‘Perfectly Healthy’ Florida Doctor Dies Weeks after Getting Pfizer COVID Vaccine
by
Children’s Health Defense Team
Commentaries by Robert Gorter, MD, PhD.
January 7th 2021
Miami medical examiner is investigating the death of 56-year-old Dr. Gregory Michael who reportedly died from a rare autoimmune disease 15 days after being vaccinated. Michael’s wife wants her husband’s death to serve as a warning to others.
The wife of a Florida doctor who died 15 days after receiving Pfizer’s COVID-19 vaccine told reporters at USA Today and the Daily Mail that her husband was “perfectly healthy” before he got the vaccine. Heidi Neckelmann said her husband, 56-year-old Dr. Gregory Michael, “sought emergency care three days after the shot because he had dots on his skin that indicated internal bleeding.”
Michael received the vaccine on Dec. 18 2020 at Mount Sinai Medical Center in Miami Beach, where he is a staff physician who worked for 12 years as an OB-GYN specialist. He died on Jan. 3 2021 after suffering a hemorrhagic stroke related to a lack of platelets (thrombocytes), a condition called thrombocytopenia, or as the Daily Mail reported, acute idiopathic thrombocytopenic purpura (ITP).
Dr. Gorter:
Although vaccine manufacturers, including Pfizer, Moderna and AstraZenica deny any correlation between their vaccines in general -and the current mRNA vaccines in particular- and the onset of several (often fatal) autoimmune diseases, like ITP, Lupus Erythematodes Disseminatus (LED), Peripheral Neuropathies and Guillain-Barre.
These companies cannot say seriously anything about an absence of any correlation between these and other autoimmune diseases and their new mRNA vaccines which have never ever been applied to 160 healthy humans yet for longer than 3-4 months.
At the end of this contribution, one can find a selection of links to peer-reviewed articles documenting these correlations. There are hundreds of these peer reviewed articles in top medical journals and many of them recommended by the CDC and NIH in the USA.
In Appendix 3, you will find a description of how clinical trials are to be conducted and that a final safety and efficacy phase-3 trial in approx. 44,000 healthy people lasts 4 to 5 years before approval (licensing) can be awarded and the results were scrutinized by peer reviewers and the FDA.
Pfizer, Moderna and AstraZenica got approval to start a phase-3 after a phase-1/-2 trial after 3-4 months in 160 volunteers and data shared through a Press Release only. And, mRNA-based vaccines have never been tested in humans before…..
Heidi Neckelmann told the Daily Mail:
“He was in very good health. He didn’t smoke; he drank alcohol once in a while but only socially. He worked out, we had kayaks, and he was a deep sea fisherman.
“They tested him for everything you can imagine afterwards, even cancer, and there was absolutely nothing else wrong with him.”
Pfizer, in a statement to USA today, said the vaccine maker was aware of and “actively investigating” the death, but also added “we do not believe at this time that there is any direct connection to the vaccine.”
Pfizer also told USA Today:
“There is no indication — either from large clinical trials or among people who have received the mRNA vaccine since the government authorized its use last month – which it could be connected to thrombocytopenia.”
But Neckelmann told the Daily Mail that in her mind, her husband’s death was “100% linked” to the vaccine.
Children’s Health Defense (CHD) President Lyn Redwood, RN, MSN, said ITP is a well-known and multiple times published adverse event associated with (routine) vaccinations.
The vaccine most often implicated is the measles-mumps-rubella (MMR) vaccine, where the disease occurs in approximately 1 in every 25,000 to 40,000 doses of the vaccine, Redwood said. ITP has also been associated with hepatitis A and B virus (HBV), human papilloma virus (HPV), varicella-zoster, diphteria-tetanus-acellular pertussis (DTap), polio myelitis, pneumococcus vaccines and influenza and corona in the yearly anti-flu jab.
According to Redwood, a study comparing adverse effects following influenza vaccination found that ITP was the third most common autoimmune condition (after Guillain-Barre and rheumatoid arthritis linked to Lupus Erythematosus Disseminatus (LED)).
Redwood also pointed out that ITP has been reported to occur following exposure to drugs containing polyethylene glycol (PEG), a compound used in both the Pfizer and Moderna vaccines.
“Considering that according to the United States Court of Federal Claims, several cases of ITP have been compensated in the National Vaccine Injury Compensation Program (NVICP) from tax-payers money, it is completely disingenuous for vaccine manufacturers to deny this risk,” Redwood said.
As Heidi Neckelmann told the Daily Mail, Michael suffered no immediate reaction to the vaccine, but three days later he noticed petechiae — spots of red indicative of bleeding beneath the skin — on his hands and feet.
After checking himself into the hospital, doctors confirmed Michael was suffering from an acute lack of platelets.
According to Heidi Neckelmann:
“All the blood results came back normal except for the platelets which came back as zero.”
“At first they thought it must be a mistake. So they did the test again and this time did a manual count which is supposed to be more accurate. This time it showed just one platelet.”
Doctors told Michael his condition was “incredibly dangerous” and could lead to a brain bleed and/or death.
Heidi Neckelmann told USA Today that a team of doctors tried unsuccessfully for two weeks to raise his platelet count. She told the Daily Mail that her husband had no prior history of acute idiopathic thrombocytopenic purpura, the illness her husband was diagnosed with. The disorder causes the immune system to mistake platelets for foreign objects and instructs the spleen to destroy them. This is characteristic for each autoimmune disease: the immune system wrongly identifying tissue in the body as foreign and must therefore be destroyed.
In a Facebook post, Heidi Neckelmann wrote that her husband was a pro-vaccine advocate. But, she said:
“I believe that people should be more aware that life-threatening side effects can happen; that it is not good for everyone and in this case destroyed a beautiful life, a perfect family, and has affected so many people in the community.”
“Do not let his death be in vain and please save more lives by making this information news.”
https://childrenshealthdefense.org/defender/healthy-florida-doctor-dies-after-pfizer-covid-vaccine/
Appendix 1
Guillain–Barré Syndrome (GBS) is a rapid-onset muscle weakness caused by the immune system damaging the peripheral nervous system. Typically, both sides of the body are involved, and the initial symptoms are changes in sensation or pain often in the back along with muscle weakness, beginning in the feet and hands, often spreading to the arms and upper body. The symptoms may develop over hours to a few weeks. During the acute phase, the disorder can be life-threatening, with about 15 percent of people developing weakness of the breathing muscles and, therefore, requiring mechanical ventilation. Some are affected by changes in the function of the autonomic nervous system, which can lead to dangerous abnormalities in heart rate and blood pressure.
Georges Guillain, together with Barré and Strohl, described two cases of self-limiting acute paralysis with peculiar changes in the cerebrospinal fluid.
Although the cause is unknown, the underlying mechanism involves an autoimmune disorder in which the body’s immune system mistakenly attacks the peripheral nerves and damages their myelin insulation. Sometimes, this immune dysfunction is triggered by an infection or, less commonly, by surgery, and by vaccination. The diagnosis is usually based on the signs and symptoms through the exclusion of alternative causes and supported by tests such as nerve conduction studies and examination of the cerebrospinal fluid. It is classified as an acute polyneuropathy.
In those with severe weakness, prompt treatment with intravenous immunoglobulins or plasmapheresis, together with supportive care (respirator), will lead to good recovery in the majority of people. Recovery may take weeks to years, with about a third having some permanent weakness. Globally, death occurs in approximately 10% of those affected. Guillain–Barré syndrome is rare, at two cases per 100,000 people every year but with the incidence (new cases) are increasing. Both sexes and all parts of the world have similar rates of disease.
https://www.cdc.gov/vaccinesafety/concerns/guillain-barre-syndrome.html
https://www.medscape.com/…/which-vaccines-have-been-proven-to-cause-guillain-barre-syndrome-gbs
https://pubmed.ncbi.nlm.nih.gov/19388722/
https://pubmed.ncbi.nlm.nih.gov/463869/
Appendix 2
Immune thrombocytopenic purpura (ITP), also known as idiopathic thrombocytopenic purpura or immune thrombocytopenia, is a type of thrombocytopenic purpura defined as an isolated low platelet count with a normal bone marrow in the absence of other causes of low platelets. It causes a characteristic red or purple bruise-like rash and an increased tendency to bleed. Two distinct clinical syndromes manifest as an acute condition in children and a chronic condition in adults. The acute form often follows an infection and spontaneously resolves within two months. Chronic immune thrombocytopenia persists longer than six months with a specific cause being unknown.
ITP is an autoimmune disease with antibodies detectable against several platelet surface structures.
In mild cases, only careful observation may be required but very low counts or significant bleeding may prompt treatment with corticosteroids, intravenous immunoglobulin, anti-D immunoglobulin, or immunosuppressive medications. Refractory ITP (not responsive to conventional treatment or constant relapsing after splenectomy) requires treatment to reduce the risk of clinically significant and fatal bleedings. Platelet transfusions may be used in severe cases with very low platelet counts in people who are bleeding.
ITP is increasingly diagnosed in people who received several types of vaccines.
https://www.hindawi.com/journals/crihem/2016/7913092/
https://www.ijidonline.com/article/S1201-9712(20)30629-9/fulltext
https://ashpublications.org/…/Risk-of-Vaccine-Induced-Immune-Thrombocytopenia-in
https://adc.bmj.com/content/84/3/227
https://pediatrics.aappublications.org/content/138/6/e20160124
https://pubmed.ncbi.nlm.nih.gov/28483543/
https://www.who.int/vaccine_safety/…/hep…and_rheumatoid_arthritis/en/
https://www.hss.edu/conditions_vaccinations-rheumatic-disease.asp
Appendix 3
Which steps must be taken to have a new vaccine licensed for use in humans?
A vaccine trial is a clinical trial that aims at establishing the safety and efficacy of a vaccine prior to it being licensed.
A vaccine candidate drug is first identified through preclinical evaluations that could involve high throughput screening and selecting the proper antigen to invoke a proper immune response.
Preclinical stage
The preclinical stages are necessary to determine approximate dose ranges and proper drug formulations (i.e., tablet, injection etc…)
This is also the stage in which the drug candidate may be first tested in laboratory animals prior to moving to the Phase I trials. Vaccines such as the oral polio vaccine have been first tested for adverse effects and immunogenicity in monkeys as well as non-human primates and lab mice.
Recent scientific advances have helped to use transgenic animals as a part of vaccine preclinical protocol in hopes to more accurately determine drug reactions in humans. Understanding vaccine safety and the immunological response to the vaccine, such as toxicity, are necessary components of the preclinical stage. Other drug trials focus on the pharmacodynamics and pharmacokinetics; however, in vaccine studies it is essential to understand toxic effects at all possible dosage levels and the interactions with the immune system.
Phase I
The Phase-1 study consists of introducing the vaccine candidate to assess its safety in healthy people. A vaccine Phase-1 trial involves normal healthy subjects, each tested with either the candidate vaccine or a “control” treatment, typically a placebo or an adjuvant-containing cocktail, or an established vaccine (which might be intended to protect against a different pathogen). The primary observation is for detection of safety (absence of an adverse event) and evidence of an immune response.
After the administration of the vaccine or placebo, the researchers collect data on antibody production, on health outcomes (such as illness due to the targeted infection or to another infection). Following the trial protocol, the specified statistical test is performed to gauge the statistical significance of the observed differences in the outcomes between the treatment and control groups. Side effects of the vaccine are also noted, and these contribute to the decision on whether to advance the candidate vaccine to a Phase 2 trial.
One typical version of Phase-1 studies in vaccines involves an escalation study, which is used in mainly medicinal research trials. The drug is introduced into a small cohort of paid healthy volunteers. Vaccine escalation studies aim to minimize chances of serious adverse effects (SAE) by slowly increasing the drug dosage or frequency. The first level of an escalation study usually has two or three groups of around 16 healthy volunteers each. Each subgroup receives the same vaccine dose, which is the expected lowest dose necessary to invoke an immune response (the main goal in a vaccine – to create immunity). New subgroups can be added to experiment with a different dosing regimen as long as the previous subgroup did not experience SAEs. There are variations in the vaccination order that can be used for different studies. For example, the first subgroup could complete the entire regimen before the second subgroup starts or the second can begin before the first ends as long as SAEs were not detected. The vaccination schedule will vary depending on the nature of the drug (i.e. the need for a booster or several doses over the course of short time period). Escalation studies are ideal for minimizing risks for SAEs that could occur with less controlled and divided protocols.
Phase-2
The transition to Phase-2 relies on the immunogenic and toxicity results from Phase I in a small cohort of healthy volunteers. Phase-2 will consist of more healthy volunteers in the vaccine target population (~ hundreds of people) to determine reactions in a more diverse set of humans and test different schedules.
Phase-3
Similarly. Phase-3 trials continue to monitor toxicity, immunogenicity, and SAEs on a much larger scale. Usually, approx. 44,000 healthy volunteers over approx. 4 to 5 years. The vaccine must be shown to be safe and effective in natural disease conditions before being submitted for approval (licensing) and then general production. In the United States, the Food and Drug Administration (FDA) is responsible for approving vaccines.
Phase-4
Phase IV trials are typically monitor stages that collect information continuously on vaccine usage, adverse effects, and long-term immunity after the vaccine is licensed and marketed.[7]
Methodological issues and problems
Normally, vaccine trials will take 4-5 years to complete, since a sufficient time period must elapse for the subjects to react to the vaccine and consistently develop the required antibodies (immunity).
References
Halloran, M. Elizabeth; Longini, Ira M., Jr.; Struchiner, Claudio J. (2010). Design and analysis of vaccine studies. Statistics for biology and health. New York: Springer. pp. xviii+387. ISBN 978-0-387-40313-7. MR 2572061.
World Health Organization. (2012). Standard Operating Procedure: Neurovirulence test of types 1, 2, or 3 live attenuated poliomyelitis vaccines (oral) in transgenic mice susceptible to poliovirus. Retrieved November 10, 2015″ (PDF).
World Health Organization. (2012). Standard Operating Procedure: Neurovirulence test of types 1, 2, or 3 live attenuated poliomyelitis vaccines (oral) in transgenic mice susceptible to poliovirus. Retrieved November 10, 2015″ (PDF).
Vaccine product approval process”. US Food and Drug Administration. 30 January 2018. Retrieved 25 September 2020.
Saul, Allan (April 2005). “Models of Phase 1 vaccine trials: optimization of trial design to minimize risks of multiple serious adverse events”. Vaccine. 23 (23): 3068–3075. doi:10.1016 / j.vaccine.2004.10.048. PMID 15811654.
Bloom, B. R., & Lambert, P. H. (2003). The Vaccine Book. Academic Press. Retrieved from https://books.google.com/books?id=D0QW31ivHcwC&pgis=1
Research, Center for Biologics Evaluation and. “Biologics License Applications (BLA) Process (Biologics) – Vaccine Product Approval Process”. www.fda.gov. Retrieved 15 November 2015.