Here’s Why We Shouldn’t Have a Vaccine Before November
It’s not a race. It has nothing to do with politics.
Unless you have been living under a rock for the last several months, humanity is in the throes of a pandemic the likes of which we have not seen similar since the Spanish Flu of 1918. Of course, if you have been living under a rock, you may just want to stay there.
With the ease of transmission of the virus and the tragic global death toll topping 1 million, to say these are trying times seems like an insult. To put it simply, humanity is struggling to adapt to the over-cited ‘new normal’. With oversized trucks and ice rinks converted into makeshift morgues and convention centers-turned-hospitals, we are doing the best we can to accommodate the changes.
The pandemic is nonpartisan.
People worldwide are looking for answers. Unfortunately, the search has led many vulnerable to snake-oil cures. From false claims that advocate for injecting bleach or assertions that blow-driers will cure the coronavirus, we have been subject to a wide range of misinformation in the absence of longitudinal data for a novel virus.
Thankfully, science is here to help. Scientists and other academics worldwide are accelerating research to help us understand how to slow the spread, and hopefully, cure what’s currently ailing the globe. Unfortunately, however, the claims around a potential vaccine timeline are almost as outlandish as the aforementioned “cures”. Despite talk of a vaccine being available “momentarily”, this is a dangerous assertion. And it has nothing to do with politics.
The pandemic is non-partisan. It doesn’t care which political party you affiliate yourself with or if you vote by mail. It has no regard for your views on gun control, abortion, or immigration. It is an equal-opportunity infector, with a relatively easy mode of transmission from person to person.
Despite the lack of long-term longitudinal data, medical professionals are doing the best they can to better understand the means of transmission and the dynamics of the virus. From studying antibodies of those infected to looking into genetic signatures, the medical community is thoroughly investigating COVID-19 in hopes that it will yield a safe, effective vaccine.
However, clinical trials have only just begun. And there is a long road ahead.
If we consider the average timeline for drug development, from pre-clinical trials to final drug approval in the United States, it is extensive. The average time for drug approval is 12 years, and the costs associated are astronomical.
The cost to take a drug from novel concept to market is in the excess of $1 billion. If we look at the current clinical trials for a potential COVID vaccine, we are still in infancy, relatively speaking. Considering the fact that we only began trials earlier this year, we are only around the 6-month mark. But if we also account for the temporary halting of trials, such as those in the UK paused due to safety concerns, there is even less time in the developmental phase.
This pause was not unusual. For anyone who has done any sort of research in medicine or been involved in clinical trials, you will know this is fairly normal, especially for large trials. The temporary suspension was taken out of an abundance of caution and regard for the safety of the participants.
We want to take these types of precautions in medicine. There are many variables to consider when conducting drug trials, especially when one is taking a drug from concept to market. And each one of them should be considered carefully. Harmful drug interactions can arise, complications with proper dosage, unintended side effects, and more, can all crop up during the phases of a clinical trial. This is precisely why the process is extensive and thorough.
The development of a vaccine is costly in terms of human and financial resources. Vaccine development requires the following of standard procedure, including exploratory laboratory research, pre-clinical trials, human clinical trials, regulatory review, manufacturing, and quality control. This process takes several years.
Considering the dire circumstances across the globe, with over 200,000 deaths due to the coronavirus in the United States alone, it is understandable for one to want a quicker solution. Although there are pathways for accelerated development, such as Emergency Use Authorization (EUA), this methodology is not without its risks.
In the United States, there are means by which therapeutics may be developed outside of traditional clinical trial processes in extenuating circumstances. The EUA allows the Food and Drug Administration (FDA) to facilitate the development of a drug outside of normal protocols.
The EUA may be invoked during a state of emergency such as in the case of the current pandemic to accelerate development. However, there are numerous risks associated with rushing a vaccine or other drugs and/or medical devices to the market. If you have ever looked at the long list of potential side effects associated with most medications, you will understand. Except, in this case, we often do not even know what the side effects may be in the case of a rushed vaccine.
And unknown unknowns can be deadly.
We owe it to the human lives at risk, and the lessons we can learn from history, to take extra precaution.
There is a long history of empirical data that shows the benefits of vaccines; however, there is also a history of events that show some of the safety concerns which have helped enrich protocols over the years.
The Cutter Incident of 1955, pertaining to the polio vaccine, is perhaps the most well-known in terms of revolutionizing safety protocols in vaccine development. Although the vaccine passed the safety requirements during that time, hundreds of cases of polio were found linked to the vaccine. This led to the development of more stringent government oversight and vaccine manufacturing methodologies which have benefitted vaccine development in the decades that followed.
But if we consider that this happened after passing the required testing, we should reflect on what may happen without extensive safety testing. This is precisely what we are proposing with a rushed vaccine timeline. The consequence could be deadly.
We owe it to the human lives at risk, and the lessons we can learn from history, to take extra precaution. We need to ensure any potential vaccine is safe and effective with valid, reliable testing.
Our lives depend on it.
About James Goydos, M.D.
James Goydos is an expert in melanoma research and specialist in surgical oncology with an M.D. from Rutgers University. With over 20 years of experience as a Professor, Surgeon, and Clinical Trial Lead, he is a leading expert in his field.
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