COVID-19 Vaccine Analysis

No one could have imagined the challenges over this past year and how much life has changed since the onset of the COVID-19 Pandemic. We mourn those who have lost the battle with COVID-19. We uphold those who are fighting the illness, those on the front lines, those who protect and serve the most vulnerable, and those in places of authority making decisions in our thoughts and prayers.

At the time of the initial writing and research for this article in early January 2021, there were almost 100 million cases across the globe with 2.1 million deaths attributed to COVID-19. The United States accounted for over 25 million cases and over 425,000 deaths attributed to COVID-19.

Now in early March, statistics have increased to 116 million cases of illness and over 2.57 million deaths across the globe. In the United States, there are over 29 million cases and more than 531,000 deaths attributed to COVID-19. The general COVID-19 global trend, however, shows a global steady decline of daily new cases and daily deaths from January 2021 to March 2021.

Vaccines in the Making

Operation Warp Speed was implemented for vaccine development to stop the COVID-19 Pandemic spread and illness. Two vaccines (Pfizer and Moderna) became available for emergency use in early January and now a third (Johnson & Johnson – Janssen) vaccine is in distribution. Even more vaccines are in development. According the World Health Organization, there are more than 60 vaccines in clinical evaluation and over 170 vaccines in preclinical evaluation across the globe.

These developments have brought hope and success at reduction of severe COVID-19 disease and mortality. For others, these vaccines raise significant questions and concerns. Here are some things to review and discuss with your health care professional in your decision making process.

CDC and NIH on Pfizer and Moderna

The National Institutes of Health (NIH) stated in January 2021 “that the mRNA-1273 vaccination 3 is highly efficacious in preventing symptomatic COVID-19”. These vaccines are considered highly effective with 95 percent efficacy or more at prevention of severe COVID-19 disease and mortality.

The NIH further stated “There is not yet enough available data to draw conclusions as to whether the vaccine can impact SARS-CoV-2 transmission.” Two months into their use with the general population, it is still unclear if the vaccines can reduce transmission or spread of the virus, but many are hopeful and expect it will help over time. There are no long-term studies beyond four months as to how long COVID-19 disease vaccination protection lasts. Many speculate there may be need for additional vaccinations after the original shots. There are no clinical trials for the virus variants.

The Centers for Disease Control (CDC) and NIH state:

FDA has authorized the emergency use of the Pfizer-BioNTech Vaccine/ Moderna/ Janssen vaccines. These are not FDA-approved vaccines.
• The recipient or their caregiver has the option to accept or refuse the vaccine.
• The significant known and potential risks and benefits of Pfizer-BioNTech/Moderna/Janssen COVID-19 Vaccine, and the extent to which such risks and benefits are unknown.

Until “herd immunity” is obtained with about 70 percent of the population, social distancing guidelines and wearing a mask are still required. The CDC also recommends that you avoid any other vaccines within 14 days of COVID-19 vaccination.

Breaking news from March 8, 2021 CNN on upcoming CDC guidelines state:

The CDC says fully vaccinated people can:
• Visit other vaccinated people indoors without masks or physical distancing
• Visit indoors with unvaccinated people from a single household without masks or physical distancing, if the unvaccinated people are at low risk for severe disease.
• Skip quarantine and testing if exposed to someone who has COVID-19 but are asymptomatic, but should monitor for symptoms for 14 days
However, people who are fully vaccinated still need to take precautions in many scenarios. The guidelines say fully vaccinated people must:
• Wear a mask and keep good physical distance around the unvaccinated who are at increased risk for severe COVID-19, or if the unvaccinated person has a household member who is at higher risk
• Wear masks and physically distance when visiting unvaccinated people who are from multiple households.
Check with your state mandates for regulations.

Pfizer Vaccine Ingredients

The Pfizer-BioNTech COVID-19 Vaccine includes the following ingredients:
mRNA, lipids ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3-phosphocholine, and cholesterol), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose.

Click here for the Pfizer COVID-19 Fact Sheet for Recipients and Care Givers, the Pfizer Fact Sheet for Healthcare Providers Administering Vaccine, and Frequently Asked Questions.

Moderna Vaccine Ingredients

The Moderna COVID-19 Vaccine contains the following ingredients:
messenger ribonucleic acid (mRNA), lipids ( SM-102, polyethylene glyc ol [ P EG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSP C]), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate, and sucrose.

Click here for the Moderna COVID-19 Vaccine Fact Sheet for Recipients and Care Givers, the Moderna Fact Sheet for Healthcare Providers Administering Vaccine, and Frequently Asked Questions.

Adverse Reactions – Clinical Trials 2020

The Pfizer mRNA-1273 vaccine clinical trial studies published in December 2020 listed adverse reactions from the COVID-19 vaccine participants 16 years of age and older. These included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%). Officials say these symptoms reflect that the vaccine is working and has triggered an immune response.

After the second dose, at least 50 percent of volunteer participants in the vaccine trials experienced moderate to severe side effects. Symptoms listed above lasted up to a week in most participants. These are much less severe symptoms than those hospitalized with COVID-19 and “long-haul COVIDers” experienced.

To read the New England Journal of Medicine Pfizer December 2020 clinical trials on general safety and efficacy, click here. For safety in older adults, click here.

Fewer Adverse Reactions Post-Vaccine in General Population March 2021

On March 4, 2021, The Preprints with The Lancet released preliminary findings of the Pfizer vaccines adverse effects within the UK general population. This is follow-up Phase IV testing after the December 2020 trials described above.

Systemic side effects were noted in 11.8 percent of vaccine recipients after the first dose. After the second dose, 29.4 percent of individuals experienced side effects. COVID-19 infection risk reduction occurred within 12-21 days after the first dose. This shows considerably smaller percentage of individuals who experienced side effects as opposed to the clinical trials. This is early stage research and is not peer-reviewed.

Preliminary Pfizer Post-Vaccine Results in Elderly and Health Care Workers

A number of media outlets recently reported on preliminary findings obtained from the Public Health England and Preprints with The Lancet March 3, 2021 on vaccination responses now in the general public. This is also early stage research and is not peer-reviewed.

The report submits that one dose of the Pfizer vaccine demonstrated 71.4 percent effectiveness in substantial reduction in the risk of COVID-19 related hospitalizations in elderly, frail, patients with multiple underlying health concerns.

Preprints with The Lancet February 22, 2021 preliminary findings on vaccine effectiveness in health care workers shows Pfizer vaccine was successful. A single dose of the vaccine showed 72 percent effectiveness after 21 days after the first dose. After seven days past the second dose, the vaccine effectiveness was 86 percent in working adults in prevention of symptomatic and asymptomatic infection. This is again early stage research and is not peer-reviewed.

Johnson & Johnson - Janssen Vaccine

On February 27, 2021 Janssen Pharmaceuticals Company of Johnson & Johnson received emergency use approval for its single-use COVID-19 vaccine called Ad.26.COV2S or JNJ-78436725 from the US Food and Drug Administration. This single dose vaccine uses a different method of vaccination rather than the Pfizer and Moderna mRNA two-dose vaccines.

The Janssen vaccine uses a human adenovirus to express the spike protein found on the surface of the SARS-CoV-2 virus that causes COVID-19. This virus that causes infections of the respiratory and digestive tract has been modified so it can no longer replicate and cause infections.

Science Mag June 12, 2020 reports that the Janssen vaccine in current distribution uses cells lines from aborted fetal tissues. The Moderna and Pfizer vaccines used aborted fetal cell lines in initial research, but they are not present in current vaccines.

Janssen Vaccine Ingredients

The ingredients of the Janssen vaccine include the following: recombinant, replication-incompetent adenovirus type 26 expressing the SARS-CoV-2 spike protein, citric acid monohydrate, trisodium citrate dihydrate, ethanol, 2-hydroxypropyl-β-cyclodextrin (HBCD), polysorbate-80, sodium chloride.

Janssen Vaccine Adverse Reactions

Adverse reactions reported in a clinical trial following administration of the Janssen COVID-19 Vaccine include injection site pain, headache, fatigue, myalgia, nausea, fever, injection site erythema and injection site swelling. In clinical studies, severe allergic reactions, including anaphylaxis, have been reported following the administration of the Janssen COVID-19 Vaccine. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Janssen COVID-19 Vaccine.

Click here for the Janssen Fact Sheet for Recipients and Care Givers, the Janssen Fact Sheet for Healthcare Providers Administering Vaccine, and Frequently Asked Questions

Adverse Event Report System and Population Risks

If you experience an adverse reaction or event after a vaccination, report it to your health care provider or go to Vaccine Adverse Event Reporting System (VAERS). For in-depth information about adverse effects, risks, and recommendations go to the CDC site on vaccine information Appendix B.

The current VAERS statement from the CDC states:

“Over 76 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through March 1, 2021. During this time, VAERS received 1,381 reports of death (0.0018%) among people who received a COVID-19 vaccine. CDC and FDA physicians review each case report of death as soon as notified and CDC requests medical records to further assess reports. A review of available clinical information including death certificates, autopsy, and medical records revealed no evidence that vaccination contributed to patient deaths. (Highlighted by the CDC.) CDC and FDA will continue to investigate reports of adverse events, including deaths, reported to VAERS.” Other countries and websites have raised questions.

Click here to read more about actual vaccine adverse events reports.

As of January 2021, no studies have determined the safety of the emergency use COVID-19 vaccines during pregnancy or breast feeding, or for infants exposed during pregnancy. Vaccine safety has not been tested on children and adolescents. There are no studies on long-term safety in individuals with complex health concerns, those with frail health, morbid obesity, those undergoing cancer treatments, or the extreme elderly.

Health officials state that those who have a history of anaphylaxis or severe allergic reactions or who are allergic to the adjuvant polyethylene glycol, and potentially polysorbate, need to be monitored closely immediately after the vaccine. There is also concern from prominent researchers and other immunologists that these vaccines may trigger autoimmune inflammation by molecular mimicry in susceptible individuals.

Animal studies are normally done with vaccines for a lengthy period of time before FDA approval and release to the public to understand long-term effects. This process was not followed for the COVID-19 emergency-use vaccines.

I encourage you to read the article from Toxicology Reports October 2020 entitled Vaccine- and Natural Infection-Induced Mechanisms That Could Modulate Vaccine Safety. It provides a powerful information about vaccine concerns.

Resources for Immune Compromised Individuals

For immune compromised individuals, the CDC states:

Immunocompromised individuals may still receive COVID-19 vaccination if they have no contraindications to vaccination. However, they should be counseled about the:
• unknown vaccine safety profile and effectiveness in immunocompromised populations
• the potential for reduced immune responses
• need to continue to follow all current guidance to protect themselves against COVID-19

Click here for the full statement from the Centers for Disease Control for those with underlying health conditions.
Some medical experts who specialize in treating patients with chronic autoimmune disorders suggest waiting a few months to see how vaccine responses affect a larger percentage of the population. This may naturally occur as it will take more time for the vaccines to reach more of the general population and various tier groups which will make risks and benefits more apparent. Each person has a different immune system and levels of inflammation. Discuss the risk versus benefits with your health care professional.

You may access a position paper published February 2021 in RMD Open of British Medical Journals on the vaccination against COVID-19 in patients with autoimmune inflammatory rheumatic diseases. This article provides in-depth points of discussion for risk and benefit in those who have autoimmune inflammatory rheumatic diseases. It is a great resource to share with your health care provider and how to navigate through the questions of vaccines. It may also provide helpful questions and topics of discussion for those with other types of disease.

The British Medical Journal published a very interesting article in late 2020 on COVID-19 vaccines. Although the article is rather technical, I encourage you to peruse this and review the responses with how other prominent researchers and scientists view vaccines concerns.

Vaccine Makers and FDA Exempt from Liability

COVID-19 vaccination manufacturers, the FDA and administrators are exempt from liability. If you are injured from the vaccine, Pfizer, Moderna, Johnson & Johnson etc. have been granted immunity from any liability. You cannot sue the vaccine makers, the FDA, or your employer for vaccine injury or death.

Decisions

These vaccines offer hope and rescue for many in the midst of these challenging times. Yet, other remain concerned. Preliminary results from The Preprints with The Lancet in the various population studies listed above show benefit and significant reduction in severe COVID-19 disease and mortality. This was seen for the most vulnerable elderly and frail population and front-line workers. Speculation suggests that over time, the vaccines may affect SARS-CoV-2 transmission. This however has not been proven, thus the continuance of social distancing and other measures.

Each person needs to make a choice about the vaccines. Some of you have already received one or both shots of either the Pfizer or Moderna vaccine. Others are still deliberating. Yet others have chosen to wait or refrain. Many remain concerned about the long-term effects, autoimmune risks, and unknowns.

Throughout history, human beings have adapted to change and immune challenges by learning what works and that which is risky. Unlike generations before us, we have more toxins, high calorie/ low nutrient intake and other dietary challenges, EMF/electromagnetic fields exposure, sleep deprivation, E-cigarettes and tobacco, petrochemical and plastics exposure, antibiotics and other multiple medication use. There are more health conditions like obesity, diabetes, autoimmune disorders, gut inflammation, and cancer, etc. than ever before that pose even more challenges to adaptation and immune integrity. All of these concerns and more have dropped our country to #35 of global list of health status. All of these things take a toll on your vitality and resilience.

No matter what direction you take with the vaccines, you want to support your health to help with the new, novel demands of the vaccine(s) or to help manage immune vitality in the face of challenge. The health (energetic reserves, antioxidants status, and stress tolerance) and terrain (gut-immune microbiome, liver-kidney-lymph detoxification, etc.) of your body directly impacts your health risks and immune tolerance response. Take charge of your health and manage your body’s terrain no matter which road you take.