The more I read about the rush for a new vaccine, the more I am becoming a coronavirus vaccine skeptic. I think that we’re doing this all wrong, and I think that this vaccine could be a disaster if it is rushed to the market.
Because too many people don’t read articles beyond the title, like anti-vaxxers who can’t be bothered to delve into the science beyond abstracts, I want to be clear about something. All vaccines available today are overwhelmingly safe and effective – any possible issues with vaccines are substantially smaller than the harm caused by the disease.
This is settled science.
I am a passionate supporter of all vaccines, anyone who reads this blog knows that. I am only a coronavirus vaccine skeptic – and just to be clear again, I am a scientific skeptic which means I follow evidence derived from the scientific method to a conclusion.
My coronavirus vaccine skepticism, at least right now, is based on the fact that there is little evidence supporting either it’s effectiveness or safety, although those are not really issues because we are very early in the development of these vaccines. My skepticism is in the methods that we are employing to rush this vaccine to market.
Although I’ve written about my concerns regarding our rush to get a vaccine previously, I’ve made more observations that bother me.
Probably the number one reason for being a coronavirus vaccine skeptic is the lack of fully understanding COVID-19. Generally, before we develop a new vaccine, scientists have a very thorough knowledge of the pathogens’ pathophysiology – the physiological processes that lead to disease.
For example, with measles, we have a thorough understanding of how the measles virus enters the body. We understand how it causes measles. We know how the immune system responds to the virus. And we know how to create a vaccine that teaches the immune system how to attack that virus before it gets a foothold.
The problem is that we don’t have that kind of information about the SARS-CoV-2 virus that causes COVID-19. Every day, in what I call science by dueling press releases and preprints, we get new information about COVID-19.
We learn about mutations that may or may not exist. We learn about immunity which may or may not last very long. We learn about the long-term consequences of the disease which may or may not be accurate. In fact, what we know about the pathophysiology of COVID-19 may fit in a thimble.
Without this information, we are attempting to create a vaccine without knowing precisely what we’re doing. With all other vaccines (despite the misinformation from anti-vaxxers), scientists spend years or even decades understanding the virus and years and even decades developing the vaccine for the virus.
Furthermore, we actually need this thorough understanding of the virus and the disease to create effective treatments or strategies. Right now, physicians are using trial and error to improve outcomes, but that’s not going to “cure” the disease. A powerful vaccine and effective treatments require more science, and we seem to be ignoring that.
First, our drug regulatory system is robust, again, despite the contradictory beliefs of many. It keeps out ineffective and unsafe drugs (yes, that includes vaccines), which only approving ones that have are much better than the diseases that they may treat or prevent.
As I’ve said on a number of occasions, the vast majority of drugs (around 99%) fail to ever get FDA approval after the initial discovery. This is one of the major issues that contribute to my being a coronavirus vaccine skeptic – we may have a vaccine, because of the rush, that is neither safe nor effective.
It isn’t easy to make a new vaccine, that’s why it takes years to develop one. Even among the so-called pro-vaccine crowd, there seems to be complete ignorance of drug development. The standard process to get a new vaccine is really difficult.
Even though I am accused of being a Pharma Shill™ (if only), the fact is that I say publicly all the time – don’t trust pharmaceutical companies. That’s why the FDA and the whole scientific peer-review process are important to weed out the marketing hype. Or in the case of Moderna, stock price hype.
Just because a pharmaceutical company says they have a vaccine candidate, it doesn’t mean we can assume it is safe and effective. Who knows, that’s why we wait for peer-reviewed data published in real medical journals.
I keep reading where lots of people are “volunteering” to be clinical trial participants for a new coronavirus vaccine. I’m not sure of the motivation, and it could be just pure altruism, but let me bring some reality here:
- The vaccine is probably not going to work, because we’re rushing this so fast, we don’t even have good pre-clinical studies that would give us some optimism.
- You might be put in a placebo group, so don’t expect that once you got the shot, you can run out to party with your friends.
- We have no clue about its safety profile since, again, we don’t have preclinical data to review.
- You’re not going to get paid. This has nothing to with science, but some people think they’re going to score a big bundle of Big Pharma Cash™ if they sign up.
So, if you want to join a clinical trial, be my guest. I think that is really great, but don’t expect a lot. In fact, don’t expect anything. And don’t assume that just because you joined we’ve speeded up the process by any significant amount.
But let me be clear what that means. I demand that any new vaccine, whether it’s for coronavirus, measles, whooping cough, or some other disease in the future, meet exacting standards for safety and effectiveness. Every vaccine before 2020 did that, again, despite the rants of the anti-vaccine crowd.
I just saw a report where one of the vaccine candidates show “antibodies to the coronavirus.” But going back to my points about the pathophysiology of the disease, we have no clue, really no clue, whether those antibodies actually provide immunity to the disease and we don’t know whether that immunity is long-lasting.
I am a skeptic today, because all I keep reading is hype, retracted papers about the virus, non-transparency with pharmaceutical companies in clinical trials, and the lack of preclinical trials. I can retrieve all of that for HPV, measles, and chickenpox vaccines. I can read thousands of pages of research, then feel pretty good that myself and my children and everyone else will receive safe and effective vaccines.
But I’m getting that shiver up my spine about a potential coronavirus vaccine.
Professor Reiss spent a good portion of her paper on the COVID-19 vaccine discussing messaging. People like me are troubled by what we’re seeing with the rush with this vaccine (and I am not alone) and are worried that it will be a failure.
It’s hard for me to put out optimistic messaging on a new vaccine when I see no data in unbiased sources that would convince me that it is safe and it works. All we have are anecdotes from patients in phase 1 trials, government officials, optimistic scientists, and pharmaceutical companies to support what we’ve got.
And bad messaging is going to lead to several issues:
- The anti-vaxxers will use the evidence to support a condemnation of all vaccines. They’re already saying, “this is how we make all vaccines.” It isn’t, but that is what they’re doing.
- Parents and individuals “on-the-fence” about this vaccine are going to see the rhetoric of the anti-vaxxers followed by growing concerns in the scientific community which will make them avoid the vaccine. I know that some pro-vaccine people will say “screw them,” but without a high percentage of vaccinated people, we will not get a herd effect, and more people will die. That is not good.
- What worries me the most is that a bad vaccine is not only going to cause uptake in all vaccines to fall, but also will make some people think that the battle with COVID-19 is over.
I know that every day that is lost in getting a new vaccine to market could mean thousands of lost lives. I understand that and it is painful.
We are actually doing things that can rush the vaccine to market without sacrificing safety and effectiveness. Many companies are betting on a new vaccine using their own or government money across the world to build up manufacturing facilities. This alone could cut 1-2 years off the timeline. In normal times, a company wouldn’t do that until they’re really sure they have FDA approval, but we don’t have that luxury now.
Also, there are more resources being put into analyzing results which can speed up the timeline.
But there are things we should not rush. We need to have time to determine if the vaccine is effective for more than a few days or weeks. We need to determine if there are some rare adverse effects that may not show up for a few weeks.
Most vaccines fail in clinical trials. Now, we do have many starting in clinical trials now, so that improves the odds in our favor – unfortunately, several of these vaccine candidates are using novel methods that have never been shown to work in humans.
But it gets down to the same points I always make with respect to topics about which I write – the only thing that matters is evidence. If I see overwhelming evidence for the safety and effectiveness of a potential coronavirus vaccine, I will give it my full-throated support as I do with all other vaccines that already have overwhelming supporting evidence.
However, as of today, I don’t think we’re researching this vaccine in a scientific manner. We are doing guesswork in a rush to just get a vaccine, and that’s not going to get anyone’s enthusiastic support. And it could destroy our hard-won victories with other vaccines.
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