The end of the COVID-19 emergency response in the United States might be a milestone this spring, but for St. Paul's Suzanna Newell it will feel like the nation is moving on without her.
The 51-year-old mother and former bank executive believes a COVID vaccine reaction caused her disabling health problems, which have sent her across the country in search of treatments. She filed a claim with a federal program that compensates people for rare vaccine-related injuries, but that was 11 months ago.
Newell has only received an autoreply to her claim — prolonging the mystery of the vaccine's role and limiting treatment options. The triathlete was able to cross a finish line this summer, but in a wheelchair pushed by a friend. She's often bedridden in pain.
"It's not going in the direction I was hoping," she said.
Newell isn't alone in her struggle to establish a vaccine connection to her disabilities and receive help with a mountain of medical bills. She learned that as volunteer treasurer of React19, an organization that has raised $700,000 to treat vaccine-related injuries.
The federal Countermeasures Injury Compensation Program (CICP) has received 11,196 claims related to COVID, including 8,447 related to vaccines. Only 543 have been resolved. No payouts have been made, though 19 claims have been declared eligible.
"The sad reality is if something goes wrong, there is no safety net for you," said Brianne Dressen, a former Utah school teacher who co-founded React19 and suffered health problems after her COVID vaccination in a clinical trial.
Numerous peer-reviewed studies have upheld the safety and effectiveness of COVID vaccines. The Minnesota Department of Health contributed to a federal report last week showing that people who received the latest boosters were 14 times less likely to die than unvaccinated people late last year.
Even so, COVID-19 vaccines were always going to hurt some people while protecting millions of others, said Dr. Harlan Krumholz, a Yale University cardiologist who expanded a study of long-COVID patients to include vaccine injuries.
"There is almost nothing in medicine that you could call unequivocally good," he said. "Even if you have an operation that saves your life, there are some people for whom the operation can actually go wrong."
People claiming vaccine injuries have nonetheless become "radioactive," Krumholz said, because they've been lumped in with anti-vaccine conspiracies that health officials have discredited to maintain public confidence in COVID vaccine recommendations.
The toxic political environment has reduced interest and funding in research of vaccine-related injuries, he added, which has stacked the odds against claims by Newell and others.
A high bar
CICP is a small program within the Health Resources and Services Administration that has paid $6 million over 13 years, mostly related to H1N1 flu pandemic vaccines. Critics have consequently questioned the Trump administration's decision in 2020 to make it the arbiter of COVID vaccine injuries instead of a larger federal program with $4 billion at its disposal.
CICP is the only recourse because manufacturers were shielded from liability so they could swiftly produce vaccines to confront COVID. It awards compensation presumptively when claims involve illnesses on a federal list of vaccine-connected conditions.
No such list exists for COVID vaccines, though — leaving people to meet CICP's high bar of presenting "compelling, reliable, valid, medical, and scientific evidence" to prove a connection to their illnesses.
Problems for Newell started 30 hours after her second COVID vaccine jab in her right arm in April 2021. She felt exhausted, a lymph node bulged on the left side of her neck and a rash emerged on her forehead. Then came chest pain, trouble concentrating, and stinging discomfort in her right thigh.
Diagnoses by her doctors have included small fiber neuropathy — a nerve disorder marked by persistent, burning pain — and Sjogren's syndrome, an autoimmune disorder that can cause joint pain and fatigue. Newell took a leave as U.S. Bank's vice president of corporate social responsibility before losing her job. The mother of two teenagers has lamented missed opportunities to see them in school and sports activities.
The vaccine connection isn't certain. Incidents of small fiber neuropathy were increasing before the pandemic, especially in woman around age 50 — but usually in those with diabetes or other conditions. Newell in contrast was healthy at the time of her vaccination and training for her next race.
Case reports have suggested a link between her conditions and COVID vaccination. Some doctors remain skeptical, but Newell said more seem willing later in the pandemic to discuss the possibility.
Dr. Suzanne Gazda, a Texas neurologist, has consulted with React19 and is convinced the vaccine caused Newell's problems.
"The sequence of the onset of symptoms that occurred after the vaccination ... there is just no other thing that could have caused this," she said.
Talk without shame
Diagnoses based on the proximity of events can be misleading. More than 269 million Americans received COVID-19 vaccine in two years, and some were bound to suffer unrelated medical problems at the same time. CICP consequently disqualifies "temporal" observations as proof.
Dr. Michael Ackerman of Mayo Clinic said these assumptions have led skeptics to make unproven claims, including blaming COVID vaccines for recent high-profile cardiac arrests in young adults and athletes. Ackerman, a genetic cardiologist, tracks causes of sudden cardiac deaths worldwide and said there is no proof of a dramatic increase that implicates vaccines.
"The anti-vax community will take a temporal association and say, 'See, it was the vaccine. Guilty as charged,' " he said. "But we could have done that before the coronavirus and said guilty as charged to all kinds of activities."
Protective benefits of vaccines have far outweighed risks, according to the Vaccine Safety Datalink, a group of 13 health systems including Bloomington-based HealthPartners that treats 3% of the U.S. population. They found elevated rates of non-COVID deaths and medical care in unvaccinated people, which is the opposite of what they would expect if the vaccine were a widespread problem.
Some risks have emerged. Blood clots in a few cases paused the rollout of the Johnson & Johnson COVID-19 vaccine in 2021, and limited its use. Surveillance found elevated rates of myocarditis, or heart inflammation, in recipients of the Pfizer and Moderna COVID-19 vaccines.
Seventeen of 19 claims approved for compensation by CICP have involved myocarditis or pericarditis, an inflammation of tissue surrounding the heart. Claims of conditions without such supporting evidence haven't been approved.
Ackerman said researchers must explore vaccine risks to get beyond conspiracies. Myocarditis isn't necessarily found in unexplained sudden cardiac deaths, which is unusual if the vaccine is at fault. He is reviewing cases and examining patients' heart cells to see if the virus or vaccine could trigger these deaths without inflammation.
Krumholz and Yale immunologists are checking medical histories and blood samples for similarities between people with long-COVID and vaccine-related injuries. Similar immune system overreactions could be behind both problems.
Newell said people need urgent help. Her bills include $80,000 for a chemotherapy drug that reduced her leg pains. She has been denied insurance coverage for intravenous immune globulin (IVIG), a costly treatment that has worked for others but lacks proof of effectiveness.
Dressen is far from her rock-climbing days, but she said IVIG through a federal clinical trial has increased her mobility. She also filed a claim with CICP, which has a $7 million annual budget and was created to compensate victims for injuries sustained in public health emergencies — just not at the scale of COVID-19.
Dressen and Newell have lobbied the Biden administration and lawmakers for immediate help by switching their claims to the Vaccine Injury Compensation Program (VICP). The program compensates for injuries from established vaccines, and it has more resources as a result of a 75-cent tax per shot. The switch would subject COVID vaccines to the tax.
Newell considers herself lucky, because she has financial resources and health insurance, so she has tried to fight for others. Beyond React19, she formed a Team Humanity website so people could discuss vaccine injuries without judgment.
"Those things we don't talk about," she said, "create shame and isolation."