Paul A. Byrne, M.D.
INTRODUCTION
We are continually bombarded with information about the COVID-19 pandemic and encouraged to receive the COVID-19 vaccines. Many are making the decision to consent or refuse these with little information. To make an informed decision about receiving a vaccine requires: 1) full and complete information regarding safety and side effects, 2) explanations of efficacy and effectiveness, 3) ingredients including any adjuvants, preservatives, and genetic material, and 4) vaccine companies’ lack of liability for damages. The use of human fetal cell lines should be made known to all recipients and those who administer the vaccines. This includes development, production or any testing of the vaccines, no matter how remote the cooperation.
COVID-19 PANDEMIC VIRUS
The cause of the present pandemic is a virus, first labeled as the Wuhan virus or the China virus. The official name of the virus is Severe Acute Respiratory Syndrome Coronavirus 2, abbreviated (SARS-CoV-2). The name of the disease it causes is coronavirus disease 2019, abbreviated as COVID-19. In COVID-19, 'CO' stands for 'corona,' 'VI' for 'virus,' and 'D' for disease. There are many types of human coronaviruses including some that commonly cause mild upper-respiratory tract illnesses.
www.cdc.gov › coronavirus › 2019-ncov › faq (Accessed 1-23-21)
A pandemic is a contagious illness that spreads widely. In this pandemic, people in 188 countries have the virus. A virus is a microorganism that cannot reproduce outside of a cell. It can be seen only through a microscope that magnifies by 500,000 times. A virus can cause disease in human persons by spreading from one human being to another human being.
SARS-CoV-2 is a respiratory virus that can have no symptoms, or a range of symptoms from minimal to severe. These may include runny nose, sneezing, sore throat, cough, fever, headache, muscle aches, fatigue, abdominal pain, vomiting, diarrhea, or eye irritation. More severe respiratory illness can include shortness of breath. Also, losses of smell and taste have been reported.
When a virus enters the body, at first, it is not associated with any symptoms. This is known as the incubation period. For COVID-19, the median duration of this incubation period is about 7 days but can be as short as 5 days and usually not longer than 12 days. Near the end of the incubation period and just before symptoms make their appearance, the patient might be contagious. If so, the virus could spread from one person to another even before any symptoms. The patient continues to be contagious throughout the course of the Illness.
COVID-19 may spread through the air as droplets and aerosols that come out of the nose and mouth. This is the rationale to wear a mask, keep distance between persons, and wash hands. Droplets are larger particles that may be visible and tend to fall to the ground or are deposited on another’s nose, mouth, and/or eyes or onto objects that the person touches, thereby inoculating themselves if they touch their nose, eyes or mouth. Aerosols are smaller particles that can float in the air and are not usually visible but may be inhaled. The warm exhaled breath that is seen in cold temperatures is an example of an aerosol.
To cause disease, the virus must get out of the infected person, then spread into the other person. The COVID-19 virus can enter only through the nose, mouth, or eyes. Remember, to cause disease, the virus must get from one person with the virus to another, then enter via the nose, mouth, or eyes of the next person. Keeping the environment clean and washing hands is important in stopping this kind of spread. Do not suck your fingers; do not pick your nose; wash your hands before you eat, and before and after touching your nose and mouth or eyes if you must touch them. Cover coughs and sneezes with a tissue or into one’s sleeve and then discard tissue and wash hands.
The virus itself does not cause the symptoms. It is the response of the body trying to get rid of the invading virus that results in the symptoms. A runny nose can be thought of as washing away the virus; a cough can be thought of as expelling it away. Fever is a body response that can be measured easily and accurately without bias from the patient or examiner.
COVID-19 is associated with an inflammatory reaction of increased congestion and swelling of the affected tissues with damage to the lining of blood vessels and tendency for blood clots to occur. A lesser amount of an inflammatory response may protect against the virus. However, sometimes the inflammatory response is exaggerated and overwhelming. This has been observed to be especially significant in the lungs of patients with COVID-19. In addition, blood clots may form and cause blockages that can be life threatening if in the lungs, heart, or brain.
This exaggerated and overwhelming response has been labeled a hyper-inflammatory response. The lungs swell; air passages get obstructed. Thus, the ventilator cannot effectively expand the lungs as a ventilator does for other patients. Ventilators have been used successfully in many patients with COVID-19, but for others, the ventilator has not been as helpful as desired, possibly because the exaggerated inflammatory response does not allow expansion of the lungs.
Most patients with COVID-19 recover without treatment. Others may have a more prolonged course of chronic illness. Some require more intensive treatments, especially if there would be the new onset of shortness of breath and difficult breathing. In these patients, early treatment is important and vitamins and medications may need to be given intravenously.
Although persons with other medical conditions, such as, diabetes, obesity, hypertension and/or heart disease, are at higher risk of death, with timely treatment survival is possible, even among older aged persons. This is a serious disease that is associated with mortality that increases with age and co-morbidities (other disease conditions).
THE NOVEL COVID mRNA VACCINES
Pfizer-BioNTech and Moderna vaccines are not FDA approved but have been released under Emergency Use Authorization (EUA). These are novel vaccines that use messenger ribonucleic acid (mRNA), which is a molecular portion of the virus’ total genetic information. The clinical trials had followed recipients for 2 months after 2 doses. Long-term side effects are unknown. Neither mRNA nor the lipid nanoparticles have been tested in humans.
https://www.pfizer.com/news/hot-topics/the_facts_about_pfizer_and_biontech_s_covid_19_vaccine
(Accessed 1/31/21)
Vaccines commonly use a weakened or killed virus or part of the virus toxin to inject. This triggers the person’s immune system to make antibodies that would recognize and neutralize an infecting virus. A mRNA vaccine works differently because laboratory-made genetic material coding for a part of the virus (spike protein) is injected. It first relies on the recipient’s cells to read this genetic code and make more of the foreign protein molecule for the spike protein. Then it relies on the immune system to make antibodies to this part of the virus. These antibodies are presumed to inactivate the foreign virus and not attack the person’s own cells.
DNA and RNA
DNA and RNA are molecules of genetic information that make a person biochemically unique. DNA is composed of double-stranded nucleic acids; RNA is composed of only one strand of nucleic acids. The genetic information in the RNA is read by structures in the cell called ribosomes, resulting in the production of proteins needed by the cell.
A virus has genetic information as DNA or RNA but needs host cells to “read” this information to replicate (i.e., make more of itself). Sars-CoV-2 virus has mRNA that codes for its spike protein. It enables the virus to enter the human cells. The mRNA vaccines work by getting the person’s own cells to read this foreign mRNA and then to have the person’s cells make more copies of the foreign spike protein. This will allegedly trigger an immune response in the person to make antibodies and T cells (killer white blood cells) that will target spike proteins and thus prevent viral entry into the human cells.
The Pfizer and Moderna vaccines use genetically engineered foreign mRNA sequences that code for the viral spike protein. They rely on ribosomes, which (as noted) are structures in the cell that read the mRNA code and make protein molecules. In the case of these mRNA Covid vaccines, the ribosomes make the foreign spike protein which would not naturally occur.
There are ribosomes in several places inside the cell. Ribosomes are both inside and outside the cell nucleus, and produced in the mitochondria (the energy producing structures of the cell).
Many do not understand that it is incorrect to say that the human genome is made up only of DNA in the cell nucleus. The human genome includes both the DNA in the nucleus and the DNA in the mitochondria outside the nucleus. DNA are the blueprints for making protein molecules. mRNA is akin to work orders for the ribosomes. Ribosomes are akin to machines that fabricate the final protein products.
It is in mitochondrial produced ribosomes in the cytoplasm where the vaccine-delivered foreign messenger-RNA makes the foreign spike protein. According to Biochemist/Biologist Dianne Irving, Ph.D. foreign m-RNA could also be read by ribosomes located outside and inside the cell nucleus and the foreign protein could also thus enter the cell nucleus.
Dr. Irving explains that while it may be correct to say that the foreign mRNA does not change the DNA structure inside the nucleus, or the DNA structure of the mitochondrial DNA, it does change the functioning of the mitochondrial-bound ribosomes and thus the functioning of the mitochondrial DNA. Mitochondrial DNA is part of the human genome. Therefore, foreign messenger-RNA causes a change in function of mitochondrial-bound ribosomes, and thus in mitochondrial DNA function. This change in function of the mitochondrial DNA is to produce a foreign protein that it would never make naturally. This change in function of the mitochondrial ribosomes can affect all cells in the body including those that can be passed down through the egg (oocyte) and sperm to next generations. https://en.wikipedia.org/wiki/Human_genome (Accessed 1-28-21) https://www.ncbi.nlm.nih.gov/books/NBK21134/ (Accessed 1-28-21)
RISKS and BENEFITS
The Pfizer-BioNTech COVID-19 and Moderna vaccines are made from messenger RNA, tiny lipid nanoparticles, and polyethylene glycol (PEG). PEG is a stabilizing component of the vaccine. Anaphylaxis is rare but some people are allergic to PEG and could have a life-threatening reaction needing immediate life-support treatment. Patients who are allergic to PEG should not get the vaccine. Since a life-threatening reaction, even though rare, may occur without warning, receiving the vaccine in a health care facility with life-support available is desirable, as is being observed for 15-30 minutes after the injection.
In 2016 scientists from the University of North Carolina at Chapel hill advised the potential importance of screening patients for PEG antibodies before receiving therapeutics with PEG, “The widespread prevalence of pre-existing anti-PEG Ab [antibodies], coupled with high Ab [antibody] levels in a subset of the population, underscores the potential importance of screening patients for anti-PEG Ab [antibody] levels prior to administration of therapeutics containing PEG.” https://pubs.acs.org/doi/full/10.1021/acs.analchem.6b03437 (Accessed 1-23-21)
Vaccination reactions can occur without prior history. The US CDC reported that of the six persons with “severe allergic reaction” out of >250,000 vaccinations, only one had a “history of vaccination reactions.” The American College of Allergy states, “The Pfizer-BioNTech COVID-19 vaccine should be administered in a health care setting where anaphylaxis can be treated." https://college.acaai.org/acaai-guidance-on-risk-of-allergic-reactions-to-pfizer-biontech-COVID-19-vaccine/ (Accessed 1-20-21)
Norway reported 23 deaths after vaccinations; thirteen have been investigated; these were old and frail persons. Subsequently, Norway recommends, “If you are very frail, you should probably not be vaccinated.”
https://norwaytoday.info/news/norwegian-medicines-agency-links-13-deaths-to-vaccine-side-effects-those-who-died-were-frail-and-old/ (Accessed 1-20-21)
The public may think that the vaccine will prevent spread of the virus, but public health experts have repeatedly said that is unknown. Therefore, the public is still expected to use masks, social distance, and limit contacts. Pfizer did tests on monkeys and found that vaccinated animals still got Covid although the duration of infection was shorter.
The clinical vaccine trials did not test for Sars-CoV-2 in all participants so it cannot answer the question of whether the vaccine actually reduces infection or transmission of the virus. The trials only tested for presence of the virus if the test subject became symptomatic. 170 of the total 41,135 (0.41%) subjects given two doses of the vaccine or placebo became symptomatic. Of these 170 subjects, 162 were in the unvaccinated group and 8 were in the vaccinated group. From these small numbers of symptomatic test subjects the 90-95% efficacy claims were calculated. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine (Accessed 1-31-21)
The small number of test subjects in both groups who became symptomatic and then tested positive for Covid (170/41,135 x 100 = 0.4%) could also reflect decreased exposure, transmission, and/or virulence of the virus.
The CDC posts deaths and infection fatality ratios by age but has not released calculations for age-specific “survival rates” or “mortality rates.”
America’s Frontline Doctors White Paper On Experimental Vaccines For COVID-19, using CDC data on infection fatality ratios, total cases and total deaths, calculated and estimated risks of Covid deaths according to age. They state, “When talking about the risk/benefit ratio of any treatment we must consider the Infection Fatality Ratio or IFR. The IFR for COVID-19 varies dramatically by age, from a low of 0.003% for Americans under age 19 to as high as 5.4% for those 70 years of age and above.19 That is an 1800x risk difference based upon age! It is quite clear that young people are at a statistically insignificant risk of death from COVID-19. Nearly 80% of all coronavirus-related deaths in the US through November 28, 2020 have occurred in adults 65 years of age and older and only 6% of the deaths had COVID-19 as the only cause mentioned. On average, there were 2.6 additional conditions or causes per death.20”
The CDC Infection Fatality Ratios by age according to CDC’s best estimate considering disease severity, virus transmissibility, and transmission are:
0-19 years: 0.00003; 20-49 years: 0.0002; 50-69 years: 0.005; 70+ years: 0.054.
The Frontline doctors calculated survival rates from this data to be:
<20 years: 99.9%; 20-49 years: 99.8%; 50-69 years: 99.5%; 70+ years: 95%.
https://www.cdc.gov/coronavirus/2019-ncov/hcp/planning-scenarios.html
https://www.cdc.gov/nchs/nvss/vsrr/COVID_weekly/index.htm#Comorbidities
As of Jan 23, 2021, CDC reported most of the deaths from Covid were in inpatient facilities 229,265 out of 359,265 x 100=64%. 79,134 or 22% of the 359,265 Covid deaths were in nursing homes or long term care facilities.
https://www.cdc.gov/nchs/nvss/vsrr/covid_weekly/index.htm#PlaceDeath (Accessed 1-13-2021)
“CDC data also show that Americans, regardless of age group, are far more likely to die of something other than COVID-19. Even among those in the most heavily impacted age group (85 and older), only 10.8 percent of all deaths since February 2020 were due to COVID-19.”
https://www.heritage.org/data-visualizations/public-health/COVID-19-deaths-by-age/
FDA admits long list of possible negative side-effects. The list has 22 separate entries of “possible adverse event outcomes.” First on the list is “Guillain-Barré syndrome”, described as “a rare disorder in which your body's immune system attacks your nerves.” The syndrome has “no known cure” and it’s mortality rate is “4% to 7%.” “Acute disseminated encephalomyelitis,” a “rare inflammatory condition that affects the brain and spinal cord,” is second on the FDA’s list. Third is “Transverse myelitis,” a neurological disorder that inflames the spinal cord, causing “pain, muscle weakness, paralysis, sensory problems, or bladder and bowel dysfunction.” Also listed as a possible outcome of a potential vaccine is “Anaphylaxis,” the severe allergic reaction which can lead to anaphylactic shock. A “stroke,” and “convulsions/seizures” are further possible side-effects, along with “Acute myocardial infarction” or heart attacks, inflammation of the muscles around the heart, and even death.
The FDA also suggested that Kawasaki disease as being a possibility after the vaccine. The disease “mainly affects children under the age of 5,” and is “always treated in hospital.”
EFFICACY and EFFECTIVENESS
The public might assume that the words “efficacy” and “effectiveness” mean the same thing. In medical/scientific talk, they are different. “Efficacy” refers to the results observed in ideal or controlled conditions, like a vaccine clinical trial. “Effectiveness” is the result seen in the real world after widespread use. Hence the quote 95% “efficacy” in the controlled vaccine experimental trials may not be achieved in the real world after widespread vaccination. Recall that the clinical trials were testing for the virus only if the subjects became “symptomatic.” Asymptomatic persons in the trial were not tested so the overall effectiveness of the vaccine to prevent infection cannot be known.
https://pediaa.com/difference-between-efficacy-and-effectiveness/ (Accessed 1-20-21) https://www.businesswire.com/news/home/20201118005595/en/ (Accessed 1-20-21)
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-COVID-19-vaccine (Accessed 1-20-21)
VACCINE INJURY AND SIDE EFFECTS REPORTING
“Furthermore, mandating vaccines is a blatant violation of medical informed consent—a basic tenet of ethical medical practice. With numerous vaccines currently mandated for work, school, college, and daycare—and soon a coronavirus vaccine likely added to the list when marketed—the potential for harm increases.” “If an adult or child is killed or injured by a vaccine, federal law—the National Childhood Vaccine Injury Act of 1986—prohibits the person from suing the drug company that made the vaccine.” https://clmagazine.org/topic/medicine-science/should-we-be-concerned-about-ethical-vaccines/
The FDA in October listed possible side effects that are to be monitored in conjunction with administering a COVID-19 vaccine. There is to be both passive and active surveillance of side effects related to the vaccine. Under the former system, the FDA is to partner with the Centers for Disease Control (CDC) to manage the Vaccine Adverse Event Reporting System (VAERS), whereby individuals report adverse side effects to their health care provider.”
“With the active surveillance, the FDA plans to use the “Biologics Effectiveness and Safety (BEST) System,” with numerous partners. MarketScan, the largest number of the partner companies, has over 250 million patients.
Along with the Center for Medicare & Medicaid Services (CMS), the FDA states that its data can cover “approximately 55 million elderly US beneficiaries >65yrs of age.” It is through using the CMS data that the FDA plans to monitor side-effects from COVID vaccines, based on rapid-cycle analyses.”
PREGNANCY and mRNA COVID VACCINES
There is usually caution about giving medications to pregnant women. In spite of the many unknown and unstudied effects of these new vaccines, the CDC guidelines allow pregnant women who are part of a group (e.g. essential workers) to choose to receive them. Given that the risk of serious sequelae of COVID-19 disease is very low in young people, why would anyone who is pregnant or sexually active decide to receive the vaccine?
ABORTED BABIES
Use of aborted babies’ DNA? Pfizer and Moderna used cell cultures made from at least one aborted baby to test the vaccines, albeit not manufacture them. Although there are no cells from aborted babies in these mRNA vaccines, the remains of the murdered child were still illicitly used in testing to develop these vaccines. It must be mentioned that at least 7 other companies use aborted fetal cell line cultures in the manufacture and/or testing of Covid vaccines. https://soundchoice.org/vaccines/covid-19-vaccine-chart/
YOU MAY—YOU SHOULD—YOU MUST
At this time that vaccines are being made available to certain groups, thus a person “may” receive the vaccine. There are three verbs that usually follow. Now it is “you may,” “you should” often follows. Will there be a “you must”?
CONCLUSIONS & ONE PAGE SUMMARY
- The new mRNA COVID vaccines are experimental. Emergency Use Authorization (EUA) is not the same as FDA approval. There are many unknowns long-term and already more side effects short term, including life-threatening anaphylaxis, than for other vaccines. COVID-19 survival rates in the young are high and even in those >70+ years or older are 95%.
- To make an informed decision about receiving a vaccine requires full and complete information regarding safety, side effects, ingredients including preservatives, use of fetal cell lines, and vaccine companies’ lack of liability for damages. Pfizer-BioNTech and Moderna vaccines are not FDA approved but have been released under Emergency Use Authorization (EUA). These are novel vaccines that can affect all cells in the body
- FDA lists 22 separate entries of possible adverse event outcomes, including “Guillain-Barré syndrome”, (no known cure and it’s mortality rate is 4% to 7%), Acute disseminated encephalomyelitis (condition that affects the brain and spinal cord), Transverse myelitis (inflames the spinal cord, causing pain, muscle weakness, paralysis, sensory problems, or bladder and bowel dysfunction, Anaphylaxis, (severe allergic reaction which can lead to anaphylactic shock), stroke, convulsions/seizures” are further possible side-effects, along with Acute myocardial infarction, heart attacks.
- Pfizer-BioNTech, Moderna and 7 other companies used cell cultures made from at least one aborted, killed baby to test the vaccines, albeit not manufacture them.
- Despite unknown and unstudied effects of these new vaccines, the CDC guidelines allow pregnant women to choose to receive them. Given that the risk of serious sequelae of COVID-19 disease is very low in young people, why would anyone who is pregnant or sexually active decide to receive the vaccine?
- If an adult or child is killed or injured by a vaccine, federal law—the National Childhood Vaccine Injury Act of 1986—prohibits the person from suing the drug company that made the vaccine.
- Is there a need for this vaccine? The calculated survival rates are: <20 years: 99.9%; 20-49 years: 99.8%; 50-69 years: 99.5%; 70+ years: 95%.
- CDC data also show that Americans, regardless of age group, are far more likely to die of something other than COVID-19. Even among those in the most heavily impacted age group (85 and older), only 10.8 percent of all deaths since February 2020 were due to COVID-19.
- These new mRNA COVID vaccines are experimental. Emergency Use Authorization (EUA) is not the same as FDA approval. There are many unknowns long-term and already more side effects short term, including life-threatening anaphylaxis.
- Now, you may, or should get the vaccine. Will it be mandated?
- This information is to better inform your conscience when deciding to consent or decline the novel mRNA Covid-19 vaccines.
- I decline to get the vaccine.
The views expressed by RenewAmerica columnists are their own and do not necessarily reflect the position of RenewAmerica or its affiliates.
