December 14th, 2020
1) A few SARS2/COVID19 vaccines are on the horizon and there is a ton of misinformation flying all around. If I told you that I thought that the medical community would have pulled it off within two years, let alone under a year, I would be lying and you would have thought that I am nuts. And you would have been as wrong as I am. On June 26th, I wrote a newsletter stating:
"COVID vaccine - what is the story?
Has there ever been a successful vaccine made against a beta coronavirus? Not to my knowledge despite the common cold being represented by 30% coronaviral etiology and efforts being made in the past. Dr. Peter Hotez and his group in Texas were apparently close for SARS1 years ago before the funding dried up. There are many groups working feverishly and competitively to be the first to succeed at this major task.
To my knowledge, this is a very very tricky vaccine effort to say the least. SARS2 is an RNA virus. RNA viruses infect and lead to the death of millions of people every year worldwide. The list of RNA viruses is: human immunodeficiency virus (HIV), hepatitis C virus (HCV), Ebola virus, Zika virus, respiratory syncytial virus (RSV), influenza viruses, yellow fever virus, dengue virus, rhinoviruses (common cold), poliovirus, and measles virus. As of 2020, many of these viruses have no effective treatment or vaccine and the available vaccines are not highly effective with the exception of polio and measles.
The SARS2 virus is 29,900 base pairs long which is huge for an RNA virus. It also has the ability to self correct its replicated copies if a mistake occurs which is rare for an RNA virus. This is a unique adaptation to prevent dysfunctional viral particles from being produced and reducing viral spread. We know a lot about this virus to date but have little quality experience with a vaccine antidote. That data is forthcoming although I am less optimistic that it will be anytime soon. I am putting my money on a biological antibody to prevent death like an IL6 or CCR5 inhibitor.
The other rub is that studies being done on a SARS2 vaccine are being primarily done in young and healthy patients who are more likely to develop an immune response. This means that when it is released to the elderly, it will be a complete unknown as to the risk benefit ratio."
Fast forward to today. Operation Warp Speed seems to have been a resounding success as Pfizer's mRNA vaccine has received FDA approval and Moderna is poised to get authorization to release the vaccine for those interested in taking it. What an accomplishment! The United States Government has bank rolled this project to take the financial risk out of a very expensive developmental process allowing the scientists and the companies to focus on one thing only, SARS2 viral disease resistance. The first two studies have shown over a 95% success rate. This is remarkable. No matter where you stand on the vaccine debate, the science and speed of this endeavor is nothing short of amazing.
Now we come to the pressing question on everyone's mind. Do you and does your family opt to receive the vaccine when it is available and offered?
The simple answer is to weigh and measure risk and reward. What are the negative outcome possibilities for you and your child/ren from contracting the SARS2 virus and developing COVID19 versus developing a side effect from the vaccine as currently produced with the current safety data sets in place.
The safety data as it stands seems very safe for an acute, within months, serious side effect. There have been two, temporally associated, nasty autoimmune diseases, transverse myelitis and multiple scelrosis, in the two vaccine trials using the replication defective adenoviral vector. So far, the powers that be have deemed them not related and furthermore, these are not the vaccines slated for early use in the US.
The first two vaccines to be used in the US are using the novel messenger RNA technology. Pfizer and Moderna are the current early players in the vaccination of America program. With north of 73,000 people receiving the mRNA vaccines already and close safety monitoring showing no major issues, we can safely say that the safety in the short run appears excellent for these two front runners. We also know that they tested the vaccine in many adults over the age of 65. That is welcome news. However, this is not the same as completely safe. Over the past 50 plus years of vaccine development, some serious diseases were not found for years because they are infrequent in volume making it necessary for hundreds of thousands to millions of individuals to get the vaccine before one person will develop a life changing illness.
I lived this experience in my early training years with Rotashield, a vaccine against rotavirus in children. We started giving this vaccine in the mid 90's only to see it pulled from use after it was determined that it was causing intussusception, intestinal blockage requiring surgery, in infants. Mind you, this was years after study and FDA licensure. The vaccine began study in 1987, was FDA approved in 1997 only to be removed from market in October of 1999.
The take home point is that the only harbinger of vaccine safety is time. With COVID19, we do not have the luxury of 5 to 10 years of safety trials. At current daily rates, we are losing the equivalent of the deaths from the World Trade Center Towers tragedy daily. That is a lot of loved ones to be mourned. Thus, we have a lower bar to pass to push vaccination as every day wasted without vaccination is many more deaths.
Thus, we are left weighing and measuring a reality where 99.7% of us will survive this illness. A subset of those survivors will develop a long hauler problem, chronic fatigue and other symptoms, which is no joke based on the current data. The vaccine and it's side effects seems far less risky based on my simple analysis. The scales are definitely tipped toward getting the vaccine. However, that risk is not and never will be zero. The debate will continue in my mind until I am offered the choice.
Those of us that feel amazingly healthy, are young and at low risk could easily make a case that no intervention is needed for survival. Those of us that are less healthy will have a harder time making this case in any way. Advancing age, heart disease, high blood pressure, diabetes, obesity, cancer, kidney disease, lung disease and many other chronic age related diseases are risk factors that must be taken into account and make vaccination an absolute safety position. More than 112 million Americans will be over the age of 50 years this year. Many of them have other chronic diseases especially obesity. The under age 50 group has a large percentage of obese individuals at roughly 42% based on the CDC stats. Thus, it seems highly likely the majority of adult Americans will be at higher risk of COVID death or long hauler disease than the fractionally small risk of a persistent vaccine side effect.
This is just straight non emotional statistics. Every decision that you make from here on out is a choice of risk categorization. If you are high risk and choose to avoid the vaccine, then based on what I have read and understand, you are choosing the higher risk bucket.
I have received the influenza vaccine every year since 1991. I have received yellow fever, hepatitis A and most boosters for health as I traveled often to remote parts of the world over the years. That is just me and these have been my choices. I still sit here today with the solid belief that vaccines are good for us and that the biggest mistake most people make is that they believe that they are immune to risk if they follow a healthy lifestyle. A healthy lifestyle as we have discussed for a decade is absolutely key to good health and also happens to increase your response to a vaccine and its effectiveness. It, however, does not preclude risk to a negative outcome from an infectious disease.
I have been very humbled over the years to the sight of a dead child from a vaccine preventable disease. It is not pretty. I have received many notes over the years decrying my vaccine stance as an Integrative Functional medicine provider that "should know better". I believe in conscious thought that is rooted in the scientific evidence before making any decision. Therefore, my decisions are based on today's evidence. Time can change anything. Holding truths loosely is the key to growth.
I will leave you with this final note. When an immigrant comes to the United States from a developing country they often want every vaccine available. When I ask them why? They say because these pathogens kill children. They have seen it over and over again. There is no black swan in their world as pathogens are in their view.
2) More on vaccines: There were two serious non lethal allergic reactions to the mRNA Pfizer vaccine in the United Kingdom. Both individuals apparently had a history of severe allergic reactions requiring epinephrine in the past. The recently completed phase 3 trials did not find any allergic reactions to the two mRNA vaccines. I would guess that this is because they did not test the vaccine in individuals with severe allergic history. We will continue the follow the post release data safety monitoring as they come out.
3) Previous common cold coronavirus exposure associated with reduced morbidity in new SARS2 cases. (Sagar et. al. 2020) This data mirrors the research from a few weeks ago where adults exposed to children younger than 5 years of age had less disease related to SARS2. Immune crosstalk from genetically related coronaviruses appears to be very real which again is great news for teachers, daycare workers and pediatric office workers.
4) Being lonely and stressed out is associated with increased inflammation as noted with increased serum levels of cytokines and other inflammatory proteins including Il-6, fibrinogen and hsCRP. (Smith et. al. 2020) The results speak to the effects of stress on the hypothalamic pituitary axis and thus cortisol activity. Excess cortisol and excess sympathetic nervous system activity are routes to increased inflammation via NFkB and other genes. Thus, instead of taking a reductionistic approach that says just socially distance and mask to stay alive, how about we look at the whole human and focus our energy on positive social interactions between everyone and reach out to the lonely, marginalized and stressed with a phone call, a zoom call and a collective prayer for happiness. Collective human behavior and consciousness is one of our greatest gifts when we exercise them.
5) Vitamin D - just take it already. "Vitamin D level is markedly low in severe COVID-19 patients. Inflammatory response is high in vitamin D deficient COVID-19 patients. This all translates into increased mortality in vitamin D deficient COVID-19 patients. As per the flexible approach in the current COVID-19 pandemic authors recommend mass administration of vitamin D supplements to population at risk for COVID-19." (Jain et. al. 2020)
6) A large meta analysis of coronavirus sex related outcomes was just published in Nature Communications. It confirms the previous data sets showing men are three times more likely to end up in the ICU and 1.3 times more likely to die than the stronger female counterparts. As stated in previous newsletters, the female immune strength comes in many forms. They have more robust anti viral interferon levels coupled with more circulating cytotoxic T cells allowing for a strong early innate immune response to the virus. They also produce more antigen specific adaptive antibodies than men, which helps tremendously in the later inflammatory stage of the illness.
On a social level, men are more likely to smoke, drink and be less clean making immune suppression and viral exposure more common than females. Let's face it, men are just more likely to make the negative choice when compared to women.
7) SARS2 was here in the United States in December of 2019. Analysis of blood donations from 9 states during this time frame found that 106 of 7389 samples were positive for SARS2 antibodies. (Basavaraju et. al. 2020) This means that 1.4% of samples tested were positive for SARS2 exposure. My interpretation of this data is that there was a lot more circulating disease in the United States than anyone ever suspected. Remembering that antibodies wane rapidly in up to 20% of infected individuals, these numbers are likely underestimates. It is highly likely that this virus was around in the fall of 2019.
8) In a massive meta analysis in JAMA Pediatrics, we see a large data set where 135,794 tested children turned into 5374 positive tests, 359 were admitted to a hospital, 99 required ICU care and 8 died. (Bailey et. al. 2020)
Per the American Academy of Pediatrics, since the pandemic onset, 1,461,000 COVID-19 cases in children have been reported. COVID-19 incidence among adolescents aged 12–17 years was approximately twice that in children aged 5–11 years. Underlying conditions were more common among school-aged children with severe outcomes related to COVID-19.
Our experience in clinic has been different. One hospitalized child out of many positives. No deaths and no long term morbidity noted to date at our clinic. North Carolina has had one death in a child to date. Nationally, that number stands ay 154. Thus, the case fatality rate in children is 0.01% or said another way, 99.9895% chance of survival. The Infection fatality rate will be markedly lower when those studies are performed in the future. Therefore, the chances of dying are actually even significantly less than 0.01%. This is all great news if you are under 18 years of age.
The data distilled analysis shows us that COVID19 barring a future mutation is about as deadly as the seasonal influenza for children which accounted for 188 deaths last year. The only difference when you look closely at the deaths is that influenza has a predilection for infants whereas SARS2 attacks the metabolically unhealthy and compromised children.
Stat Pearls SARS2 Picture
Sagar J Clinical Investigation
Smith Neuroscience and Biobehavioral Reviews
Jain Nature Scientific Reports
Peckham Nature Communications
Basavaraju Clinical Infectious Disease
Bailey JAMA Pediatrics