The Flu Forecast for 2021

The Flu Forecast for 2021

HEART HEALTH

Predicting the 2021 flu season

This year, the term “twindemic” captures the overlap of the flu and COVID pandemic

The CDC established National Influenza Vaccination Week (NIVW) in 2005 to highlight the importance of continuing flu vaccination through the holiday season and beyond. Every year, it seems we deal with a devastating strain of the flu. This year, the term “twindemic” captures the overlap of the flu and COVID pandemic. With that said, only 48% of adults were vaccinated last year. Healthcare providers insist that this year, it is more important to get a flu shot than ever.

“I am cautiously optimistic that vaccination rates will be higher this season,” states Dr. Brion Winston, a board-certified cardiologist at Capital Cardiology Associates. Along with his specialty as an interventional cardiologist, Dr. Winston also holds a Masters of Public Health. He has been keenly observing the coordination and communication of federal, state, and local guidelines issues during the pandemic to keep the public safe. “Certainly what we are concerned about is the twindemic, that cases of both influenza and COVID present in the same person. That would be quite devastating.” The flu, by itself, led to 400,000 hospitalizations and 22,000 deaths, according to the Centers for Disease Control and Prevention estimates for 2019-2020.

What makes the flu dangerous for heart patients

The nation’s leading public health expert, Dr. Anthony Fauci, proudly showed off his arm bandage, confirming that he had received his flu shot in September. During a press conference, Fauci proclaimed, “It’s our personal responsibility to protect ourselves. But we also have a responsibility to protect the vulnerable around us, including young children, pregnant women, adults, 65 years of age or older and those with underlying chronic health conditions.” For heart patients, the flu is a viral infection that causes an inflammation response that adds stress to the body and makes the heart worker harder. People with heart disease or who have had a stroke can experience difficulty breathing or shortness of breath, persistent pain or pressure in the chest or abdomen, dizziness, confusion, seizures, severe muscle pain, weakness, or worsening of chronic medical conditions. The other health issues that heart patients usually have (comorbidities like diabetes, kidney damage, or COPD) make older people more vulnerable to negative outcomes associated with the flu.

Photo of Dr. Anthony Fauci provided by the National Foundation for Infectious Diseases

“The vaccine is quite effective, it’s not a guarantee, but it does reduce cases by almost 50% for those who receive the shot. That is quite remarkable. For those that do get the flu, the general rule is a much more mild case despite the vaccination,” adds Winston. The National Foundation for Infectious Diseases reported that flu vaccines prevented 7.5 million flu cases, 3.7 million flu-associated medical visits, 105,000 flu hospitalizations, and 6,300 flu deaths. The flu shot has proven to lower cardiac arrest rates in heart patients, reduce admissions for stroke or heart failure, and reduce death rates in adults with Type 2 diabetes. For those who have received the vaccine and still get infected, their body can better fight the flu, lessening the intensity of symptoms and shortening the duration of illness. Plus, for Americans with a health insurance plan (private or public), your provider will cover the cost of the flu shot entirely. Outside of visiting your doctor, there are also more options, like pharmacies allowing you to schedule an appointment.

The flu forecast for 2021

The New York Department of Health has a flu tracker on their website, updated weekly on Thursday evening. Last year’s flu season (2018-2019) was the longest in a decade, lasting 21 weeks. It wasn’t as brutal with illnesses, hospitalizations, and deaths as previous years, but for those who visited a Capital Region hospital in mid-February through April, it seemed like waiting rooms and patient areas were filled with people seeking relief from their infection. The predictor for the American flu season is the largest continent in the Southern Hemisphere: Australia. The flu season south of the equator generally runs from April to October, peaking in August. Health officials and epidemiologists monitoring Australia’s season noted two factors: unusually low numbers of cases and an unprecedented demand for flu shots in 2020. Australia reported just over 21,000 confirmed flu cases and administered a record 18 million flu vaccines this year.

Experts are encouraged with Australia’s diminished season but cautioned that what happens in other parts of the world doesn’t guarantee success in the United States. “How we can predict the effectiveness of the flu vaccine six months in advance is impressive. Our flu vaccine is based on two antigens; they look at the circulating flu levels in Asia and North America. From that, they come up with a cocktail, for lack of a better term, of antigens that will elicit the antibody response. It’s a probability model in terms of predicting which strain we are likely to see,” noted Winston. There is also the theory that more people practicing COVID guidelines (wearing a mask, social distancing, and frequent hand washing) could sustain the flu virus’s spreading. “I am impressed with the way that New Yorkers have responded to the pandemic,” said Winston.

Be smart and stay safe

Influenza pandemics have been reported for at least 500 years. Historians report the flu has likely been around for millennia. The first report was from Hippocrates, who described a highly contagious disease from northern Greece around 410 BC. Science and technology have limits to protecting us from the flu virus. The problem is that the virus mutates, developing a standard cure that will eradicate influenza difficult to produce. To beat the flu season, we must remain smarter than the virus. Avoiding unnecessary risks like large gatherings, remember to wash our hands after touching public surfaces, and this year, wearing a mask when we are within six feet of others lower infection risks from the flu and COVID. We also need to be aware of our health and the health of those in our home. “We had scenarios in the spring (patients not aware of COVID symptoms — see emergency warning signs*); unfortunately, we will continue to see this. Now with the availability of rapid testing for COVID, we already have rapid testing for flu; I’m hoping we can avoid the problem of uncertainty. There is an amount of overlap between the symptoms, quite a bit; there is that possibility of having severe flu symptoms, like shortness of breath or extreme fatigue, especially shortness of breath, this warrants immediate medical attention,” added Winston. Bottom line: if you display any of the warning signs, seek emergency medical care immediately!

When to seek emergency medical attention


Look for emergency warning signs* for COVID-19. If someone is showing any of these signs, seek emergency medical care immediately: › Trouble breathing › Persistent pain or pressure in the chest › New confusion › Inability to wake or stay awake › Bluish lips or face
*This list is not all possible symptoms. Please call your medical provider for any other symptoms that are severe or concerning to you.

Written by: Michael Arce, host of HeartTalk presented by Capital Cardiology Associates. HeartTalk airs Sunday at 1PM on NewsRadio 810 and 103.1 WGY. You can listen anytime on iHeartRadio.

Healthcare trends for 2021

Healthcare trends for 2021

HEALTH TRENDS

Healthcare trends for 2021

Three areas to watch as America braces for a COVID cure

Forecasting healthcare trends for the ensuing year in standard times usually considers examing the current focus’s effect while balancing future needs. But we do not live in normal times. Forecasting during a global health pandemic is driven by one constant need: a safe, effective coronavirus vaccine delivered to a massive population. COVID will continue to be a massive demand for 2021, but two other major areas will most likely emerge — one that affects how healthcare is delivered, the other on how care is administered.

The cure for COVID

This week, news broke that Pfizer’s COVID-19 vaccine is more than 90 percent effective was initially met with excitement and optimism. The headline was promising, delivering almost full prevention of symptomatic illness. However, the full details of the study analysis have not yet been released. This void has left scientists and physicians with questions on the individuals enrolled in the testing. What were their ages and backgrounds? We know that the virus produces the most risk for children, pregnant women, those with compromised immune systems, pre-existing conditions, co-morbidities, and seniors. Would this vaccine also be effective in protecting against possible reinfection?

One win for the Pfizer vaccine trial was that this uses new messenger-RNA (mRNA) technology. This delivery system trains the immune system to target the “spikes” (spike protein) of coronavirus versus using a small dose of the virus to allow the body to fight and overcome the infection. Much of what we have learned about mRNA vaccines comes from research on cancer, where the oncology field uses tumor mRNA to activate the body’s T-cells (part of the immune system) to destroy cancer tumors. Researchers in this area admit that there are many unknowns in mRNA, like whether these vaccines can trigger a strong and safe immune response in humans that doesn’t produce side effects like inflammation or aggravate the infection.

The hope in the coronavirus research is that mRNA would turn the healthy body cells into hunters, almost an anti-virus force preventing those receiving the vaccine dose from becoming infected with SARS-CoV-2, the virus that causes COVID-19. Another sign of encouragement with an mRNA vaccine is that it is easier to mass-produce than traditional vaccines. Scientific experts estimate just a few months instead of the standard 1-2 years for manufacturing.

Lost in the excitement of the first COVID vaccine candidate’s advancement to market where the challenges with the distribution issues. For one, the Pfizer vaccines must be administered within five days after being thawed from their subzero storage temperatures. If not, the shots go bad. This creates a logistics challenge, not only in creating a deep-freeze storage/transfer network to transport the drug but also vaccination centers that have the proper storage equipment. The World Health Organization has stated their goal to raise almost $20 billion to purchase vaccines for poorer countries. Even with assistance funds, there will be many areas that cannot afford to build proper facilities or are simply too distant for safe, reliable transport. Moderna, one of the many other possible COVID vaccine candidate drugmakers, shared that it expects to have news on the data of the first analysis of its testing by the end of the month. As the picture clears on the effectiveness of possible vaccines and how the drugs are adminstered, we can understand the point made by health experts that there will mostly be multiple vaccines for COVID.

New healthcare horizons

Searching for the possible silver lining during the pandemic points to the expanded role of technology in healthcare. “This will be a growing part of how we bring care to more people,” states Dr. Connor Healey, a board-certified cardiologist with Capital Cardiology Associates. “While telehealth is great for primary providers, it can be a challenge for specialty physicians. In cardiology, it’s difficult to provide virtual type meetings without having access to EKG or vital information on patients if they are at home.” However, like many healthcare providers in the United States, Capital Cardiology shifted our focus to include virtual visits as an option for patients during the pandemic. This will continue to grow as telehealth services improve to include features like Bluetooth stethoscopes and diagnostic equipment that can be administered by a technician or provider working with the patient and simultaneously reviewed by a physician connected at a remote location.

Mobile health has emerged in the form of wearable activity & fitness trackers and remote monitoring, which offers physicians and healthcare providers the opportunity to watch patient health data in real-time. Mobile health also incorporates Health Apps, user-centric programs, and software installed on smartphones, tablets, and wearables that connect a vast amount of data into one reporting module. The Apple Health app, for example, takes information from devices and displays them in one place. We live in a time where your healthcare provider can quickly glance at the Health app on your iPhone to get information on changes in your activity, cholesterol or blood pressure, or sleeping patterns.

The downside of collecting health data is privacy and security issues. Many legal experts predict that with integrated data collection, like the Apple Health app, the same devices used in smart home technology to turn on lights or the heating and air conditioning place our data at-risk to hackers. As it is referred to by tech giants (Apple, Google, and Microsoft), Big Data puts millions of personally identifiable health records on servers and storage devices out of reach of the individual user. The collection and usage of this user’s data will continue to be a legal and policy concern until there are clear regulations on how much medical information is covered under user agreements in the fine print on the apps and devices we use. American consumers are pushing for more control over how our data is used, who has access to it and want to be able to make decisions on how a company can interact with us in advertising and marketing generated from using their product.

Healthcare reform

While the Affordable Care Act (ACA) is the law of the land, there continue to be legal challenges on the largest healthcare legislation that impacts over 23 million Americans. Currently, the future of the ACA is before the United States Supreme Court in the case California vs. Texas, an argument to overturn the ACA in its entirety. “That will have long-term consequences beyond the presidential election cycle,” pointed out Dr. Healey. President-elect Biden called for building on the ACA during his recent campaign, vowing to continue to give Americans a public option to affordable health insurance, increasing tax credits to lower premiums, and expand coverage to low-income Americans. “It’s imperfect; I get that. There are a lot of bipartisan accomplishments that everyone agrees on. Allowing young people to keep their parents’ coverage until they are 26. Eliminating pre-existing conditions. Problems with transparency in health care plans and coverage. These are all excellent moves. I don’t see any strong impotence to change them. If you make the ACA in general illegal or reverse it, you are rolling back those advances. Furthermore, what is the alternative plan?”

Ultimately, the future of healthcare in 2021 and beyond revolves around offering patient-focused care that improves health and quality of life. As a physician engaged in actively improving his patients’ outcomes, Dr. Healey points to an important lesson he learned during the COVID pandemic. “Social determinants of health should not be barriers to healthcare. Many of us see this on a day-to-day basis and can at least enact some form of change, even if it’s just simply having the conversation. If we are still having this talk in ten years, then what have we done?” The entire healthcare system is committed to advancing awareness and education initiatives that create healthier citizens and communities. From adding sidewalks in our neighborhoods to smoking cessation programs to promoting annual health visits and flu vaccinations, public health officials, healthcare providers, and health insurance are investing resources in creating value in individual citizens taking an active role in their daily health.

Written by: Michael Arce, host of HeartTalk presented by Capital Cardiology Associates. HeartTalk airs Sunday at 1PM on NewsRadio 810 and 103.1 WGY. You can listen anytime on iHeartRadio.

Sudden Cardiac Arrest

Sudden Cardiac Arrest

PATIENT EDUCATION

What you need to know about sudden cardiac arrest

During sudden cardiac arrest, minutes matter

Sudden Cardiac Arrest Awareness Month is a vital initiative set forth by the Heart Rhythm Society to educate the public and raise awareness for sudden cardiac arrest. Sudden Cardiac Arrest (SCA) can lead to death within just minutes of the event if the victim doesn’t receive immediate medical attention or help. These episodes are aptly named as they happen suddenly, “meaning that there is often no warning ahead of time that there could be a problem,” adds Dr. Kevin Woods, a board-certified cardiologist at Capital Cardiology Associates. He explained how SCA is the leading cause of death, taking more lives than breast cancer, lung cancer, or AIDS in the United States. How the most important person during an SCA event is YOU.

Not a heart attack or stroke

SCA is often confused for a heart attack because they share a cardiac connection due to the instant onset that can strike without warning. What makes cardiac arrest dangerous is that there are underlying causes that trigger the heart to beat out of rhythm or sync. “Usually, it’s a problem when the heart rate beats very fast, not as you see in movies where someone flatlines or needs to be shocked,” explained Dr. Woods. SCA typically originates as an electrical problem, an arrhythmia. When the lower chamber of your heart (ventricle) receives erratic signals, it will throw off the heart from beating and pumping blood efficiently. When an event occurs, the victim may complain of chest pain, discomfort, heart palpitations, shortness or difficulty breathing, feeling faint, lightheaded, or dizzy. Sudden cardiac arrest will cause the heart to beat out of sync, robbing the brain of blood flow, leading to unconsciousness.

The breakdown of a sudden cardiac event sounds very much like a heart attack, but it’s important to note the main difference: SAC is an electrical issue where heart attack is a plumbing problem. In a heart attack, we see blood flow interruptions due to plaque (a fatty substance) clogging arteries. “When plaque ruptures, a blood clot forms that robs the heart muscle of oxygen, inducing a heart attack. That can precipitate sudden cardiac death, which is where a heart attack can overlap with sudden cardiac arrest,” noted Dr. Woods. In both cases, when the heart stops beating, the loss of blood can cause permanent brain or heart muscle damage or death after as few as 10 minutes.

Another distinguishing fact is that sudden cardiac arrest can strike anyone, at any age. Thankfully, cardiac arrest events are rare in children between the ages of 5-19 years old, claiming the lives of over 2,000 children a year. When these deaths are reported, they are tragic, leaving communities to seek what can prevent future loss. Parent Heart Watch is a national organization that strives to protect youth from sudden cardiac arrest. Their website states that 72% of students who suffered from SCA were reported by their parents to have had at least one cardiovascular symptom before the event. They didn’t recognize it as life-threatening. Many young people don’t speak up about possible symptoms because they are not aware of their unusual condition, are afraid of being different, or fear losing playing time.

What can be done

Communication with your teenager is key in creating awareness. As a physician and father, Dr. Woods understands the challenge of talking with teens about their health. “The important point is when you are aware of a family history of heart problems, that is definitely a reason to be specific with your children and your health care provider. With teens, you will have to engage them in the conversation. You should also have an open dialogue with your provider on your concerns.” A grandparent or parent that had a heart attack at a young age, like 50, is information you should share with your children and doctor. “People are labeled as having a heart attack frequently when it might not be exactly what happened. It could be a cardiac symptom or seizure that was misdiagnosed at the time. If it’s an event that happens at 50 or younger, that results in death, that is a major red flag.” You also play a major role in your health. Self-prevention includes regular checkups with your healthcare provider, being screened for heart disease, and making good lifestyle choices.

Quickly reacting to a sudden cardiac arrest can dramatically increase the chance of survival. For every minute in SCA, the chance of survival decreases by about 10%. Health experts point out that calling 9-1-1 isn’t enough to provide support during this health emergency. The amount of time it typically takes emergency medical services to arrive, around 10 minutes in the best estimates, affects survival chances. In his initial setting with patients, Dr. Woods experiences best and worst-case scenarios. “There are patients who come in unconscious due to treatment on the way to the emergency department. Some we have to induce a coma as part of a protocol to cool down their core temperature to improve the chance of having fewer neurological defects or brain damage after their event.” Since an SCA episode contains sudden collapse, unresponsiveness, or loss of breathing, CPR is a life-saver. Beginning hard and face chest compressions at the center of the chest can stimulate the heart to start working again.

The shock of an automated external defibrillator (AED) can re-establish an effective heart rhythm. The American Red Cross is one of many organizations that offer AED training. These small, portable devices deliver a strong shock while waiting for emergency responders. The sooner the AED shock is given, the better the outcome as these devices are most effective if used within three minutes after cardiac arrest. In New York State, every school must have an AED – especially at sports/athletic activities. High school seniors are now required to learn how to administer an AED or CPR. AEDs are also required at beaches, pools, trampoline parks, and state buildings. “The good news is that we do save people. Those numbers are on the rise due to awareness in the general population, the availability of AED’s, more people getting certified in CPR, and new protocols that we follow in the hospital to help people recover. It’s amazing to see how far people can go after an event of this magnitude,” Dr. Woods optimistically added.

Written by: Michael Arce, host of HeartTalk presented by Capital Cardiology Associates. HeartTalk airs Sunday at 1PM on NewsRadio 810 and 103.1 WGY. You can listen anytime on iHeartRadio.

Your Heart

Your Heart

HEART HEALTH

Love your heart

“We are blessed to have
this special organ, and I’m
glad we are celebrating it.”

“We are blessed to have this special organ, and I’m glad we are celebrating it.”

In the time of COVID-19, taking care of your heart is more important than ever. That was the reminder the World Heart Federation (WHF) shared on World Heart Day 2020. This year’s theme was “Use Heart” in all decisions, as your heart is the only organ you can hear and feel. In their statement for 2020, the WHF proclaimed that “cardiovascular disease is the number one cause of death on the planet,” which has produced significant health challenges and dangers to heart patients and their families. We invited Dr. Lance Sullenberger, a board-certified cardiologist, to a recent HeartTalk episode for World Heart Day.

Since the pandemic began in March, heart patients and Americans with underlying cardiovascular problems have held strong concerns about their safety from possible COVID-19 infection. It has been widely reported that health conditions like high blood pressure, coronary artery disease, or heart failure place people at higher risk for infection and complications. In some cases, death. The WHF noted the double-edged threat for patients, increased fear of protecting their health mixed with hesitation to seek ongoing care for their hearts. Dr. Sullenberger recognized patients’ fears when seeking health care. “At Capital Cardiology Associates, we wanted to create the atmosphere where patients feel comfortable coming to the office to be seen for issues that have nothing to do with COVID like high blood pressure, cholesterol, or chest discomfort.”

Heart health during COVID

One theme we have used several times this year is that heart disease does not take time off during a pandemic. World Heart Day is one day in September (September 29) that unites people from all countries and backgrounds to take action in their lives and communities to fight cardiovascular disease. One of the challenges in creating awareness for heart health are the medical terms associated with heart disease. Hypertension, for example, is high blood pressure. It’s one of the main risk factors for cardiovascular disease. As Dr. Sullenberger noted, it is also known as the ‘silent killer’ because it usually has no warning signs or symptoms. “High blood pressure is one of the most difficult risk factors for cardiovascular disease, but also heart attack, stroke, kidney failure, and blindness,” Dr. Sullenberger added. When the compression sleeve is wrapped around our bicep with each pump, your health care provider measures the force of the blood against the artery walls in your vascular system. Uncontrolled high blood pressure leads or hypertension, over time, causes your heart to work harder than normal to pump blood through your body. Cardiologists, like Dr. Sullenberger, advise patients that “you don’t want to wait until you have a symptom like heart failure or you have a stroke until you realize that losing weight, cutting sodium intake, or starting an exercise program to get your blood pressure under control.”

How alcohol affects blood glucose levels

Alcohol, beer, and wine can cause blood glucose levels to rise or fall, depending on how much you drink. The American Heart Association defines a moderate amount of alcohol consumption as one to two drinks per day for men and one drink per day for women. Specifically, a drink is one 12-ounce regular beer, 5 ounces of wine, or 1.5 ounces of 80-proof spirits, such as bourbon, vodka, or gin. For many people, an occasional glass does not pose a problem. Dr. Sullenberger expanded on how a lifetime of drinking affects the blood sugar levels in normal adults. “If you exceed the moderate levels (guidelines) on a daily basis, then you increase your risk of developing hypertension, blood glucose abnormalities, and heart disease itself.” He also cautioned that saving or excessive consumption on the weekends, for example, presents additional risks. “We, as physicians, need to educate patients on what is the recommended level of alcohol on a daily basis. I try to counsel patients on what is acceptable. A glass, not the bottle. And a glass, not a chalice.”

Cholesterol and heart health

Cholesterol is associated with around 4 million deaths per year; this is one reason why your health care provider will ask you about your diet or check your levels at your office visits. Many Americans do not understand cholesterol levels, as more than 100 million adults in the United States have high levels. While most adults are unaware of what cholesterol is, we understand that the risk of heart attack and stroke is based on the build-up of blockage in our arteries. Dr. Sullenberger broke down the long-term role this waxy, fat-like substance plays in heart disease development. “We know that cholesterol levels can help be predictive of coronary artery disease, but the level of blood cholesterol only tells part of the story. The rest is how predisposed the patient is to those deposits forming in their vessels and how angry the cholesterol is. The actual particles in cholesterol can differ in patients. One has a more angry or atherogenic, and the other has a more benign panel. There are multiple ways to determine this; one is with coronary calcium scoring. We use a non-contrast CT scan to get a picture of the heart to see if there is plaque developing in the blood vessels. If there is plaque in the heart, we can determine that the body has developed plaque and the need treatment no matter the cholesterol level. On the other hand, if a person has no plaque with a high cholesterol level, they may genetically be predisposed to high cholesterol levels. Regardless, based on many studies of a wide variety of ethnicities and populations, we know that patients with no plaque in the arteries have a good outcome over the next five to eight years. That’s how we gauge whether patients need to be treated with medicines for cholesterol. Eating a healthy diet and keeping your body in shape will help keep your levels within range; that is the best investment you can make in your health.”

Your heart is a muscular organ

The heart is an organ which is made from muscle. One line from World Heart Day worth repeating is; your heart is the only organ you can hear and feel. The fact that it is the hardest working muscle in my body is an amazing concept. “I think about periodically is that the heart beats 100,000 times a day, every day,” Dr. Sullenberger reflected. “It’s amazing when you consider that those muscle cells that we are born with can do that. The heart’s normal pacemaker system senses the changes in body chemistry and can adapt the heart rate second by second. We look at heart monitors that show the heartbeat and pulse rate that adapts to the activity level, walking up the stairs, getting in a car, and being excited about something you hear. We are blessed to have this special organ, and I’m glad we are celebrating it.”

Written by Michael Arce, host of HeartTalk, presented by Capital Cardiology Associates.

Developing a COVID vaccine

Developing a COVID vaccine

HEALTH NEWS

Exploring the steps to developing a vaccine

The global race to produce a
coronavirus cure

Four US drug companies are in the late-stages of trials on a possible coronavirus vaccine. This week, Johnson & Johnson announced that it is the latest developer to begin the final clinical trial stage. While they are behind their competitor’s (Moderna, Pfizer, and AstraZeneca), the Johnson & Johnson trial will be the largest, enrolling 60,000 participants. We connected with Dr. Maura Falli, a graduate of Albany College of Pharmacy and Health Sciences, on a recent HeartTalk episode, presented by Capital Cardiology Associates. Dr. Falli has an interest in research, academia, and critical care. She explained the timetable of drug development.

Vaccine companies started working on the genetic sequence of the coronavirus in January. This was before the virus reached the United States. The goal was to begin sharing scientific information on a new disease spreading in China and other parts of the world. Dr. Falli outlined what these discussions would most likely include. Researchers would “first begin by identifying the need,” she began. The next step would be to develop a few potential testing options, consider conducting trials first in animals, and then in humans. Finally, developers must submit various applications to the FDA along the way to gain approval to market these products. It wasn’t until early March that President Trump took the first step when he met with top drug manufacturers’ executives to discuss developing an American vaccine.

The timeline for developing a coronavirus vaccine has been a constant newsmaker this year. The current record for developing a vaccine is four years for the mumps vaccine. The process of bringing a vaccine to market typically takes about ten years. Dr. Anthony Fauci predicted “a year to a year and a half” for a COVID vaccine, even with an accelerated timetable. The goal of the Department of Health and Human Services (HHS) is to deliver “300 million doses of a safe, effective vaccine for COVID-19 by January 2021” as part of Operation Warp Speed (OWS). OWS is a never-before partnership of several federal agencies (including the CDC, FDA, National Institutes of Health (NIH) and Department of Veterans Affairs) coordinating with the Department of Defense for the rapid production of a COVID vaccine.

Photo by Chokniti Khongchum from Pexels

Dr. Falli detailed why it traditionally takes years to produce a vaccine and how bringing a cure to market on a rapid timeline would be a massive win. “The stages are primarily in place to make sure that the vaccine is both safe and effective. The first step is to conduct extensive research, break down the virus’s genetic sequence, identifying the viable targets. Next, we develop the vaccine itself.” Over 100 vaccine candidates are currently under development; 14 promising candidates were narrowed down to 7, which were allowed to proceed to early-stage clinical trials. In this phase, scientists test on lab animals. If the vaccine passes those tests, the team moves to human clinical trials, broken into three phases. Dr. Falli elaborated, “Phase one is where we are screening for safety. This is typically done in a small group of patients. In this phase, we ensure that there are no safety issues or dangers with the vaccine itself. This is typically between 20-80 patients, a smaller evaluation group. Phase two is where we are evaluating efficacy. We are testing the vaccine in a small group of people who might be at risk of infection. You could also look at it as a small group of people who share a group of similar characteristics like age or gender, like the population that the vaccine is aimed at. In this phase, we are primarily determining that the vaccine works for the purpose that it is intended. Typically our phase two trials are larger than our phase one trials. Phase three is the final confirmation for safety and efficacy. Here were are testing a large group of people and monitoring for side effects. Phase three is larger than the other trial groups, as we build up in size.”

And what happens if a vaccine clears phase three? There is another lengthy analysis of the results, Dr. Falli shared. “After we are confident that the vaccine works and that it is safe, the next step is approval for mass production in general use. There actually is a phase four clinical trial that happens after the vaccine goes to market. This is known as post-marketing surveillance, continued monitoring of the drug after it has been widely released. Once we have the general population, millions of people, using the vaccine, we may notice some observations that did not occur in our smaller clinical trials. After we use the vaccine more globally or broadly, we can see these observations and report them to ensure continued safety and monitoring of the product after it is released.” Considering all of the steps and phases involved in vaccine development, it is obvious how ten years can pass from start to finish.

Not all drugs or vaccines see the finish line. According to a 2018 study from the MIT Sloan School of Management, nearly 33.4 percent of vaccines for infectious diseases in clinical trials eventually win approval from the FDA. The primary reason for failure is cost. Dr. Falli noted the astronomical amount of funding needed to bring a drug to market. “The median cost reported in a study on drug development quoted a price of $985 million, but it can be up to $2.6 billion depending on the nature or duration of the study.” Congress has appropriated about $10 billion to help companies with data analysis and development in the COVID vaccine. The idea behind government funding is to make a vaccine or treatment that is affordable for the American people. Public funding of research is also a new level of involvement in a process that is usually reserved for private companies. Incentivizing companies to produce doses of vaccines removes the burden of financial risk that is the largest barrier to success — a place known as the “valley of death” in drug research. This is the point where a lack of funding prevents research or discovery from clearing clinical trials in over 65% of vaccine progress.

The United States is one of several nations developing vaccine candidates. The World Health Organization is working with scientists and health partners in over 90 countries to guarantee rapid, fair, and equitable access to COVID-19 vaccines worldwide. The goal is to deliver two billion doses of safe, effective vaccines by the end of 2021. Currently, experimental versions in China and Russia have been reported to have reached the Phase 3 trial stage. These vaccines differ in how they attack coronavirus. The consensus in the scientific and medical communities is that there will be multiple vaccines for COVID. “It’s difficult to say at this time what the differences will be because so many of the vaccines are in the early stages of development,” added Dr. Falli. Ultimately, the best outcome is to have several vaccines produced to meet global needs across various age groups or demographics. “Until we have a vaccine, social distancing, wearing a mask, and frequent handwashing continues to be the most significant steps we can take to protect ourselves from the virus,” concluded Dr. Falli.

Written by Michael Arce, host of HeartTalk, presented by Capital Cardiology Associates