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CORONAVIRUS PANDEMIC: 2nd Wave? Vaccine On The Way! Plus Other Promising Treatments

Brian Turner

Posted on June 16 2020

By Steve Blechman

 

On Monday, June 15, 2020 past commissioner of the Food and Drug Administration (FDA) Scott Gottlieb and Yuval Levin wrote an editorial in The Wall Street Journal entitled, New Rules for Covid Summer: Be Flexible and Vigilant in which they said, “even as economic activity is resuming COVID cases are rising in about a dozen states. This isn’t a second wave; it’s a series of spikes off the first surge. In the coming months, some states will see infections rise while others fall. The trick will be to manage the constant risk of COVID-19 while restarting normal life.”

I agree. We need to learn to live with the virus, but we can’t let it control our lives. How can we make society move forward without closing down? We can fight the virus and open the economy! Gottlieb and Levin further say, “That means for example, encouraging and practicing (sensible) behavior that can reduce the speed. Wearing face masks is the simplest and most effective, along with efforts to practice hygiene and distancing when possible.” They go on to further say, “When local hotspots arise, mayors and governors must trace the outbreaks to their origin and be ready to curtail specific activities that are the source of spread. The public is clearly willing to follow focused guidance. Broad shutdowns are unlikely to be tolerated this summer – and therefore are unlikely to be proposed regardless of what epidemiology shows.” Long shutdowns can also be bad for our health. They severely damage our economy and result in loss of jobs, which cause severe stress and human suffering for millions of Americans and their families.

Stress hormones are surging in our bodies, which can damage our health by causing hypertension, heart disease, obesity, diabetes and mental illness, alcohol and drug abuse, depression and suicide. COVID-19 has been a tragic nightmare causing loss of lives, pain and suffering for many. We will get through this! I have no doubt. Hope is on the way that a vaccine will be available sooner than later as well as other promising treatments.

According to Dr. Anthony Fauci (Healthline, June 8, 2020), “Hopefully by the end of this year, we will develop a vaccine we can deploy. We can never guarantee that. We can never, ever guarantee the success of a vaccine. We just have good experience to know that we are aspirationally, cautiously, optimistic that we will have one by the end of the year. If we do that, that will overwhelmingly be the fastest we’ve ever gotten a vaccine. That gives me hope.”

The race for a coronavirus cure is picking up speed. This summer, three experimental vaccines will enter Phase 3 trials, the final stage of testing meant to determine their safe and effectiveness, The Wall Street Journal reported. Moderna’s vaccine is set to be first, followed by one co-developed by Oxford University and AstraZeneca BLC and won by Johnson & Johnson. (The Wall Street Journal, Saturday/Sunday June 13-14, 2020). Other companies working on a vaccine are Pfizer, Sanofi US, Novartis, Merck & Company, Inovio, CanSino and the German pharmaceutical company BioNTech and Sinovac Biotech, based in China. President Trump is overseeing, “Operation Warp Speed” to hopefully get millions of doses available by the end of the year. China/India are also working on a vaccine at great speed. The key is who will win the race and provide billions of doses to the public. No one wants to wait several years while many die and our economy is destroyed. But what if it takes two to five years to provide a safe and effective vaccine in mass quantities in millions and billions of dosages? Or never, like in the case of treating immune deficiency virus (HIV), which has treated successfully without finding a cure or a vaccine but a drug cocktail to contain the virus?

That’s why it is important to continue work on other drugs and therapeutics to help fight against the coronavirus pandemic until a vaccine is available. There is no magic pill! The key is finding the ultimate drug cocktail and proven safe and effective in well-controlled clinical trials. Researchers are looking at hundreds of existed drugs being used for other treatments in trials at this time and hopefully some will be clinically tested and quickly available in the near future.

One of the most promising drugs and getting much publicity lately is the anti-viral drug remdesivir. In May, a study from the National Institutes of Health published in the New England Journal of Medicine found that remdesivir can speed recovery of Covid patients. It has modest effects. Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Disease said, “It doesn’t seem like a knockout 100%,” but has potential because it has proven it can block the virus. The FDA has granted emergency authorization to use Gilead Sciences’ remdesivir to treat Covid-19. The bottom line is no one anti-viral drug is going to be a magic cure! It will most likely take a cocktail of several different existing or new anti-viral drugs possibly combined with immunotherapies, convalescent plasma, monoclonal antibodies, hyperimmune globulins, anti-inflammatory drugs, ACE-2 receptor modulators and stem cell therapy.  We won’t know for sure until we do properly controlled trails to test for safety and efficacy when combined.

Regeneron Pharamceuticals, Inc. announced on June 11, 2020, the first clinical trial of REGN-COV2, its investigational dual antibody cocktail for the prevention and treatment of COVID-19. “We have created a unique anti-viral antibody cocktail with the potential both to prevent and treat infection, and also to preempt viral escape, a critical precaution in the midst of an ongoing pandemic,” said George D. Yancopoulos, MD, Ph.D., co-founder, President and Chief Scientific Officer of Regeneron. “REGN-COV2 could have a major impact on public health by slowing the spread of the virus and providing a needed treatment for the already sick and could be available much sooner than a vaccine.”

A new study published May 21 in the American Journal of Tropical Medicine found that the drug metformin was effective treatment in COVID-19 patients with diabetes and decreased mortality. A total of 283 patients (104 in metformin and 179 in no-metformin group) were included in the study. Diabetics are at major risk for getting and dying from COVID-19. “Anti-diabetic treatment with metformin was associated with decreased mortality compared to diabetics not receiving metformin. This retrospective analysis suggests that metformin may offer benefits in patients with COVID-19 and that further study is indicated,” the researchers concluded. Metformin is an amazing and very promising drug with an excellent record of safety for many years for the treatment of diabetes. It is now being prescribed off-label by some physicians for the treatment of aging, obesity, heart disease and certain cancers. The research is very promising! Metformin also has anti-inflammatory properties and may be useful in the battle and treatment of the cytokine storm, an uncontrolled hyperimmune response that increases mortality in COVID-19 patients.

It was reported in the Wednesday, June 3, 2020 in The Wall Street Journal that, “Amarin Corporation’s plans to test whether its fish oil-derived drug, Vascepa, can prevent and treat COVID 19 infection and reduce risk of cardiovascular problems in patients who sustain heart damage during their illness.” The story added:  “Amarin says Vascepa may help prevent or treat inflammation caused when the SARS-CoV-2 virus attacks the endothelium, layer of the cells lining blood vessels and inner walls of the heart chambers.”

An anti-inflammatory drug approved for treating rheumatoid arthritis, tocilizumab (Actemra), which I mentioned in my past articles, developed by the biotech company Genentech and sold by Roche Holding AG, has great potential in treating COVID-19 patients with the deadly cytokine storm. The cytokine storm elevates levels of proinflammatory cytokines such as interleukin-6 (IL-6), interleukin-1 (IL-1) and tumor necrosis factor (TNF). Research has shown that cytokine storm causes a hyperimmune response that can not only damage the lungs but also the heart, cardiovascular system, blood vessels, liver, pancreas, intestines, kidney and brain.  The cytokine storm also causes severe blood clots all over our body, increasing the risk of heart attack, stroke and pulmonary embolism. Other promising anti-inflammatory drugs for the possible treatment of COVID-19 include: an approved cancer drug called acalabrutinib (Science Immunology, June 5, 2020; Medical News Today June 10, 2020.) Also Humanigen’s lenzilumab, a monocolonal antibody therapy that calms down the cytokine storm, which kills many COVID-19 patients.

A major breakthrough treatment was reported this week (Reuters, June 16, 2020) that, “giving low doses of the generic steroid drug dexamethasone to patients admitted to the hospital with COVID-19 reduced death rates by around a third on those with the most severe cases of infection.” Scientists from the United Kingdom “suggest the drug should immediately become standard care in patients treated in hospital with the pandemic disease.” Peter Hornby, one of the lead clinical investigators, said that dexamethasone – a generic steroid widely used in other diseases to reduce inflammation – is, “the only drug that so far shown to reduce mortality and reduce it significantly. It’s a major breakthrough,” he said.

A major breakthrough was most recently reported and published in the May 4th 2020 issue of the journal Nature Communications, which reported “the first report of a (human) monoclonal antibody that neutralizes SARS-CoV-2.” The antibody is called 47D11. Neutralizing antibodies can alter the course of infection in the infected host, supporting virus clearance or protect an uninfected host that is exposed to the virus. “This is groundbreaking research,” said Dr. Jingsong Wang, the founder of Harbour BioMed (HBM), which carried out the study in the Netherlands with researchers at Utrecht University Erasmus Medical Center.

We already know that people over the age of 65 are at the highest risk of dying from the coronavirus. People who are overweight and obese (which increases inflammation) and those with preexisting ailments such as metabolic syndrome, hypertension, diabetes, heart and cardiovasacular disease are also at greater risk of death from COVID-19.

Like I said in my past articles, a healthy diet and lifestyle changes such as following the anti-inflammatory Mediterranean diet along with exercise has been shown to lower the risk of metabolic syndrome, and high-risk ailments. The Mediterranean diet is the healthiest diet, based on the latest scientific research. The Mediterranean diet, an anti-inflammatory diet, has great potential to naturally help tame down the uncontrolled hyperimmune response, which causes the potentially deadly cytokine storm and severe inflammation. The cytokine storm not only damages the lungs but also the heart, cardiovascular system, blood vessels, liver, pancreas, intestines, kidneys and brain. And it causes severe blood clots all over the body, increasing the risk of heart attack, stroke, and pulmonary embolism. The anti-inflammatory Mediterranean diet is rich in fish and seafood (containing omega-3 fats) and extra-virgin olive oil and nuts (rich in monounsaturated fats) and antioxidant-rich fruits and vegetables and red wine, and berries rich in polyphenols.

Recently, the Cleveland Clinic published a scientific review (June 2, 2020, Cleveland Clinic Journal of Medicine) entitled, What is the role of supplementation with ascorbic acid, zinc, vitamin D, or N-acetylcysteine for prevention or treatment of COVID-19? The review mentioned that zinc, vitamin D, and N-acetylcysteine (NAC) can lower proinflammatory cytokines such as interleukin-6 (IL-6), interleukin-1 (IL-1) and tumor necrosis factor (TNF.) The authors outline, “the biological plausibility, applicable clinical data and potential role of each of these agents.” The Cleveland Clinic Investigators continued to say that, “several agents intended to supplement dietary intake or indigenous molecules may have a theoretical role in preventing or treating COVID-19.” Based on their scientific review, the authors further acknowledge that “ascorbic acid, zinc, vitamin D, and N-acetylcysteine have biologic plausibility for prevention and treatment of COVID-19 and are candidates for clinical trials evaluating patients with these indications.”

In conclusion, as the economic pain of shutdown lessens and our economy begins to reopen, we cannot take our foot off the pedal in trying to curb the spread of the coronavirus! Eating healthy, exercising more, less daily stress, and getting adequate sleep can all help control our weight and improve our overall metabolic health. We also need more testing, which includes for diagnosis and antibodies (from an established FDA-approved company, such as Roche Holding AG) plus, social distancing (six feet separation), the use of face masks, and properly washing your hands. Also, most important, big pharma successfully finding the ultimate drug cocktail until an effective and safe vaccine is made available!!

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  1. Dietary Fats and Cardiovascular Disease: A Presidential Advisory From the American Heart Association Frank M. Sacks, MD, FAHA, Chair, Alice H. Lichtenstein, DSc, FAHA, Jason H.Y. Wu, PhD, MSc, Lawrence J. Appel, MD, MPH, FAHA, Mark A. Creager, MD, FAHA, Penny M. Kris-Etherton, PhD, RD, FAHA, Michael Miller, MD, FAHA, Eric B. Rimm, ScD, FAHA, Lawrence L. Rudel, PhD, FAHA, Jennifer G. Robinson, MD, MPH, FAHA, Vice Chair, Neil J. Stone, MD, FAHA, and Linda V. Van Horn, PhD, RD, FAHA, Vice Chair On behalf of the American Heart Association.
  1. Genentech Announces FDA Approval of Clinical Trial for Actemra to Treat Hospitalized Patients With Severe COVID-19 Pneumonia. March 23, 2020. AP News Wire https://apnews.com/Business%20Wire/9e97b7ad899e4bb4bcc80b0d5fc72c7d
  1. Mediterranean Diet Reduces Risk of Incident Stroke in a Population With Varying Cardiovascular Disease Risk Profiles. Paterson, K. E., Myint, P.K., Jennings, A., Bain, L., Lentjes, M., Khaw, K.T., & Welch, A.A. (Oct 2018). Stroke, 49 (10), 2415-2420. Advance online publication. doi:10.1161/STROKEAHA.117.020258   
  1. Weight Loss with a Low-Carbohydrate, Mediterranean, or Low-Fat Diet. Iris Shai, R.D., Ph.D., Dan Schwarzfuchs, M.D., Yaakov Henkin, M.D., Danit R. Shahar, R.D., Ph.D., Shula Witkow, R.D., M.P.H., Ilana Greenberg, R.D., M.P.H., Rachel Golan, R.D., M.P.H., Drora Fraser, Ph.D., Arkady Bolotin, Ph.D., Hilel Vardi, M.Sc., Osnat Tangi-Rozental, B.A., Rachel Zuk-Ramot, R.N., et al., for the Dietary Intervention Randomized Controlled Trial (DIRECT) Group. July 17, 2008. N Engl J Med 2008; 359:229-241   
  1. Dietary Fats and Cardiovascular Disease: A Presidential Advisory From the American Heart Association Frank M. Sacks, MD, FAHA, Chair, Alice H. Lichtenstein, DSc, FAHA, Jason H.Y. Wu, PhD, MSc, Lawrence J. Appel, MD, MPH, FAHA, Mark A. Creager, MD, FAHA, Penny M. Kris-Etherton, PhD, RD, FAHA, Michael Miller, MD, FAHA, Eric B. Rimm, ScD, FAHA, Lawrence L. Rudel, PhD, FAHA, Jennifer G. Robinson, MD, MPH, FAHA, Vice Chair, Neil J. Stone, MD, FAHA, and Linda V. Van Horn, PhD, RD, FAHA, Vice Chair On behalf of the American Heart Association.