Doctors challenged by post-vaccine deaths in India, US

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Pfizer said that to date millions of people have taken the vaccine and the company is closely monitoring all adverse events in individuals who are administered the shot.

A Florida-based physician died 16 days after he received the Pfizer vaccine, while in Madhya Pradesh, India, a man died nine days after receiving a Covaxin shot. 

Pfizer Inc and US federal health officials are investigating the death of a healthcare worker 16-days after the person received the first dose of the company’s Covid-19 vaccine. Pfizer on Tuesday said in a statement that so far, the evidence doesn’t suggest a connection. The deceased who is a Florida-based physician developed a rare disorder called thrombocytopenia that decreases the body’s ability to clot blood and stop internal bleeding.

The company cited its clinical trials and data collected since the vaccine developed with Germany-based BioNTech SE was authorized in the United States in reporting its initial conclusion that the evidence doesn’t suggest a causal association to the shot.

Pfizer said that to date millions of people have taken the vaccine and the company is closely monitoring all adverse events in individuals who are administered the shot. It further stated: “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.”

Centres for Disease Control and Prevention (CDC) Spokesperson Tom Skinner stated that it is aware of the death and “will evaluate the situation as more information becomes available.” 

The New York Times was the first to report the death of Gregory Michael, a 56-year-old obstetrician, and gynecologist located in Miami Beach. The Times cited a Facebook post uploaded on January 5 by his wife, Heidi Neckelmann, who stated that Michael had died from a brain hemorrhage.

According to Skinner, CDC along with the US Food and Drug Administration and other federal agencies, regularly review Covid-19 vaccine safety monitoring data and share their findings with a group of vaccine safety experts, who give independent guidance to the federal officials. He also expressed condolence to the deceased’s family. 

Meanwhile, in India, as we have reported, a case of death after receiving the Covid-19 vaccine. Deepak Maravi, a 42-year-old man from Bhopal, Madhya Pradesh passed away nine days after receiving a shot of Covaxin on December 12. Indian drug regulators approved Covaxin developed by Hyderabad-based Bharat Biotech on a Phase 3 clinical trial basis. 

The deceased’s wife told the Indian news website The Quint that her husband had died “because of the vaccine.”

Bharat Biotech in a statement said that the cause of death was poisoning by citing the report issued by the Gandhi Medical College, Bhopal, that the site received from the Bhopal Police.

The statement added, “The volunteer passed away nine days after the dosing and preliminary reviews by the site indicate that the death is unrelated to the study dosing. We cannot confirm if the volunteer received the study vaccine or a placebo as the study is blinded.”

According to Bharat Biotech, during the time of enrolment, the deceased had fulfilled all the inclusion and exclusion criteria to be accepted as a participant in the Phase 3 trials and was also reported healthy in all the site follow up calls after seven days of administering the shot.

The firm also added: “There are several factors that can cause an adverse event during a clinical trial, including the patient’s underlying disease, other pre-existing conditions or any other unrelated occurrence like an accident. We are also continuing to cooperate with the investigation requirements from the Madhya Pradesh Police in Bhopal.” 

As reported earlier, groups working for Bhopal victims allege serious violations during the vaccine trial at Bhopal. 

Also Read: Vaccine diplomacy: How Modi govt is trying to project India as vaccine centre of the world

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