After a Miami doctor died this month from an unusual blood disorder just 2 weeks after receiving the COVID-19 vaccine, state and federal officials are investigating the case further.
Gregory Michael, MD, a 56-year-old ob/gyn in private practice in Florida, died from complications of immune thrombocytopenia (ITP), according to written by his wife, Heidi Neckelmann.
Public health officials at the state and federal level are continuing to investigate Michael's case in relation to the COVID-19 injection, but vaccine experts and hematologists have emphasized that this case is extremely rare, and the coincidental timing of ITP and vaccination doesn't demonstrate causality.
Michael went to the hospital three days after getting his first dose of Pfizer's mRNA injection after noticing petechiae on his hands and feet, Neckelmann wrote on Facebook. He was admitted to the emergency room, where his blood test showed his platelet count at zero, and he was diagnosed with ITP.
For 2 weeks, Michael's care team tried to increase his platelets, but their attempts were unsuccessful, Neckelmann wrote. Doctors scheduled him for a last-resort splenectomy; then, two days before the procedure, Michael suffered a fatal hemorrhagic stroke, . He died in early January, 16 days after he was first immunized.
Neckelmann wrote that Michael was "very healthy," stating that he delivered many babies during the pandemic and was loved by his community. She added that Michael was a "pro vaccine advocate," which is why he got it himself.
Federal public health officials confirmed to MedPage Today their investigation into Michael's death. CDC spokesperson Kristen Nordlund told MedPage Today in an email that officials will continue to evaluate the situation and provide timely updates. "Our thoughts are with the family during this heartbreaking time," she said.
The Florida Department of Health did not respond to a request for comment.
Immune thrombocytopenia is characterized by a decrease in platelets, caused by the immune system attacking its own thrombocytes. The illness often has no identifiable cause and is very difficult to diagnose without a blood test. The autoimmune disease is sometimes referred to as a "diagnosis of exclusion."
"The vast majority of time, we don't know why it happens," Gregory Poland, MD, an internist at the Mayo Clinic in Rochester, Minnesota, told MedPage Today. In most cases, it resolves on its own and causes no ill effects, he said.
Around three in every 100,000 adults in the U.S. are diagnosed with ITP each year. As the CDC reports that , Poland suggested it's inevitable that a few ITP cases would develop after vaccination, simply by chance.
"Once you start to vaccinate millions and millions of people, there are going to be these associations in time," Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia, told MedPage Today. "I don't think this should be reported as causally associated, because we just don't know."
Several studies have investigated whether other vaccines might be related to immune thrombocytopenia, but there are almost no known associations. The condition is rare, and the only vaccine where there is a demonstrated, causal relationship is the measles, mumps and rubella (MMR) vaccine in children. ITP occurs in between 1 and 3 out of 100,000 MMR vaccine doses -- less than the occurrence with any of those diseases themselves.
As measles, mumps, and rubella infections have been associated with ITP, some researchers found a similar association with . But its relationship with the COVID-19 vaccine is not defined, as there were no ITP cases observed in Pfizer's clinical trials.
James Bussel, MD, a professor emeritus of pediatrics at Weill Cornell Medicine in New York, said that Michael's case is out of the norm for ITP, as the sudden drop in platelet count to zero in just three days would be extremely unlikely. Bussel said that while we do not know what happened, there is a chance Michael may have been predisposed to ITP, and the vaccine may have triggered an immune attack on his thrombocytes.
Bussel said that there are also two other ITP diagnoses that physicians know of which occurred after vaccination for COVID-19, but those cases responded to treatment. "Even if you accept all three of these cases, that's three out of millions of vaccinations, and they are quite likely to be coincidental," he said.
"At this time, the risk-to-benefit ratio for vaccination is in favor to receive it due to the rarity of such adverse events including thrombocytopenia," said Caroline Kruse, president and CEO of the Platelet Disorder Support Association. She told MedPage Today via email that the organization encourages ITP patients to talk to their hematologist about concerns prior to vaccination.
Offit said that while it is important to investigate whether or not the vaccine may be associated with adverse events such as ITP, just because two things happen at the same time does not mean their relationship is causal. He compared it to the pattern of a rooster calling when the sun comes up.
"The rooster isn't causing the sun to come up," Offit said. "I don't think that study has ever been done, but I bet if you make it so a rooster can't crow, the sun is still going to come up."