Biotechnological advances have allowed scientists to develop a vaccine against COVID-19 that pharmaceutical and biotechnology companies can manufacture relatively quickly and distribute around the globe, albeit with many supply chain challenges.  The combination of “warp speed” and “new technology” has made many people skeptical of the vaccine’s safety, a problem that could seriously hinder its rollout and our turn to relatively “normal” activities. Background on the “new” technology that has been under study for two decades and information on the clinical-trial requirements to ensure the safety of vaccines demonstrate that the initial mRNA vaccines are far safer than infection with SARS-CoV-2.  The utility of every new vaccine or treatment is a balance between benefit and risk, and in this case, most knowledgeable scientists and physicians would agree that the benefits far outweigh the risks.  

The vaccines currently authorized for emergency use by the FDA and EMA are both mRNA vaccines produced by BioNTech/Pfizer and Moderna. mRNA technology works by informing cells how to produce harmless proteins that match those on the SARS-CoV-2 virus (such as the “spike” protein found on the surface of the virus). After your cells produce this protein, the immune system responds by producing T-lymphocytes and B-lymphocytes that can identify the real virus in your body and kill it before it causes infection and spread of the disease to distant organs. Then, your body destroys the mRNA genetic material, leaving none of the nucleotides behind. 

While this may seem like a newly discovered technology, it has been studied extensively for its disease-fighting potential in mice back to the 1990s. However, scientists struggled to find a way to get the mRNA safely into the cells without the body destroying it on the way. Scientists continued work on the mRNA technology and discovered that a modified version of the mRNA was able to get into cells without destruction by an immune response. This research laid the groundwork for the subsequent development of mRNA vaccines for COVID-19, accelerating the process to get a vaccine into human studies at the beginning of 2020.

The COVID-19 public-health emergency allowed scientists to overlap trial phases, expediting the clinical-trial process. However, despite the accelerated timeline, the FDA set strict standards that all researchers were required to adhere to before the FDA authorized either vaccine for widespread use. Rigorous clinical trials established both the safety and efficacy (effectiveness) of the COVID-19 vaccine. Each vaccine candidate was studied in about 40,000 subjects in these trials.  In addition, the FDA will keep track of all reported adverse effects as the vaccine is administered to monitor for any problems or side effects that may arise following issuance of the EUA. Both manufacturers plan to obtain formal approval and licensure of their mRNA vaccine later this year after completing longer term follow up of patients enrolled in the original clinical trials.

The mRNA vaccines currently authorized for use by the FDA and EMA are both safe and effective for protection against development of COVID-19 disease. Both vaccines are approximately 95% effective, which means that getting a COVID-19 vaccine is one of the best steps you can take to protect against COVID-19, once the vaccine is available to you. However, ongoing clinical trials are still needed to ensure that the vaccines protect against the new variants or strains of the virus, prevent viral transmission, even if patients are asymptomatic, and to ensure that the vaccines can be administered safely with approximately the same level of efficacy in pregnant or lactating women, children of all ages, the elderly and those with a compromised immune system such as HIV-AIDS.

Sources: CDC, STAT, Johns Hopkins

 

During the ongoing COVID-19 pandemic, healthy individuals can avoid infection with the SARS-CoV-2 virus by properly wearing a mask, staying at least six feet apart (ideally further, especially indoors), avoiding social gatherings and crowds, and washing hands frequently. However, even with the most diligent precautions, people still experience COVID-19 risk from workplaces, household exposure and essential errands, like doctor visits and buying groceries at stores. While protecting yourself against COVID-19 and other respiratory illnesses is at the top of everyone’s mind, it is important to protect your health through everyday lifestyle choices. In particular, smoking and vaping can materially increase your risk of severe and chronic forms of COVID-19,  if you do contract the disease.  This is further exacerbated by underlying chronic bronchitis emphysema and COPD.

If you regularly smoke or vape, experts suggest that now would be an opportune time to quit. This recommendation is primarily being made, because smoking has a direct link to structural and functional lung damage, including lung cancer. While young adults typically experience less severe forms of COVID-19, a study found that 13- to 24-year-old participants who vaped were five times more likely to be diagnosed with COVID-19 than otherwise, and those who smoked were seven times more likely to be diagnosed with COVID-19. This increased number of diagnoses may come from people experiencing more severe symptoms and seeking medical care.

For people of all ages, smoking can cause inflammation in the lungs and airways, which can lead to an increased inflammatory response to viruses like SARS-CoV-2. Smoking can also damage the cilia in the lungs, which are an essential part of clearing viral particles out of the lungs. In short, smoking (and likely vaping) can affect the exact mechanisms that your body uses to fight off COVID-19 and other respiratory illnesses like the flu.  A growing problem with COVID-19 is the development of “long-COVID,” which signifies a long-term, persistent form of the disease, affecting certain organs more than others.  This can occur in patients of all ages, who often go on to suffer from a form of cardiomyopathy (diffuse heart muscle dysfunction) or thromboembolic disease (clotting in blood vessels).

In addition to COVID-19 prevention methods, protecting your immune system through a healthy diet, enough sleep and quitting smoking can help to reduce your chances of severe infection if you do become infected with the virus that causes COVID-19. . If there was ever a good time to quit smoking and vaping, now is the time.  

Source: Yale Medicine

Emerging COVID-19 data suggests new treatments and increased knowledge from physicians are shortening hospital stays and reducing the virus’s mortality rates. Reports like these may seem like a relief amid the rising tide of COVID-19 cases in the United States. Still, lower mortality rates are only possible if the hospital system remains intact. As COVID-19 patients flood into hospitals, this promising data can quickly take a turn for the worst.

In November 2020, the number of daily national new COVID-19 cases shattered records from earlier in the pandemic, often repeatedly breaking records in consecutive days. Unlike the New York epicenter in the spring of 2020, outbreaks are occurring nationwide. This includes rural areas virtually untouched by the pandemic’s first wave. In some rural areas, hospital capacity is so low that even a small outbreak threatens to overwhelm the hospital system.

Hospital capacity is the number one concern for many state and local leaders who know that a percentage of the rapidly rising cases will require hospital care. Even if hospital stays are shorter and treatments are more effective, an influx of patients could quickly overwhelm both the physical number of hospital beds and the available medical providers like doctors, nurses and respiratory therapists.

If too many people seek hospital care simultaneously, shorter stays will not be enough to avoid overwhelming hospital systems. If hospitals are at capacity and can no longer provide measured care to patients, mortality rates may reach unprecedented levels. Large outbreaks may force regions to open field hospitals to treat COVID-19 patients or even turn patients away in the grimmest of situations. The result could be a public health crisis that outpaces the worst of the New York outbreak in March and April of 2020.

Until vaccines are available to large portions of the American public, social distancing, mask wearing, testing and contact tracing will be essential to prevent a public health catastrophe in the United States.

Sources: WSJ, NY Times

As of early December 2020, two breakthrough mRNA COVID-19 vaccines, the Moderna vaccine and BioNTech/Pfizer vaccine, were officially submitted for FDA approval. With promising study results, including 95% efficacy for both and no major safety concerns, these vaccines should be a stepping stone to slowing and eventually stopping the COVID-19 pandemic. 

Now, public-health authorities face two major challenges: distribution and public trust. Of these, establishing trust in a vaccine may pose the greatest threat to a swift halting of the pandemic. In fact, a November 2020 poll by Gallup found that only 58% of American adults were likely or very likely to get vaccinated when it becomes available. Even with a highly effective vaccine, over three quarters of Americans will need to be vaccinated to truly stop the current public-health crisis in the U.S.. With 42% of American adults still resistant to vaccination, challenges remain for public health officials who seek mass public compliance.

According to the same poll by Gallup, most respondents who are hesitant to vaccination note the speed of vaccine creation and safety of the vaccine as primary concerns. In fact, over 60% of Americans who do not want to receive the vaccine cite the accelerated development timeline or undocumented safety fears as their main concern.

Fortunately, these attitudes are changeable by increasing public health information and transparency around clinical study results. While Gallup’s data shows a slim majority of Americans are confident in the vaccine, the poll also demonstrates an increase in vaccine confidence from 50% to 58% between September and November. This indicates that clinical results and consistent science-based informational campaigns can shift attitudes in favor of vaccination. As the distribution of COVID-19 vaccines increases, so should campaigns for widespread confidence in vaccine safety and efficacy, which could ultimately enable a return to normal social activities in the near future.

Source: Gallup, STAT News

At this point in the COVID-19 pandemic, many Americans are getting “pandemic fatigue” and beginning to attend indoor social gatherings, often unmasked. According to the CDC, smaller social gatherings among family and friends are one of the main drivers of current COVID-19 spread. This is particularly difficult to combat as the country heads into a season of traditional family gathering times: Thanksgiving and the holidays. Unfortunately, any time small or large groups of people gather outside their households, the risk of COVID-19 spread increases. Here’s how you can celebrate the holidays safely.

Have a Traditional Dinner with Your Household Only

The best way to stay safe from COVID-19 during the holidays is to spend the day with members of your household only and avoid the traditional gathering of extended family and friends. You can still prepare traditional recipes and engage in family traditions, but without contact with other people who are not in your household. 

Have a Virtual Gathering with Family or Friends

This year is a good opportunity to gather your family and friends virtually to enjoy a shared meal or just catch up. You can swap recipes in advance or prepare meals to drop off with local relatives (with no contact). These types of virtual and contactless activities can be particularly helpful if you live alone and are craving the social togetherness of the holidays. 

If you traditionally shop on Black Friday with friends or family, this is a good year to gather via videoconference and shop online for your holidays gifts or deals.

Unfortunately, there is not a good way to safely gather for Thanksgiving or for the holidays. The best way to protect your loved ones is to remain apart until it is safe to gather together once again. Find ways to connect virtually to keep your family and friends safe during the COVID-19 pandemic.

Source: CDC

Each year, approximately half of American adults choose to skip the annual flu vaccine and take their chances with the seasonal flu. While most healthy adults recover from the flu after an unpleasant week of cough, fever and other flu symptoms, approximately 200,000 Americans are hospitalized for flu complications each year and a fraction of those patients die of more severe complications. While the CDC always recommends a flu vaccine for all Americans over the age of six months, the flu shot is even more important during the COVID-19 pandemic.

Many scientists fear that as temperatures drop and people return to indoor gatherings, the incidence of COVID-19 transmission will increase and cause a winter wave of COVID-19, potentially worse than some of the other waves we have seen. As we near Thanksgiving, we are already seeing a huge increase in the number of new COVID-19 cases, hospitalizations, ICU admissions, and deaths from multi-system organ failure.  A winter wave of COVID-19 would coincide with flu season, increasing the burden on hospitals as both flu patients and COVID-19 patients seek medical attention for severe cases. If more Americans are vaccinated against the flu, which can help to prevent and reduce the severity of the seasonal flu, more hospital beds and medical providers will be available to care for COVID-19 patients. The public health goal is clear: prevent the flu to create space to treat COVID-19.

Another issue with a simultaneous flu and COVID-19 wave is the number of symptoms that the two diseases share. Flu symptoms include fever, chills, muscle aches, cough, congestion, runny nose, headaches, and fatigue. The only symptom that COVID-19 does not share with the flu is a loss of taste and smell. This overlap makes it nearly impossible for doctors to diagnose the flu or COVID-19 without conducting a specific viral test. This could put increased strain on testing resources and cause greater testing lab backlogs or a shortage of tests.

Getting a flu shot this fall is a low-risk choice that may help to save your life or the lives of those around you. Aside from masks and social distancing, the flu shot is one of the best tools at our collective disposal this fall to prevent a looming public health disaster this winter.

In the last three decades, the rate of alcohol consumption has shown a net decrease, but cases of liver disease in young people are on the rise. This misalignment of numbers has begged the question among doctors and physician-scientists: what is causing an increase in liver disease among young adults in the United States? Experts think it may be caused by an increase in extreme binge drinking among young people.

Moderate drinking is defined as approximately one drink per day for women and two drinks per day for men. Moderate drinking is the limit of alcohol consumption that medical practitioners generally feel is safe for most people to avoid liver damage or other negative effects of alcohol. Binge drinking, on the other hand, is more than four drinks for women or five drinks for men at a single time (over a few hours). This amount of alcohol outpaces the body’s ability to metabolize the alcohol and leads to impairment mental and physical functions, also known as being “drunk.”

Even worse than binge drinking is extreme binge drinking, where people consume so much alcohol that they are barely able to walk or talk, and are in danger of fatal alcohol poisoning. Binge drinking is most common among adults between the ages of 18 and 34, and extreme binge drinking puts significant strain on the liver’s ability to process and metabolize alcohol.

Over time, this type of stress on the liver can cause inflammation and liver disease. Liver disease typically develops over years of excessive alcohol use, but doctors are seeing increases in alcohol-related liver disease fatalities among people aged 25 to 35, according to a study published in BMJ. This is a clear indicator that young adults are abusing alcohol and engaging in binge drinking or extreme binge drinking.

While the decrease in overall alcohol consumption is a positive indicator of progress, increased alcohol-related problems among young people is a step in the wrong direction. Public health campaigns aimed at exposing the danger of binge drinking may be the next step in the fight against alcohol-related disorders and disease.

Sources: BMJ, NIAAA, CDC, CDC, Yale Medicine

COVID-19 has affected the daily lives of nearly all Americans, through stay at home orders, mask mandates and business closures. But for people who are already battling other health conditions, such as cancer, many feared that COVID-19 would significantly impact access to care and advancements in treatment. Nearly a year into the pandemic, scientists are starting to measure the impact of COVID-19 on cancer research and treatment. A study by Dana-Farber and other research centers, published in Cancer Cell, explores a wide range of possible impacts, including an increased risk of COVID-19 for cancer patients, less routine screening for cancer, increased use of telehealth and implications for new cancer research.  Similar impacts are being seen in heart disease patients, where fewer of them are coming to the hospital or their doctors’ offices when they have chest pain, shortness of breath and other symptoms of coronary heart disease or heart failure.  

Common cancer treatments, like immunotherapy and chemotherapy, impact the immune system. While some cancer therapies cause a weakened immune system, others stimulate the body’s immune system, putting the patient at potentially greater risk for cytokine storm. Either way, the immune response of a cancer patient is typically less than optimal when confronted by a novel virus. However, the impact of refusing treatment or not seeking treatment can be far more dangerous than receiving cancer therapies, even during COVID-19. 

According to one study, the increased use of telehealth and virtual medical visits during COVID-19 improved the quality of life for many people living with breast cancer. Telehealth cannot be used for diagnosis, treatment or exams, but helps to offset the stress and cost of routine doctor visits. However, the decrease in routine physicals and visits to the doctor for minor complaints has led to a decrease in cancer diagnoses. This can be dangerous, because it likely means that fewer early-stage cancers are being diagnosed, which may eventually lead to more dangerous cancer presentations in the future.

Finally, COVID-19 has had effects on the conduct of cancer research, such as limiting the number of people who can be in a lab at one time, but many clinical trials have found ways to work through restrictions. The adoption of telemedicine and e-documentation allows clinical trial participants to participate from home. The continued advancement of clinical research is important to ensure that new and improved treatments are available for people battling cancer, during and after the COVID-19 pandemic.

Source: Dana-Farber Cancer Institute

With much of the country carefully following drug and vaccine trials for COVID-19, the stages of drug and vaccine testing and approval have been drawn into the spotlight from their usual place behind the scenes of drug development. Understanding the different phases of a clinical trial can help with deciphering the mass amounts of publicity surrounding COVID-19 treatment and vaccine advancements.

Before a clinical trial can be conducted, researchers must first create a drug or vaccine and conduct preliminary research in the laboratory, including cellular and possibly animal models. This can take anywhere from a few months to years depending on the amount of research required. In order to begin a clinical trial, preclinical studies, drug development and manufacturing documentation and a plan for conducting the clinical trial must be submitted to the FDA for clearance. The goal is to weed out dangerous drugs or vaccines before even one person receives it. Once the FDA (or other regulatory agencies in foreign countries) clears a drug or device for human studies, Phase I clinical trials can begin.

During Phase 1, a drug or vaccine is administered to a small number of people, usually less than 100, in varying doses. The goal of this phase is to determine safety and establish if safety varies according to dosage and type of patient. If a significant safety concern is found with the drug across all doses, then it will not be cleared to move to the second phase (in fact, phase 1 can be stopped). However, if a certain dose or doses are deemed safe and with acceptable and manageable side effects, then the clinical trial can proceed to phase 2. Because of tests run prior to the commencement of a clinical trial, the majority of new drugs and vaccines are cleared to move to Phase 2.

In Phase 2, several hundred people are usually given the new drug. Again, these people are typically healthy adult participants (in the case of a vaccine) or people who have the disease or condition (for a drug). However, the goal of this phase is to determine the efficacy of the new drug for its intended purpose and to obtain additional information about safety and the adverse-effect profile. A vaccine is tested to see if it prevents infection, while a drug is tested to see if it offers adequate treatment for a disease or condition. Another purpose of the second phase is to see if any side effects are uncovered in a larger group of people or are revealed over time or extended treatment. Only about one third of drugs make it past Phase 2.

If a drug makes it to Phase 3, the group of participants is usually expanded to a few hundred or thousand patients depending on the anticipated indication. This group typically includes people of diverse backgrounds, especially in age and health status. Phase 3 is how researchers confirm the efficacy of a drug or vaccine in varying circumstances. Phase 3 also allows for monitoring of a drug or vaccine for adverse effects over several years in typical circumstances. All of these numbers of subjects and patients is, of course, dependent on the type of disease.  In new drugs for rare diseases (e.g., genetic diseases or cancers), where there may only be a few hundred or thousand patients in the world, the size of trials may be scaled back dramatically.  

In a health crisis (e.g., a pandemic) or where there are no available treatments for a life-threatening disease (e.g, cancer), the FDA may grant researchers the ability to accelerate development and apply for fast track status or receive an emergency authorization based on less data than usually required.

If all phases of a clinical trial are successfully completed, the drug can be marketed and distributed to all patients who are indicated for treatment, but the FDA continues to monitor the new drug or vaccine for reports of adverse effects. If there are a significant number of new or unexpected adverse effects, the FDA may require additional warnings, studies or even remove the drug from the market. While this process is extensive, it ensures that new drugs and vaccines are held to the highest possible scientific standard for safety and efficacy.

Robotic surgery was created to assist surgeons with routine, minimally invasive procedures. Robot-assisted surgeries tend to take less time and result in decreased pain for the patient. However, some surgeries, including certain heart surgeries, have remained very invasive, open procedures. Now, more surgeons than ever are able to complete advanced and difficult surgeries with the assistance of robots.

While the first use of robot-assisted surgery occurred in the 1980s, and laparoscopic surgeries have been common for years, the use of robotic technology has ramped up in recent years due to technological advances. The advantages of robotic technology for surgery exist for both the patient and the surgeon. Advanced cameras help surgeons gain greater visibility, robotic arms remove tremors that could cause tissue damage and robotic technology allows for surgery with less cutting. For the patient, this means a shorter recovery and can even mean fewer complications.

The Da Vinci System is one of the most famous robotic surgery systems, offering options for cardiac, gynecological, colorectal, urological, thoracic and general procedures. Other popular robotic surgery systems include Mako by Stryker, NAVIO by Smith & Nephew and Monarch by Auris Health, but each of these systems are more limited in their potential uses than the Da Vinci.

However, while robot-assisted surgery may be the future of many surgical procedures, no robot can replace the role of the surgeon in any procedure. While robots can reduce recovery times and improve outcomes by assisting surgeons with visibility and performing less invasive procedures, the knowledge and craft of doctors is irreplaceable. The future of robotic surgery is promising, but doctors are the future of surgery.

Sources: Yale Medicine, Da Vinci, Britannica