The one-in-a-million risk of the COVID-19 vaccines: Who thinks its going to be you? – Detroit News
March 6, 2022
Markian Hawryluk| Kaiser Health News
Bend, Ore.Monica Melkonianwanted the Johnson & Johnson COVID-19 vaccine. It was only one shot and then she would be protected against the virus. So she was thrilled when the vaccination clinic at theDeschutes County Fair & Expo CenteronApril 7had her first choice.
But onApril 13, Melkonian started experiencing headaches, a sharp pain behind her left eye. That same day federal health officials announced a pause in the use of the J&J vaccine after learning that six people had developed a rare blood-clotting disorder following their shots.
Despite her ongoing headaches, she and her husband,Stan Thomas, spent the next Saturday working around their home. He hung a ceiling fan in their garage where he works on motorcycles. She spent the day pulling weeds. They walked their lot identifying the projects they wanted to complete that summer. Late into the evening, they soaked in their hot tub, drinking champagne and margaritas, eating strawberry shortcake. They watched the moon rise and the stars come out in the darkCentral Oregonsky.
We were literally talking about how amazing our lives have been and how lucky we were, Thomas said.
Less than a week later, she was dead.
The 52-year-old woman is one of only nine people in theU.S.known to have died from vaccine-induced thrombotic thrombocytopenia, a rare side effect of the J&J vaccine, and a victim of tragic timing. Thomas believes his wife would be alive today had the information about potential side effects been shared even a few days earlier. Instead, he is left to tell her story and protect her legacy.
Both were experts in the field of occupational health and safety and directly involved with the pandemic response. Both knew a one-in-a-million risk of the COVID-19 vaccines paled in comparison with the risks of the virus itself. And while Thomas remains steadfastly pro-vaccine and bristles at the idea of the anti-vaccine movement capitalizing on his wifes death, he questions whether health authorities have done enough to help people understand their vaccination options.
According to data compiled by theCenters for Disease Control and Prevention, women between ages 30 and 49 appear to be at highest risk for the complication that killed Melkonian. Federal health officials now recommend everyone take thePfizerorModernamRNA vaccines instead. Theyve left the J&J vaccine on the market to avoid undermining confidence in a vaccine that will likely play a crucial role in bringing the global pandemic to an end.
Its a decision that Melkonians death helped illuminate. Her case was presented to the experts who made that recommendation.
Now Thomas is fighting to ensure her sacrifice is not forgotten. Its easy to lose sight of the humanity hidden in the statistics of risk.
When its 8 million doses and two people are going to die from it, he said, who thinks its going to be you?
Melkonian and Thomas had met while working as fatality investigators for theOregon Occupational Healthand Safety department. He had been her mentor in 1996, overseeing her first inspections. After their respective marriages ended, their friendship turned to romance, and they got married in 2007. When COVID-19 hit, their jobs centered on the pandemic. Thomas oversaw planning for Oregons nonmedical response, while Melkonian worked for a software company that helped companies track vaccinations.
From day one, the pandemic was part of this household, Thomas said. There was no escaping it.
They talked frequently about the coming COVID-19 vaccines and the differences among them. They recognized that all three were safe and effective, and that the possibility of a bad side effect was minimal. He wanted mRNA vaccines. She wanted to be protected as soon as possible, and the one-dose J&J vaccine seemed it would accomplish that faster.
You definitely hit the jackpot, Thomas recalled telling her after she got her shot. You should go buy a lottery ticket, because todays your lucky day.
It turns out it was a lottery no one wants to win. The chance of a woman her age dying from the shot was literally 1 in 1 million.
A month later, we realized once that needle hit her arm, it was a one-way ticket to here, Thomas said.
On that day working around their home, her headaches had mostly gone. They went to bed basking in the warmth of their perfect day. But at4 a.m.the next day,April 18, Thomas heard Melkonian cry out and hit the floor. She had experienced a seizure and couldnt move her right arm. Thomas suspected a stroke and immediately thought of the vaccine.
No! This isnt happening to me, Melkonian cried out as Thomas spoke with the 911 operator.
As they waited for the ambulance, they used those precious minutes to tell each other the kinds of things you say when you dont know what the future will hold. By the time the ambulance arrived, she could no longer speak.
The progression of this was just lightning-fast, Thomas said, which I am tragically grateful for.
At the St. CharlesBendemergency room, Thomas told her to squeeze his hand once for yes and twice for no, as doctors asked her questions.
The last thing that I said to her was that I loved her and asked her to squeeze my hand twice, Thomas said. She did.
They rolled her out of the room to get a CT scan, and when she returned, she couldnt respond in any way.
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Dr.Scott Rewinkel, a neurologist who specializes in clinically complex patients at the hospital, was paged about a seizure patient. He reviewed Melkonians CT scan. She had experienced several brain bleeds on the left side of her frontal lobe.
And thats an unusual spot for somebody her age and her general health, he said.
Just days earlier, Rewinkel and his neurology colleagues at the hospital had discussed guidelines for identifying and treating the very condition that had struck Melkonian. Its a paradoxical condition in which the immune system destroys the platelets needed for clotting, while leading to blood clots in the venous sinuses of the brain. The patient experiences clotting and bleeding at the same time.
Thomas thought if he could just get his wife home, shed be all right.
That was my hope: Get her back, and then therapy and everything, and we can still go have fun and live our lives, Thomas said. By Sunday night, that hope was gone.
Despite doing everything called for in the treatment guidelines, doctors were struck by how quickly her condition deteriorated. Every successive CT scan showed the bleeding spreading over more of her brain. There was one last-ditch effort they could try. They could open her skull to allow the brain to swell outside its fixed confines. But her brain had already been so damaged, she likely would have faced significant disabilities. The bleeds had hit areas of the brain associated with language and personality.
Who am I getting back? Thomas recalled asking the doctor as they weighed the procedure. What Im getting back is somebody thats going to be sitting in a wheelchair with drool running down her stomach, not knowing what shes looking at off the deck.
The doctors estimated that without further intervention Melkonian would die by the end of the week. Thomas told them to take any blood or tissue samples, to run any tests that might help doctors understand why the J&J vaccine was causing this side effect or how to reverse it.
The body is a vessel for the soul, and the soul is gone. So get what you can, Thomas said he told them.
On the afternoon ofApril 20, some 200 doctors, nurses and other staffers lined the hospital hallway as they pushed Melkonian on her final journey. Thomas, along with her son and her brother, walked behind them. Then they went outside the hospital, lowered the American flag, and raised the Donate Life flag beneath it, while inside doctors removed her organs. Her liver and right kidney went to a 40-year-old man, her left kidney to a 50-year-old man, her heart to a 40-year-old man.
Three days later, aCDCadvisory council reviewed the data on the J&J vaccine and recommended lifting the 10-day pause. The committee members felt taking one of the approved vaccines off the market would hamper vaccination efforts, and that the one-dose vaccine offered important benefits for people who might be difficult to bring back for a second shot, or for places where the super-cold storage required for the mRNA vaccines might not be available.
Then the FDA updated its fact sheet on the vaccine, advising women under 50 of the potential side effect. Rewinkel had presented Melkonians case so it could be included in the analysis.
The big takeaway is that the risk is very, very small, Rewinkel said. Its simply a game of statistics and numbers.
The odds of having a complication from a COVID-19 vaccine, he said, are incredibly small compared with the risks of the virus.
In December, the committee reviewed updated data on the J&J vaccine throughAugust 2021. After more than 14 million doses were administered, 54 total cases of the clotting disorder had resulted in eight deaths. Thats 0.00006%. TheU.S.case fatality rate for COVID-19 is 1.2%. A ninth clotting death occurred but doesnt change the death rate measurably.
The committee considered whether the now ample supply of the mRNA vaccines meant the J&J vaccine could be pulled, but decided to leave it in place. Instead, the panel recommended the mRNA vaccines over the J&J shot. The J&J shots are still being given and more than 18 million shots have been administered in theU.S.
Thomas inquired about aFederal Emergency Management Agencyprogram to help with burial costs for people who died of COVID-19 but was told his wife was not eligible because her death certificate didnt list COVID-19 as the cause of death. To Thomas, such rules seem to ignore her death as part of the full toll of pandemic fatalities.
Shes a hero of the times that were living in, in this pandemic, in this world which we are faced with today, he said, for the legacy of the work she did, and doing her societal obligations, and giving her life for it.
Thomas is also upset that the risks of the various vaccines werent communicated earlier and more clearly.
Theyre not taking time to explain the acceptable risk, he said. Theyre not taking time to communicate what shots are good for what age groups."
Maybe officials didnt know of the risk before Melkonian got her shot rare side effects often emerge only when a vaccine is administered to large numbers of people. In the clinical trials of the J&J vaccine, one person developed that side effect and survived.
Thomas would have preferred a more nuanced public health message, explaining the differences among the vaccines and how women ages 30 to 49 were at higher risk of complications from the J&J vaccine. Although Melkonian was a few years older than that range, her husband feels she would have heeded such a warning.
It was an absolute failure to some degree, he said. The fear of scaring everybody away from the vaccines overran the ability to educate the public correctly.
A couple of weeks after Melkonian died, Thomas still hadnt been vaccinated. He called up a friend who was helping to run the countys vaccine clinic. He knew her from years of working withDeschutes County Search and Rescue.
I cant go get a shot where Monica got her shot, he said he told her. I cant go in there.
She arranged for him to get his first vaccination shot at the search-and-rescue teams building. Several friends showed up to support him. One made breakfast. They did their best to keep his mind off the circumstances, but his mind was awash with conflicting thoughts.
My wife, my best friend, my soulmate is dead because of whats happening to me right now, he recalled thinking. I know people are going to look at me and go, Youre an idiot!
He figured people would second-guess his decision to get vaccinated after her death. Ive got friends that refuse to get a shot and theyre losing their job because they dont want to get a shot. And theyre like, But look what happened to Monica, he said. They use her as justification.
However, he said, he still believes in COVID-19 vaccines and that his choice was made before his wife died. He is now among the more than 200 million Americans vaccinated against COVID-19.
(KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.)
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The one-in-a-million risk of the COVID-19 vaccines: Who thinks its going to be you? - Detroit News