In-Depth: Why California's vaccine mandate presents 'impossible choice' for some with tinnitus

covid vaccine tinnitus
Posted at 6:46 PM, Apr 15, 2022
and last updated 2022-04-15 21:54:32-04

SAN DIEGO (KGTV) – The World Health Organization said it is investigating a potential link between the mRNA COVID-19 vaccines and rare reports of tinnitus, but those findings may not come in time for one San Diego nurse.

Escondido resident Shelli Russo is facing termination next month from her job as a Kaiser Permanente pediatric oncology nurse for refusing to get a third dose of the vaccine.

Russo said about a week after her second dose, she developed ringing in the ears that sounds like a constant burglar alarm. She said her tinnitus worsened months later after a breakthrough COVID infection in December. She now fears a booster dose might exacerbate the condition.

Under regulations from the California Department of Public Health, hospital nurses such as Russo are required to be vaccinated and boosted against COVID-19. The state does allow for medical exemptions, such as for a severe allergic reaction and possibly for individuals who experienced rare blood clotting or heart inflammation after a previous dose.

However, neither the FDA nor the CDC recognizes tinnitus as a side effect of the mRNA vaccines.

Russo’s request for a medical exemption was denied on March 16.

“The thought of losing my family, which is basically what I consider my co-workers and my patients, is just awful. But having to choose between my health and my work. I can't make that choice,” she said, fighting back tears in an interview.

Speaking generally, a spokesperson for Kaiser Permanente said the company reviews requests for medical exemptions on a case-by-case basis and typically reserves them for “conditions or disabilities recognized by the FDA or CDC as contra-indications.”

As of April 1, more than 15,000 people reported tinnitus to the CDC’s adverse reaction database following a COVID vaccine. That’s about one report for every 17,000 vaccinated Americans. These reports are submitted without vetting or verification.

Last year, the FDA and the European Medicines Agency added tinnitus as a potential rare side effect of the Johnson and Johnson vaccine. But the FDA said it has not made the same finding with the mRNA vaccines from Pfizer or Moderna.

“To date, we have not identified any safety signal for tinnitus following administration of the mRNA COVID-19 vaccines, but will continue to follow and evaluate this issue,” said a spokesperson for the Food and Drug Administration via email.

Dr. Gregory Poland, director of the Vaccine Research Group at the Mayo Clinic, said establishing a concrete link between tinnitus and the vaccines is challenging because millions of Americans develop the condition for other reasons. Tinnitus can be caused by head injury, stress, autoimmune disease, viral infections, and more.

“The problem with tinnitus, unlike something like a blood clot or inflammation in the heart, is that you can’t see it. You can’t measure it. There’s no imaging study,” Dr. Poland said.

However, Dr. Poland suspects there might be a link. He himself developed tinnitus shortly after receiving the COVID vaccine.

“The transparent truth is we don’t know what causes this. We don’t know how to treat it. And we have not followed large cohorts to know what the natural history of this will be,” he said. Poland added that he still believes the benefits of COVID-19 vaccination outweigh the risks, and he went ahead and got a booster dose despite his unresolved tinnitus.

This month, the World Health Organization said it was investigating a “possible link” between the Pfizer and Moderna vaccines and tinnitus. WHO scientists identified a nerve in the ear that might be the culprit.

In a bulletin to health professionals, the WHO said “further monitoring is required,” but that might be too late for Shelli Russo.

“For people like me who can’t get the booster but want to protect their patients, we need other options,” Russo said.

Russo would like the option to take a different COVID vaccine, such as the one from Novavax, as a booster, but so far, she said her attempts have been denied. Novavax is approved in 37 countries, but it is not currently authorized in the United States.

If the CDC and FDA don’t recognize tinnitus as a possible side effect of the mRNA vaccines, Russo stands to lose her job next month.

Here is the full statement from Dr. Andrew Bindman, Executive Vice President and Chief Medical Officer of Kaiser Permanente:

Privacy laws prohibit comment on any specific individual’s request; our process was designed to be objective and fair and allows every request to be thoughtfully reviewed on a case-by-case basis.

As a health care organization, Kaiser Permanente has an obligation to our 12.5 million members and patients — and our employees, physicians, and communities to ensure their safety and protect them from infection. Working closely with our labor partners last year, we acted in early August to protect the health and safety of our workforce and the communities we serve by mandating vaccinations for all our employees and physicians.

Kaiser Permanente is also deeply committed to equity and diversity. So, from the very outset, we created a process that respects and honors our employees’ sincerely held religious beliefs and medical concerns. Our process fully meets all federal, state, and local laws and allows requests for exemption from the vaccine requirement.

In a small number of circumstances, an employee may be prevented from receiving a vaccination because of a medical condition. These will generally be medical conditions or disabilities recognized by the FDA or CDC as contra-indications to COVID-19 vaccination. Employees must have a physician or licensed medical professional fill out a form certifying that they have a medical condition that prevents receiving any COVID-19 vaccine.

Employees whose exemption requests are denied are put on unpaid administrative leave and provided an opportunity to get vaccinated and return to work. We hope none of our employees choose to leave their employment rather than be vaccinated. We continue to work with our employees to alleviate concerns and educate them about the vaccines, their benefits, and their risks.

The vaccination remains the most powerful tool we have in bringing this pandemic to an end by preventing more dangerous strains from developing and helping the community return to a sense of normalcy.

We thank our staff who have moved quickly to get vaccinated and submitted verification. We understand that this may be a difficult decision for some in an already difficult time. We are doing all we can to support that decision-making process with information and discussions. We appreciate the critical role union leadership has played in encouraging employees to get vaccinated and help dispel misinformation.

We sincerely appreciate the extraordinary commitment and dedication of all Kaiser Permanente employees and physicians throughout our response to the pandemic, especially those serving on the front lines to fight this deadly virus. We encourage everyone to play a role in ending the pandemic by getting the safe and effective COVID-19 vaccine.
Dr. Andrew Bindman, Executive Vice President and Chief Medical Officer