In February 2021, the American College of Rheumatology (ACR) COVID-19 Vaccine Clinical Guidance Task Force developed recommendations for providers regarding the use of the COVID-19 vaccine and the management of patients with rheumatic and musculoskeletal diseases (RMDs) during vaccination.1 This “living” document was updated in March 2021 to reflect evolving evidence and updates. Overall, the task force suggested that patients with RMDs and autoimmune and inflammatory rheumatic diseases be prioritized for and receive vaccination against COVID-19 when available. They noted, “The benefit of COVID-19 vaccination for patients [with RMDs] outweighs the potential risk for new onset autoimmunity.”1

However, survey findings indicated the perspectives and fears of patients with autoimmune diseases in regard to receiving the COVID-19 vaccines; some patient concerns included the rapid rate of development and approval of the vaccines and the fear of disease flares and side effects.2,3

Further, immunocompromised patients developed additional concerns and questions in light of the news about blood clots with the AstraZeneca COVID-19 vaccine (now called Vaxzevria) and the Johnson & Johnson (J&J)’s Janssen COVID-19 vaccine.


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A few weeks ago, the European Medicine Agency (EMA)’s safety committee, Pharmacovigilance Risk Assessment Committee (PRAC), reported that the unusual blood clots with low blood platelets may be a very rare side effect of Vaxzevria, with the benefits of vaccination outweighing the risks for side effects.4 In addition, on April 20, 2021, J&J released a statement on their website based on the EMA PRAC approval on the overall positive benefit-risk profile of the J&J/Janssen COVID-19 vaccine.5

In the United States, following reports of rare but severe blood clots in 6 individuals who had received the J&J COVID-19 vaccine, the Centers for Disease Control (CDC) and the US Food and Drug Administration (FDA) recommended a pause in the administration of this vaccine. The CDC’s Advisory Committee on Immunization Practices (ACIP) noted that more information was needed about the J&J COVID-19 vaccine and the cases of blood clots before further action be taken.6

While the risk for severe COVID-19 and its related factors in rheumatic disease are still being investigated, the CDC recently updated their website to include the higher risk for COVID-19 among immunocompromised patients or those with weakened immune systems.7 Therefore, it is likely that the news of the recent J&J COVID-19 vaccine in the US brings up certain concerns and may be of significance to this population who have received and/or were intending to receive this particular vaccine, as well as those who were already hesitant about getting vaccinated against COVID-19.

We spoke — about the potential concerns of immunocompromised patients, vaccine hesitancy, and how providers can advise their patients about the J&J COVID-19 vaccine — with Allan Gibofsky, MD, attending physician at the Hospital for Special Surgery, New York, and professor of medicine at Weill Cornell Medicine, New York, and Michael Schweitz, MD, a longtime volunteer rheumatologist with the John Whelton Arthur Virshup CreakyJoints South Florida Arthritis Clinic, the past president of both the Coalition of State Rheumatology Organizations and the Florida Society of Rheumatology.

What Your Immunocompromised Patients Should Know About the J&J COVID-19 Vaccine

In an overarching statement intended for all providers and their patients, Dr Gibofsky noted, “For all the vaccines, including the J&J, the benefit of getting vaccinated significantly outweighs the risk to a patient in terms of an adverse event. The benefit includes a significant reduction in the risk of acquiring COVID-19, and there are reports suggesting that even if a vaccinated patient acquires COVID-19, the likelihood of getting significantly ill or hospitalized is reduced as well8; vaccination also reduces the risk of a vaccinated person transmitting COVID-19 to another individual. So despite what we’ve heard, the risk of not getting vaccinated, whether you are a patient or a healthy individual, far outweighs the benefit.”

Addressing Concerns of Immunocompromised Patients

In an interview with us, Dr Gibofsky said, “I think we have to put things in perspective. There have been 6, maybe 7, cases identified after approximately 8 million doses administered. So we’re literally talking about a 1 in a million chance [of these adverse events]. It is also not clear yet whether these events have occurred because of the J&J vaccine or in vaccinated people who may have other contributing factors. I don’t think we can say that there is a causal effect, we can only say that these events have occurred.”

“The risk is really quite low, given the incidence of these adverse events and the numbers of the J&J COVID-19 vaccine doses administered. Further, if you add the number of doses of the J&J vaccine to the number of doses administered of the Moderna and the Pfizer vaccines, the risk for an event like this is even more significantly lower in the grand scheme of things, further supporting the conclusion that the overwhelming benefit is for getting the vaccine,” he added.

To add to Dr Gibofsky’s comments, Dr Schweitz noted, “The biggest concern regarding immunocompromised patients with rheumatoid arthritis and other autoimmune diseases is getting the virus. The other concern is certain medications can blunt the antibody response to the vaccine; certain of our medications [are withheld in the] short-term to allow the body to respond efficiently to the vaccine.”

“Now with regard to the current issues of the rare clots and the more severe ones, including the cerebral venous sinus thrombosis that is associated with brain swelling, along with thrombocytopenia, we’re talking about a very serious problem, but also extremely rare. But it’s something that can’t be ignored,” he noted.

Dr Schweitz emphasized that the first goal is for patients to get vaccinated from a public health standpoint. He asks his patients not to assume that [blood clots] are a potential side effect of all COVID-19 vaccines since there are no clear data to suggest that, even with the J&J and AstraZeneca vaccines. Patients should be encouraged to seek alternatives to the J&J vaccine, practice patience, and wait for data to be released assessing the benefit-risk equation. To address current or potential vaccine hesitancy among immunocompromised patients regarding the J&J vaccine, providers need to stress the importance of the rarity of these adverse events related to the vaccine.

For individuals who have already received the J&J COVID-19 vaccine and “develop severe headache, abdominal pain, leg pain, or shortness of breath within 3 weeks after vaccination, [they] should contact their health care provider,” J&J stated. However, they also suggested that individuals who have received the J&J vaccine within the previous 3 weeks have a very low risk of developing the rare blood clot and it may decrease over time.9

What Does the Pause in Administration of the J&J Vaccine Mean?

Some experts believe that pausing the vaccine may lead to vaccine hesitancy and impact vaccine rollout in the US.10

Dr Gibofsky said he agreed with the joint decision by the CDC and FDA to pause the administration of the J&J COVID-19 vaccine6 until all data were assessed. “This pause demonstrates how seriously the clinical data are being reviewed, and may actually serve to reassure patients about the benefits vs risks of this specific vaccine and vaccination in general.”

On a similar note, Dr Schweitz said that this kind of review of data in a detailed fashion was appropriate for the J&J vaccine and is a “common mechanism” for identifying side effects of new drugs that were not discovered during the clinical trial phases.

“Fortunately there are alternatives to the J&J vaccine. So, increasing the supply of Pfizer and Moderna vaccines could help. Hopefully the J&J vaccine is a short-term pause,” Dr Schweitz also noted. “If data confirm that there is an association between these adverse events and the vaccine, then its use must and will be re-examined,” he concluded.

Disclosure: Dr Gibofsky declared affiliations with the pharmaceutical industry.

References

1. American College of Rheumatology. COVID-19 Vaccine Clinical Guidance Task Force. COVID-19 vaccine clinical guidance summary for patients with rheumatic and musculoskeletal diseases. American College of Rheumatology. Published February 8, 2021. Updated March 4, 2021. Accessed April 21, 2021. https://www.rheumatology.org/Portals/0/Files/COVID-19-Vaccine-Clinical-Guidance-Rheumatic-Diseases-Summary.pdf

2. Felten R, Dubois M, Ugarte-Gil MF, et al. Vaccination against COVID-19: Expectations and concerns of patients with autoimmune and rheumatic diseases. Lancet Rheumatol. Published online February 22, 2021. doi:10.1016/S2665-9913(21)00039-4

3. Boekel L, Hooijberg F, van Kempen ZLE, et al. Perspective of patients with autoimmune diseases on COVID-19 vaccination. Lancet Rheumatol. Published online February 22, 2021. doi:10.1016/S2665-9913(21)00037-0

4. European Medicines Agency. AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets. Published April 7, 2021. Accessed April 21, 2021. https://www.ema.europa.eu/en/news/astrazenecas-covid-19-vaccine-ema-finds-possible-link-very-rare-cases-unusual-blood-clots-low-blood

5. Johnson & Johnson. Johnson & Johnson COVID-19 vaccine roll-out to resume in Europe following European Medicines Agency (EMA) review. Published April 20, 2021. https://www.jnj.com/johnson-johnson-covid-19-vaccine-roll-out-to-resume-in-europe-following-european-medicines-agency-ema-reviewema-confirms-overall-benefit-risk-profile-remains-positive

6. Marks P, Schuchat A. Joint CDC and FDA statement on Johnson & Johnson COVID-19 vaccine. US Food and Drug Administration (FDA). Published April 13, 2021. Accessed April 21, 2021. https://www.fda.gov/news-events/press-announcements/joint-cdc-and-fda-statement-johnson-johnson-covid-19-vaccine

7. Centers for Disease Control and Prevention. People with certain medical conditions. Updated March 29, 2021. Accessed April 21, 2021. https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html

8.  British Medical Journal (BMJ). COVID-19: Single dose of Pfizer and Oxford vaccines cuts risk of hospital admission by 80% in over 80s, data suggest. BMJ. 2021;372:n612. doi:10.1136/bmj.n612

9. Johnson & Johnson (J&J). Johnson & Johnson statement on COVID-19 vaccine. Published April 13, 2021. Accessed April 22, 2021. https://www.jnj.com/johnson-johnson-statement-on-covid-19-vaccine

10. Linskey A, Diamond D, Pager T. Vaccine pause threatens to worsen ‘hesitancy’ problem. The Washington Post. Published April 14, 2021. Accessed April 22, 2021. https://www.washingtonpost.com/politics/vaccine-pause-hesitancy/2021/04/14/e2728742-9c7a-11eb-9d05-ae06f4529ece_story.html