Vaccine for immunocompromised patients is safe and effective, says study by HC da USP – 11/06/2021 – Equilíbrio e Saúde

An unprecedented study by USP’s Hospital das Clínicas sheds light on a recent controversy and indicates that vaccination against Covid-19 in immunosuppressed patients is safe and produces a good immune response, attesting that these people not only can but should be vaccinated.

On the last day 1st, during testimony to Covid’s CPI, Dr. Nise Yamaguchi said that she could not be immunized against Covid for having an autoimmune disease. It was enough to cause a stir among patients and raise doubts about the safety of immunization in this group.

On the same day, the SBR (Brazilian Society of Rheumatology) issued a note in the opposite direction of the doctor’s speech, recommending that people with autoimmune diseases be vaccinated against Covid-19 — including all vasculitis, a disease of which Nise Yamaguchi says she is a carrier. The text only considers that the most appropriate time for immunization should be debated between the patient and his doctor.

The HC study followed 1,193 people with rheumatic diseases, including rheumatoid arthritis, vasculitis, lupus erythematosus, and patients with HIV. It also looked at another 492 people in a control group without any immunosuppressive disease.​

Blood samples for antibody identification were analyzed before and after six weeks of complete vaccination with Coronavac, produced in Brazil by the Butantan Institute.

One of the main objectives was to assess the safety of the vaccine in these patients, who may already be more prone to thrombosis.

“People can take the vaccine with peace of mind. We did not have any cases of moderate or severe side effects”, says Eloísa Bonfá, clinical director of the HC and coordinator of the research.

The adverse reactions observed, according to her, were mild and already foreseen in the package insert, and very similar to those of the control group.

The other objective was to know whether these immunosuppressed patients had a good immune response to the vaccine. In general, they already have a decrease in the immune defense inherent to the disease and still take drugs that cause a reduction in immunity.

According to Bonfá, it was expected that these individuals had a lower immune response to the vaccine compared to the control group, which actually happened. In the study, the serologies of a subgroup of 910 rheumatologic patients and 182 of the control group were compared in the sixth week after application of the complete vaccine scheme, showing seroconversion to IgG-type antibodies of 70.4% in immunosuppressed patients, against 95.5% in the group control.

The activity of neutralizing antibodies, necessary to prevent virus reinfection, was also verified. It was 56.3% for patients with autoimmune diseases and 79.3% for the control group.

Bonfá says that, although lower, the rates are within the standards established by the European and American regulatory agencies (EMA and FDA) and the WHO itself (World Health Organization), which are at least 50%.

“It’s significantly smaller, but it’s still a very good answer and it’s within the parameters set by WHO. It’s worth vaccinating. There is no doubt. And we are talking about HC patients, who have severe autoimmune diseases.”

Up to ten days after the first dose of the vaccine, 33 of the study participants had Covid. Another six were infected within ten days after the application of the second dose, that is, within the period of formation of the immunological response to vaccination. Four of these participants required hospitalization.

“This happened precisely at the peak of cases in São Paulo, in April. The patients, despite being immunosuppressed, had a reduction in cases after the second dose, despite the city experiencing a very significant increase in cases.”

The study also analyzed, among the confirmed cases of Covid, the identified variants and showed that 83% of infections were caused by the Gamma strain (P.1).

Other analyzes have shown that, in the period, 60% to 70% of infections in the general population were caused by this variant. “This shows that the vaccine was working for this new variant, otherwise we would not have had this reduction [de 33 casos para seis].”

According to Bonfá, the only type of vaccine that could cause any kind of concern among immunosuppressed patients is the live attenuated virus, which is not the case with any of the immunization agents used against Covid-19.

The survey of possible new cases of Covid-19 among the participants will continue to be carried out, as well as the analysis of variants. The idea is to evaluate the immunogenicity in the medium term, and in October the serologies will be re-evaluated.

For Bonfá, the vaccine is important for the individual patient and for the population because immunosuppressed individuals have difficulty “cleaning” the virus from the body, and this can predispose to the development of mutations. “The longer the virus stays in the individual, the greater the chance of having a mutation that will become very relevant.”

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