If you have not received your Flu shot this season now is the time to schedule yours.

Vaccines provide a general boost to your whole immune system. New research shows that a flu vaccination can dramatically lower your risk of having a severe case of Covid-19. A recent large study* showed that being vaccinated against the flu cut the risk of having Covid-19 ER visits, strokes and sepsis (a life-threatening infection) by about 50%. Having a Flu shot also lowered the risk of needing intensive care for Covid-19 by 20 %.

The world had a very mild Flu season last year due to masks, cleaning and physical distancing which are well known to prevent the spread of flu. Expert opinions vary on how severe this season’s flu will be, but according to the CDC in the 2019/2020 Flu season the US had 35 million cases of the Flu and nearly 400 thousand flu-related hospitalizations. In early November 2021, the US is starting to see a rise in Flu cases.

Flu vaccination is for everyone over the age of 6 months. Our recommendation: get your flu shot now; you can have it at the same time as any Covid vaccination or booster. With the current stress on doctors’ offices, hospitals and healthcare facilities we need to avoid large twin outbreaks of both Covid-19 and the Flu. Do your part to help avoid a “twindemic” of Covid-19 and Flu. Protect yourself and others.

* journals.plos.org/plosone/article?id=10.1371/journal.pone.0255541

An Israeli Company, Enlivex, has developed a medication, EXO-CD24, that looks very promising for successfully treating seriously ill Covid-19 patients. In a small clinical trial of 30 severely ill Covid-19 patients, all patients survived without side effects, and 29 of the 30 patients recovered within 3-5 days. EXO-CD24 was given by inhalation over 2-3 minutes, once a day for 5 days. This medicine uses the body’s naturally occurring bio-chemical signals to instruct the immune system to restore its balance.

A healthy immune system has an extensive series of checks and balances controlled by many biochemical signaling compounds. These compounds turn up the immune response when it is needed and act as brakes to prevent the immune system from overreacting.

The two basic components of the immune system work together to optimize the body’s response to a foreign body such as a virus; the first component signals the immune system to attack the foreign body during the early phase of the infection, then signals the second component, to wake up and provide a longer-lasting response.

Covid-19 patients with mild illness, mount a strong early immune response, fight off Covid-19 successfully and keep the immune system in check as the second, more durable immune response system revs up.

Seriously ill Covid-19 patients have a weak early response that allows the virus to multiply and reach higher levels in the body. This weak early immune response also causes faulty signaling to the secondary response immune engine, sending it into overdrive when the immune system finally begins to respond. This over-reaction response of the immune system, in COVID-19 is known as the “cytokine storm.” The “cytokine storm” causes major tissue destruction, typically in the lungs, resulting in the critical breathing problems that cause patients to require mechanical ventilation and often death.

Allocetra contains an important signaling molecule, CD24, that puts the brakes on the “cytokine storm.” Hopefully, the remarkable success of these early trials will be replicated in larger trials that are expected to begin shortly. Interestingly, this medication also has the potential to help in many common medical conditions where the immune system is overactive including auto-immune diseases, such as multiple sclerosis and Type 1 diabetes and severe infections.

Mutations and variants are important because they can make our vaccines less effective by altering the structure of the Covid-19 virus. Mutations occur in nature to help life forms adapt and survive in changed circumstances. Some Covid-19 mutations make the virus weaker and these virus variants die off. Other mutations make the virus stronger by helping it to spread more easily. Mutations can change the structure of the Covid-19 virus making vaccines less effective.

The genetic code is like a string of beads. (See illustration Fig. A). The human genetic code is built from DNA “beads”. The Covid-19 virus genetic code is built from RNA “beads”. The genetic code carries the instructions for the reproduction of all living beings. It determines the color of our eyes, how tall we are, and even whether we are a human or a virus. A mutation is a mistake in the genetic code as it is being copied over and over, as part of the reproductive process. A mutation occurs when the wrong “bead” is inserted into the code (Fig.D). Changing the bead, alters the genetic code and changes the instructions, potentially resulting in a different structure and/or function (compare Fig. B to Fig. E). A variant is the altered life form, that results from a collection of mutations.

The Covid-19 outbreak in Manaus, Brazil taught us about the power and danger of new variants. In a severe and early outbreak, more than 75% of the people in Manaus were infected with the original Covid-19, first diagnosed in China. Infection with Covid-19 generates protective antibodies in the infected person. Antibodies work by binding onto the virus, which blocks the virus from attaching to and entering our cells. This prevents the virus from causing an infection. (Fig. C). Because the majority of the people in Manaus had protective antibodies, it was assumed that the population would not be susceptible to further outbreaks. However, a Brazilian variant emerged and caused another devastating surge of Covid-19 illness.

The Brazilian variant had mutations that changed the structure of the virus. As a result, the antibodies from the original Covid-19 infections could not bind onto the new Brazilian variant and did not protect the people of Manaus from further infection (Fig. F).

Similarly, vaccines protect us by stimulating our immune system to generate protective antibodies. Just as the infection-stimulated antibodies did not protect the people of Manaus from the Brazilian variant, current vaccine-stimulated antibodies may not protect us from future Covid-19 variants. A striking example of vaccine failure was experienced in South Africa. The Oxford AstraZeneca vaccine was reported to be 70% effective against the UK variant. The South African government purchased one million doses of the vaccine for their population. However, a South African variant emerged that was only 10% sensitive to the Oxford AstraZeneca vaccine.

The number of COVID-19 variants is directly related to the number of infections in the global population. The more infections, the more likely mutations and variants will emerge. The only way to stop this process is to achieve global vaccination with effective vaccines. For more information on vaccine effectiveness in the U.S., please read our vaccine assessments at https://www.emergencyuniversity.com/campaigns/covid-qa.

Johnson and Johnson’s (J&J) Covid-19 vaccine, Ad26.COV2.S, manufactured by Janssen Pharmaceuticals is currently administered as a single dose vaccine. The vaccine uses an adenovirus (a common cold virus) that has been modified in 2 ways. First, it has been modified so that it cannot reproduce itself or cause a cold. Second, it carries the instructions to make the Coronavirus-19 spike protein in the form of a stable DNA molecule. Once the vaccine enters the recipient’s cell, the cell uses the DNA to make copies of COVID-19’s spike protein. These copies of the spike protein activate the body’s immune system to create “warriors” ready to fight the COVID-19 virus if it enters the body.

Is the J&J vaccine effective?

In J&J’s Phase 3 Clinical Research Trial, J&J submitted to the FDA that their COVID-19 vaccine was effective at preventing severe illness (85%) and COVID deaths (100%). When moderate and severe disease are combined it is moderately effective (66%) at preventing illness caused by the original COVID strains. The vaccine begins to provide protection 14 days after administration of the single dose, and its efficacy continues to rise over the next 3 months. By 4 weeks post vaccination, the J&J vaccine appears very effective at preventing COVID-related hospitalizations and deaths, but is not as potent at preventing Covid-19 illness as Moderna and Pfizer vaccines (90+%).

Is the J&J vaccine effective against COVID-19 variants?

Covid-19 variants have continued to spread globally, including into the U.S. As the number of Covid-19 infections increase, the number of Covid-19 mutations also increase. The J&J single dose vaccine appears to be effective against the UK variant (B.1.1.7), which is currently the predominant strain in the U.S. and Europe as of May 2021. However, the J&J vaccine is less effective (52%) against newer, emerging mutations such as the South African Variant (B.1.351). This is of concern, because the South African variant has the exact same mutation now appearing in other emerging variants.

What are the side effects of the J&J vaccine?

Common side effects are similar to those experienced with the Pfizer and Moderna vaccine; pain at the injection site, fever, fatigue, muscle aches, and headache. These side effects are generally mild and resolve within 2 days. A rare side effect, occurring at a rate of 2 events/million doses is the formation of clots in large blood vessels, including the brain. The large clots are accompanied by a dangerous drop in the cells that prevent clotting in the blood. This rare event occurs mostly in women 18-49 years old. If you experience severe headache, abdominal pain, shortness of breath, leg swelling, or new and easy bruising, within 3-4 weeks of vaccination with J&J, contact your physician immediately. The CDC has added a warning to its FDA approval regarding the devastating but rare risk of blood clots.

Moderna’s Covid-19 vaccine, mRNA-1273, appears to be safe and effective. Phase 3 clinical trials demonstrated that the vaccine was 94% effective at preventing Covid-19 illness. Studies conducted during real-life vaccination programs demonstrate a similar efficacy at preventing Covid-19 illness. The Moderna vaccine also prevents severe illness requiring hospitalization and Covid-19 deaths. There are fewer large studies on the Moderna vaccine than on the Pfizer vaccine due primarily to funding. However, both Pfizer and Moderna are based on mRNA technology, are the first human FDA approved mRNA vaccines and have very similar content.

An interim report from an ongoing study published in the New England Journal of Medicine established that protective antibodies levels from the Moderna Covid-19 vaccine remain high in all age groups through at least 6 months (See Figure-1). There was a small but statistically significant reduction in antibody levels seen in patients over 70 years old.

Is the Moderna vaccine effective against Covid-19 variants?

Covid-19 variants continue to emerge. The longer the pandemic continues, the greater the probability that variants will develop that may be resistant to current vaccines. Several studies show that mRNA vaccines offer protection against current variants, but at a lower level when compared to the original Covid-19 strain. The advantage of mRNA technology, used to develop the Moderna and Pfizer mRNA vaccines, is that it offers the ability to rapidly modify vaccines to protect against new variants. Moderna already has a vaccine specific for the UK variant B1.1.1.7 in testing.

Is the Moderna vaccine safe?

The Moderna vaccine is safe. Severe allergic reactions were extremely rare in individuals who received the Moderna Vaccine. Only 10 cases of severe allergic reactions occurred after administration of 4 million doses, 0.00025 %. This rate compares favorably to the Pfizer vaccine’s slightly higher rater of 0.0011%. As with Pfizer, vaccinated individuals are reporting some chills, fevers, muscle and joint aches and fatigue. These side effects are more commonly reported after receiving the second dose, are more common in woman and typically resolve within 1 to 3 days.

A large well controlled study of 1.2 million people published in the New England Journal of Medicine (NEJM) reported that the Pfizer vaccine is 94% effective at preventing illness from Covid-19. The vaccine was similarly effective at reducing hospital and intensive care unit admissions and preventing deaths. This compares to the annual influenza vaccine which is approximately 50% effective.

Is Pfizer’s vaccine effective against Covid-19 variants?

There are multiple Covid-19 variants circulating around the globe. The Pfizer vaccine appears to be effective against the UK variant, B.1.1.7, based on the 1.2 million person study which was conducted in Israel during the time the UK variant was spreading rapidly there. A small study, conducted in the US and Germany on infected patient’s serum, published in the NEJM, showed potential protection against the South African variant, B1.351 and the Brazilian variant, P1, as well. The virus continues to mutate and widespread vaccination is an important part of reducing the number of mutations we will be exposed to.

Is the Pfizer vaccine safe?

There was initial concern about serious allergic reactions. The CDC has issued a report based on 4.5 million vaccine doses administered in the US. The CDC concluded that vaccine allergic reactions do occur, however the rate is similar to that seen with influenza and other vaccines. Most reactions occur in individuals with a history of vaccine allergic reactions and the majority of serious reactions happen within the first 15 minutes after the vaccine is administered.

The Pfizer vaccine is effective with tolerable side effect levels and does appear to provide protection against the UK and other variants. It is heartening to see some light at the end of the pandemic tunnel.

Yes, please continue to wear your mask for several reasons.

No vaccine offers 100% protection. Manufacturers are reporting a range of effectiveness for their vaccine products. This information is obtained from carefully controlled research trials. Most vaccines are less effective in real-life than in research trials, due to factors including how the vaccine is stored, the vaccine dose, and individual variables such as age, health and genetics. Even when a vaccine is highly effective (95%), this still means that 1 out of 20 of us will not be protected.

Once you’ve had your vaccine it takes a while to build up immunity. Most reports show that protection is not achieved until several weeks after completing full vaccination. We have not yet determined if vaccinated individuals who achieve individual protection from Covid-19 illness can still carry the virus in their system, as we have seen in other vaccines and infections.

New strains of Covid-19 continue to emerge. Researchers are studying how effective the current vaccines are against the new strains. For Covid -19 strains with minor mutations, the current vaccines appear to offer good protection. Unfortunately, some Covid-19 mutations such as the rapidly spreading South African strain are very different. Therefore, even individuals who have recovered from Covid-19 or have been vaccinated may still become ill with these new variants.

Protect yourself, protect others, wear your mask, maintain social distance and keep washing your hands. These critical actions help to limit the spread of Covid-19.

Simply put, yes.

Flu shots are especially important this year for many reasons, including emerging evidence that a flu shot may help to protect you against COVID-19. Scientists have known for a while that receiving certain vaccines helps to wake up the immune system, so that it is better able to fight off many different infections. One large study in Brazil showed that a recent flu shot meant you were 8% less likely to end up in an intensive care unit with COVID-19, and 17% less likely to die of COVID-19. Others studies also show lower rates of COVID-19 in Flu-vaccinated groups. Experts believe that children have milder COVID-19 in part, due to the many vaccines they receive.

Due to a property with the wonderful name of Antigenic Original Sin, your immune system remembers similar prior exposures and provides cross protection, so getting your Flu shot also helps to protect you against other strains of the Flu.

We also want to save our healthcare resources for people being affected by the COVID-19 pandemic. The symptoms of Flu and COVID-19 are so similar, that your doctor will need to test to tell them apart. In the United States last year (2019-2020 flu season) 38 million people had the flu, 18 million visited healthcare providers for Flu sick visits, 400,000 were hospitalized and 22,000 died. Getting your flu vaccine will help to ease this burden.

Everyone age 6 months and older, that does not have a contraindication (a specific reason to avoid Flu vaccine) should be vaccinated. If you are over 65, the high dose Flu vaccine is preferred, but the regular dose is an acceptable option and much better than no vaccine. Flu is caused by the influenza virus, which is a rapidly mutating (changing) virus. Because the flu virus is always changing, you need a new vaccine dose, each year. We strongly encourage you to get vaccinated, it will help you, your family and public health.

Experts are seeing skyrocketing rates of mental health issues both in the general population and in survivors of Covid-19. We are all being affected by the anxiety and stresses of the Covid-19 pandemic and this is driving a new pandemic of mental health problems. Concerns for illness, grief, job loss and financial insecurity are taking a toll.

How Serious is the problem?

A recently published CDC study revealed that 41% of U.S. residents surveyed, reported experiencing mental health effects as a result of the pandemic. A full 31% reported anxiety or depression, 26% reported trauma/stressor related issues from the pandemic and 13% have started or increased their use of alcohol and other drugs.

10% of those surveyed reported suicidal thoughts within the last 30 days. More than 40 states in the U.S. report significant increases in opioid deaths with some reporting opioid deaths that have more than doubled in the last year. While opioid prescriptions are down, due to increased awareness of physicians, opioid mortality is now often linked to the increased use of fentanyl- a very potent opioid- laced into street drugs.

After a summer of nationwide violence and protests, and an additional 3 months of pandemic related stress, these numbers likely underestimate the severity of the problem.

Covid-19 Survivors and Mental Health

There is also growing evidence of mental health issues specific to Covid-19 survivors. Early study results are concerning. One study looked at survivors, 1 month after hospital discharge. The study found that 56% of survivors suffered from serious mental health issues including depression, anxiety and insomnia. 28% of Covid-19 survivors exhibited symptoms of Post Traumatic Stress Disorder (PTSD).

If you would like to explore your sense of well-being, we encourage to take our free Mental Health Awareness Program at https://www.emergencyuniversity.com/training/mental-health.

If you or someone you know is suffering from significant mental health issues, encourage them to reach out to their doctor and mental health care providers for support.

National Suicide Prevention Lifeline
Available 24 hours. English, Spanish support
1-800-273-8255

SAMHSA’S National Helpline: 1-800-662-HELP(4357)
a free, confidential, 24/7/365 treatment and information service for individuals
and families facing mental and/or substance use disorders.

Flavonoids are a diverse group containing thousands of compounds that naturally occur in plants. There has been a lot of interest in these compounds in the last few years because of their known health benefits. Examples are Curcumin (turmeric), Resveratrol (red wine and grapes) and Quercetin (red, blue and purple food like berries, and also kale). Flavonoids are known to have roles in fighting off viruses, keeping blood vessels healthy (a Covid-19 target), and in keeping the immune system healthy. Flavonoids also help Zinc do its work. The US National Institutes of Health is actively studying flavonoids for use in preventing and treating Covid-19.

Food Sources of Flavonoids are obtained from eating a colorful diet

• Red, purple and blue food; berries, red cabbage, red onion, grapes and red wine
• Teas especially green tea
• Greens foods especially kale, broccoli and parsley
• Dark chocolate!
• Red kidney beans, pinto beans, black beans
• Spices like cinnamon, turmeric, mustard
• Citrus fruits

Should you take a flavonoid supplement?

To absorb flavonoids, you need a healthy gut. The good news is that all high flavonoid foods help you achieve a healthy gut. Also, most plant foods have multiple types of flavonoids in them, so there is synergy. Flavonoids appear to be safe to consume, so taking a supplement is a reasonable choice to make. Look for a respected brand that contains a variety of flavonoids. The scientific studies on Covid usually include Quercetin in their flavonoid mix.

Selenium has multiple roles in the immune system, one of which is to block viruses from entering cells, a critical step in virus infections. Studies published in the 1990s revealed that individuals with selenium deficiency were more likely to be critically ill when infected with RNA viruses such as COVID-19.

A recent study from China determined that individuals who became infected with COVID-19 in Selenium deficient areas of China had significantly higher Covid-19 death rates than individuals in areas of China with normal Selenium levels.

Selenium status is one of several risk factors that may impact on the outcome of COVID-19 infection, particularly in populations where Selenium intake is sub-optimal or low, such as areas in China and Europe.

Selenium also plays a role in protecting the heart and other organs from damage during infections.

Should you take a selenium supplement?

Only a small amount of Selenium is required for proper functioning of the immune system. The majority of individuals in the US ingest sufficient Selenium in their diet. Food sources include pork, beef, turkey, chicken, fish, shellfish, and eggs as well as some beans and nuts, especially Brazilian nuts, contain Selenium.

Kidney dialysis patients, individuals with severe gastrointestinal conditions, those living with HIV infection or who have had bariatric (weight loss) surgery tend to have low levels of Selenium. Selenium supplements may be beneficial for these individuals.

Because high levels can cause toxicity, the majority of healthy adults do not need to take a Selenium supplement. We recommend you discuss taking a Selenium supplement with your physician, to determine if it will benefit you, and the recommended dosage.

We have long known that Zinc has important roles in fighting infections. Zinc possesses a variety of antiviral properties both alone and potentially in conjunction with anti-viral medication. Zinc is particularly important in COVID-19. Studies conducted in live cell cultures demonstrated that Zinc blocks the Covid-19 virus from reproducing. Zinc also acts to maintain a tight healthy barrier in the linings of our nose, sinus and lungs. Several recently published studies suggest that Zinc supplementation may be of benefit for prevention and treatment of COVID-19.

Zinc deficiency results in a compromised immune system. Zinc deficiency increases your risk for contracting viral infections. U.S. Government studies reveal that up to 25% of adults over age 60 are Zinc deficient. Many common diseases like diabetes and gastrointestinal disease, and conditions including pregnant and breast-feeding woman, can result in low Zinc levels.

Since milk, red meat and poultry are excellent sources of Zinc, individuals eating vegan and vegetarian diets need higher Zinc intake. Lastly, many common medicines, including some blood pressure medicines, block zinc absorption.

Should you take a Zinc supplement?

Always start by eating a healthy varied diet. In addition to milk, red meat and poultry, whole grain products, baked beans, chickpeas, cashews and almonds are excellent sources of zinc. Zinc can interfere with common prescription medications, and excessive Zinc can cause problems. It is recommended that you discuss taking Zinc supplements with your physician to ensure it is safe for you, and to understand what dose is right for you. Because Zinc can interfere with many common nutrients and medicines, be sure to take it 2 hours before meals or medications.

Vaccines are intended to sensitize your body’s immune system to prepare for an unwanted invader. In the United States, the two vaccines that have entered Phase 3 clinical testing are both mRNA vaccines. Both Moderna and Pfizer initiated Phase 3 clinical trials in July, with a goal of testing the vaccine on 30,000 diverse volunteers who reflect the broad spectrum of the U.S. population. Their goal is to conclude the study by the end of October 2022, and report on the vaccine’s safety and efficacy. Both companies have recruited over one half the necessary volunteers for testing as of the end of August 2020. mRNA vaccines are atypical vaccines that scientists have been working on in various forms for over a decade.

Antigens (Ags)—the “invaders”-- are substances that are foreign to your body, such as bacteria and viruses, that stimulate your immune system’s white blood cells to generate proteins called antibodies (Abs). These antibodies bind to the foreign antigens, and interfere with their ability to survive or replicate.

Traditional vaccines work by administering an antigen which has been killed or neutralized into your system. The body “sees” this inactive antigen and is “fooled” into building up an army of antibodies, so that when you are later exposed to the live antigen, your body has a ready army, which attacks the antigen/microbe and prevents infection.

mRNA vaccines work very differently. RNA is the genetic code for an antigen. The “m” stands for messenger. The mRNA vaccine is injected into the individual. The mRNA attaches to and enters the body’s own cells, where it replicates and releases thousands of copies of the antigen. Covid-19 mRNA vaccines contain key portions of the Covid-19 virus genetic code, such as a critical portion of the “spike” protein. Theoretically, these antigens will stimulate the body’s immune system to generate a large and strong army of antibodies against Covid-19.

Will mRNA vaccines work and why are we trying this new technology?

Scientist have been working on developing mRNA vaccines for many years, but as of yet, none have been successful. The advantage of mRNA vaccines is that they are faster to develop and easier to mass produce than traditional vaccines. It is also theorized that mRNA may stimulate a much stronger and more complete immune system response.

The problem is that mRNA tends to be unstable. It is a messenger molecule. Its usual job is to deliver a message and then rapidly fade away. Because of this, it is hard to keep the vaccine in a stable form for transport.

Researchers are also concerned how long it will be stable and effective inside the body. Early studies on mRNA vaccines for Covid-19 are promising but not yet proven. Still to be determined are the significance of the side effects, and what populations they will be effective for.

Vitamin D plays critical roles in fighting off viruses by helping your body make specific infection fighting compounds. A recent study in Europe demonstrated a higher COVID-19 mortality in countries where citizens have a higher prevalence of Vitamin D deficiency.

Vitamin D is called the sunshine vitamin because our main source is sunlight. When the sun shines on our skins, our bodies turn it into Vitamin D. So be certain to spend time outdoors.

Fish, of all varieties are also an excellent source of Vitamin D. A high fish diet could explain why countries such as Finland, Denmark and Norway, have a very low incidence of Vit. D deficiency, despite long periods without significant sunshine.

Approximately 8 % of individuals in the U.S. are Vitamin D deficient. However, this does not tell the whole story. Individuals with darker skin pigmentation have higher rates of Vitamin D deficiency. Deficiencies as high as 30% have been documented in Black Americans and 13% in Hispanic Americans. It may be noteworthy that individuals with darker skin pigmentation also make up a disproportionate share of COVID-19 deaths. Of course, any correlation with Vit D deficiency is confounded by many other variables, such as socio-economic status, and pre-existing underlying medical conditions.

Vitamin D deficiency is more common in the elderly, individuals who have limited time outdoors, have darker skin pigmentation, are overweight, or have severe kidney or GI disease. Vit D. supplements may be very beneficial to support the immune system in these circumstances. The recommended amount for healthy adults is 800 IU/D. If you have any of the conditions described above, you may need more.

In order to effectively absorb Vitamin D supplements, they must be taken with a meal that includes fats or oils. Unlike Vitamin C, the body cannot easily rid itself of excess Vitamin D, and therefore excessive Vitamin D supplements can be toxic. Speak with your physician to determine if you should be tested for Vitamin D deficiency, and whether Vitamin D supplements would benefit you.

YES! You can pro-actively boost your immune system. Ensuring you consume critical nutrients and engaging in healthy behaviors can reduce your risk for many medical conditions. These actions can also potentially reduce the severity of your illness, and help you heal faster if you do get sick. As of August 2020, we have early studies specific to boosting your immune system for Covid-19, and many years of studies on flu and other virus infections that demonstrate that your lifestyle choices can, indeed, make a difference.

The Immune System is a complex, sophisticated system composed of organs as well as numerous types of attack and scavenger cells that circulate in your blood stream, these are stimulated when your body detects a foreign organism. It also includes defensive chemical compounds and proteins such as antibodies that are created and released in your body. The immune system acts to defend us against attacks from undesirable invaders, such as viruses, bacteria, and even cancer cells. You can think of the immune system as an army of warriors protecting us from enemies including infections like Covid-19.

The immune system and Vitamin C

Vitamin C is essential for optimal functioning of the immune system. Vitamin C is a potent anti-oxidant, which means it neutralizes toxic free radicals. It is theorized that much of the damage caused by COVID-19 is caused by the body’s inability to defend itself against the overwhelming numbers of free radicals.

Vitamin C deficiency results in impaired immunity and greater vulnerability to infections.

In turn, infections themselves, significantly reduce the body’s vitamin C levels, due to the body’s continuous utilization of Vitamin C in fighting the infection. Some physicians suggest ingesting more Vitamin C if you are fighting an infection. Several peer review studies suggest higher doses of Vitamin C are more effective in reducing severity and duration of illness caused by bacteria or viruses.

Vitamin C is not made within your body, so it must be consumed, most effectively by including Vitamin C rich foods in your diet. Food sources include papaya, bell peppers and citrus fruits, like limes, lemons and oranges. However, for most of us, the body easily clears out unneeded Vitamin C, so it is generally safe to take a Vitamin C supplement. Prior to initiating supplements, it is important to discuss your plan with your physician, to ensure it does not interfere with any medical condition or medications you may be taking.

There are currently over 100 Covid-19 vaccines in development globally. Eight of these vaccines are now in the all-important Phase 3 clinical testing trials.

What process does the FDA require to ensure that vaccines are safe for use in people?

Traditionally, vaccine developers first test the viability and effectiveness of the proposed vaccine in laboratories, petri dishes and test tubes. If the vaccine appears to be effective, developers initiate testing on various animal models to assess efficacy and understand side effects and potential toxicities. These initial stages usually take many months to many years. Only if a vaccine appears effective and safe in animals, do human trials begin.

In order to speed the availability of an effective vaccine to address the COVID-19 pandemic, World Health and Research Organizations have reduced the requirements to move from the laboratory stage, to animal studies, and into human clinical trials. In many cases, vaccine developers have been permitted to initiate human trials prior to realizing final results from their animal trials.

Human clinical trials undergo three phases.
In Phase 1, the vaccine is administered to small groups of people, usually 20-50 volunteers. During phase 1, dosages are assessed to maximize efficacy and minimize toxicity. Toxicity, side effects and effectiveness are all assessed.

If the vaccine produces safe and promising Phase 1 trial results, Phase 2 is initiated by testing the vaccine on several hundred people. Developers focus on people that represent the population most likely to receive the vaccine. For Covid-19, this requires testing on a wide range of ages, both men and woman, with varying health issues, and from a variety of genetic backgrounds.

During Phase 3, the vaccine is tested for efficacy and safety on thousands of people. Does the vaccine induce the desired immune response? Is the immune response effective in preventing the disease and/or reducing the severity of the disease? How long does the immunity last?

What’s happening with Covid-19 vaccines in the US?

Two vaccines currently under development in the US have begun Phase 3 clinical trials as of July 27, 2020.

The US Government has created Operation Warp Speed and invested/pledged billions of dollars in funding to speed development of a Covid-19 Vaccine. To further speed the availability of the vaccine for human use, the government/FDA have approved concurrent vaccine manufacturing during Phase 3 clinical trials. If the Phase 3 clinical trials are successful, vaccine doses will be ready immediately to administer to the public.

However, this is another departure from traditional pharmaceutical and vaccine development. Normally, pharmaceutical developers are required to complete their Phase 3 clinical trials, provide the FDA with conclusive evidence that the pharmaceutical is both safe and effective in order to receive FDA approval. Only then does manufacturing begin.

The normal timeline for vaccine development is 5-20 years. Scientists, pharmaceutical developers and government agencies seeking to provide a COVID-19 vaccine within 1-2 years have dramatically changed the development landscape. Yet to be seen, is whether a safe and effective vaccine can really be developed with this accelerated timeline, even with streamlined testing requirements. In the next segment, we will review some of the most promising vaccines, available clinical results, and projected timelines.