August 13, 2020

6 min read


Source/Disclosures



Disclosures:
Calabrese reports consulting for AbbVie and speaking for Sanofi-Regeneron. Kirchner and Offit report no relevant financial disclosures.

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Among the medical and media storylines that have surrounded the COVID-19 pandemic, the hunt for a vaccine has largely simmered in the background. Until recently, that is.

As multiple candidates enter phase 3 trials, the reality that a safe and effective product could be available at some point in 2021 is becoming increasingly likely. Rheumatologists, then, must prepare for a whole new rendition of the vaccine conversation with their patients.

As big pharma races after a COVID-19 vaccine, physicians are left in the difficult position of discussing risk/benefit to vulnerable patients. Source: Adobe Stock

But even for Paul A. Offit, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, and one of the world’s foremost voices on vaccines, “increasingly likely” remains a far cry from reality.

“There is no COVID-19 vaccine as of yet,” Offit said in an interview with Healio Rheumatology. “Yes, it is important to explain the necessity of vaccination to patients, but, at the moment, it is difficult to know how to explain it.”

Paul A. Offit

Paul A. Offit

The first issue, for Offit, is that there are multiple vaccine types moving through clinical trials. While two of the candidates that have reached phase 3 — one from the Wuhan Institute of Biological Products and China National Pharmaceutical Group (Sinopharm) and one from the Chinese firm Sinovac — are inactivated vaccines, the leading U.S. product, mRNA-1273 from Moderna, utilizes an RNA-based approach. Other candidates are DNA-based or live-attenuated products.

“A recent ABC News poll showed that more than two-thirds of Americans said they would get the COVID vaccine, sight unseen,” Offit said. “That is amazing to me, that so many people are confident in a vaccine without knowing any of its characteristics, how many have received it safely, or what percent efficacy it had. I would probably be in the one-third group.”

It is because of this uncertainty that many clinicians are wary of having the conversation about a COVID-19 vaccine just yet. But that does not mean that clinicians should avoid the conversation, either.

“I don’t think the patient/vaccine relationship needs to be complicated,” Elizabeth Kirchner, MSN, CNP, of the department of rheumatologic and immunologic disease at the Cleveland Clinic, said in an interview. “Because of the nature of rheumatic disease, we are privileged to take care of our patients for years or, in some cases, decades. An open and honest dialogue about risks and benefits of any recommendation, including vaccines, is part of each visit.”

Elizabeth Kirchner, CNP, RN-BC

Elizabeth Kirchner

While Cassandra Calabrese, DO, also of the department of rheumatologic and immunologic disease at the Cleveland Clinic, expressed a similar sentiment, she is preparing herself for pushback even after a definitive COVID-19 vaccine becomes available. “Patients who have been hesitant about vaccines in the past are likely to remain so, at least in part because of the speed at which the COVID vaccines are being produced,” she said. “Those patients have said they definitely will not be first in line for a shot.”

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That said, Calabrese stressed that most of her patients have not expressed thoughts on a potential COVID-19 vaccine one way or the other.

Cassandra Calabrese

However, with influenza season approaching and the transition from virtual back to in-person visits nearly complete, the challenges presented by a COVID-19 vaccine may be just around the corner.

Upcoming Flu Season

A lurking concern among experts across the medical community is that COVID-19 will still be in full swing as flu season approaches. But Calabrese offered sound reason for optimism on this front. “Interestingly, it has been speculated that flu season may not be terrible this year — it may even be nearly nonexistent — because people are so engaged in infection prevention measures,” she said. “People are not flying, they are not traveling, they are wearing masks and washing their hands. So that may be one thing in our favor.”

Kirchner offered further evidence of the likelihood of this phenomenon. “Here in Ohio, we were having a particularly harsh flu season in terms of hospitalizations in 2019-2020,” she said. “However, that flu hospitalization rate plummeted in March as soon as the governor closed schools and the lockdown went into effect for COVID-19.”

Yet it remains to be seen whether this trend will continue through the end of 2020 and entering 2021. In short, Kirchner wondered if the U.S. will be able to “get our act together” on the aforementioned infection prevention measures. Given that most states have reopened and infection rates are spiking around the country, that is a big ‘if’.

That said, if there is one further bright spot pertaining to co-circulation of influenza and COVID-19, it is that fear of one or the other virus may make patients particularly motivated to get their flu shot, according to Calabrese. She suggested that this can help rheumatologists drive home the message that all vaccinations are of the “utmost importance.”

For Offit, a key issue is whether the flu shot and the potential COVID shot can be administered together safely. “Hopefully, there will be studies done to determine this,” he said.

Logistical Considerations

Clinical matters aside, many experts are at least as concerned about the logistics administering a COVID-19 vaccine as they are about efficacy and safety parameters. “One consideration is that, in all likelihood, the vaccine that emerges is going to be a two-dose series,” Offit said. However, it is unknown whether a COVID-19 vaccine will have a tight window for the second dose, or whether there will be flexibility.

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This is a consideration because rheumatology patients already have a fairly busy vaccination schedule. They are recommended to receive a two- or three-dose pneumococcal series, a two-dose herpes zoster series — which must be given within a tight 2-6-month window — plus an annual flu shot. The sheer number of visits required to administer all of these shots would be significant even during normal times.

The pandemic made keeping up with this schedule that much more difficult, according to Calabrese. “Many of our patients have lapsed these series deadlines due to the quarantine,” she said.

Kirchner highlighted another logistical consideration. “The day when a patient comes in for an infusion is probably not the best choice for vaccination, especially if their pre-medications include IV steroids,” she said.

It is with all of this in mind that Kirchner stressed organization. “I often give my patients a list of what vaccines they need and when I recommend they get them, and ask them to take the list to their local pharmacy so they can get vaccinated there. That way they do not have to wait for an appointment with me or risk falling behind on their recommended immunizations. And because Ohio has a statewide immunization registry, I can easily import that information into their chart.”

The final logistical consideration pertains to the path of the virus itself. From state to state, the U.S. is a patchwork of surges and flattened curves, re-openings and re-closings. This much uncertainty can breed fear, or at least caution, and keep many more patients out of the clinic than need be. In times like these, every visit and every conversation is critical.

Having the Conversation

Kirchner holds that until the product is in clinics and pharmacies, all conversations surrounding a COVID-19 vaccine remain hypothetical. But she is still considering how the vaccine may impact the doctor-patient relationship. “In terms of new approaches, I may encourage patients who are not willing or able to get their flu shots — and, if one becomes available, COVID-19 shots — to stick to virtual visits instead of coming in to be seen once flu season starts,” she said. “This would be for their protection as well as the protection of the other patients in the department. Of course, it would not be an absolute rule, just something to consider when the time comes.”

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For Calabrese, the myriad complications presented by COVID-19 underscore the important role physicians play in maintaining public health. “Messages are received most effectively when patients hear them from a trusted health care provider,” she said. “I just keep trying to explain to patients that it is important for them and their family members to get vaccinated.”

Looking at the bigger picture, Offit said that the efficacy and safety of whatever COVID-19 vaccine emerges is going to play a critical role in the future of public health worldwide.

“This plays out one of two ways,” he said. “The first is that vaccine or vaccines are very safe and effective. As we see them taken up, in concert with hygienic measures, the disease declines. At this point, vaccines are a hero.”

But there is also the potential for the opposite outcome. “We have little experience with mRNA and DNA vaccines,” he said. “The learning curve may be steep, and there may be side effects we have not anticipated. There may also be shorter term immunity than we thought. In this case, it could shake what is already a fragile confidence in the importance of vaccines.”

References:

For more information:

  • Cassandra Calabrese, DO, can be reached at 9500 Euclid Ave., Desk A50, Cleveland, OH 44195; email: [email protected].
  • Elizabeth Kirchner, MSN, CNP, can be reached at 9500 Euclid Ave., Desk A50, Cleveland, OH 44195; email: [email protected].
  • Paul A. Offit, MD, can be reached at 3401 Civic Center Blvd., Philadelphia, PA 19104-4399; email: [email protected].



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