Now that a few Covid vaccines have received approval in record time, the US is faced with another challenge – many Americans are unwilling to take the vaccine. The media have blamed this on people’s distrust in government, but a recent ICF survey revealed politics has nothing to do with it -- the biggest reason why Americans are reluctant to take the vaccine is safety concerns. And honestly I am in that camp.
As someone who has been working in the healthcare industry for decades, I’m a staunch believer in medical technology and innovation and their amazing contribution to increased longevity and quality of life. But I am also acutely aware we have only scratched the surface of understanding the mystery of our body. Western medicine, in particular, tends to treat symptoms in isolation, and all too frequently, will solve a targeted problem in one area only to cause problems in other areas of our body.
I learned this through my own personal pain. As a pre-mature baby, I suffered from poor health growing up. The miracle drug back then was tetracycline, an antibiotic that was very effective in curbing my fever and infections. It was not until years later that I learned one of the common side effects of tetracycline is discoloration of teeth. In fact, it is very common for people my age to have discolored teeth because tetracycline was the drug of choice at that time and no one (including the patients and doctors) knew about the side effect until decades later.
If you watch “The Bleeding Edge” on Netflix, an award winning documentary, you will see Essure, a permanent birth control implant for women, which was first brought to market in 2002, had many side effects, some of them so severe and so debilitating that they have literally destroyed the health for these women. But it took 16 years for these problems to surface and the voices of the victims to be heard. Bayer, the manufacturer took the product off the market in 2018, partially due to the exposure of the documentary.
Unsurprisingly, the documentary blamed the device industry for this tragedy. It is easy to point fingers at the big pharma, the medical device industry, and even the FDA, but the truth is most people I know who work in healthcare, have a true passion to help people. They do not intentionally pray on the vulnerable people, rather, they have dedicated their lives to helping people. Some of them may get too far with their ambition, but most of the unfortunate medical accidents happen because of the limitation of our knowledge. Medicine is an imperfect science and we are in a constant learning journey. Do you realize on average, about 4,500 drugs and devices are pulled from U.S. shelves each year? And among those, over 100 are classified as Class I recalls, products that have the potential to cause serious harm or death. For reference, FDA only approves fewer than 100 new drugs and medical devices each year. In other words, we are recalling previously approved drugs and devices more than we are approving new ones.
My point is we should all acknowledge that whenever we get a medical treatment, we are making a probability calculation: Does the benefit outweigh the risk. While the manufacturers, the FDA, the doctors, all play a role in helping us do that calculation, the ultimate responsibility resides in us, the patients. Nobody will know and care about us as much as we do. So we have to do the due diligence to fill out that probability equation rather than blindly trusting the “experts”, because the risks are different for each person and there is no one size that fits all.
Going back to the vaccine conversation, there are two vaccines currently available in the US: one from Moderna and one from Pfizer-BioNTech, both use a new technology called mRNA. Unlike traditional vaccines which place a weakened or inactive germ in our body, mRNA encodes the antigen of interest in messenger RNA (mRNA). The RNA is then injected inside the cell and it starts producing antigens on its surface. Our immune systems recognize that the protein doesn’t belong there and begin building an immune response and making antibodies, like what happens in natural infection against COVID-19. Scientists have been studying the mRNA technology for decades, but this is the first time it has been put in human bodies, at a large scale. And to be clear, these two vaccines have not been approved by FDA. They only got emergency use authorization, signaling while the FDA deems the benefits of making these unapproved products available for use during the pandemic outweigh the risk of not making them available, they have not yet met the FDA standard for full approval.
So what to do when you are faced with this impossible choice between a deadly virus and the unknown risk of a new vaccine? The answer is it depends. Each of us has a very different risk profile when it comes to Covid. John Hopkins has developed a mortality calculator based on health conditions, lifestyle, and where you live: https://covid19risktools.com. When I put my information into the calculator, it shows I am lucky enough to be in the very low risk category – I have 0.17 (95% CI: 0.15 - 0.18 ) times the risk of dying from COVID-19 compared to the average risk for the US population. My absolute rate of mortality is 2.8 (95% CI: 2.1 - 3.8) per 100,000 individuals in subgroups of the population with a similar risk profile to mine. But if I enter my dad’s information, the calculator comes out with a very high risk profile, with an absolute mortality of 1.7 per 1,000 individuals. So it would absolutely make sense for my dad to get the Covid vaccine because the risk of getting the disease and die from it clearly outweighs the risk of unknown side effects of the Covid vaccine. For me, the risk of getting exposed to the virus is fairly low right now as I’m working from home, and the risk of dying from the disease is also extremely low, it becomes much harder to evaluate whether it is worthwhile for me to risk the unknown side effects the vaccine might cause.
So what do I do? Well, first of all, I’m not in the priority category (65 or older, healthcare worker, essential worker), so I would not be able to get the vaccine even if I want to. But that’s exactly where I want to be right now: to wait. I want more time to gather more safety data. So far, we are already seeing some severe, although rare reactions like anaphylactic shock (11.1 cases per million doses). According to the Texas Department of State Health Services, through end of 2020, 250,000 vaccines were administered in Texas. During that same time frame, 287 adverse events were reported, eleven of which were classified as serious. This included the death of an 84-year old woman and another person who reported they were permanently disabled.
I also want to wait to see if other vaccines will come to market. The Vaccine Alliance (www.gavi.org) offers a great overview of 4 types of vaccines. Unlike the mRNA technology, the other 3 types are older technologies and have been time tested and proven. Newer is not necessarily better when it comes to medicine. Two specific ones I’m watching are:
1) Vaccine developed by AstraZaneca, which is already in use in the UK and is targeting to be authorized in the US in March. It is based on the viral vector technology, which has been used in the Ebola vaccine.
2) Vaccine developed by SinoPharm, which has been conditionally approved in China. Although its reported efficacy of “79%” is not as impressive as Pfizer’s “94%” or Moderna’s “95%”, it is based on the oldest vaccine technology: inactive virus.
Finally, when the vaccines become available to me, I will probably do an antibody test first. My husband and I went to the Mardi Gras in New Orleans in February 2020 and came home really sick. Back then no Covid tests were available in the US so we don’t know if we had Covid or not. If we did and have already developed some immunity then we may not need to risk taking the vaccine any more.
So it is a complicated decision. And it should be. It’s not that I do not believe in science, nor am I making any political statement. It’s simply I recognize I only have one body and it is me who will live with this body every minute of the day. So I take it very seriously. You should too -- do your own due diligence and make your own risk benefit analysis.
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