The Pfizer vaccine against COVID-19 is effective and safe for people suffering from autoimmune inflammatory rheumatic diseases, according to a study by the Institute of Rheumatology at Ichilov Hospital.
Eighty-six percent of the patients who participated in the study, conducted in cooperation with Carmel and Hadassah hospitals, developed sufficient antibodies to protect them from the virus, and the prevalence and seriousness of side effects among them were similar to those in the general population.
Autoimmune inflammatory rheumatic diseases are a group of diseases characterized by abnormal immune responses in which the immune system attacks parts of the body itself. These include ailments of the musculoskeletal system, bones, tendons, joints, blood vessels, skeleton and internal organs.
The study ended three weeks ago with 686 participants (475 women and 211 men) who suffered from various autoimmune ailments, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis (arthritis of the spinal joints), lupus, myositis (a group of diseases that cause muscle inflammation and degeneration of muscle tissue), and vasculitis (inflammation of blood vessels).
The researchers sought to evaluate the safety of the vaccine, its effectiveness in terms of producing antibodies and its effect, if any, on the chronic illness they suffered from. They followed the condition of participants for a month after they had received the second dose of the vaccine. The findings were compared to a control group of 120 healthy individuals. The findings showed that antibodies were generated in 100 percent of the healthy individuals, compared to 86 percent of those suffering from the chronic conditions. Fourteen percent of the ill group did not produce sufficient antibodies.
According to Prof. Ori Elkayam, director of the rheumatology institute and the study’s leader, most of the participants who did not respond to the vaccine were taking the drug Mabthera, a drug used to treat rheumatoid arthritis, which has a side effect of reducing white blood cells, which are responsible for, among other things, the creation of antibodies and boosting immunity to infections. “It’s logical, something that is familiar to us from other vaccines,” she said.
There were a few unusual developments among patients who got the vaccine; there were six cases of herpes zoster (shingles); one case of perimyocarditis, and two cases of eye infections. The researchers noted that common immediate side effects of the vaccine, like pain and redness where the vaccine was administered or fever, were less common among the patients than among the healthy people in the control group.
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The study also found that biological treatments against inflammation, like TNF-Alpha inhibitors and cytokine inhibitors, which many sufferers of these diseases use, did not undermine the immune response against the coronavirus. Moreover, Elkayam said, “For most of the patients the vaccine did not cause any aggravation or eruption of their underlying illness.”
No patients with autoimmune inflammatory rheumatic diseases or any other patients with suppressed immunity were included in Pfizer’s clinical trials so as not to skew the results.
When the vaccination campaign was launched in Israel, the question arose as to whether people suffering from these diseases should receive the shot and under which conditions. In December the Israeli Society of Rheumatology issued a position paper calling for giving the vaccine to those with autoimmune inflammatory rheumatic diseases. The experts stated then, in recommendations adopted by the Health Ministry coronavirus vaccine committee, that vaccinating such patients with mRNA-based vaccines should be viewed positively, but stressed that each case must be weighed individually.
“When the vaccines began there was uncertainty about these groups of patients and how it might impact their chronic illnesses. Some of the doctors feared the vaccine could cause an eruption of the patients’ autoimmune conditions,” said Elkayam. “On the other hand, testimonies were accumulating that at least some of these patients, when infected with the coronavirus, developed more serious illnesses. The findings of our study show that these patients can be wholeheartedly vaccinated.”