As the pandemic rages on and the numbers of both infections and deaths are staggering, one of the most pressing questions on everyone’s mind is what about the COVID19 vaccine. California is America’s hot spot now with someone being diagnosed with COVID every 6 seconds and someone dying from COVID complications every 8 minutes. The situation is truly horrific and very few families are untouched by the ravages of this disease. As an Integrative and Functional Medicine practitioner who wants to empower people to be informed and make the best choices for themselves based on solid information, I have done my best to put together extensive information to educate you. I will not tell you what to do, but I hope this information will allow you to make a decision based on your unique health situation.
If after reading this information, you have more individual questions, these can be explored further in an appointment with our new Physician Assistant, Matt McGarvey or Dr Kelly. We also intend on holding a Zoom meeting at end of January, to provide a more interactive discussion. Please note, I will not be answering questions regarding personal circumstances during the zoom call.
Let’s start with some basic information and get into more details down below. We will cover the following:
I will address each of these questions.
Additionally, I want to encourage you all to watch a video of Pierre Kory, MD from the FLCCC Alliance testifying to the senate committee about I-MASK+ study. He speaks on the medication Ivermectin which is an anti-parasitic medication shown to be a potent anti-viral in the fight against COVID 19. It is being used for prevention, for post exposure prophylaxis and in early-stage disease. There are 1000s of participants in 11 studies from all over the globe. Since Ivermectin was developed in 1981, over 3.7 billion doses have been administered worldwide, with an unparalleled safety profile. Doses vary depending on weight and indication.
When can I get vaccinated?
As most of you know, the vaccine distribution is going much slower than anticipated. There are 2 vaccines currently available, one from Pfizer and the other Moderna. Other vaccines options are in the pipeline. I will discuss the distinctions between options below. The CDC’s Advisory Committee on Immunization Practices (ACIP) and the state Health departments have determined that the vaccine will be distributed in phases. We are currently in Phase 1A which include HealthCare workers and residents of Long Term care facilities at risk. In Phase 1B, vaccine should be offered to persons aged ≥75 years and frontline essential workers (non–health care workers), and that in Phase 1cC persons aged 65–74 years, persons aged 16–64 years with high-risk medical conditions, and essential workers not recommended for vaccination in Phase 1b should be offered vaccine.
If you reside or work in Orange county, please keep an eye on the OCgov.com website for COVID19 information. https://occovid19.ochealthinfo.com/
ACTIVE PHASE IN ORANGE COUNTY - as of 1/11/2021
ALL TIERS + PEOPLE AGED 65+
ALL TIERS - Actively Vaccinating
Phase 1A Includes:
Estimate December - March
Phase 1B & 1C | High-risk Individuals
estimate February - March
California Department of Public Health (CDPH) is developing detailed guidance for this distribution phase. We will post additional information as it’s available.
Phase 2 | Critical Workers and Moderate-risk Individuals
estimate March - April
CDPH is developing detailed guidance for this distribution phase. We will post additional information as it’s available
Phase 3 & 4 | Everyone
Populations not identified in prior phases above, will be addressed and defined further by CDPH.
We will also try and keep you posted as we learn more about the vaccine distribution phases. People can also check with their employers if they are considered Essential Workers. The Spring Center will not be offering the vaccine due to the substantial storage requirements of these vaccines.
Where can I go to get my vaccine?
If you fall into Phase 1A, please contact your employer, long-term care facility for vaccination instructions, or register online through www.Othena.com. Additional information will be provided here in the near future as details become available.
What are these Vaccines and how do they work?
On December 11, 2020, the U.S. Food and Drug Administration (FDA) issued the first emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 for individuals 16 years of age and older. A week later the FDA issued an EUA for the Moderna COVID-19 vaccine for individuals age 18 and older. Both the Pfizer and Moderna COVID-19 vaccines use pieces of genetic material, laboratory-created messenger RNA (mRNA) instead of virus particles to create an immune response. This means that the vaccines do not contain live virus, inactivated virus, or preservatives. The vaccine work by providing messenger RNA coding information to your own cells instructing them to temporarily manufacture the coronavirus spike protein. Remember it is the SAR COV-2 viral spike protein that attaches to your cells, injects its genetic material into your cell, hijacking your DNA replicase, turning that cell into a factory that exponentially replicates and spreads the virus throughout your body, causing the infection. The sections of the mRNA and the modifications differ between the 2 companies.
The mRNA is wrapped in a lipid bubble to protect it and to enable entry into the cell. Our cells absorb the lipid bubble along with the mRNA which goes to a cellular organelle called the ribosome where the mRNA is translated into a spike protein (or a portion of the spike protein). The cells release the spike protein (which is non-infectious since there is no virus attached to it.) Your own immune system (T and B cells) create antibodies against the spike protein. The first vaccine dose primes your immune response so that your immune system will recognize the virus and this process takes 2-3 weeks. The second dose allows your immune system to build the Immunoglobulins which are the long-term defense against the virus. Should you get the COVID virus at a later date, your immune system will already have prepared T and B cells to neutralize the virus, so you should have minimal effects from the virus.
As far as we know, neither the mRNA, nor the manufactured spike protein will not permanently embed in your DNA and should not cause any long -lasting effects. Some estimate that due to this and the mutability of the virus, the covid vaccine may become a yearly vaccination.
Both vaccines seemed to reduce the risk of severe Covid disease. It’s not yet known if either prevents asymptomatic infection with the SARS-CoV-2 virus. Nor is it known if vaccinated people can transmit the virus if they do become infected but don’t show symptoms. I’ve put together a table to delineate the differences.
What Are the Various Ingredients in the COVID-19 Vaccines?
The medical ingredients are the messenger RNA. The non-medicinal ingredients are predominately lipid bubbles to surround and protect the mRNA so cells in your body can pick it up and deliver it to your cells. Four types of lipids are used in the Pfizer vaccine:
ALC-0315 is the main lipid ingredient. The others are used in smaller amounts to stabilize the bubbles. The other ingredients are saline/ salt solutions made up on phosphate buffer solution (PBS), sugar and water.
Moderna’s vaccine also has mRNA that contains the genetic code for the SARS-CoV2 spike protein, but the mRNA in the two vaccines is slightly different. Each company made changes to the genetic sequence of the mRNA they used so the vaccines would produce a stronger immune response. Moderna’s mRNA is also produced in laboratory equipment instead of in live cells.
Moderna’s lipid bubble ingredients are:
Instead of PBS, the saline component of this vaccine uses another common medical ingredient called a tris buffer, the purpose of which is to make the pH level of the vaccine close to that of our bodies. The liquid part of this vaccine contains:
What are potential side effects of the vaccines?
Most people will have some potential side effects which can be minor, like injection site reactions, fatigue, flu-like symptoms in the first 1-2 days after the vaccination. These reactions are expected to be similar or heightened after the second dose. Generally, the older patients have less reactions, likely due to a reduced immune response. Despite similarity to COVID symptoms, this is NOT an infection as there is no infectious material in the vaccine. It is your immune system responding to a foreign antigen which is a normal response. To be clear, these “side effects” are a sign that your immune system is kicking into gear.
As many of you may know there have been very rare reports of extreme reactions, especially anaphylactic allergic reactions. The initial reports surfaced from the UK and the Pfizer vaccine, but then a Boston physician also had an anaphylactic reaction to the Moderna vaccine. These reactions may be due to an ingredient in the lipid bubble, namely polyethylene glycol, which appears in both recipes although in slightly different formulations.
According to Morbidity and Mortality Weekly Report released Dec 23, 2020, the rate of anaphylaxis is 10 times higher following the COVID19 mRNA vaccines than the reactions documented for the Flu vaccines. As of that date there have been 21 cases of anaphylaxis in 1.9 million doses which is 11.1 case/ million versus 1.3 cases per million following the influenza vaccines. This report was released just 2 days after the Moderna vaccine was available, so further information will be forthcoming. 17 of the 21 cases had a history of anaphylaxis and 19 were women. 70% had reactions within 15 minutes. Of those who reacted, 17 were treated in the ER department and four were hospitalized, 3 in the ICU. All were discharged home.
Compare this to anaphylaxis and Guillain-Barre Syndrome (GBS) from the flu vaccines. As above 1.31 cases/million for anaphylaxis and 1-2 persons developed Guillain-Barre. This translates to 210 cases of anaphylaxis in 161 million Americans who get the flu shot, with a fatality of between 0.25 – 0.33 percent, approximately 1 death every 2-3 years. Around three to five percent of people with GBS will die and a small number are permanently affected. In raw numbers, between 4 and 15 people die from the flu vaccine and between 300 and 400 suffer vaccine injuries. However, nearly 55,000 people die every year from the flu itself with most deaths among the unvaccinated.
What do these numbers all mean? That there is a risk-benefit to the COVID vaccine, just as there is with the flu vaccine, and other conventional vaccines, as well as lifestyle choices that we may make. Think about car accident statistics. There are nearly 40,000 fatal car accidents per year in the US, more than 90 die daily in car accidents and nearly 2.5 million are seriously hurt or permanently disabled. 40% of these are due to drunk driving, one every 50 minutes. The US has more than 220 million licensed drivers. Despite these stats, most of us don’t think twice about hoping in the car and running out to the store, or getting behind the wheel after a drink or two. Likewise, hundreds of thousands of people will die from heart disease which is largely preventable by healthy lifestyle, but we love our sweets and junk food too much. (As a population, not most of the Spring Center patient!)
There is a trade off in this situation too. There will be folks who have adverse reactions to the COVID19 vaccines, in exchange for preventing 1000s of more deaths and the eventual return to a normal life. Each person has to determine their own risk-benefit ratio and act accordingly.
Antibodies against polyethylene glycol
It appears that the non-medical ingredient to which people developed allergic reactions, was the PEG or polyethylene glycol. Numerous medications contain either PEGs or structurally similar polysorbates. PEG is found in a bevy of pharmaceutical products, including ultrasound gel, laxatives and injectable steroids. PEG is extremely well known as the primarily ingredient in Miralax. It is also used in the pharmaceutical industry to stabilize medications. Originally thought not to be immune provoking, there is now emerging evidence of anti-PEG antibodies detected not only in patients treated with PEGylated therapeutics but also PEGylated drugs treatment-naïve individuals with a prevalence from <1% to 72%. These existing anti-PEG antibodies reduce the efficacy of PEGylated drugs and increase adverse effects. Obviously, this is a huge spread from 1% to 72%. Other studies seem to suggest about 7% in the population.
As far as I can tell, there are no conventional lab that tests for antiPEG antibodies, though the literature points to the use of allergy patch tests. For those of you who are under the care of an allergist and who have anaphylactic reactions to different substances, consider inquiring if the allergist will test you for AntiPEG antibodies/reactions. There is a company called ELISA/ACT that analyzes Lymphocytes reactions to polyethylene glycol. We are looking into this possibility for concerned patients.
Polyethylene Glycol is not a benign ingredient. Merck’s Miralax is only indicated for 7 days in adults and it does not have FDA approval for children. However, pediatricians often recommend Miralax for extended periods of time for children. The active ingredient Polyethylene Glycol (PEG 3350) is linked to thousands of reports of neurological, psychiatric, and kidney side effects. PEG 3350— comes from petroleum and it is made of Ethylene Glycol (EG), a toxic antifreeze chemical, but PEG 3350 is not easily absorbed by the body.
Reporting of Vaccine Adverse Events
Adverse events that occur in a recipient after receipt of COVID-19 vaccine should be reported to the Vaccine Adverse Events Reporting System (VAERS). FDA requires that vaccination providers report vaccination administration errors, serious adverse events, cases of multisystem inflammatory syndrome, and cases of COVID-19 that result in hospitalization or death after administration of COVID-19 vaccine under EUA. Reporting by anyone who gives or receives a COVID-19 vaccine is encouraged for any clinically significant adverse event, whether or not it is clear that a vaccine caused the adverse event. Information on how to submit a report to VAERS is available at https://vaers.hhs.gov/index.htmlexternal icon or 1-800-822-7967. In addition, CDC has developed a new, voluntary smartphone-based tool, v-safe, that uses text messaging and web surveys to provide near real-time health check-ins after patients receive COVID-19 vaccination. The CDC/v-safe call center follows up on reports to v-safe that indicate a medically significant health impact to collect additional information for completion of a VAERS report. Information on v-safe is available at https://www.cdc.gov/vsafe. Information on how to use both reporting systems is included in the EUA Fact Sheet.
Need more details on the vaccines
Peter Doshi’s editorial at the BMJ on the need for more details and raw data regarding the mRNA vaccines is compelling. He states that all the attention has focused on the dramatic efficacy of the Pfizer vaccine reporting 170 PCR confirmed COVID19 cases, 8 in the vaccine group and 162 I the placebo group. However, there was a very large suspected covid-19 group of 3410 cases, 1594 in the vaccine group and 1816 in the placebo group. With 20 time more suspected than confirmed cases, the rough efficacy of the vaccine drops to 19-29% (29% if we remove the symptoms occurring within the week post vaccine which may reflect the reactogenicity of the vaccine itself. We know that the PCR tests are not perfect, so some of these suspected but not confirmed cases are true covid, the efficacy of the vaccine may be somewhere in the middle, between 29% and 95%. Pfizer’s 92 page report didn’t mention the 3410 suspected covid19 cases, nor did its publication in the new England Journal of Medicine. Nor did any of the reports on Moderna’s vaccine. Dr Doshi goes on to point out a few other worrisome discrepancies as well, such as Pfizer employees adjudicating the results not independent university-affiliated physicians, as was done with the Moderna vaccine and the fact that Pfizer had 8 confirmed cases of symptomatic SARS-CoV2 infection at baseline. These phase III trials are not designed to demonstrate that the vaccines will save lives, improve health outcomes or reduce hospital admissions, whether they will really prevent transmission and how long the immunity will last and what short term and long term side effects may occur which may take up to 20 years to determine.
Our thoughts and recommendations
If you have had a previous adverse vaccine reaction, or if you have developed an autoimmune condition or had a worsening of an existing autoimmune disease or immune dysfunction when exposed to a vaccine of any kind, for example the flu vaccine or the Gardisil vaccine, you will want to be cautious before getting this vaccine. You have to balance the risk of a severe adverse reaction or development of an autoimmune condition against the risk of dying from COVID or developing post COVID syndrome.
An autoimmune condition does not mean that you have a compromised immune system.
And not everyone with chronic infections like Lyme disease also has autoimmune disease. Although Lyme patients and people who have mold illness from mold exposure often have immune dysregulation and inflammation and may have more severe outcomes from COVID infection than from the vaccine.
Patients with Mast Cell Activation or severe allergies also need to balance the risk of reaction against the risk of severe disease should you contract COVID. Also depending on where you are in your treatment may also inform your decision. Patients whose MCAS symptoms are well managed may be in a better position to take the vaccination.
Ultimately, the choice is up to each individual.
Please spend time reading the references below.
Dr Kelly and the Spring Center Staff
https://pubmed.ncbi.nlm.nih.gov/27804292/Analysis of Pre-existing IgG and IgM antibodies against Polyethylene Glycol(PEG) in the general population in 2016. Looking through samples collected from 1970-1999.
https://pubmed.ncbi.nlm.nih.gov/31981619/Jan 2020 article. antiPEG antibodies inprevalence from <1-72%
Sahin U, et al., Covid-19 vaccine BNT162b1elicits human antibody and TH1 T cell responses, Nature 2020 Oct; 586 (780):594-599.
Jackson LA., An mRNAVaccine against SARS-COV-2- Preliminary Report N Engl J Med 2020 Nov 12;383(20): 1920-1931
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