The development, authorization, and distribution of hundreds of millions of doses of the COVID-19 vaccine was both an amazing feat of collaboration by scientists, private companies, and governmental organizations and the turning point in one of the darkest periods in public health. The journey of a COVID-19 vaccine: where the vaccine comes from, how it is manufactured, who plays a role in its approval, and how it officially arrives for widespread use is complex.  Many regulatory organizations, such as the FDA, CDC, HHS, and WHO, all had a hand in this journey. From the research lab to the patient,, there are several steps in this process that fully vet a vaccine for its safety and efficacy.

Step One: Research

The journey of the COVID-19 vaccine begins with research and lab work. As with any vaccine, there are specific guidelines that must be followed in order to take steps toward proper creation, use, and understanding of the vaccine. 

In the Lab 

Federally-funded scientific research launches a vaccine into the exploratory stage. Scientists hired by the government identify disease-fighting antigens of either natural or synthetic origin. Once identified, the same researchers may enter pre-clinical studies, performing animal testing to ensure the safety of a vaccine candidate. In the case of mRNA vaccines, such as the COVID-19 vaccine, this research had been performed for decades before COVID-19 ever surfaced. 

In fact, in its early stages, mRNA technology has been used as a research tool to study gene expression, protein production, and potential cancer treatment. In 1996, scientists even applied for funding to develop the technology into a treatment for seasonal coronaviruses. Although mRNA technology has met both funding and patent challenges, it has continuously remained in research with several different organizations. By the late 2000s, BioNTech and Moderna had both entered the mRNA research field — particularly in vaccine production. 

Typical vaccine research, whether privately funded by pharmaceutical companies or the government, can take anywhere from 10 to 15 years to complete. During this phase, scientists develop potential vaccines based on how the virus causes illness or disease in humans. 

The mounting pressure of COVID-19, however, brought increased demand from scientists to complete clinical research in a time frame far shorter than normal. Luckily, due to the previous research performed on coronaviruses by the NIH, and the previous research performed on mRNA technology by different organizations, scientists were quickly able to leverage what had already been in development for years. 

Before a vaccine can move forward into clinical trials in humans, researchers must perform efficacy and safety studies. 

These studies are typically sponsored and funded by a private manufacturing company. Sometimes, the government (National Institutes of Health) may offer public funding as well. These sponsors submit an Investigational New Drug application, or IND, to the Food and Drug Administration before the clinical trials can begin. In this application, the sponsor’s manufacturing process is outlined and finalized to ensure the safety and consistency of the vaccine from batch to batch (lot to lot), any preliminary research is summarized, and the clinical study is proposed in detail. This information must be reviewed and approved by the institution where the sponsor plans to conduct the research. 

The Food and Drug Administration is a government agency part of the United States Department of Health and Human Services (HHS), designed to ensure the safety and efficacy of drugs and foods for human consumption and use. The FDA approves uses for certain drugs, and in this case, vaccines, via the Federal Food, Drug and Cosmetic Act.  

Clinical Trials

Once the FDA has approved the IND, researchers can begin human-based clinical trials. COVID-19 vaccine clinical trials consist of three phases. These trials determine the safety and efficacy of the vaccine. Participants are volunteer-based, and each participant agrees to report any side effects and allows for any follow-up physical examination conducted by scientists.

Phase One

During the first phase of clinical studies of the COVID-19 vaccination, scientists gather 20 to 100 volunteers to answer the following questions: 

• Is this vaccine safe?
• Are there any serious side effects?
• Is the vaccine causing an immune response?
• Which immune responses are triggered at different doses of the vaccine?

Phase Two

After phase one has answered basic questions about the safety of the vaccine, researchers can gather a larger study group consisting of several hundred volunteers. According to the National Institutes of Health, phase two participants and scientists aim to answer the following, more in-depth questions: 

• What are the most common short-term side effects?
• What’s the body’s immune response?
• Are there signs that the vaccine protects against infection?

Phase Three

Following the results of phase two, there are now over 1,000 volunteer clinical study participants in phase 3. Just as phase two expanded detail on hypotheses and questions, phase three does as well. However, it is during this phase that the NIH created the COVID-19 Protection Network (CoVPN) to perform these trials. Researchers answered the following questions: 

• How do disease rates compare between people who get the vaccine and those who do not?
• How well can the vaccine protect people from disease?

After completing all three phases, the sponsoring organization will submit the results to the FDA for approval. Results from phase three research on COVID-19 vaccines determined that early, experimental versions of the vaccine were safe for consumer use. However, research actively continues through the present day. 

Other Clinical Trials

To continue research on potential COVID-19 treatments and vaccinations, the National Institutes of Health (NIH) set up the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) trials.

The treatments actively tested are for patients who have never had COVID-19 and those in every stage of the illness — from minimal symptoms to hospitalizations, to those in recovery.  

Step 2: Manufacturing

There are three FDA-approved vaccine manufacturers in the United States, and you’ve likely heard of them: Pfizer-BioNTech, Moderna, and Johnson & Johnson/Janssen. All vaccines approved by the FDA are safe, effective, and reduce your risk of severe illness.

Manufacturing Process

Once all preliminary clinical trials and research have concluded, the FDA can work closely with vaccine manufacturers to create lot-release protocols. These protocols ensure that original manufacturing processes are followed and that consistent testing is maintained to ensure the safety of each lot for consumer use. The FDA will also closely monitor and examine any manufacturing facility to ensure compliance with FDA regulations. 

Emergency Use Authorization (EUA) 

In this case of the urgent need for COVID-19 vaccinations, manufacturers submitted requests for Emergency Use Authorization. Once the requests were made, researchers in medical and scientific disciplines from the FDA’s Center for Biologics Evaluation and Research (CBER) reviewed Phase 3 clinical trial data. This data was reviewed against EUA criteria (safety, effectiveness, and manufacturing processes), and potential benefits and risks were weighed, resulting in vaccine authorization instead of full FDA licensure.

The EUA process reviews the same core information as a BLA, however, the process is substantially faster in order to meet emergency use demands. Each EUA released by the FDA has adjusted the criteria for patient use (age, pre-existing conditions, etc) and is specific to each manufacturer. 

Biologics License Application (BLA)

After the FDA deems the manufacturing process as reliable and consistent, and all clinical research and development is completed, manufacturing companies can submit a Biologics License Application to the FDA. A BLA allows companies to apply for the ability to create and distribute the COVID-19 vaccination in the United States. This application details all clinical data and research information and includes all manufacturing processes and facilities. Currently, manufacturers are beginning to submit Biologics License Applications as a next step toward solidifying the COVID-19 vaccine as an official FDA licensed, common use vaccine in the near future. 

Step 3: FDA Approval

Before a vaccine can obtain full “FDA Approval,” there are multiple factors that must be vetted. The FDA will review and inspect the thousands of pages of the BLA before it can move forward to licensing, CDC review, and eventually prescribing and labeling. 

Reviews and Inspections

Upon receipt of a Biologics License Application, the FDA will evaluate its comprehensive components. The decision to license (approve) a vaccine comes from an intensive review of any beneficial or risk-oriented outcomes of vaccine use versus the disease the vaccine is intended to prevent. 

The FDA’s “Vaccine Development 101” list comprises an average FDA scientific team that reviews this information and the BLA closely: “physicians, chemists, statisticians, pharmacologists/toxicologists, microbiologists, experts in postmarketing safety, clinical study site inspectors, manufacturing and facility inspectors, and labeling and communications experts.” 

During this time, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) gives input to the FDA on any scientific or public health data before vaccine approval. VRBPAC is a panel of independent experts in diverse scientific or public health fields that may provide input in a public-facing meeting. 

Official Approval

If all criteria have been met for a Biologics License Application, and the FDA has determined the benefits of the COVID-19 vaccine outweigh its potential risks and  the risks of COVID-19 itself, the vaccine is officially approved and licensed by the FDA.

Prescribing and Labeling

After licensing the vaccine, the FDA will return to the information found in the BLA. A careful review of this information allows the FDA to determine the accuracy of prescribing information. This includes determining dosing and usage. Prescribing and labeling information is updated by the FDA on an as-needed basis in accordance with the most current COVID-19 and vaccine information available. 

CDC Recommendations

After final approval, the CDC’s Advisory Committee on Immunization Practices (ACIP) will review the newly licensed vaccine to determine recommendation eligibility. 

What is the CDC?

The Centers for Disease Control (CDC) is a government agency part of the United States Department of Health and Human Services, designed to protect Americans from threats to health security. The CDC equips Americans with health information to stay safe in times of health crisis and sets schedules for immunizations based on ACIP recommendations. 

What is the ACIP?

The Advisory Committee on Immunization Practices consists of a panel of 15 medical and health experts who vote on recommendations in vaccine use for United States disease control. Additionally, there are 30 non-voting members who are highly regarded healthcare professionals.

Before a vaccine has received FDA approval, the ACIP actively reviews all information available, allowing for thorough preparation for recommendations by the time the vaccine is approved. After FDA approval, however, the ACIP considers several factors of a vaccine before making an official recommendation. These factors include: 

• Vaccine efficacy and safety at specific ages
• Disease severity compared to vaccine efficacy
• Recommendation practicality (feasibility for the American public)

All ACIP recommendations are unofficial until the Director of the CDC has given approval. Then, ACIP recommendations become official CDC public health guidance.    

Step 4: Public Release

By Step 4, a COVID-19 vaccine has received FDA licensing and CDC recommendation and is ready for public release. However, it must undergo safety surveillance as vaccine lots are released for production. 

Vaccine Safety Surveillance 

Following FDA approval, the COVID-19 vaccine will undergo safety surveillance. Using the Vaccine Adverse Event Reporting System (VAERS), Vaccine Safety Datalink (VSD), and the Clinical Immunization Safety Assessment Project (CISA), the CDC and FDA monitor the safety and efficacy of the vaccine after FDA approval.  These surveillance systems remain active after the public release of the vaccine in order to track adverse effects and monitor updated safety risks.

Vaccine Adverse Event Reporting System (VAERS) 

VAERS is a vaccine monitoring system run by both the CDC and FDA. It collects reports of negative effects after vaccination. Anyone is able to flag an adverse event, including patients, caregivers or parents, and healthcare professionals. 

Vaccine Safety Datalink (VSD)

The CDC collaborates with several healthcare organizations to monitor vaccine administration in real-time. This data allows for continued vaccine research. 

Clinical Immunization Safety Assessment Project (CISA)

Several medical research centers, in collaboration with the CDC, provide healthcare providers with answers to vaccine safety questions on behalf of their patients. Additionally CISA conducts continued clinical research to maintain vaccine safety.

Lot Release

Following final safety checks, the FDA releases a “lot” of the COVID-19 vaccine to manufacturers for production. If a manufacturer is permitted to produce the vaccine lot, the FDA has reviewed and approved vaccine safety criteria, such as sterility, potency, and consistency. 

The federal government distributes FDA-authorized COVID-19 doses on a state and jurisdiction basis weekly. Additionally, the government created specialized programs to distribute vaccines to high-risk communities directly. Through the Federal Retail Pharmacy Program, 40,000 pharmacies in high-risk zip codes receive COVID-19 vaccines. Community health centers that administer the COVID vaccine can apply for the Health Center COVID-19 Vaccine Program. Medically underserved rural communities are distributed COVID-19 vaccine lots through the Rural Health Clinic COVID-19 Vaccine Distribution (RHCVD) Program. Beyond these programs, all states, territories and tribes are responsible for developing a plan for distribution to people who live in their communities. 

Public Education

Many organizations formulate campaigns to increase and maintain public knowledge and education about the COVID-19 vaccine and preparedness. Two of the biggest contributors to this educational goal are the United States Department of Health and Human Services (HHS) and the World Health Organization (WHO).

HHS

The HHS is a government agency that houses the FDA and the CDC. It is a resource for anyone looking for updated vaccination processes, treatment information, and general education about COVID-19. However, it has also initiated the COVID-19 Public Education Campaign, which aims to increase consumer confidence surrounding COVID-19 vaccinations. Additionally, the HHS has an official government website dedicated to empowering Americans to “Combat Covid” in their local communities and acts as a resource for healthcare professionals who must advise their patients. 

WHO

The World Health Organization has consistently worked to keep the public informed about COVID-19 preparedness and vaccination since the start of the pandemic and throughout vaccine development. WHO is an agency of the United Nations that aims to promote worldwide health and health education. They are responsible for compiling the COVID-19 Strategic Preparedness and Response Plan (SPRP) and other plans of action. 

In Summary 

From the science lab to consumer use, the journey of a COVID-19 vaccine is intensive and rigorous. Through clinical trials, manufacturing processes, and other inspections, the FDA and CDC/ACIP closely monitor the vaccine for safety and efficacy before it reaches the consumer. Education of the vaccine stems from organizations such as WHO or HHS, and is available for the public. It is through the collaboration of these organizations that COVID-19 vaccinations are widely available for the safety of Americans.

Whether you are young or young at heart, there is no doubt that you have experienced the feeling of being cold in your life. However, as we age, we may notice the cold feeling creeping in more often than it ever used to. Why is this? A new study by Yale and UCSF published in the journal Cell Metabolism may be able to explain. 

Regrowth is Not Restoration, but Replacement May Be

In the study, researchers found that the immune cells stored within fat that have evolved to protect humans from the cold are to blame for increased susceptibility during the aging process. The study discovered that as mice aged, they lost innate lymphoid cells (ILC2.) These are the very same cells that rebuild and restore body heat while in the presence of cooler temperatures. 

When researchers attempted to stimulate the production of new ILC2 cells in these same mice, they discovered that the aging mice were more likely to face a cold-temperature induced death. In fact, while the aging mice had a restored immune system, they were far more susceptible to the cold. 

However, researchers found that transplanting ILC2 cells from younger mice into the aging mice did produce positive results. The aging mice were now more tolerant of the cold. 

Bottom line: based on non-clinical research, regrowing the ILC2 cells did not actually restore them to their fullest potential, but full replacement allowed for potential tolerance against the cold to be met.  

What About Aging Humans

These findings bring about an interesting thought: how can we restore the health, or in this case, cold tolerance, of the elderly? Potential eventual manipulation of the immune system must be undertaken with extreme care and diligence, and further studies are warranted. . 

Sources: Yale, Cell Metabolism

You’ve heard it before: wear sunscreen any time you are in the sun. It’s true — it is important to wear sunscreen with an SPF of at least 30 any time you spend prolonged time outdoors. However, recent reports have surfaced that are flagging certain sunscreens as unsafe and potentially cancer-causing. 

Chemicals To Avoid 

While the FDA is still investigating this issue, Valisure, an independent quality assurance company, recently found high levels of benzene in 78 sun products. Benzene is a known human carcinogen, according to the CDC, the World Health Organization, and more. Not only is this chemical highly flammable, it is used to make plastic and synthetic products, dyes, lubricants, drugs, pesticides, and more. It is also naturally found in crude oil, gasoline, and cigarette smoke. 

The short of it: long-term exposure to inhaled benzene is a known risk factor for leukemia. This chemical is not intentionally added to sunscreen, but there is no level of benzene that is considered safe in topical or aerosol products. 

How to Stay Protected

To stay protected against the sun in the meantime, switch to a mineral-based sunscreen and continue to wear protective clothing while the FDA investigates this problem.It is important to research any sunscreens or after-sun products that currently are in the homes of consumers — these products from popular brands such as Johnson & Johnson may be recalled off the shelves. 

Sources: Yale Medicine, Valisure, AAD

Breast cancer is the second most common cancer in women, with the first being skin cancer. With 1 in 8 women affected by the disease, experts want you to know these 5 things about breast cancer and screening for it.

1. Your family history matters, but isn’t the final word. While it is extremely important to know your family history to determine if you are at higher risk for breast cancer, you are not locked into developing the disease simply because your family members have. In fact, more data are surfacing about family history’s importance aligning more with the personalization of treatment and screenings and less with your likelihood of developing the disease. 

 

2.  Know your density. Yes, density, not destiny. Women who have dense breast tissue are no more likely to develop breast cancer than those without, but this type of tissue can pose difficulties when screening for breast cancer with mammography. If you are a part of the 50% of women who have dense breasts, experts recommend scheduling a breast ultrasound at the time of your next mammogram to get the clearest reading. If you do not know if you have dense breast tissue, make sure to ask your healthcare provider.

 

3. You have options beyond a mastectomy. Breast cancer does not always equate to a mastectomy, especially extensive surgery. If the cancer is detected early, a lumpectomy to remove the localized breast cancer followed by other methods of treating  the remaining malignant breast tissue. 

If you do choose a mastectomy, you even have different types of reconstruction options, including breast implants or your own breast tissue. 

 

4. Breast cancer isn’t caused by breast implants, deodorant, or underwire bras. While the direct cause of breast cancer has not yet been determined, outside factors such as tight or underwire bras cannot cause cancer on their lonesome. In fact, even with known carcinogens (which deodorant and bras are not), it typically takes several, long term exposures to any outside factor before a cell can turn cancerous. 

 

5. Create a team of treatment all-stars. When it comes to breast cancer, it is important to know that you will be seeing a team of experienced healthcare providers. From a radiotherapist, to a surgeon, and everything in between, it is vital to know that your team can communicate with each other to get the best treatment for you — especially if you are going to multiple practices. Do not be afraid to choose your healthcare providers carefully — they are going to work together to provide the best care for you. 

 

Sources: Yale Medicine

In the midst of summer, many people are taking advantage of outdoor activities. No matter what age, it is important to stay hydrated in hot weather. From playing sports to traveling to the beach, hydration helps support healthy heart function in the hot weather and can help avoid frustrating side effects of dehydration. Follow these hydration tips to avoid ruining your summer fun with headaches, swollen feet, or even heat stroke. 

Know How Much Water to Drink

Depending on the weather, type and amount of clothing being worn, amount of energy exerted and body type, the amount of water you need to prevent dehydration varies. Additional factors include medical conditions such as diabetes, cystic fibrosis, or heart disease, medications taken, or even perspiration rates. 

Easily recognizable signs of dehydration go beyond just thirst. In fact, it is important to note that if you feel thirsty, you are most likely already dehydrated. A more telling factor is urine color. The paler and clearer the better. If your urine appears dark in color, drink water. 

Another sign of dehydration is lack of perspiration during physical activity. If you do not sweat while heavily exercising, you may be close to developing heat exhaustion.

In order to calculate a general idea of how much water to consume to avoid dehydration, weigh yourself before and after exercise. The difference in weight can tell you how many pints of water to drink, with each pound lost equating to one pint of water needed to replenish. 

Water is the Winner  

While sports drinks stocked with electrolytes might seem tempting, nothing replenishes hydration in the body quite like water. You can source water from more than just the faucet as well. Fruits and vegetables tend to have a high water content, allowing the body to replenish from a seemingly different source. Sugary drinks such as soda, or caffeine, should also be avoided. 

Other Tips

Now that you know how much water to drink, and that water is the drink of choice, it is a good idea to follow these additional tips to avoid dehydration: 

• Drink water before exercising, not just during, to avoid making your heart work harder than it has to. 
• Drink water even when you aren’t planning on exerting energy. A day of sitting in the sun can be just as dehydrating as exercise. 

Sources: American Heart Association

According to a new study published in Nature with over 200,000 female participants, there are over 290 genetic variants that could signify an estimated menopause start date. The findings from this study open a door to many new variables in the prediction of menopause timing. While it may seem daunting, this type of prediction is (eventually) possible. 

Egg Quality and Count

Those who are assigned female at birth are born with cells that will eventually turn into eggs in the ovaries and are released during ovulation in a normal menstrual cycle. Over time, the body will eliminate any eggs containing damaged DNA. This process begins around 10 years before menopause and drastically increases during menopause, causing a sharp decrease in fertility. 

According to the study, women who have lost function of the gene CHEK2, a protein that can trigger a cell to self-destruct, had about a 10% variation in age for the start of menopause from those with the functioning protein. This finding notes that women with the underactivity of this gene typically had a 3.5-year delay in the start of menopause. This means that immature eggs survived longer in the ovaries in women who lost the function of CHEK2. 

What can this discovery do?

While the prospect of manipulating the timing of menopause by targeting CHEK proteins is an idea fit for future exploration, it is not human-ready– yet. There might be other health concerns to take into consideration. While the delay of menopause could lead to a reduced chance of developing type two diabetes or poor bone health, there may be an increased risk of hormonal cancers, such as breast cancer. 

Final Thoughts

This discovery is a stepping stone to a vast topic of research into fertility and menopause. Eventually, scientists hope to predict the length of a given fertility window, allowing for reproductive choices to be made in a more informed manner, according to John Perry, a geneticist at the University of Cambridge. 

Sources: Nature, Nature, Nature

As the new school year is quickly approaching, parents are gearing up to send kids back to school. Beyond the worries of COVID-19, there are still regular health concerns for heading back to school. To have the best school year yet, follow these three easy steps to maintain a healthy lifestyle. Odds are, you’re probably already familiar with them. 

Prepare Healthy Lunches

According to the American Cancer Society, it is vital to maintain a healthy diet at all ages. While it may be quick and easy to send your kids to school with snacks like potato chips or sugary drinks (or to make a box of macaroni and cheese for lunch if your kids are learning from home), it’s a good idea to take time out to prepare healthy foods for lunch and snacks during the school day. Doing so can help foster more energy, a better diet, and a healthier lifestyle for your kids.

The best way to go about getting the healthiest foods in your kids’ diet (and your own) is to ensure there are a variety of colors on the plate (or in the lunch box). Standbys like whole grains, fruits and vegetables are always a good choice for a healthy dose of carbohydrates. Including healthy fats such as cheese, hummus, avocado, or peanut butter instead of fried foods is a good way to ensure a variety of nutrients enter the body. 

By following a healthier diet during the school day, kids can learn how to make healthier diet choices on their own, setting them up for a healthier lifestyle. 

Catch Enough Sleep

Sleep is an extremely important part of a healthy lifestyle, especially for children. Not only does sleep support a healthy body, but it also supports a healthy mind. From positive mental health to good grades in school, children and teenagers need to get about at least 8 hours of sleep each night to function properly, according to the National Sleep Foundation.

According to the Association for Child and Adolescent Mental Health, the COVID-19 pandemic may have disrupted routines and sleep schedules for children and teens alike. To help regain a sense of normalcy and support a good night’s sleep, try to create a bedtime routine that excludes electronics and is consistent seven nights a week. By removing stimulation offered by cellphones, video games, computers and television, the brain can more easily relax into a state ready for sleep. Wind-down activities that are healthier include reading, yoga, meditation, or listening to calming music. 

Much like setting a healthy diet for your kids, a healthy sleep schedule can also benefit you. By following the same rules and routine, your own levels of stress may go down, just like your children’s. 

Get Daily Exercise

According to the American Cancer Society, children and adolescents should get about an hour of moderate exercise every day to maintain a healthy lifestyle. In a time where team sports or school exercises have been made difficult by pandemic restrictions, it is important to keep your family moving. Biking, yard work, or running are easy options to get up and moving. Obesity has been increasingly common in children, especially at young ages.  We also know that obesity increases the risk of developing diabetes, heart disease and cancer later in life. The best time to deal with this and set off in the right direction is when kids are still in school.

Consistent exercise routines offer a chance to decrease stress and anxiety that often comes from the pressures of school and work. Additionally, vigorous exercise can set up the body for a heavy night’s sleep, effectively checking two boxes on this list. 

How to Get Started

To get a head start on organizing sleep and exercise schedules, as well as a healthy diet, it is important to keep a tracker of each. Writing down your food, sleep and exercise plans can help keep you and your family accountable, as well as provide an easy-to-follow framework for day-to-day life. Be sure to begin these lifestyle changes a few weeks before school starts to let your kids’ bodies adjust to the new normal. 

The steps are easy: eat right, sleep and exercise. When children and teens follow these three pillars of health, they will be ready for the healthiest school year yet. 

Sources: American Cancer Society, Sleep Foundation, Association for Child and Adolescent Mental Health  

Throughout the COVID-19 pandemic, researchers have tried to identify early indications of disease severity in patients at higher risk for complications, such as people with obesity or people over the age of 65. Recent studies by Yale show promising results that saliva tests and blood tests may allow doctors to predict how severe patient symptoms will be on a case-by-case basis. 

 

While similar in outcome, the studies each took largely different approaches to the topic: one study examined the accuracy of a saliva test while the other examined blood testing. This begs two questions: what is the difference between the two tests, and will either provide accurate predictions? 

 

Predicting COVID-19 Severity Using Saliva 

 

While simpler in use than the standard nasal-swab currently performed in COVID-19 testing, the saliva collection technique is only available today at select laboratories. Saliva COVID-19 testing is not currently available to most people, but researchers have become increasingly interested in the potential of the saliva testing method. 

 

Research on the saliva test shows that patients with increased SARS-CoV-2 viral load could be more susceptible to disease complications. Unlike the nasal-swab testing method, the saliva test can provide information on the condition of a patient’s lungs. Mucus regularly travels via cilia (hair like structures) from the lungs to the throat where it combines with saliva; if the virus is found in saliva, it is possible that the virus has entered the lungs — where COVID-19 complications are typically most severe. 

 

According to the preliminary results of the study, saliva viral load directly relates to disease severity, as well as other parameters tested by Yale. These include obesity, age, immune response and more. 

 

Blood Testing Evaluates Biomarkers

 

Much like the saliva-based study, the blood test study aimed to find early predictors in patients who later developed severe COVID-19 complications. Researchers found that certain biomarkers associated with white blood cell activation were potential early complication indicators. 

 

While blood samples were only taken from 100 patients, a clear pattern in results emerged. Those who later experienced critical illness in relation to COVID-19 showed increased levels of five proteins related to neutrophils, a type of inflamed white blood cell. Those who did not experience symptoms or complications did not show the increased protein levels or neutrophil biomarkers. 

 

Results from this study note that neutrophils are increased in both cases of COVID-19 and obesity. These biomarkers appeared in COVID-19 patients before they began to experience symptoms and were not previously associated with COVID-19.  While neutrophils are common in infections and other causes of inflammation (such as obesity), understanding the link between neutrophils and COVID-19 can help doctors better predict severity and treat patients accordingly.

 

The Bottom Line

 

Both studies have provided insights in the hunt for new information about early indication of COVID-19 complications. While each study requires expanded research before public use and implementation, both collaboratively provide a glimmer of hope for COVID-19 treatment and preparedness. 

 

Sources: Yale Medicine, Yale School of Medicine

There are many cancer treatments available to patients, with new cancer treatments in clinical trials every day. Cancer treatment typically depends on the type of cancer, and certain treatments are only applicable to cancers with certain “markers.” While this may seem confusing, the vast majority of cancer treatments fit into a few categories, namely immunotherapy, chemotherapy (both classical and molecularly defined), radiation therapy, hormonal therapy and surgery. Here’s a breakdown of the different cancer treatments and what you need to know.

Immunotherapy

The body’s natural immune system works to eliminate abnormal cells in the body, but some cancers are particularly adept at avoiding immune responses. Tumors can have proteins that allow them to evade detection by the immune system or can alter the cells around them to interfere with the immune response. Immunotherapy works to boost the body’s natural immune response to cancer, often by enhancing the overall immune system or reducing the natural “checkpoints” that the immune system utilizes to prevent dangerous immune responses. Some forms of immunotherapy also involve creating specific cancer antibodies in a lab to educate and bolster the immune system. 

Immunotherapy is being used effectively for a wide range of cancers but is still relatively new compared to traditional cancer treatments like chemotherapy and radiation therapy. However, immunotherapy holds great potential for personalized, effective cancer treatment and is the largest area of growth today for cancer treatment.

Chemotherapy  (Classical and Molecularly Targeted)

Chemotherapy is an effective cancer treatment that uses medication to kill or reduce cancer cells. Many people are familiar with chemotherapy, because it has been a first-line cancer treatment for decades. Chemotherapy can completely eliminate cancer cells and may be the only treatment that a cancer patient receives, or chemotherapy can be used to reduce the size of a tumor to increase the odds of a successful surgical removal. For advanced cancers with no other treatment options, chemotherapy can also be used to temporarily relieve symptoms and increase life expectancy.

While classical chemotherapy can be a life-saving cancer treatment, it often comes with some unpleasant side effects. Chemotherapy affects the way that cancer cells divide and multiply, but it can also impact healthy cells in the process. For this reason, patients may experience nausea, hair loss or fatigue, which can make it necessary to alter daily routines or work schedules. Nevertheless, chemotherapy is still the gold standard of treatment for many forms of cancer because of its favorable outcomes.  More recently, many forms of molecularly targeted therapies have been discovered and approved.  They are much more specific than the traditional chemotherapies and target the actual control mechanisms that regulate the growth, proliferation and spread of cancer cells.  This represents an area of cancer treatment with virtually limitless options as we learn more and more about the genes that regulate cancer in children and adults.  

Radiation Therapy

Radiation therapy works to kill cancer cells and shrink tumors with high amounts of radiation. The goal of radiation therapy is to damage the DNA of cancer cells to the point that the cancer cells can no longer divide and ultimately die, prompting the body to remove them. While radiation therapy can be an effective cancer treatment in certain cancers, it takes time and repeated radiation sessions to yield the necessary damage to cancer cells. Then, it takes months for all of the cells to die and for the body to completely remove the dead cells.

The primary drawbacks to radiation therapy are the side effects and the safety limits for lifetime exposure to radiation. Radiation therapy can affect both the cancer cells and nearby healthy cells, causing a lot of internal damage. Depending on where the radiation therapy is administered, you can have a wide range of side effects from headaches to fertility problems. Regardless of where your cancer is located, it is very likely that you will experience fatigue as your body works to repair the damage.

Luckily, side effects usually fade away in the months that follow radiation therapy, and radiation therapy can cure or shrink your cancer significantly.

Surgery

During surgical cancer treatment, a surgeon removes a tumor or cancer cells from your body. Surgery can be very effective for local cancers and can even eliminate your cancer without additional treatment. Surgeons can also use different devices, like lasers, to kill abnormal cells. Surgical treatment works best for localized cancer and is not effective for blood-borne cancers, such as lymphoma or leukemia, or cancers that have metastasized (spread) to other locations in the body.

Often, surgery is used in combination with chemotherapy or radiation therapy. Surgery may be done first to remove the primary tumor and followed by chemotherapy or radiation to kill additional cancer cells. Or, surgery may be done after chemotherapy or radiation therapy has reduced the size of a tumor.

For local cancers, surgery can be a very effective treatment with few side effects. Catching cancer in its early stages can reduce the chances that the cancer has metastasized and increase the efficacy of surgery and overall survival.

Hormone Therapy

For specific types of cancer that are reliant on hormones to grow, hormone therapy can be a treatment option. Certain types of breast cancer and prostate cancer fall into this category and can be treated with hormonal medications. Medications that block hormones do not cause the same destruction to healthy cells as radiation therapy and chemotherapy, but the impact on hormones is likely to cause temporary hormonal imbalances and corresponding side effects, such as hot flashes and changes to libido.

Genetic Testing and New Advances

With increased genetic testing and other medical advances, new cancer treatments are being tested every day. Some promising cancer treatments include the molecularly targeted therapies briefly mentioned earlier, which attack the specific changes in cancer cells that allow them to multiply and genetic therapies for cancer, including precision medicine and biomarker testing. Understanding the specific genetic qualities of different cancers can help doctors provide the most effective and precise treatment with as few side effects and as little impact to healthy cells as possible. 

Source: NIH

During the COVID-19 pandemic, health care providers across the country were forced to find new ways to provide patient care, often embracing the use of telehealth. While telehealth services have been available for years, the practice of online medicine has typically been reserved for low-risk medical issues that could easily be identified and treated without lab testing or a physical examination. However, during the pandemic, many health care centers and providers that had relied on in-person visits were forced to turn to telehealth when travel and hospital visits were restricted. A study at Dana-Farber Cancer Institute found that using telehealth visits for some cancer follow-up visits was a success for both providers and patients.

The study, which was conducted through Dana-Farber, analyzed the satisfaction of both medical providers and patients with virtual visits specifically for childhood cancer follow-up care. According to the study, health care providers at Dana-Farber were overwhelmingly pleased with their virtual patient visits, with 86% of providers stating that they were either very satisfied or completely satisfied with their virtual visits. While lack of physical examinations and lab testing did prevent medical providers from accomplishing some clinical goals, their overall satisfaction with the virtual visits was high.  On a personal note as a patient, I have found telemedicine in clinical areas beyond oncology to be immensely helpful and effective.. 

In this same study, patients (childhood cancer survivors) were also satisfied with the overall experience, even more so than providers. About 95% of patients said that they were either completely or very satisfied with their virtual experience. Perhaps even more telling was the fact that about two-thirds of patients found their visit to be almost as helpful as an in-person visit and more than four out of five participants preferred virtual visits either in combination with or instead of in-person visits.

While the success of virtual health care was particularly important during the COVID-19 pandemic, virtual cancer follow-up visits may reduce the long-term burden of receiving cancer treatment at a long-distance facility. By reducing the amount of travel to and from top cancer treatment centers, more people could receive the life-saving advantages of cancer follow-up visits without the personal and financial impact of travel but yet providing them with access to the leading clinicians at major medical centers like Dana-Farber.. More research into the benefits and consequences of virtual or hybrid care for cancer survivors is needed to understand the true potential and risks of such health care models.

Source: Dana-Farber Cancer Institute