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The family of a woman who died shortly after receiving a coronavirus vaccine had a private autopsy performed on her last week because the state did not do one while investigating her death, her daughter said.
Drene Keyes, a 58-year-old Gloucester resident who died following a Pfizer shot, was buried Friday. Lisa Jones, Keyes’ daughter, said they are waiting for the results from their own investigation, an expense they hope will shed light on her death and bring them closure. It was not certain whether the Virginia Office of the Chief Medical Examiner would incorporate the findings into the state’s cause of death analysis, she said.
A comment in internal emails between state officials raises more questions.
State Health Commissioner Norman Oliver told public information officers in an email Feb. 5 that if reporters asked whether an autopsy was done, they should say “a full autopsy was not needed in order to ascertain whether the death was related to the vaccination.”
In a follow-up interview with The Virginian-Pilot, Oliver said he misspoke in that email. What he meant was the preliminary findings did not indicate Keyes had anaphylaxis, a severe allergic reaction, he said. Oliver clarified he did not mean they had ruled out whether the vaccine contributed.
When asked why the state didn’t do an autopsy, he referred the question to the chief medical examiner, Dr. William Gormley, who reports to him.
“I do not tell the medical examiner how to be a pathologist,” Oliver said.
Gormley declined to be interviewed, instead providing written statements through a Virginia Department of Health spokeswoman, who said he wouldn’t talk about any specific case.
Oliver’s email was part of a public records request that also revealed some officials inside and outside the health department were concerned the death of Keyes, who is Black, could worsen vaccine hesitancy among minorities.
When health department spokespeople crafted a statement following her death, they included Gov. Ralph Northam’s press secretary and another Northam staffer in the editing process. Wording on the close timing of the death after the vaccine went from saying there may appear to be a relationship, “But that is not necessarily the case,” to the timing “is not evidence of it being related,” highlighting their focus on deterring speculation.
Surveys show public trust in the vaccines has grown, but confidence among Black people is somewhat lower than in other demographics, although they are at higher risk of getting COVID-19 and becoming seriously ill from it. That erosion of trust stems from a history of disparities in the health care system and unethical medical practices, such as the Tuskegee study of 1932. That study, which lasted 40 years, involved federal health officials injecting syphilis into several hundred Black men without their informed consent.
In the fight to end the pandemic, public health experts have emphasized the need to reach Black and brown people, who have been inordinately impacted by the virus. Public health officials do not have complete race and ethnicity data for Virginians who have been vaccinated, but of the individuals whose information is provided, about 19% have been Black and Latino.
Anaphylaxis after COVID-19 vaccination continues to be extremely rare, federal scientists say, occurring in about 2 to 5 people per million in the United States, based on events reported in the national Vaccine Adverse Event Reporting System. The reaction almost always occurs within a half hour of receiving a shot. Vaccinators are required to have medicine on hand to treat anaphylaxis immediately.
How the state chose to investigate Keyes’ death will influence how federal agencies view the case. When the U.S. Centers for Disease Control and Prevention is alerted to a fatality through the surveillance system, for instance, it does not perform its own tests. Rather, CDC staff look at documents provided to them, such as hospital records, death certificates and autopsy reports.
Martha Sharan, a CDC spokeswoman, said the system, which accepts reports from anyone, is designed to track recurring problems that suggest unexpected safety issues. The agency is monitoring reports of severe allergic reactions, but also a long list of other severe conditions to which the shots could have contributed, such as heart attacks, strokes and seizures.
So far, the system hasn’t revealed patterns in cause of death that would indicate a safety problem with the vaccines.
But whether there is a relationship between a vaccine and a medical emergency that led to death relies on the opinions of those who treated and examined the patients. That means local and state health-care providers and death investigators will play a critical role in detecting potential problems with the coronavirus vaccines that have received emergency use authorization.
“We don’t determine causality,” Sharan said. “That is determined by those death certificates and medical records and autopsy reports.”
Keyes died Jan. 30, shortly after getting a first dose of the Pfizer vaccine. She waited about 20 minutes after the shot to be observed by health care providers on site, but soon after reaching her car, had difficulty breathing, then vomited, Jones said.
There a medic gave her epinephrine shots in her leg and arm and medicine through an oxygen mask. An ambulance took her to VCU Tappahannock Hospital, where she died. A hospital physician told Jones that her mother suffered from “flash pulmonary edema,” a condition that caused her lungs to rapidly fill with fluid.
Jones said even before state officials had her mother’s postmortem preliminary test results, the medical examiner’s office told her they would not perform an autopsy.
She had tried to persuade them otherwise — to consider other tests and look at her heart and tissues — to gather more information on what happened in the last hours of her life. They told her nothing could be gleaned from an autopsy that would relate the vaccine to her death, she said.
“They said that their primary objective was to determine if she was having an allergy or not,” Jones said.
In a statement released through a spokeswoman, chief medical examiner Gormley said a severe allergic reaction generally can be ruled out with blood work. When anaphylaxis happens, itching, rash and swelling come on quickly and can obstruct the airway. During the inflammatory reaction, mast cells release a high level of an enzyme known as tryptase. If the deceased person’s tryptase level is normal, that person did not suffer a life-threatening allergic reaction.
Depending on the death, Gormley’s staff decide whether to conduct an autopsy. They choose “the least invasive procedures required to document the cause and manner of death and answer specific questions related to public safety,” according to a statement.
State officials still haven’t answered how medical examiners could thoroughly rule out other potential causes of death triggered by or linked to the shot without an internal examination of the body.
Death investigations are not handled consistently throughout the United States, making it impossible to have uniform protocols amid the pandemic, according to the National Association of Medical Examiners. From one state or jurisdiction to another, cases are overseen by elected lay coroners, sheriff coroners, medical examiners who are physicians and justices of the peace.
Though there’s a long history of public fear associated with dead bodies during pandemics, concerns about spreading COVID-19 between the dead and the living likely are unjustified, the association has said. Still, the Occupational Safety and Health Administration has previously recommended that people suspected of having died from the coronavirus not be autopsied, though it has softened its position more recently, as long as they are done in an appropriate setting with protective gear.
It’s not clear how dramatically COVID-era precautions might be impacting the rate of death cases receiving autopsies compared to before the pandemic. Gormley said in a statement that Virginia medical examiners continue to perform them “as needed.”
Out of more than 76 million doses of coronavirus vaccines administered throughout the country between mid-December and March 1, the federal surveillance system received 1,381 reports of death among people who had gotten a shot. CDC and Food and Drug Administration physicians have so far found no evidence in their reviews that a vaccination contributed to death.
For Jones, the speed of the vaccine rollout and her mother’s death compel her to search for answers. She has wondered whether her mother could have survived if doctors and pathologists understood more about how people’s medical history and conditions play into a severe reaction. She hopes people with underlying health conditions will talk to their doctors before getting the vaccine.
“There’s a lot of things that need to improve,” she said. “Because of the millions they say are faring well with response to the vaccine, I think they’re just not concerned about a small minority that is being affected in such a rough way.”
For more information on COVID-19 vaccine safety monitoring, go to bit.ly/vacsaf. .
Elisha Sauers, firstname.lastname@example.org, 757-222-3864