COVID-19 Vaccines Safe in SSc, With Few Reported Flares, Survey Finds

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by Patricia Inacio PhD |

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People with systemic sclerosis (SSc) vaccinated for COVID-19 fare well, with no serious adverse events and a low rate of reported flares, according to an international survey.

“To our knowledge, this is the first large study that details experiences with COVID-19 vaccines in systemic sclerosis. Vaccination was safe in this group,” the researchers wrote.

The survey results were reported in “Systemic sclerosis and COVID-19 vaccines: a SPIN Cohort study,” published in the journal The Lancet Rheumatology.

Several vaccines have been developed against SARS-CoV-2, the virus that causes COVID-19. Initial clinical trials supporting the use of these vaccines enrolled only healthy individuals and so there is little information regarding their safety among people with autoimmune rheumatic disorders, such as SSc, also known as scleroderma. This may contribute to patients’ hesitancy in being vaccinated.

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In fact, a prior study, published in mid-2021, suggested that SSc patients might be more hesitant to get a COVID-19 vaccine than those with other rheumatic diseases.

To learn more, an international team led by researchers from the department of rheumatology at the Hospital for Special Surgery, in New York, evaluated the proportion of SSc patients enrolled in the Scleroderma Patient-centered Intervention Network, called SPIN, who were vaccinated against COVID-19. SPIN is an organization of researchers, healthcare providers, and people with SSc from around the world, which aims to develop strategies to help scleroderma patients better cope with and manage their condition.

In addition, the team investigated whether medications were altered before vaccination, as well as adverse reactions. The degree of vaccine hesitancy, and patients’ perceptions on vaccination, also were evaluated.

Participants in the SPIN group were invited to complete the COVID-19 vaccine survey, delivered by email. Responses were linked with their clinical and sociodemographic data.

A total of 932 (66%) of the 1,410 patients actively enrolled in SPIN completed the full survey and were included in the analyses. These patients, who had a mean age of 60, were mostly from the U.S., France, Canada, and the U.K., and 89% were women.

Results showed that 699 patients (75%) received at least one vaccine dose and 358 (38%) two vaccine doses.

Most received the Pfizer/BioNTech vaccine, followed by the vaccine from Moderna, and then the one from the University of Oxford/AstraZeneca. Other vaccines brands — Novavax, Johnson & Johnson, Sputnik V, and Convidicea (Ad5-nCoV) — were less commonly used. The vast majority of respondents had been vaccinated by mid-May of last year, or intended to be vaccinated.

Changes in medication among vaccinated patients were rare, occurring only in 42 patients (6%) before their first dose and in 28 patients (8%) before their second dose.

Adverse reactions following the first dose of the vaccine were reported by 270 patients (39%) and, after the second dose, by 209 participants (58%). The most common reaction was a sore arm, as reported by 30% of participants after the first dose and 45% after the second dose. Other common reactions were fatigue, as noted by 22% after the first dose and 40% after the second, and muscle ache — 9% first dose; 22% second dose. No severe reactions were reported.

Worsening of at least one SSc-related symptom was reported by 6% of participants after the first dose and 8% after the second.

After the first dose, factors linked with an adverse reaction — other than a sore arm — included age, being male, a history of COVID-19 infection, and taking the Oxford/AstraZeneca vaccine. The factors linked with adverse reactions after the second dose also included age and being male, as well as non-white race or ethnicity, being French, use of immunosuppressants, and having had the Moderna vaccine. The researchers noted that, for the second dose, only 21 patients received the Oxford/AstraZeneca vaccine.

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A total of 90 patients (10%) were classified as vaccine-hesitant. Being hesitant was linked with younger age — a mean age of 55 versus 60 for people vaccinated or willing to be vaccinated — as well as a history of COVID-19 infection (21%), and with being a current smoker (25%). Patients from France showed the highest hesitancy (16%), while those from the U.K had the lowest (3%).

The reasons for the hesitancy included doubts regarding vaccine effectiveness, the potential for adverse reactions, the development process of the vaccines, and the overall need for COVID-19 vaccination.

Compared with vaccine-hesitant patients, significantly more individuals who were vaccinated or were willing to be considered the vaccine a civic duty (74% vs. 13%). This group also rated information sources as important or very important — namely, recommendations by their doctors (80% vs. 50%) and the ability to discuss concerns with their doctor (74% vs. 62%) — more often than the vaccine-hesitant group.

In addition, vaccine-hesitant patients gave higher importance to having time to assess the long-term negative effects of the vaccine (80% vs. 59%) and to knowing the experiences of other SSc vaccinated people (64% vs 51%), as compared with those who were vaccinated or were willing to be.

“There is little information on the safety of COVID-19 vaccines in patients with autoimmune rheumatic diseases, and patient concerns about possible adverse outcomes in these diseases contribute to vaccine hesitancy,” the researchers wrote, adding that this survey suggests that the vaccine is “safe in this group.”

There were “no serious adverse events, a side-effect profile similar to that seen in other populations, and a low rate of reported systemic sclerosis flare,” they concluded.