International survey confirms short-term safety of vaccines… : Neurology Today

Article in brief

A muscle and nerve A study has found that COVID-19 vaccines are safe for people with idiopathic inflammatory myopathies and other systemic autoimmune and inflammatory disorders.

A study based on self-reported surveys from multiple countries provides further confirmation that COVID-19 vaccines are safe for patients with autoimmune disease.

The latest study focused on people with idiopathic inflammatory myopathies (IIM) and other systemic autoimmune and inflammatory disorders (SAIDS) who responded to an online survey to find out if they had experienced any related adverse events to the vaccine (ADE) within seven days of their vaccination against COVID -19.

The international survey found that ADEs were comparable in people with IMI, other SAIDs, and healthy controls, except for a higher risk of rashes in people with IMI. The findings should reassure patients, clinicians and public health officials who, nearly three years into the COVID pandemic, still face questions and debates about the safety of COVID vaccines and recalls. -19.

“Our study adds to the growing body of evidence indicating that the benefit of preventing severe COVID-19 through vaccination in SAIDS, particularly in IMI, likely outweighs the risk of adverse events post-vaccination. “said the study’s lead author, Latika Gupta, MD. , DM, from the Department of Rheumatology at the Royal Wolverhampton Hospitals NHS Trust in England.

General information about the study, published online July 23 in muscle and nerve, noted that while several studies have demonstrated the safety and effectiveness of COVID-19 vaccines in the general population, little information is available on certain patient populations, including people with IBD and other AIDS patients. and those taking immunosuppressive drugs, in part because they weren’t included in vaccine studies. This lack of information can be a factor of reluctance to vaccination.

“An interaction between underlying autoimmunity and dysregulated immune pathways, compounded by the effect of immunosuppressive drugs and potentially affected by comorbid disease, may predispose IMD patients to an increased risk of post-vaccination IMD, including allergic reactions, anaphylaxis, and disease flares,” the study authors wrote, adding, “Concerns have recently emerged that adjuvants and immune activators in vaccines induce self-induced disease flares. immune and de novo immune thrombotic and demyelinating events.

Given these issues, there is a “need for evidence-based vaccine safety data with appropriate characterization of post-vaccination adverse effects to potentially improve vaccination rates in patients with IBD, a vulnerable patient group” .

Inquiry Details

Researchers used a 36-question electronic survey to collect demographic details, SAID diagnosis, treatment details, current symptom status, history of COVID-19 infection including symptoms, duration and complications (based on Centers of Disease Control and Prevention criteria), immunization details, ADRs seven days post-vaccination, and patient-reported outcome measures, based on the system tool. information on the measurement of patient-reported outcomes.

The survey was tested, validated and translated into 18 languages ​​before being uploaded to the online platform surveymonkey.com and disseminated by the COVAD Study Group, made up of 110 physicians at health care centers in 94 countries, according to the newspaper. The survey was voluntary for patients, and all responses were retrieved for analysis on September 30, 2021. Of a total of 16,328 respondents, 2,866 had not received a single dose of COVID-19 vaccine at the time of survey. completion of the survey, and 2,562 did not complete the survey. These two groups were excluded from the analysis.

The 10,900 vaccinated respondents, 74% of whom were female, with a median age of 42, came mainly from Turkey, Mexico, India, the United Kingdom and the United States. Of the cohort used for analysis, 11.2% (1227) had IMIs, 42.6% (4640) had other SAIDs, and 46.2% (5033) were considered healthy controls. The most frequently reported AIDS was rheumatoid arthritis, followed by IMI and hyper/hypothyroidism. In the IIM group, 34% had dermatomyositis, 17% had polymyositis and 23% had inclusion body myositis.

The highest number of respondents received the Pfizer/BioNTech vaccine (39.8%), with 13% receiving the Oxford/AstraZeneca vaccine, 8% Moderna and 1% Johnson & Johnson, to name just a few of the vaccines available globally .

Of the IIM patients, 76.3% reported minor adverse effects (such as body aches, fatigue fever, chills, diarrhea) and 4.6% reported major adverse effects (such as anaphylaxis, difficulty breathing, closure of the throat, severe rash). All-cause hospitalization occurred in only 0.6% of vaccinated respondents.

Among other findings: Patients with active IBD were more likely to have AEs than those with inactive disease, and skin rashes were more common in IBD patients than in healthy controls.

“ADEs were not impacted by steroid dose, although hydroxychloroquine and intravenous/subcutaneous immunoglobulins were associated with a higher risk of minor ADEs,” the researchers reported. They noted that global ADRs were less common in inclusion body myositis and among those who received the Pfizer vaccine.

Since the study only looked at seven days after vaccination, Dr Gupta said his group was conducting a follow-up survey to explore long-term events after vaccination and disease flares. She said the expanded timeframe “will address additional questions not previously explored in the baseline survey, such as de novo the emergence of autoimmune diseases, the effects of booster doses of the vaccine and the specific risks of prenatal vaccination. The original survey was also conducted before the COVID booster was available, so that’s something the next survey will capture.

“More in-depth information on the effects of vaccination on the functional status and quality of life of patients with autoimmune diseases, in particular idiopathic inflammatory myopathies, as well as pregnant and breastfeeding women will also be acquired”, said Dr. Gupta.

The study had limitations, including the fact that it was based on self-reported information, which was not verified by medical records. The cohort is also a “convenience sample,” where low-income patients without internet access, severely disabled people, and deceased people are not represented, the researchers noted. People of African and African American descent are underrepresented. Another limitation is that the study only focused on short-term adverse effects and did not assess long-term outcomes and disease flares, which will be the focus of the follow-up study.

Reaffirm clinical practice

J. Robinson Singleton, MD, professor of neurology at the University of Utah and chief of neurology at the Salt Lake City Veterans Health System, said one of the limitations of the study was based on an investigation and not on a more scientifically rigorous method. — was also a positive, as it allowed researchers to easily gather information from several geographically diverse centers. Dr Singleton said the incidence of COVID-19 vaccine-related ADEs in people with IIM and other SAIDs is likely lower than reported in the study, as people could have been more susceptible to respond to the survey if they had had anything unfavorable.

“Of all the patients I care for in my neurology practice, patients with inflammatory myopathy have asked the most questions about the vaccine (COVID). ‘Is it safe, what vaccine to take and when is the best time to vaccinate it?’”—DR. CONRAD WEIHL

Figure 2

“Our study adds to the growing body of evidence indicating that the benefit of preventing severe COVID-19 through vaccination in SAIDS, particularly in IMI, likely outweighs the risk of adverse events post-vaccination. .”—DR. LATIKA GUPTA

Dr Singleton said the new study generally confirms what has been established in other studies and clinical experience – that COVID-19 vaccines are safe, even in people with compromised immune systems, whether due to of a disease or treatment.

“How many times do we have to demonstrate that the benefits outweigh the risks? ” he said.

Conrad Weihl, MD, PhD, professor of neurology and head of the neuromuscular division at Washington University School of Medicine in St. Louis, said IMIs are rare, making it difficult to gather enough cases to study safety. of the COVID vaccine in this population.

“Of all the patients I care for in my neurology practice, patients with inflammatory myopathy have asked the most questions about the vaccine (COVID). “Is it safe, which vaccine to take and when is the best time for the vaccine?” Dr. Weihl said.

He said there had been a theoretical concern that COVID vaccines using mRNA technology could increase muscle inflammation in these patients, because intramuscular injection of these types of vaccines triggers muscle cells to make the antigenic region of the COVID-19 spike protein, eliciting an antibody response. He said the concern likely led to vaccine hesitancy in some patients.

Dr. Weihl said the new study results, while not surprising, help confirm “that the public health guidelines we followed (to encourage patients to get vaccinated) did not had no negative effect on our patient population within seven days of getting the vaccine. These patients tolerated the vaccine very well. It’s reassuring. »

Disclosures

Dr. Weihl revealed that he received fees from Sarepta and Acceleron Pharma and consulting fees from Casma Therapeutics.

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