Vaccines for COVID are being distributed in the United States at a much faster rate than I would have expected. In two to four weeks, the United States is expected to reach the point in which the supply of vaccines is going to outpace the demand of vaccines. As of April 28, 2021, 54.2 percent of adults have received at least one dose of the COVID vaccine. This would normally be good news for the goal of herd immunity, which is when a high enough percentage has developed immunity (either through contracting the disease or getting vaccinated) in which the spread of a disease is highly unlikely. The reason why I hold back on expressing joy in "returning to normal" is because herd immunity now has another obstacle: vaccine hesitancy.
Vaccine hesitancy is the reluctance or refusal to vaccinate against contagious diseases. Morningstar Consulting provides some interesting insight on those who are vaccine-hesitant. Below are some demographic trends on who is vaccine-hesitant, but I want to touch upon the "why" for a moment. Those who are unsure about the vaccine (as opposed to those who simply refuse to vaccinate) have a few reasons to not vaccinate. The most often-cited reasons are concerns about the side effects and worried about the vaccines having moved too quickly through the clinical trials. There are other reasons (e.g., questioning the effectiveness of the vaccines, perceived unlikelihood of contracting COVID), but I want to touch upon safety and the rate at which the vaccines were produced because they seem to be the major drivers of COVID vaccine hesitancy.
I understand the issues of safety and whether a vaccine development with the name of "Operation Warp Speed" meant we rushed things or cut corners. I expressed these very concerns back in October and had correctly predicted that it would be difficult to persuade a significant percentage of citizens that the process was not needlessly hastened. A couple of weeks ago, I was able to get a vaccine appointment. The hesitancy went rushing through my mind. Ironically, I was more unnerved about getting the vaccine than I was throughout the rest of the pandemic. In November, I had COVID with two strains of pneumonia, and the unknowns of the vaccine were more distressing than the unknowns of what having COVID would mean for me. Granted, I'm a healthy thirty-something that exercises regularly, which is significant because a study from the British Journal of Sports Medicine released a study this month showing that regular exercise greatly reduces the likelihood of severe COVID (Sallis et al., 2021).
In spite of hesitating, I surpassed the worries, fears, and trepidations and I received my first Pfizer dose. First and foremost, I had to remind myself of the messaging I had been using throughout the pandemic: there is no such thing as living a zero-risk life. There are only tradeoffs. There is a risk to getting the vaccine, but there's also a risk of not getting the vaccine. Clearly, the risk is higher if you're in a high-risk category, such as being elderly, immunocompromised, or simply living an overall unhealthy lifestyle that would make fighting off an infection all the more difficult.
If you don't believe me, ask rock star Ted Nugent. Throughout the pandemic, he flat-out denied that coronavirus existed. He thought it was a hoax, at least until he contracted COVID-19. When he had COVID-19, it was so bad that he thought he was dying. We will talk more about risk momentarily, but I want to emphasize the point of "a zero-risk life" because society has become so risk-averse during that this pandemic that many have come to think that a life without risk is possible. It is how "follow the science" resulted in implementing onerous lockdowns with zero evidence, keeping schools closed when evidence showed that schools are not super-spreaders, and people became obsessed with cleaning surfaces, even thought the likelihood of catching COVID-19 through a contaminated surface is next to nil.
Fear has been used to keep most citizens compliant with the regulations, regardless of how much or little evidence there actually is. That motivation of fear is now being used to keep people from getting vaccinated. I'm not arguing for living a life without fear. There are things that can and do kill people. We need to find the balance between making sure fear doesn't paralyze us from living and being so fearless that we are oblivious to that which could harm or kill us. After all, that is the point of risk assessment. To do that, we need facts about the vaccine development. We cannot be so scared of COVID-19 that we take the vaccines without asking any questions. We also cannot be so scared of the vaccine that we refuse a vaccine, facts be damned.
This is why before getting my vaccine, I talked with multiple friends in the medical community, ranging from doctors and biologists to chemists and virologists. I also did my own research because I am an applied social sciences researcher by profession and it is what I do generally. I consider myself as someone who as a healthy dose of skepticism, and it has fared well for me over the years. I have to keep in mind that I can be both skeptical of the vaccine and what would happen if I did not get the vaccine. With so many other things in life, I wondered about alternate scenarios. Even so, I chose to get the vaccine. What I outline below are facets I discussed with my friends in the medical community and what I found through research. So what are reasons to believe that getting the vaccine is significantly safer relative to not getting the vaccine?
- Currently available COVID vaccine data. Whether it is Moderna, Pfizer, or Johnson and Johnson, the FDA reports pointed out that were no serious or prevalent safety concerns during clinical trials. Even with the blood clot issue in the Johnson and Johnson vaccine, that was less than a 1 in a 1,000,000 likelihood, which is much lower than the probability of 1 in 20 getting a blood clot if you got a severe enough case of COVID in which you were hospitalized. Regarding short-term data, it has been found that the Moderna and Pfizer vaccines were shown to have over 90 percent effective (about 67 percent effective for Johnson & Johnson). Essentially, the vaccines are shown to be efficient at preventing getting COVID-19 generally, even more effective at preventing moderate-to-severe cases, and all the while, adverse reactions are extremely rare (e.g., Baden et al., 2021; Polack et al., 2020).
- We still do not know how long the COVID vaccine lasts, nor do we know of long-term health effects. These are completely valid concerns to have, and ones that I share. At the same time, there are already concerns about the long term-effects of COVID, commonly known as long COVID. Other diseases have resulted in long-term effects, including, but not limited to, the West Nile Virus, the Spanish Flu, celiac disease, and diabetes. If you are going to be scared of the unknowns of the long-term effects of the vaccine, you also need to be scared of the unknown, potential long-term effects of COVID-19. That argument cuts both ways if you are going to be consistent with having the unknown dictate your life.
- Until we have such data on long-term effects of the vaccines, we can use other licensed vaccines as a proxy. What we do know is that currently licensed vaccines are not shown to have long-term effects, certainly at the likelihood at which people are concerned (UC-Davis). Throughout vaccine history, if an issue is to arise, it has reared its ugly head within the first two months. More than two months have passed since the clinical trials and beginning with mass vaccination. If vaccine issues are most likely to happen within the first two months, wouldn't we have noticed by now?
- 5/7/2021 Addendum: As mentioned above, vaccine history suggests problems are most likely to arise within the first two months, which means we should have enough vaccine data to infer something about safety. I want to do an apples-to-apples comparison on the likelihood of dying from COVID versus dying from the vaccine, and to do so with assumptions generous to the vaccine-hesitant. According to a Stanford professor and scientist (Ioaniddis, 2020), the median infection fatality rate across 51 countries is 0.23 percent. This assumption about IFR is generous because the estimates for the IFR has ranged from almost 0.0 percent to 1.6 percent (Gøtzsche, 2020). Per the CDC's vaccine database, there have been 245 million doses administered as of May 3. There have been 4,178 deaths reported for those who had the COVID vaccine. For argument's sake, let's assume that all of those deaths were caused by the vaccine. That still means 0.0017 percent likelihood of dying from the vaccine. What is the relative likelihood that you will die from COVID versus dying from the vaccine given those generous assumptions? If you do the math (0.23/0.0017), it means that you would be 135 times more likely to die from COVID than you are from the vaccine.
- Already-existing vaccine research. The idea of a vaccine is not new. Vaccine development has existed for about 200 years, and that has resulted in the development of highly effective and highly safe vaccine platforms. As the technology improves, the timeline for such development shortens, as we will see shortly. The challenge is not developing the vaccine platform, but making sure that the right viral antigens are safe and effective for humans (University of Chicago). I'm not here to say there has never been a single issue related to vaccines in the entire history of man, but vaccines generally have had an overall good track record historically. Like with other technological developments, the quality of safety gets better over time. To quote FactCheck, "No vaccine or medical product is 100 percent safe, but large randomized control trials, reviewed by multiple groups of experts, revealed no serious safety concerns and showed that the benefits [of vaccines] outweigh the risks."
- We had a head start in terms of coronavirus research. The media loves to peddle the idea that COVID-19 as a "novel virus." That, of course, is to stoke fear and boost their ratings of the supposed unknownness of COVID-19. The fact of the matter is that COVID-19 is hardly a novel virus. As a matter of fact, there are hundreds of coronaviruses, according to the National Institutes of Health. Prior to COVID-19, the two most famous coronaviruses were severe acute respiratory syndrome (SARS) and the Middle East respiratory syndrome (MERS). We did not start from scratch on COVID-19 research. We already had research from SARS and MERS that provided a foundation for the COVID vaccine research and development process. Plus, scientists have been studying coronaviruses for the past 50 years, including the structure, genome, and life cycle of coronaviruses.
- mRNA technology is not new. It is true that mRNA technology, the technology used in the Moderna and Pfizer vaccines, has not been previously used to produce a marketable product (i.e., licensure). At the same time, scientists have been researching mRNA technology for about four decades now. As for mRNA vaccines specifically, that has been in the works for about a decade. It has been used in the clinical trials to develop vaccines for Zika, rabies, and influenza. To quote the Word Health Organization, "mRNA vaccines are not live virus vaccines and do not interfere with human DNA." mRNA vaccines are not based on live virus. The spike protein is primed in our immune system and disappears forever, just like it has for so many other already-proven vaccines.
- Global collaboration. As soon as the genome sequence was discovered in January 2020, it was shared with scientists throughout the world. Since then, there has been a high level of collaboration in terms of sharing research results with other scientists. This collaboration is a continuation of what was developed during the Ebola and Zika outbreaks, including the Coalition for Economic Preparedness. The collaboration is important because the more information scientists have and share with one another, the faster they can produce a vaccine.
- There was unprecedented funding in COVID vaccine development. Vaccine development is a financially risky endeavor for pharmaceutical companies. It costs billions for a vaccine that may never work. A lack of funding is one of the primary reasons that vaccine development can be dragged out over a period of years. In the case of COVID-19, there was a lot of money allocated. With Operation Warp Speed under the Trump Administration, $18 billion was allocated to offset the price of vaccine development. Additionally, the government taking on the financial risk meant that the earlier clinical stages were consolidated.
- Enrollment numbers for COVID clinical trials. One of the reasons that vaccine development has historically been long is because finding a sufficient number of participants. Phase III of clinical trials typically require 3,000 participants. For less common diseases, filling up those spaces can take years. Given the prevalence of COVID-19, it was easy to accumulate trial participants. The Moderna trial had 30,000 participants, which is well above average. Not only did we see an adequate number of participants, but the larger-than-average sample size of participants should inspire greater confidence because the findings have greater statistical significance.
- Cutting through the red tape. Normally, it takes two months to a year because there is so much administrative work before a trial can even begin. With the urgency of the pandemic, regulatory agencies prioritized the vaccine studies and essentially cut through much of the red tape. This is significant because as the libertarian Cato Institute points out, the FDA approval process is so long to begin with that it actually costs lives. Let's hope that cutting through this red tape is not a one-time occurrence.
- Review process. One argument used against the vaccines is that only emergency use authorization (EUA) is being used by the FDA. The reason is because that the medium-to-long-term effects are not understood. They instituted what is referred to as rolling reviews. Instead of reviewing all the data once at the end of the clinical trial, the data were reviewed throughout the trial on an ongoing basis. More to the point, there are independent bodies that monitor both the data and the safety, as well as the ethics of the clinical trials. Even well after the EUAs and the rollouts of the vaccines, the vaccines will continue to undergo rigorous monitoring and evaluation to make sure that there are no widespread, long-term effects. What is going on in terms of oversight is far from the notion peddled by anti-vaxxers that it was simply thrown together with no consideration for safety.
- Vaccine development was streamlined. With a global pandemic such as this one, time was of the essence. Under an accelerated timeline, stages in the vaccine development process either overlapped or occurred simultaneously. Even when the clinical trials were ongoing, the funding from Operation Warp Speed was already being used to simultaneously manufacture the vaccine doses. Also, vaccine developers were able to combine Phases II and III because they had so many participants. For more information on how the vaccine process was streamlined while still assuring safety protocols, please see the video from the World Health Organization below.
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