Caprara said his office is working with the Florida Department of Health and the US Centers for Disease Control and Prevention to investigate the death of Dr. Gregory Michael. His death has not definitively been linked to the vaccine, but that is among the possibilities being explored, Caprara added.
The CDC confirmed it “is aware of a reported death in Florida of an individual who received the Pfizer-BioNTech COVID-19 vaccine about two weeks before passing away,” a spokeswoman said by email Wednesday night.
According to Michael’s website, he was an obstetrician/gynecologist “in private practice at Mount Sinai Medical Center in Miami Beach for the last 15 years.” He was 56, according to public records.
Caprara said Michael received a vaccine around December 19 and died “late January 3rd into the 4th.” An autopsy was conducted Tuesday, Caprara said, with cause of death pending the completion of studies by the medical examiner and partner agencies.
Pfizer also said it was investigating.
“Pfizer and BioNTech are aware of the death of a healthcare professional sixteen days after receiving a first dose” of the vaccine, Pfizer said in a statement. “It is a highly unusual clinical case of severe thrombocytopenia, a condition that decreases the body’s ability to clot blood and stop internal bleeding,” it added.
“We are actively investigating this case, but we don’t believe at this time that there is any direct connection to the vaccine,” the company said in the statement.
“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.”
CDC officials told reporters Wednesday it had not seen any worrying severe reactions to coronavirus vaccines beyond 29 cases of severe allergic reactions — or just 11.1 cases of anaphylaxis per 1 million doses administered.
“The known and potential benefits of the current Covid-19 vaccines outweigh the known and potential risks, getting Covid-19,” said Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases. “That doesn’t mean, however, that we couldn’t see potential serious health events in the future.”
According to the CDC, more than 5.3 million people have received their first dose of a Covid-19 vaccine in the US.
In its statement Wednesday night, the agency said it regularly reviews safety data along with other federal agencies like the US Food and Drug Administration, as well as vaccine safety experts who independently review the data, make recommendations and provide guidance.
“CDC will evaluate the situation as more information becomes available and provide timely updates on what is known and any necessary actions,” the statement said.
Both Pfizer and the CDC said their thoughts were with the family.
“It’s been a difficult year as each of us grapple with a worldwide pandemic,” the CDC said. “Use of COVID-19 vaccines is the next step in our efforts to protect Americans and reduce the impact of the
Mount Sinai Medical Center said in a statement that, due to medical privacy laws, it “cannot confirm or deny information about any patient. To the extent that we are aware of an incident involving any patient, the appropriate agencies are contacted immediately and have our full cooperation.”