it also kills three of your main organs, it may be effective but it doesn’t work specifically on what you want it to work on,” said Block, who is part of Northwell Health’s Institutional Review Board, which approves and monitors biomedical research on humans at the organization’s hospitals.
The last step, and sometimes the most involved, requires demonstrating that the drug is effective in different populations, and thus would be safe and ready to administer widely.
But over the course of a clinical trial, there are few, if any, opportunities to speed up the process, Block said, particularly because scientists need to monitor the long-term effects of these new drugs.
“All these things take time, and if we cut corners, bad things can happen,” he said.
In 1982, for instance, research emerged that benzyl alcohol — which is used as an anti-bacterial agent in some medical solutions and was approved for use in adults but had not been studied in children and infants — was associated with 16 neonatal deaths at two medical centers in the U.S. And in the 1970s, pressure to rapidly develop and issue a new flu vaccine was later associated with hundreds of cases of a type of paralysis known as Guillain-Barré syndrome.
Avoiding these types of dangers is even more important during a pandemic, because researchers will likely have to weigh potential risks and benefits that are magnified by the urgency of the situation, according to Orenstein.
“Ideally you want a vaccine that is more than 90 percent effective,” he said. “But we would have to look at: Even with a less-than-ideal effectiveness, are there greater benefits if we can reduce the pressure on the health system? So it may be that under certain circumstances, a 50 percent effective vaccine is better than nothing.”
Regulators will most likely also have to weigh these same risks in deciding whether a potential vaccine is safe for the general public, he said. In some cases, this may involve accepting the results of smaller trials that may carry more uncertainty than normal.
Orenstein said that over the course of his career, which includes 26 years working at the CDC, he can’t recall a situation comparable to the one unfolding now.
“Nothing comes to mind of this kind of setting, where we’re talking about a massive pandemic occurring and the longer we wait, the more we have potential for really adverse outcomes,” he said.
But Thorp cautioned that putting pressure on the meticulous and sometimes deliberately lengthy scientific process could have negative impacts for both members of the public looking for hope and answers, and the scientists who are trying to deliver them.
“I worry that engendering false hope will cause complacency that will deprive us of the time needed to find a lasting solution. And I worry about lasting damage if science overpromises,” he wrote in Science. “Let’s underpromise. Let’s overdeliver.”
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Here's the deal. As the pandemic continues, larger portions of the global population will develop natural immunity and won't need a vaccine. Commercial availability won't be that important. The slow progress means the problem corrects itself to a large extent. While all the safety boxes are checked, those who need it most may already have died.
The slowness of the process also involves risk. People are dying while scientists focus on standard operating procedures and commercial requirements. COVID-19 doesn't care about the scientific method and won't wait for all those boxes to be checked. The heroes in the story aren't acting heroically.
On occasion, vaccines have actually caused people to get sicker when they contract an infection than if they hadn't been vaccinated. Avoiding making things worse by hastily releasing an inadequately-tested vaccine is not heroic. It's irresponsible.
Respiratory syncytial virus is a common cause of morbidity and mortality in children. A vaccine for it was developed and administered in the 60s. It caused vaccinated children to get sicker than their non-vaccinated peers.
First, do no harm.
Ah yes, the Doctors old adage. However, it is being tried in New York right now. We shall see!
I don't mind it being subjected to clinical trials. That is, of course, part of the scientific method. But just cavalierly saying "We need to rush it. Forget science. It's too slow." is reckless. Taking risks with other people's lives is not heroic. Attempting to assuage risk to others is, even if it's by way of dreaded science.
I don't see where anybody has said to forget science and just push it out there. Can you provide a link?
All I've heard on this from Trump is that he's pushing for them to work as fast as they can,
That was from Nerm. The scientific method is how we do, well, science. Acting without regard for the science (not waiting for "all those boxes to be checked") is irresponsible.
ahh, thank you. Now I follow the thread. And in a way he's right, the disease doesn't care about science. All it wants to do, like any virus, is replicate and live. But you are correct, we should care about science and doing what is right for the vaccine. That doesn't mean they can't work as fast as possible because right now people around the world are dying. To borrow a phrase, they need to do it right so that the cure isn't worse than the disease.
Exactly so. We're presumably going to inject this into kids and grandmas. Let's not kill them.
The Food and Drug Administration on Sunday gave doctors emergency permission to use the anti-malarial drugs hydroxychloroquine and chloroquine to treat the coronavirus.
Amen!!! Especially since it's been used for 65 years to treat Malaria!!!
We were talking about a vaccine, Vic. At least, that's what Nerm mentioned in his @2, so that's what I was talking about.
Unfortunately, use of Plaquenil (hydroxychloroquine) is causing shortages of it for patients with lupus and rheumatoid arthritis. If we're going to be taking it away from patients who need it, and who could also suffer severe consequences from lack of treatment of their condition, we should probably make sure we have a good reason for doing so, yes?
Is it shortages or medical hoarding?
If we're going to be taking it away from patients who need it, and who could also suffer severe consequences from lack of treatment of their condition, we should probably make sure we have a good reason for doing so, yes?
Defeating the China virus would be a huge reason. In France the drug is a top priority. In America progressives seem to be against using the drug. You are not against using it in this war against this highly infectious disease, are you?
Hoarding leads to shortages.
Yes, progressives are against people getting medical care
. I, like most people, would like to have a bit of reassurance that the drug is effective, especially if we're going to end up withholding it from others who need it, and who have serious conditions for which it has been shown effective. How very partisan of me.
You wouldn't be the type of person who thinks that everyone who disagrees with you politically is a bad person, would you, Vic? I only ask because some of your questions seem to imply it.
There is only one way to find out ins't there? Or do we wait until after November?
You wouldn't be the type of person who thinks that everyone who disagrees with you politically is a bad person, would you, Vic?
No, I'm not. I give some, but not all the benefit of the doubt.
I only ask because some of your questions seem to imply it.
The implications are real, but not personal. You said something on another seed this morning. You said Dr Fauci is on "our side." What I say is not directed at you personally, but rather at "your side!"
Why assume you're not included in the "our", Vic?
You seem determined to think the worst of some people.
Sad.
That's the way it is with us bad guys. "irredeemable!"
Not true at all. Where was the natural global immunity to smallpox, bubonic plague, or polio?
Yes it will.
I am trying sooooo hard to be good right now................ the stupidity of this comment is....... okay let me make sure I won't be banned for my response.
OMG.... the stupidity is almost overwhelming.. I am trying so hard to not be suspended...
I am not even going to read the rest of your comment because if I do I probably won't just be suspended but banned completely.
People who were infected and survived those diseases did develop immunity. Without an immune response, a vaccine will not work.
The coronavirus is spreading too quickly for an 18 month period of vaccine development to be of benefit. Since immunity is not necessarily passed on to offspring (the exception being genetic mutations) a coronavirus vaccine would be of benefit for future generations and prevent future pandemics. But it is highly unlikely that a vaccine will stop the current pandemic.
For the immediate pandemic the development of treatments to lessen the severity of symptoms would be of higher priority.
Development of a coronavirus vaccine should have started 15 years ago when the 2003 coronavirus epidemic spread to 26 countries. Now is not the time to play catch up by fast tracking vaccine development. The immediate needs are treatment of symptoms and testing for immunity.
I am sorry for my other response, Nerm you are doing great, just keep doing your thing buddy.
New York, Big UPS to you - Continue to Endure. We love Y'all!
Can someone in some way in the know comment on the mask in the seeder's image? I understand it is about 70% effective against viruses. Is that right? Is the person in the photo wearing the appropriate mask for the work she is doing? Really curious about these masks. BTW, I now have several really good masks with me from a treasured loved one!
You can see her reflection in front of her, so she's working in a flow hood. The purpose of a flow hood in a laboratory is to protect workers by containing vapors, dusts, gases, and fumes generated within the hood, and removing them as air flows into the hood and then out via the laboratory exhaust system. The mask in this case is to prevent her from contaminating any of the work as air flow goes into the hood where her arms are and out thru an exhaust system. The air flow prevents the virus from getting out to her so she doesn't need the high-tech masks, just the normal surgical mask. Hope that helps.
It does help! I totally looked at her hands and sleeves to see if her hands were inside something and not being certain from it—I totally missed her reflection in the glass! Thank you for sharing in these critical moments.
It should be a negative air flow
yep, that's how a flow hood works. It sucks air into the hood and out thru a filtered laboratory exhaust.