July 23, 2020

Cures Are Around the Corner

When will a COVID-19 vaccine be introduced to the market? What treatments are most effective for ill patients? And, what antibodies will protect people from getting the virus?

Many of us don’t know what to believe because we read and hear from extremes on both sides. Information is frequently misunderstood or manipulated. Data and messaging have been inconsistent, which is frustrating for those of us who are looking for research-based, accurate information about the virus. The reason we provide these regular updates is to hopefully help you gain information from the best medical, economic, research and financial experts in the world. We are distilling information we gather and read so you can read different viewpoints about COVID-19 and share with others who are interested. I’m appreciative of the significant assistance I’ve had from Kristen Hampshire in the research and writing of these articles.

Currently, research scientists and our talented medical professionals are working around the clock to answer these questions.  Across the globe, more than 14.7 million people have been infected with COVID-19. More than 609,000 people have died, and one-fourth of these deaths have occurred in the United States, based on Johns Hopkins University data.

The United States has a number of hotspots, where COVID-19 cases are spiking—states including Florida, Texas and Arizona, where confirmed cases are on the rise.

What’s interesting is, Western Europe’s reopening—which has included gathering in bars, restaurants and beaches—has not resulted in a surge of COVID-19 cases. Countries are citing behavioral change as the reason for their success. The three-pronged approach includes: 1) social distancing; 2) enhanced hygiene and mask-wearing when necessary; and 3) older adults and vulnerable individuals being especially careful.

It’s important to understand how people are getting the virus, and how they are not getting it. Anecdotally, we are hearing from U.S. infectious disease doctors that positive cases are traced back to gatherings indoors, such as spending time in bars without social distancing or entertaining groups of people at home indoors for prolonged periods of time. When people wear masks, social distance, wash/sanitize their hands, and avoid large indoor gatherings, they significantly reduce their risk of getting the disease.

Fear and Uncertainty

The other week, I shared insights about immunity and ways to protect our health so we can hopefully prevent the disease, or at least curb its worst side effects. Ultimately, what we need to return to work and rebuild the economy are vaccines, treatments and available testing. This will help settle the tremendous amount of fear and uncertainty around this virus.

While some of us have loved ones who are struggling to beat the virus, most of us don’t know anyone who has been diagnosed, based on the number of people infected in Ohio. Some people get deathly ill from the disease, others don’t get that sick, and many more will not get the virus at all.

There is also fear about returning to work and school, and whether resuming daily activities is safe. It doesn’t appear that most people will feel comfortable until there is effective drug therapy and/or a vaccine.

Finally, the nonstop information filtering from news media, social media and other outlets is driving uncertainty. There is a lot of misinformation. Not to mention, this unfortunately has become a political issue when it should be treated purely as a medical crisis.

There is a cure around the corner. My hope here is to share reputable, reliable insight about ways to boost immunity, drug therapies that hospitals are testing, and vaccine research and clinical trials.

I trust our world-class medical team at Cleveland Clinic and other renowned hospital systems, and our country’s dedicated research scientists—along with the caregivers who are working on the front lines. I hope you find this information helpful and share it with those who are interested.

Who’s Most Susceptible to the Virus?

Based on what we know, there are at least thousands of people walking around with the virus, yet they are completely asymptomatic. Some get COVID-19 and never know it, while others are ushered to the ICU, put on a ventilator and suffer greatly. 

World Health Organization (WHO) data suggests that 80% of infections are mild or asymptomatic, 15% are severe and require oxygen, and 5% are critical, requiring ventilation.

According to the CDC, almost 90% of COVID-19 hospitalized patients have some type of underlying condition: hypertension (high blood pressure), obesity, chronic lung disease or cardiovascular disease. New York University (NYU) showed that obese patients under the age of 60 were twice as likely to be hospitalized for COVID-19 than those of a normal weight; and 40% of adult Americans are considered obese. Most underlying risk factors are related to lifestyle.

There is also interest in blood type. A study published in the New England Journal of Medicine found stretches of DNA that harbor risks for severe COVID-19. One determines blood type. Findings suggest that people with blood type A face a 50% greater risk of needing oxygen or a ventilator if they are infected with the virus. However, people with blood type O seem to have a 50% reduced risk of severe COVID-19.

How many people are dying across the world of the virus? According to a July 21 Wall Street Journal article, research examining deaths out of the total number of infections suggests COVID-19 kills 0.3 to 1.5% of people infected. Most studies say the rate is 0.5 to 1.0%. So, for every 1,000 people infected, 5 to 10 people will die on average.

But what health professionals say is important to note is how contagious the disease is. It is deadlier than the seasonal flu, but not as fatal as Ebola and some other infectious diseases.

Boosting Immunity 

Building immunity is a topic of greater interest now than ever before as we gradually re-open the economy. What supplements, whole foods and health habits can prevent us from getting COVID-19, or improve our chances of recovering should we get the virus?

There have been many studies evaluating intakes of nutrients and how they might combat infection. Dr. Todd Pesek, holistic physician and author at VitalHealth Partners, advises supplementing a healthy diet with whole foods with supplements. Since releasing the last article, Block the Virus, Build Immunity, a number of friends and colleagues have reached out to let me know they are now supplementing their diets with these vitamins, minerals and probiotics because they believe it will make a difference. Here is what Dr. Pesek recommends:

  • Vitamin D3. A daily dose of 6000 to 8000 IU is when blood vessels are optimal, he says. A global collaborative study showed that Vitamin D supplementation can cut the risk of respiratory infection in half.
  • Iodine. Take 3 to 6 mg per day, and double up during illness, stress or travel. Even fluctuating weather can stress the body and warrant a higher dose, he says.
  • Probiotics. Dr. Pesek recommends 30 billion CFU of a good, quality probiotic blend.
  • Zinc. According to the Harvard School of Public Health, inadequate zinc levels limit your ability to fight infection. Oral zinc supplementation reduces the incidence rate of acute respiratory infections by 35%, shortens the duration of flu-like symptoms by about 2 days and improves the rate of recovery. Studies used a dose of zinc ranging from 20/mg per week to 92 mg/day.
  • Vitamin C. Again, Harvard reported that Vitamin C acts as an antioxidant by limiting inflammation and tissue damage. Some critically ill patients with COVID-19 have been treated with high doses of IV vitamin C to hasten recovery. There is no clear scientific evidence.
  • Elderberry and Turkey Tail Mushroom. Dr. Pesek says these have shown to decrease the severity and duration of viral infections by more than half and are more effective than drugstore options like Tamiflu.

Beyond Supplements

Cleveland Clinic conducted a COVID-19 risk prediction study using data from 12,000 patients enrolled in the Clinic’s COVID-19 Registry of more than 23,000 patients. Here’s what the study found:

  • Those who received the flu vaccine and PPSV23 vaccine for pneumococcal disease are less likely to test positive for COVID-19.
  • Patients who take melatonin, carvedilol (for high blood pressure) or paroxetine (anti-depressant) are less likely to test positive with the virus.

Treating Coronavirus—Drug Therapy

We will feel more confident returning to work and school, and being out in the community to run errands or handle everyday business, when we know there is an effective treatment for COVID-19. There is a lot of research activity and hospitals are utilizing drugs already on the market to see if they will counteract the virus.

We know that many regions have experienced a spike in cases, and our communities are preparing for a second wave in the fall. Because of this, hospitals are stocking up on drugs to treat the sickest patients who end up on ventilators—medications like the steroid dexamethasone and the antiviral remdesivir. As for treatment efficacy, dexamethasone was shown in June to be effective in treating the sickest patients, according to University Hospitals’ pharmacy and supply chain services head, Shawn Osborne, who reported to the Wall Street Journal that it is now part of their protocol.

What other drug therapies are hospitals relying on to either treat the symptoms or hopefully stop the virus from escalating? Health systems are building safety stocks of 20 critical medications, according to Premier Inc., as reported in a July 14 Wall Street Journal article. Demand for these medications is even higher now that many hospitals have revised treatment guidelines and are trying to use ventilators less.

Here is some of the information we are learning more about how COVID-19 impacts the body and what treatments might work.

  • Harvard reported that Vitamin C acts as an antioxidant by limiting inflammation and tissue damage. Some critically ill patients with COVID-19 have been treated with high doses of IV vitamin C to hasten recovery. Although, there is no clear scientific evidence on this.
  • Some argue for the use of inhaled corticosteroids (used for asthma) to improve outcomes in acute respiratory infections due to COVID-19. A trial in France is looking at adding Symbicort to its standard of care. However, Midland Memorial Hospital in Texas weighed in on the issue of inhaled corticosteroids and said there is no evidence as to whether inhaled corticosteroids can improve outcomes in acute respiratory infections due to COVID-19.
  • Mount Sinai Health System in New York City is testing whether a drug derived from the blood plasma of recovered COVID-19 patients can prevent infections in front line workers, including doctors, nurses and military forces. A Wall Street Journal article shared that this would help protect essential workers who are caring for high-risk patients until a vaccine is ready. Plus, some people do not tolerate vaccines, and this could be an alternative preventative solution for that population. Researchers want to find out if drugs made by purifying antibodies taken from donated blood might work better than convalescent plasma. Those drugs are known as COVID-19 hyperimmune globulin (COVID-HIG). Two trials sponsored by the National Institute of Allergy and Infectious Diseases will begin in seriously ill patients this fall.
  • Drug companies including SanofiPfizer and Mylan sell hydroxychloroquine under different brand names, and the drug has been a controversial subject as researchers test new and old treatments to find a COVID-19 cure. Hydroxychloroquine is a safer derivative of chloroquine and is an anti-parasitic, disease-modifying anti-rheumatic drug approved for malaria, lupus and arthritis. It was originally approved by the FDA in 1955 and sold under the brand name Plaquenil. Hydroxychloroquine is thought to lift the pH level of an acidic part of the cell membrane, preventing the virus’s ability to enter the body and replicate. The FDA granted emergency use of the drug in late March. However, a July 16 report in Reuters announced that the antimalaria drug hydroxychloroquine did not reduce symptoms in those newly diagnosed and reporting mild symptoms better than a placebo. This came from a 491-person study led by researchers at the University of Minnesota.
  • The nutraceuticals bioflavonoid and green tea polyphenol are zinc ionophores, which have been studied for their anti-viral and anti-cancer activities. The plant flavonoid Quercetin plus zinc is in clinical trials being tested as an anti-viral for COVID-19. A large-scale trial will begin in China. This information was provided by Peter D’Adamo on his forum, People, Nature and Data.

The Race for a Vaccine

The last couple of weeks, there have been significant developments on the vaccine front, with Moderna and Oxford-AstraZeneca moving into Phase III clinical trials. This is positively impacting the economy, too. On July 15, the Dow Jones Industrial Average climbed, partially by the study results of an experimental coronavirus vaccine.

Moderna reached a breakthrough after 45 patients when an early-stage human trial showed a desirable immune response, according to a Wall Street Journal report. Positive vaccination news benefits the markets and gives us hope that we’ll have a way to curtail coronavirus soon. A large clinical trial called Cove will start July 27, with an aim to enroll 30,000 adults from 90 different U.S. locations, primarily where the virus is surging.

During an interview with Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, he noted this: “The gold standard of protection against a viral infection is neutralizing antibodies. Data from the study, small numbers as it may be, are pretty clear that this vaccine is capable of inducing quite good levels of neutralizing antibodies.”

Moderna announced it has enough doses to start the new study and is on track to deliver about 500 million doses a year and possibly up to 1 billion a year in 2021. A Motley Fool report noted that Moderna is currently manufacturing doses at three different U.S. manufacturing facilities—at its own risk—with a mind to meet the target dose number.

A vaccine called AZD1222 developed by Oxford University-AstraZeneca is in Stage III trials with 8,000 volunteers enrolled. The trial will assess how the vaccine works in people age 18 and older, according to a Reuters report. If proven effective, AstraZeneca lined up agreements to produce 2 billion doses and will sell it on a not-for-profit basis during the crisis.

The U.S. government is backing vaccine efforts and gave $2 billion to two pharmaceutical companies to fund clinical studies and manufacture doses. Novavax received $1.6 million for its experimental coronavirus vaccine and says it will deliver 100 doses for use possibly by the end of 2020. On the antibody front, Regeneron Pharmaceuticals was granted $450 million to manufacture its treatment to distribute at no cost to the public, according to a July 8 Wall Street Journal report. Regeneron’s drug combines two antibodies and is targeted as an antiviral for already infected patients, and a temporary preventive. The company is moving the drug into later-stage clinical studies and said initial doses could be ready in late summer.

Pfizer and BioNTech partnered to develop a coronavirus vaccine using technology known as “messenger RNA,” or mRNA. According to Pfizer, mRNA vaccines could offer more flexibility and quicker development timelines than traditional vaccines. mRNA delivers genetic information to cells to produce antigens, which the immune system recognizes and responds to by producing antibodies. On July 24, the federal government announced a $1.95 billion advance order for 100 million doses of the vaccine that could be available by the end of the year.

Johnson & Johnson will begin the first human studies of its COVID-19 vaccine this month, also hoping to make it available in early 2021. The initial study’s goal is to enroll 1,000 healthy adults, beginning in Belgium on July 22 and then in the U.S.  The vaccine, Ad26, is reportedly ahead of Moderna “by months,” according to news sources like Bloomberg.

Meanwhile, the accelerated pursuit of a vaccine is evolving into a political race, with sources like Barron’s acknowledging that a vaccine released before the election would be a win for President Trump. Ultimately, it’s a win for everyone because the sooner we can deliver a vaccine to the market to protect people, the faster we will return to work and rebuild our economy with confidence that people can be safe.

Will COVID-19 Vaccines Be Safe?

Some people are concerned about the safety of COVID-19 vaccines. The FDA created the Coronavirus Treatment Acceleration Program to move new treatments to patients quickly and safely. Currently, there are more than 510 drugs in development and more than 230 trials have been reviewed by the FDA. There are 19 treatments authorized by the FDA for COVID-19 use.

Types of Vaccines. The FDA explains the types of coronavirus vaccines being developed on its Coronavirus Treatment Acceleration Program dashboard. The FDA notes: “The diversity of therapeutic approaches being investigated is important because it rapidly expands our understanding of the effect of different categories of potential treatments.”

  • Antiviral drugs keep viruses from multiplying and are used to treat many viral infections (such as HIV, Herpes, Hepatitis C, and influenza).  
  • Immunomodulators are aimed at tamping down the body’s own immune reaction to the virus, in cases where the body’s reaction basically goes overboard and starts attacking the patient’s own organs.
  • Neutralizing antibody therapies may help individuals fight the virus and include manufactured antibodies, animal-sourced antibody therapies, and blood-derived products such as convalescent plasma and hyperimmune globulin, which contain antibodies taken from people who have previously had COVID-19.
  • Cell therapy products include cellular immunotherapies and other types of both autologous and allogeneic cells, such as stem cells, and related products.
  • Gene therapy products seek to modify or manipulate the expression of a gene or to alter the biological properties of living cells for therapeutic use.

Encouraging Developments

We are blessed to live in a state, and a country, with talented healthcare professionals including world-class organizations like Cleveland Clinic and other renowned hospital systems that are working diligently to care for the sick and develop solutions for managing and preventing COVID-19. Our local, state and federal government officials are navigating complex decisions to protect health and safety, while urging the economy toward recovery. Also, we are seeing early signs from the stock market that indicate that an economic come-back is not only possible, but probable—in due time.

This coronavirus is “novel” for many reasons. It instigated a self-imposed shut-down of the economy, and it has prompted us to seriously consider how prepared we are for future pandemics so we can plan for what’s ahead. We are experiencing a once-in-a-generation event and learning from it. 

I am encouraged when I read the latest news about treatments and vaccine developments. I hope this summary of research is useful to you, and I wish you and your families continued good health and happiness.

All my best,

Umberto P. Fedeli

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