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Thursday, January 28, 2021

Miami Obstetrician Dies After Getting COVID-19 Vaccine

 

Miami Obstetrician Dies After Getting COVID-19 Vaccine

Analysis by Barbara Loe Fisher Fact Checked


Story at-a-glance

  • Dr. Gregory Michael, an obstetrician in Miami Beach, received a first dose of the Pfizer/BioNTech COVID-19 vaccine and died 16 days later of a cerebral hemorrhage (stroke)
  • Within three days of taking the shot, he developed symptoms of a severe autoimmune bleeding disorder, idiopathic thrombocytopenic purpura (ITP)
  • According to his wife, the 56-year old OB/GYN physician was healthy when he received the COVID-19 vaccine and began exhibiting symptoms of bleeding under the skin within 72 hours
  • He was hospitalized in the intensive care unit but none of the treatments were able to stop the internal bleeding
  • During the past decade, there have been a number of studies showing that ITP develops after receipt of vaccines, with authors calling for more research into the association between vaccination and ITP

Dr. Gregory Michael, an obstetrician in private practice at Mount Sinai Medical Center in Miami Beach, received a first dose of the Pfizer/BioNTech experimental mRNA COVID-19 vaccine on December 18, 2020 and died 16 days later of a cerebral hemorrhage (stroke).1

Within three days of taking the shot, he developed symptoms of a severe autoimmune bleeding disorder, idiopathic thrombocytopenic purpura (ITP), often referred to as immune thrombocytopenia.2 According to his wife, the 56-year old OB/GYN physician was healthy when he received the COVID-19 vaccine and began exhibiting symptoms of bleeding under the skin within 72 hours.

He was hospitalized in the intensive care unit but none of the treatments were able to stop the internal bleeding.3 The case is being investigated by the Miami-Dade County medical examiner, which is working with the U.S. Centers for Disease Control and Prevention and Florida Department of Health.4

According to the Miami Herald, as of January 7, 2021, a Pfizer official said Michael died of a “highly unusual clinical case of severe thrombocytopenia, a condition that decreases the body’s ability to clot blood and stop internal bleeding.”

The Pfizer spokesman added, “We are actively investigating this case but we don’t believe at this time that there is any direct connection to the vaccine.”5 A CBS report quoted the Pfizer spokesman as saying:6

“There have been no related safety signals identified in our clinical trials, the post-marketing experience thus far or with the mRNA vaccine platform. To date millions of people have been vaccinated and we are closely monitoring all adverse events in individuals receiving our vaccine.

It is important to note that serious adverse events, including deaths that are unrelated to the vaccine are unfortunately likely to occur at a similar rate as they would in the general population.”

Wife: Gregory Michael ‘Loved by Everyone in the Community’

The well-known and popular obstetrician, who was a Miami native, Michael had operated a private OB/GYN practice in Miami Beach for 12 years and also worked as a clinical instructor and faculty member for the physician assistant program at Barry University and Miami Dade College. He was the father of a 15-year-old daughter.

His wife, Heidi Neckelmann, made a heartfelt post online7 calling her husband “the love of my life” who was “loved by everyone in the community, delivered hundreds of healthy babies and worked tirelessly through the pandemic.” When informing her friends about his death, she asked them to share her post so the public is more aware that the COVID-19 vaccine is not risk-free. She said:

“He was a pro vaccine advocate and that is why he got it himself. I believe that people should be aware that 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, please save more lives by making this information news.”

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CDC: ‘Potential Benefits’ of COVID Vaccines ‘Outweigh Risks’

A CBS report quoted Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, as saying, “The known and potential benefits of the current COVID-19 vaccines outweigh the known and potential risks of getting COVID-19. That doesn’t mean, however, that we couldn’t see potential serious health events in the future.”

Reportedly, CDC officials told reporters they had not seen any serious reactions beyond 29 cases of severe allergic reactions — or about 11 cases of anaphylaxis per 1 million doses of COVID-19 vaccinations administered.8

ITP Caused by Autoantibody-Mediated Platelet Destruction

Idiopathic or immune thrombocytopenic purpura (ITP) is a complex autoimmune disorder caused by autoantibody-mediated destruction of platelets, which are cells in the blood that help stop bleeding.9 Basically, the immune system malfunctions and produces antibodies that attack the body’s platelets. In some cases, T-cells (a type of white blood cell) will directly attack and destroy the platelets.10

ITP has been reported to develop after infections, including SARS-CoV-2 infection;11 reactions to prescription drugs and over-the-counter medications,12 pregnancy, exposure to chemical toxins,13 vaccination,14 or as a complication of autoimmune disorders like rheumatoid arthritis and lupus, but all the causes of ITP are still not known.

A normal platelet count is between 150,000 to 450,000 platelets and ITP can drive the platelet count down to less than 10,000 platelets, which causes significant internal bleeding.

Symptoms of ITP may begin with the appearance of tiny red dots under the skin, which indicate very small bleeds, and progress to purple blotches and bruises on large areas of the skin, as well as nosebleeds, bleeding in the mouth and around the gums, and blood in the vomit, urine or stool, which indicate much more serious internal bleeding.

The most dangerous complication of ITP is bleeding in the brain causing a cerebral hemorrhage and catastrophic brain damage or death.15 Treatments that try to slow or stop the destruction of platelets during ITP are limited and include intravenous gamma globulin (IVGG) and platelet infusions, steroids and several other medications, or removal of the spleen.16

ITP in children, which occurs in 1 in 20,000 children, can be more easily reversed than ITP in adults, which occurs in about 1 in 15,000 adults in the U.S. and is more common in women and individuals over age 60.17,18 The majority of children recover from acute ITP but approximately 30% of adults have chronic disease after developing ITP and 5% die from hemorrhage.19

ITP Reported After and Causally Related to Vaccinations

In 1991, an Institute of Medicine committee at the National Academy of Sciences stated in its report titled “Adverse Effects of Pertussis and Rubella Vaccines” that there were too few scientific studies published in the medical literature investigating ITP following whole cell pertussis (DPT) vaccination or rubella (MMR) vaccination for the committee to determine whether or not DPT or MMR vaccine causes ITP in children.20,21

However, reports continued to be published in the medical literature.22 In 2001, a study was published in Archives of Disease in Childhood confirming a causal association between measles-mumps-rubella vaccine and ITP.

Study authors said, “The absolute risk within six weeks of immunization was 1 in 22,300 doses, with two of every three cases occurring in the six-week post-immunization period being caused by MMR.”23 The CDC’s website currently states:24

“Immune thrombocytopenic purpura (ITP) is a disorder that decreases the body’s ability to stop bleeding. It can happen after both natural measles infection as well as after getting the MMR vaccine.

However, it is usually not life threatening. Treatment may include blood transfusion and medications. The risk of ITP has been shown to be increased in the six weeks following an MMR vaccination, with one study estimating 1 case per 40,000 vaccinated children.”

During the past decade, there have been a number of published studies from the U.S. and other countries that ITP develops after receipt of vaccines, including HPV25 and influenza vaccines,26,27 with authors calling for more research into the association between vaccination and ITP.28,29,30 One group of researchers looking at the relationship between ITP and vaccinations said in 2014:31

“Vaccines may induce ITP by several mechanisms. Vaccine-associated autoimmunity may stem not only from the antigen-mediated responses but also from other constituents of the vaccine, such as yeast proteins, adjuvants, and preservative diluents. The most likely is through virally induced molecular mimicry …

The autoantibodies hypothesis is not sufficient to explain all ITP cases: In the anti-platelet antibody-negative cases, a complementary mechanism based on T cell immune-mediated mechanism has been suggested. In particular, T cell subsets seem dysregulated with an increased production of pro-inflammatory cytokines, as IFN-y and TNF, and chemokines, as CXCL10.”

An editorial in the October 2020 International Journal of Infectious Diseases titled “ITP Following Vaccination” pointed out that “the term ‘mosaic of autoimmunity’ indicates that immune mediated disorders can involve different sources, including genetics, environmental factors and hormonal or immune defects.”32

The editors noted that vaccination is one of the “environmental triggers” that has been described in the medical literature in association with ITP. The journal editors, who called for more research into the vaccination-ITP association, stated:33,34

“Regardless of the mechanism through which artificial immunization causes ITP, it has been reported following vaccinations against various infectious agents, especially measles-mumps-rubella (MMR), but also Haemophilus influenza [HIB], hepatitis B (HBV), human papilloma virus (HPV), varicella zoster [chickenpox], diphtheria-tetanus acellular pertussis (DTap), polio and pneumococcus vaccines.

A French study that evaluated drug-induced ITP found that around 45% of the cases were post-vaccinal.”

FDA: Moderna COVID-19 Vaccine Trial Had ITP Case

Pfizer did not report a case of ITP occurring in clinical trials of its experimental COVID-19 mRNA vaccine, which was the vaccine that Michael received.35

However, in a briefing document prepared for the December 17, 2020, Vaccines and Related Biological Products Advisory Committee meeting, where members of the committee voted on granting Moderna an Emergency Use Authorization (EUA) to distribute its mRNA COVID-19 vaccine in the U.S., the FDA did note a case of ITP in a 72-year-old clinical trial participant who was hospitalized with thrombocytopenia and obstructive kidney stone disease after receiving the experimental vaccine and died of multiorgan failure.

In discussing deaths that occurred in the Moderna COVID-19 vaccine clinical trials, the FDA stated:36

“One case was a 72-year-old vaccine recipient with Crohn’s disease and short bowel syndrome who was hospitalized for thrombocytopenia and acute kidney failure due to obstructive nephrolithiasis [kidney stone] 40 days after dose 2 and developed complications resulting in multiorgan failure and death.”

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