U.S. FDA investigates sharp drop in platelets in Pfizer vaccine recipients, raising concerns

This week, some Americans who received the vaccine against the Chinese communist virus (Wuhan pneumonia) developed the rare blood disease thrombocytopenia, and several people have died. Federal authorities said Thursday (Feb. 11) that they had stepped in to investigate and urged people not to panic.

A spokesman for the U.S. Food and Drug Administration (FDA) told via email that the agency is investigating and evaluating the reported cases.

The spokesperson said, “At this Time, we have not found a causal link and we will update the public as we learn more about these events.”

The FDA last year listed blood disorders as a possible adverse reaction to vaccination, alongside other serious adverse events such as “Guillain-Barré syndrome” and death.

According to the Vaccine Adverse Event Reporting System (VAERS), dozens of cases of thrombocytopenia after vaccination have been reported across the United States. As of Feb. 10, about 44.7 million doses of vaccines had been administered in the United States.

In one case, a 56-year-old Florida man was given a Pfizer vaccine and was rushed to the hospital a few days later because he noticed “small blood spots” on his body. He was diagnosed with thrombocytopenia.

In another case, a 36-year-old Pennsylvania woman was admitted to the hospital emergency room after waking up one day in early January with blood blisters in her mouth two weeks after receiving the Pfizer vaccine. The diagnosis was idiopathic thrombocytopenic purpura (ITP), another version of thrombocytopenia.

And the most high-profile case was that of Gregory Michael, a 56-year-old Miami obstetrician, who died 16 days after receiving the vaccine.

His wife, Heidi Neckelmann, said Michael noticed small spots on his skin three days after he received his first dose of the vaccine, and he realized the spots indicated possible internal bleeding. Hospital tests showed that his blood cell count was well below the normal range, and after more than 10 days of treatment, the platelet count in his body never rebounded. Medical workers found his platelet count to be zero.

Michael was taken to the intensive care unit and diagnosed with acute ITP caused by a vaccine reaction, his wife said.

“No one from Pfizer or any health facility contacted me. All I know is what has been published in different news articles, which is that it is under investigation.” She told.

Dr. Jerry Spivak, a professor in the department of hematology at Johns Hopkins University School of Medicine, did not evaluate Michael and does not know about his treatment.

But Spivak said, “This is unusual for immune thrombocytopenia based on the fact that several other patients in the same time frame had rapid onset, severe disease, similar timing of thrombocytopenia, were exposed to the same vaccine, and were all male. I think a very strong argument can be made that until proven otherwise, the association (with vaccines) must be considered real and not a coincidental occurrence.”

“Vaccine-induced thrombocytopenia is recognized as a rare event, but (to say) that no one has died from it and to dismiss the event as coincidental or merely possible is unfair to Dr. Michael, to scientific inquiry, and a disservice to others who may have experienced the same adverse event. So, until proven otherwise, I think this is a COVID-19 linked event.”

In response, Pfizer responded that based on preliminary investigations of post-vaccination thrombocytopenia cases suggesting that there is no link between the vaccine and the disease, noting that the FDA and other federal health agencies would be responsible for the investigation.

A Pfizer spokesperson said, “We take reports of adverse events very seriously. We are aware of VAERS and cases of thrombocytopenia in vaccine recipients reported to Pfizer. We are in the process of gathering relevant information to share with the FDA. However, at this time, we cannot determine a causal relationship with our vaccine.”

Moderna (Moderna) did not respond to requests for comment.