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March 1, 2021
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As we turn our sites towards the final weeks of the pandemic, we must now consider how the COVIDization of healthcare will affect the future of healthcare. There are many lessons to learn, and the inevitable shift towards patient empowerment and digital technologies has only accelerated how we will implement those lessons.
Many of these lessons are hard practical truths about healthcare that we can quickly address. But there are more conceptual takeaways that we must be aware of as well. Conceptual shifts in how we approach healthcare fundamentally.
Throughout the course of the past fifty years of healthcare, we have gravitated towards medications as treatments and technologies as therapeutics. To the point that it has become reflexive. If a patient has a disease, treat the patient with medication. If the patient needs a procedure, find the latest, greatest technology to use in that procedure.
COVID-19 has introduced another key player that will be adopted in much the same way – vaccines.
One of the unexpected benefits from the pandemic was the widespread discussion of vaccine technology, and the untapped potential that technology has for healthcare. Not just for infections, but for a whole array of diseases. Soon we will have numerous vaccines attempting to preemptively address medical conditions long before they start.
And in many ways, these novel vaccines may be used in conjunction with medications in a unique, hybrid treatment. Instead of just taking daily medications for your diabetes, you would take an annual vaccine and daily medications for your diabetes.
If you have chronic pain, then you would take an annual opioid vaccine to prevent the likelihood of developing an addiction to the prescribed opioids.
The National Institute of Health has established the NIH HEAL Initiative, Helping to End Addiction Long-term Initiative, to study whether a vaccine can treat opioid use disorder.
In general, vaccines work by teaching the body’s immune system to create antibodies that can recognize an antigen, a foreign substance or toxin like seasonal flu or the bacteria Tetanus. An opioid vaccine would teach the body to make antibodies that recognize a targeted opioid. When the target opioid molecules appear in the body, the antibodies stick to them and prevent the opioids from entering the brain, triggering addiction.
Normally, opioid molecules can get through the blood-brain barrier because they are very small. But an opioid molecule that is stuck to an antibody would be too big to get through the barrier and remain circulating in the blood where it would eventually be expelled by the kidney.
Opioid vaccines could work with other medications currently used to treat opioid use disorder, and they presumably would not interfere with overdose rescue drugs like naloxone. Also, because vaccines produce antibodies that are highly specific to an opioid target, they would not interfere with the body’s natural abilities to control pain or with other pain management approaches.
At least that is the hope in this first phase of vaccine development. The main goal of this first phase of vaccine testing is to monitor safety and see if participants develop antibodies against oxycodone. And whether those antibodies bind to the oxycodone molecule to block the addictive effects of oxycodone.
Before the first injection, each patient will have a test to find out what dose of oxycodone it takes for them to feel pleasurable effects. After each vaccination, the test will be repeated, to see if the vaccine makes the oxycodone less effective – balancing the effect of oxycodone on the peripheral nervous system to control pain against the central nervous system’s addiction pathways.
A different opioid molecule will also be used to test the specificity of the vaccine response. If the vaccine works as expected, participants should have a less pleasurable response to oxycodone while still controlling their pain.
The researchers will also study how long the vaccine’s protection can last, estimating for now that the vaccine might protect against oxycodone effects for a few months. Longer-acting forms of treatment like an annual vaccine would theoretically help this type of treatment fit into people’s lives. And reduce the number of clinical visits would help patients stay compliant with treatment.
This is the potential benefit vaccines can provide. But before you get too excited, remember that we are just in the first phase of this opioid vaccine. And there is no guarantee that the vaccine will advance beyond this point.
The HIV vaccine was first developed in 1987, three years after we first discovered HIV. The first NIH sponsored HIV vaccine clinical trial enrolled 138 healthy, HIV-positive volunteers. The vaccine showed no serious adverse effects, but did not show much benefit either, and research efforts stalled. It was not until 2000 that the first HIV vaccine studies were finally completed, with equivocal results.
Although research efforts in this field continue to develop incrementally more effective vaccines, we continue to struggle to find an effective vaccine for the viral disease.
Yet we have plenty of reasons to remain hopeful as we improve vaccine design and development. Particularly since the widespread adoption of mRNA vaccines.
The mRNA vaccines have several benefits compared to other types of vaccines including shorter manufacturing times, and a greater potential for targeting a wider range of diseases. The process can also be standardized and scaled more easily, making vaccine development more cost effective than traditional methods. In addition, mRNA vaccine development techniques can make both existing DNA and RNA vaccines that are already used for other infections.
Previously, vaccines used part of a virus or another very similar virus to trigger an immune response, or a preemptive reaction to the actual virus. These parts could be a DNA strand of the virus, or an RNA strand, or some protein the virus, or a related virus creates when it reproduces in our cells. Now, with the mRNA technology, we do not need the actual viral part, we can synthetically create specific parts of a virus, or inflammatory markers from a disease, or proteins from a cancer cell. Essentially any biological molecule that we would like to trigger an autoimmune response towards.
We can create vaccines against all these diseases by creating mRNA based vaccines to trigger an immune response to these synthetically created viral parts, inflammatory markers, or cancer cells. While no widespread study has been conducted in humans, lab studies show that we can create mRNA vaccines that create immune responses to a whole array of triggering biochemicals.
Given the diverse and rapid manufacturing techniques mRNA vaccine provide, we may be able to use the technology to develop vaccines for a range of diseases at the same rate we developed the COVID-19 vaccine. And in large part due to the pandemic, we devised rapid, cost-effective manufacturing techniques to create mRNA vaccines.
In many ways, the recent techniques have increased the relative ease of manufacturing and ability to target non-infectious antigens by providing the necessary infrastructure that we can use for future vaccines.
Which is really the basis for the recent excitement for mRNA vaccines in the medical community. The technology may work, but it will not be adopted if it is too difficult to standardize.
The pandemic has brought a bright light back onto vaccines. We hope the medical community leverages this momentum to implement vaccines into more widespread use across a range of diseases.
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