Infectious Disease

What do you inform your sufferers?

January 13, 2021

5 min read

Source / information

Disclosure:
Information: Calabrese does not report any relevant financial information. Winthrop reports on research / advisory relationships with Eli Lilly, GlaxoSmithKline, Pfizer and Regeneron.

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With two COVID-19 vaccines from Moderna and Pfizer-BioNTech currently in circulation and patients receiving their starting doses nationwide, patients and providers have questions – many questions.

In search of answers, Healio Rheumatology sat down with Cassandra Calabrese, DO, the Cleveland Clinic’s Department of Rheumatologic and Immunological Diseases and Kevin L. Winthrop, MD, MPH, from Oregon Health & Science University. Both are leading voices in vaccination and immunology as they relate to rheumatic and autoimmune diseases.

“Our patients are very health conscious, so they are often interested in these details, yes. But even if they don’t, I always ask her about the vaccine at the end of a visit if we haven’t already spoken to him: “Has anyone talked to you about the COVID-19 vaccine?” Cassandra Calabrese told Healio Rheumatology. Source: Adobe Stock

Issues at hand include potential drug or disease-related effects on vaccine safety or effectiveness, potential differences between the currently available Moderna and Pfizer-BioNTech products, and the accelerated development process of the vaccines.

QQ Many people seem concerned about the speed at which vaccines have been developed. Could you address that?

Winthrop: The hesitation is somewhat understandable given that these are new or potentially unknown vaccine platforms. I try to assure my patients and friends that while the speed of these development programs is unprecedented, given the types of steps that have been taken, they are the same steps that would be taken in any vaccine development program from animal studies in early human volunteers through phase 1, 2 and 3 large scale studies. They just made it faster because it’s a pandemic.

Kevin L. Winthrop

There’s really nothing else here in terms of what we know about vaccine safety. I tell my patients that the right and right science has been used and the speed will not put them off. This is an important message to reach out to people.

Calabrian: We see this speed as a positive thing. It’s a wonder of science. We also emphasize to our patients that no shortcuts have been made in the development process. They passed rigorous testing and approval processes like any other vaccine. We tell them that we are learning more about these vaccines every day and that, as far as we can tell, they work and are safe.

QQ Should Patients Be Concerned About Differences Between Pfizer-BioNTech and Moderna?

Calabrian: I look at them together because both mRNA vaccines were made using the same technology and patients with autoimmune and rheumatological diseases were largely excluded from clinical trials. Pfizer included a handful of patients with a history of rheumatic disease, but presumably without immunosuppression. However, we don’t see any major safety concerns for our patients. However, many studies are being conducted to investigate the safety and risk of disease outbreaks following administration of the COVID-19 vaccine in patients with rheumatic diseases.

Cassandra Calabrese

When there is a disease-specific problem to consider, there may be some theoretical concerns in lupus patients with their interferon signature. However, the mRNA product in the vaccine is heavily modified so as not to trigger the immune system in this way. We have ongoing studies on this at the Cleveland Clinic. Overall, the benefits outweigh the potential risks.

QQ Going deep into the weeds about how it works in patients?

Calabrian: Our patients are very health conscious, so they are often interested in these details, yes. But even if they don’t, I always ask them about the vaccine at the end of a visit, if we haven’t already spoken to them: “Has anyone talked to you about the COVID-19 vaccine?” This creates an opportunity for us to discuss. It is important for patients to hear the facts and recommendations from us as there is so much crazy information out there, just the craziest stuff from all kinds of media. We have long-term relationships with our patients, so we are trusted sources for them. When we tell them how the vaccine works and that it is safe, they tend to believe us.

QQ Patient concerns are understandable. Do you hear concerns from other providers?

Calabrian: This can be part of the general hesitation about vaccines. There are some worrying figures about slow uptake or resistance to vaccines in people who work in nursing homes and acute care facilities. Fortunately, we haven’t seen much of this among rheumatologists. Even so, I am sure that some of our colleagues want to wait until other people are vaccinated because they fear that there is something we do not know yet, just to be on the safe side, because it was approved so quickly. We just need to constantly remind patients and providers that we firmly believe that vaccines are safe and have been around for a long time.

Winthrop: Let me add that several recent surveys have shown that a significant proportion of medical students and health workers in certain facilities are not interested in vaccination. We are also seeing outbreaks occurring in health care facilities, including transmission from health care workers to patients. Think about the liability of a health worker who refuses the vaccination and then passes the disease on to a patient. The asymptomatic transmission of this virus is extremely difficult, so that many broadcasters would otherwise not know that they are at risk for their environment.

But now that we have vaccines, we need to address the question of whether workplaces, hospitals, or other health care facilities can make vaccinations mandatory. Or when there is a health care worker who refuses vaccination in order to reassign that person to another job that does not involve patient care. There are many questions that need to be addressed in the near future.

QQ Are there any drug-specific issues that need to be considered?

Calabrian: The biggest concern concerns drugs like rituximab (Rituxan, Genentech), which break down B cells. If within 6 months you get a shot that uses up your B cells after a dose of rituximab, it may not do much. So, as rheumatologists, we really have to consider the timing. We need to ensure that our patients can be safely vaccinated without putting them at risk of life-threatening complications from vasculitis from not taking their medication. I am a member of the American College of Rheumatology’s COVID-19 Vaccine Task Force, and we will ponder such topics.

Winthrop: I would add that there are theoretical problems associated with other mechanisms of action. For example, it may be beneficial to stop taking a JAK inhibitor or methotrexate for a few weeks after vaccination, but this is not yet certain. We’re trying to extrapolate from other vaccines. We also need to consider the timing of other infusible and injectable materials. The fact that these vaccines are two doses definitely makes it difficult to timing out DMARDs to potentially improve the vaccine response.

QQ Imagine a COVID-19 vaccine would need an annual dose like a flu shot?

Calabrian: We do not know yet. There will be ongoing analysis of the experimental data and beyond to make this determination.

QQ Are some patients still concerned that the virus can be transmitted after vaccination?

Winthrop: This is more of a scientific or public health problem. Most patients seem to understand that when they are protected, they are protected. However, we’re trying to get the message across that until further notice, it is important to keep wearing masks and washing your hands.

QQ What other questions do you get from patients?

Winthrop: Patients want to know when they will be vaccinated or where they are on the “list”. Unfortunately, as far as I know, there is no “list”. We have ideas about who to go first – health workers, first responders, etc – but there are some differences in guidance at the federal level, and states are all doing their own thing right now. One problem is that we don’t have enough vaccine for everyone yet, so priorities need to be set. It’s complicated, confusing, sometimes controversial, and makes it difficult to get vaccines out quickly.

As we mentioned earlier, while it would be nice to break through this first tier of essential staff, unfortunately, not all are vaccinated. I think there is a great feeling to be waiting for the federal administration to change so that a more coordinated and efficient approach to vaccine distribution can be taken. Ultimately, we are waiting for more vaccines to hit the market. When we have three or four or more products available, we can keep distributing them and do so on a mass scale without being complicated by the need to prioritize the limited supply.

For more informations:

Cassandra Calabrese, DO, can be reached at 9500 Euclid Ave., Desk A50, Cleveland, OH 44195; Email: calabrc@ccf.org.

Kevin L. Winthrop, MD, accessible at 270 Southwest Pavilion Loop OHSU Medical Pavilion, Suite 320, Portland, OR 97239; Email: winthrop@ohsu.edu.

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