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COVID-19_Vaccine_GLA-Kobre POV

COVID-19: Is a Vaccine the Answer?

Point of View: Looking through the Lyme disease lens in weighing the vaccine and treatment path for COVID-19


by Robert Kobre, Chairman, Global Lyme Alliance

The United States is currently in a struggle between “opening up” to alleviate economic hardship and self-isolation to protect against infection from the current coronavirus. The nation can only return to pre-COVID-19 economic and social levels when the fear of death or grave illness is eliminated. As Chairman of the Global Lyme Alliance (GLA) I bring a unique perspective to this issue, as I have been deeply involved in our leading scientific research program for the last 10 years. The immune system is an extremely complex system that protects us from everyday exposure to harmful agents. Although new discoveries are constantly being made, one thing is clear that the public needs to understand, –the human immune system is not fully understood by scientists and doctors, and neither are most infectious agents. This incomplete knowledge of our immune system does not mean there is no hope, – it does mean that the general public must become well informed of this “knowledge gap” so there is no rush to judgment on any proposed solution to the current health crisis.

Thought leaders in industry, the media, and government constantly sing the same COVID-19 recovery song: “when there is a vaccine we can operate normally again.” The stock market is overreacting to morsels of embryonic vaccine research news. Dr. Anthony Fauci, head of infectious disease at NIH, has consistently referred to the development of a SARS-Cov-2 vaccine and its necessity before society can return to a ‘new’ normal. Friends, colleagues, and clients echo this all the time. The problem is that this proposition is short-sighted and focused on the wrong target. While a safe, effective vaccine is an important long-term objective, the primary focus must be effective treatments that can eradicate the virus, prevent it from infecting cells and also turn down the massive inflammatory “cytokine storm” triggered by the infection. Perhaps a genetic component in our immune system also plays a role in determining who cannot fight the disease. All angles should be intensely explored.

We should take comfort that scientific leaders and large pharmaceutical companies understand the need for speed and are focusing heavily on therapeutics while vaccine work continues in parallel. If Americans knew a simple trip to the pharmacy would stop their COVID-19 symptoms, fear would cease and the economy could safely reopen. If this were given prophylactically, it would also reduce the infection rate while a safe vaccine is finally developed. According to ClinicalTrials.gov and the World Health Organization, there are at least 1,300 COVID-19 clinical trials underway worldwide, and importantly the number of trials focused on therapeutics (drugs) outnumber those searching for a vaccine by almost 10 to 1. Why, despite the rhetoric, should there be a greater focus on a drug to stop the symptoms of COVID-19 over a vaccine?

Drugs provide great flexibility, their side effects are typically reversible once a patient stops using them, and they are easily acceptable and accessible by the general population. Vaccines are an important arsenal in the fight against disease, yet vaccines carry risks because they tamper with an immune system we don’t fully understand. Further, vaccines are one dose fits all versus a drug whose dose and usage can vary depending upon the patient’s profile like age or their symptom severity. A vaccine’s side effects (other than fever) are typically harder to measure because they occur over long time periods.

Since a vaccine’s serious side effects tend to be autoimmune in nature, they are typically not reversible as opposed to an approved drug where the side effects tend to cease when the drug is stopped (excluding those taken during pregnancy). Lastly, not everyone will be quick to be vaccinated but would be more likely to take a drug for a period of time. The COVID-19 crisis provides an opportunity for the drug approval process to be reinvented in a creative way to expedite the process with reduced costs. Vaccines do not offer that luxury. A vaccine is critical to wiping out the disease, but it must not be rushed.

A case in point occurred in the late 1990s. A new Lyme disease vaccine was introduced which was developed by some of the top researchers in the world. The vaccine was widely distributed and for most people, it worked, but for some, it may have triggered the devastating symptoms of Lyme disease. Measuring the side effects of vaccines once launched is difficult as it requires patients or their doctors to realize that current symptoms are related to a vaccine taken many months before and have enough confidence in that causal effect to report the side effect voluntarily to the federal Vaccine Adverse Effect Reporting System (or “VAERS”). While some specialists today claim the side effects of the Lyme vaccine were overplayed, there was in fact a component of the vaccine that caused an auto-immune reaction consistent with Lyme disease. The vaccine was taken off the market three years after it was introduced.

At GLA, we have Ph.D.s on staff who work closely with top immunologists and microbiologists at the world’s leading research universities. What we know is important for the American public to understand – not only are researchers still learning how the immune system works, but scientists across the globe and GLA are also looking closely at the interplay between the immune system, nervous system, and the brain. Unfortunately, we are only in the 2nd inning of a 9-inning game. As such, the neurological and psychological side effects of any new SARS-Cov-2 vaccine must be included in the suite of side effects measured – in kids, teens, young adults, adults, and the elderly. A new vaccine must be carefully developed, tested, and all side effects measured over an extended period so the public can be fully informed of the risks.

So Lyme disease again provides a lens into which we can view the COVID-19 landscape. We learned that vaccines can have real downside risks if not developed correctly. We learned that in most cases they do not help those already ill. We learned that a safe vaccine is extremely important but in the short term drugs to stop the virus and its symptoms are critical. Let’s hope that the constant discussion in the media tying economic recovery to a vaccine does not lead to rushed vaccines that may unwittingly carry side effects that negatively impact more people than the vaccine saves. Global governmental leaders, media pundits, the financial markets, and captains of industry must get in sync with pharmaceutical firms and academic researchers who understand the quickest way to normalize life again is with effective drugs. We all want a vaccine that eliminates COVID-19 from the globe like was developed for polio and smallpox. In the meantime, as that vaccine is being developed, GLA has confidence that American and global researchers will come up with effective drug treatments as long as they are provided abundant resources, inducements to collaborate and encouragement to think outside the box. GLA has been fighting a rapidly growing, crippling disease for a long time, and our research program has developed more scientific breakthroughs than any other Lyme focused not-for-profit organization. We are uniquely qualified to bring what we have learned in the lab and our experiences to the COVID-19 problem in an effort to educate and bring relief to the nation and the world.

Additional COVID-19 and Lyme Disease Resources:

GLA POV: Parallel Pandemics: COVID-19 and Lyme Disease
Blog: Q&A on COVID-19 and Lyme Disease with LLMD
Blog: Personal Patient Experience with COVID-19 and Lyme Disease
Video: Webinar with Dr. Cameron and Lyme-COVID-19 patient
Letter: GLA CEO Addresses COVID-19 and GLA Community
Letter: GLA Chairman on What We Can Learn from COVID-19 Response

Why Isn’t There a Lyme Disease Vaccine?

by Ashley Ross from The Daily Beast 

Blame its bacteria’s weird protein structure.

For 25 years, Heather McKean has experienced uncomfortable, unexplainable health issues. Since she was five years old, the 30-year-old has lived with everything from migraines to sinus infections, gastrointestinal issues and chronic fatigue. It wasn’t until June of 2017 that she finally received a diagnosis that made sense of it all: Lyme disease.

“I went from being really excited to having a diagnosis to, like, of course I get the diagnosis that’s really hard to treat,” she told The Daily Beast.

What makes it worse is the fact that there are no vaccines to help fight it.

Lyme disease is an infectious disease caused by the bacterium Borrelia burgdorferi. The disease is known to be difficult to diagnose, as many early symptoms are vague, like headaches and fatigue.

In its earliest stages, Lyme can be combated with antibiotics—but that’s if it’s recognized early. The longer it takes to treat Lyme, the more likely it is for it to become a chronic disease, like McKean’s.

“Yes, there has been difficulty moving forward, but I think we’re at a turning point.”— Richard Marconi, Virginia Commonwealth University

Which makes it even more odd that a vaccine for Lyme disease doesn’t exist, particularly because cases are spiking. Earlier this month, the CDC reported that many vector-borne infections are not reported or recognized, making it difficult to estimate the cost and burden of these diseases. “We know that the number of Lyme disease cases that actually occur each year are approximately 300,000, or 10 times higher than what is nationally reported,” Lyle Peterson, Director of CDC’s Division of Vector-Borne Diseases, said in May on a press briefing call, also reporting that Lyme disease makes up 82 percent of all tick-borne diseases.

So will there ever be a vaccine?

“There was a vaccine on the market in 1998 and for a variety of reasons, that vaccine failed and was pulled. As a result, it soured the market in big pharma’s interest in moving forward,” Richard Marconi, a Virginia Commonwealth University professor in the department of microbiology and immunology, told The Daily Beast.

That vaccine, called LYMERix, targeted Lyme’s outer surface protein A (OspA), and was not available to use in people under the age of 15. Even though 1.5 million people used the vaccine in 1999, public trust of the vaccine dissipated for various reasons including the rise of anti-vaxxers, a study citing that the vaccine could cause arthritis in hamsters and a class action suit against the vaccine’s manufacturer.

But Marconi said that the tide is turning when it comes to developing a new vaccine for Lyme.

“A couple things have happened that have turned the tide, and one of those is a much better understanding of the incidence of Lyme in humans,” he said. “We know it’s a much greater problem than had been appreciated in the past two decades, and we know that the ticks that transfer Lyme disease are spreading at an alarming rate, and we’ve actually gotten tremendous support from the National Institutes of Health and private foundations like the Cohen Foundation and The Global Lyme Alliance.

“So, yes, there has been difficulty moving forward, but I think we’re at a turning point.”

Read the full article here.