Time for something completely different – I keep reading statements by pro-vaccine people that they want to shorten coronavirus vaccine testing to get it out to the people faster. Let me slam on those brakes because nothing could be worse for public health than to engage in that type of thinking.
As I’ve written on a number of occasions, coronavirus vaccine testing is going to take a long time. Publicly, some “experts” are claiming that a vaccine might take 18 months, but that’s only if everything goes right. And since it always doesn’t go right, I would bet that it would take 4-5 years before we see a coronavirus vaccine.
Because of this pandemic has become very dangerous, and there are no “cures” right now (despite Donald Trump’s ignorance about chloroquine), the desire for a vaccine has become very loud and very annoying.
But to speed up coronavirus vaccine testing is dangerous. And let me explain why.
An average vaccine takes anywhere from 3-5 years to develop before a clinical trial can begin. With worldwide collaboration and government money, we have seen coronavirus vaccines ready for clinical trials much sooner than that.
In a sense, we have developed vaccine candidates faster than ever before. Right now, there are at least 37 vaccines in various stages of development, but none are even close to being approved.
Here are vaccine development steps in order:
- Identifying methods to induce an immune response. This was done pretty quickly as research institutions isolated the virus and sent it out to other labs to be studied. Researchers have also apparently determined what part of the glycoprotein coat on the virus seems to induce an appropriate immune response.
- Pre-clinical studies. This step will help scientists understand SARS-CoV-2 (the official name of the virus that causes COVID-19) characteristics and pathophysiology which is a critical first step in developing a safe and effective vaccine. Since it would be unethical to jump right into testing a new vaccine actual humans, researchers need to develop an animal model that mimics the human immune response. Also, researchers need to determine if the vaccine is safe and triggers an adaptive immune response in that animal model. For the SARS vaccine, ferrets were used, because their physiology and immune responses are similar to humans, so it might be used for a COVID-19 vaccine.
- IND application. The sponsoring organization (probably a Big Pharma company, but several research institutes are also developing coronavirus vaccine candidates) must make an Investigational New Drug (IND) application to the FDA’s Center for Biologics Evaluation and Research (CBER) to begin clinical trials. CBER reviews the IND, which will include preclinical data, and the sponsor can proceed with the clinical trial within 30 days if the FDA does not object to moving forward to a clinical trial. This is the process in the USA, but it’s much the same in most developed countries.
- Clinical trials. Then the sponsoring organization must get Institutional Review Board (IRB) approval to proceed with clinical trials (see this article for more information about the process). The clinical studies must go through three phases like all drugs, although the process could be shortened if the data is very clear and there is a public need (like the COVID-19 pandemic). These clinical trials will be posted to a US government website that tracks all clinical trials worldwide (and must be posted there before a drug can get US FDA approval). Some of the new coronavirus vaccines have entered Phase 1 clinical trials – this phase does not tell us much about the vaccine as it is given to “healthy volunteers”, and it is not randomized or blinded. It usually only includes 50-100 patients. Phase 2 and 3 trials are randomized, double-blind, placebo-controlled clinical trials, with a few hundred and few thousand patients, respectively. No drug (or vaccine) can be approved without Phase 2 and 3 studies successfully completed except in some very rare circumstances.
- Final regulatory approval. After all of the preclinical and clinical is completed, the sponsoring organization must make a Biologics License Application (BLA) to CBER. Although this process is what is done in the USA, it’s similar in most other countries (and some countries accept FDA review for their own country.
- Manufacturing plan. During this research, regulatory agencies must review manufacturing plans for the new vaccine and any pharmaceutical company that intends to produce it must develop a cost-effective and consistent method for production.
I remain convinced that a lot of people, whether they are pro-vaccine or anti-science, think that researchers grab a handful of viruses, a little water, some mercury, an aluminum Diet Coke can, and an aborted fetus, throw it in a Waring blender, put it in a vial, and then inject them into innocent children.
But as you can see, the process to get a new vaccine fully tested and ready for general use is hard work. There are no shortcuts.
Moreover, we have tried to make SARS vaccines before, and it hasn’t gone well. In 2002-3, we were hit by severe acute respiratory syndrome (SARS), caused by a related coronavirus. Yet, during the ensuing 18 years, we have not been able to develop a SARS vaccine despite trying really hard.
In fact, most vaccines do fail during clinical trials. They either fall to the wayside, never to be seen again, or they are re-worked to enter a whole new round of clinical trials.
So some (maybe more than that) in the pro-vaccine world have been pushing to reduce the timeline of coronavirus vaccine testing, and that we should just get a new vaccine out as quickly as possible, and allow people to choose to get it if they want. The logic is that because COVID-19 is so dangerous, we need to take a risk. I guess as long as we are aware of the risk, getting the vaccine is better than the disease.
Well, that’s not going to happen, nor should it. There are several reasons why we should never do that. Doing this without having information about the vaccine’s safety and efficacy is wrong.
Here are some of the reasons why I think we need to be as careful as always:
- Establishing effectiveness. Clinical trials tell us the level of effectiveness against the target disease. If we don’t know this, then we might be giving false hope to those who get the vaccine. If the vaccine doesn’t work well, then we would need to keep the public health initiative that we have such as social distancing and self-quarantining.
- Establishing safety. Just like the above, we need to determine if there are adverse effects of the vaccine – like we do with all vaccines, despite the false claims of the anti-vaccine squad. The reason we do large clinical trials is that it helps us determine if the rate of adverse events is above the rate for the general population (which would be the placebo group). This is a very important step that would be irresponsible to ignore.
- Establishing proper dosage. We don’t know what is the proper dosage and formulation of the vaccine. What if the new vaccine requires two or three doses? What if we need a higher concentration of antigens?
- Establishing good manufacturing processes. Some of the COVID-19 vaccines have never been manufactured before. As part of safety and effectiveness, we need to know that we can manufacture these vaccines that are consistent, safe, and effective. Once again, people think that vaccines are easy to make – they aren’t.
- Most drugs and vaccines fail in clinical trials. I know I’ve said this before here, but clinical trials weed out bad drugs (and vaccines) frequently. Almost 90% of drugs fail in clinical trials.
It’s really simple. All vaccines, again despite the irrational and pseudoscientific claims of the anti-vaccine crowd, are thoroughly tested for safety and effectiveness. This maintains the public’s “trust” in these vaccines, again, despite the anti-vaccine lies.
I expended a lot of verbiage trying to explain why “right-to-try,” the law that purports to give terminally ill patients a “right to try” experimental medications for their disease, as long as the medication had passed phase I trials. Obviously, those of us who saw right-to-try for what it was, a first step by libertarian-leaning pro-business ideologues who think the FDA kills more people than it saves through its “innovation-suffocating” requirements to weaken the FDA and lower the bar for drug approval (on the way to eliminating the FDA altogether), lost that battle, and right-to-try became the law of the land. (I have yet to find a single convincing case in which the law helped a terminally ill patient.) These are the people who think that the “free market” will take care of making sure that drugs are safe and effective.
It’s long been a strategy of the libertarian, anti-regulation right to use strategies like these to progressively weaken the FDA. They love to latch on to a crisis to push their agenda. They did it, for instance, during the Ebola outbreaks of 2014, with Nick Gillespie and Ronald Bailey arguing over at Reason.com that FDA regulations kill more people than they save and that Ebola should be a good reason to loosen up those pesky FDA requirements because don’t you realize that we don’t have time and people are dying.
The libertarian view that we’ll sort out the safety and effectiveness by speeding up coronavirus vaccine testing is ridiculous. We need to be certain that the vaccine will have high enough effectiveness that we can change our public health restrictions with confidence that we can control the spread of the virus. Moreover, we will have confidence that there are no adverse events that can be dangerous to the population.
One of the “arguments” by these people who want to reduce coronavirus vaccine testing by saying that “we can test it by putting people in front of virus out in the wild.” That is unethical to the extreme.
There would be no physician or researcher that would consciously place individuals at risk of COVID-19 vaccinated with an unproven vaccine. We just can’t use innocent individuals as an experiment in an uncontrolled manner.
There are so many issues if we speed up coronavirus vaccine testing:
- Loss of confidence in all vaccines. Can you imagine how hard our job will be to convince people to vaccinate their children against other deadly diseases, like measles, polio, and influenza, if this one vaccine is a miserable failure because we didn’t test it properly? It would be impossible.
- Lack of confidence in a new coronavirus vaccine. We already have trouble convincing people to get the measles vaccines, which if it disappeared tomorrow would lead to epidemics and deaths that could rival this coronavirus. If people are reluctant to get this vaccine for themselves or their children, then we will have a continuing epidemic.
- False hope. Again, we need to follow the public health guidelines until we have a vaccine that we know actually works. Even if we rush the vaccine out into the wild today, it would take years to know if it’s actually effective long-term.
- Unknown issues. Many of the new vaccines use an mRNA technology (see Note 1) that has never been established to work in humans. It’s a whole new technology for vaccines that have never been shown to be successful. We need to know that these are safe and effect much more than we would for standard vaccines.
I am very concerned that the Trump administration will force the FDA to approve a vaccine without appropriate testing just to take credit for doing something like he’s doing with chloroquine. This is so dangerous, that I cannot believe that I have to argue for more testing for a new vaccine.
Actually, I’m not arguing for more testing at all, just we do the standard amount of testing that we always do with vaccines. We need to have vaccines that meet our standards of safety and effectiveness. We must not fall for “taking risks” with a new coronavirus vaccine.
- These types of vaccines rely on mRNA fragments to kickstart the endogenous production of proteins similar enough to the virus that they trigger the body’s adaptive immune system to produce antibodies effective against the actual target.
- Jiang S, He Y, Liu S. SARS vaccine development. Emerg Infect Dis. 2005 Jul;11(7):1016-20. doi: 10.3201/1107.050219. Review. PubMed PMID: 16022774; PubMed Central PMCID: PMC3371787.
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