Italy is also preparing to plan an extra dose of the anti-Covid vaccine: from the end of September for fragile patients, to improve protection against the coronavirus. In the meantime, however, data are being collected. And to understand who is really needed and when, in the United States, a phase 2 clinical trial is starting that involves in particular people with autoimmune diseases – a category that, data in hand, counts a number of cases of Covid-19 (and deaths ) significantly higher than the general population. The first results are expected in November 2021.
Vaccine, Ema: “The third non-urgent dose. Only for vulnerable patients”
Autoimmune Diseases, Coronavirus and Vaccine Response
According to data released by the US National Institute of Health (Nih), patients with autoimmune diseases have been hit hard by Covid-19: the rates of severe disease and death have been higher than those in the general population. However, for the moment experts are unable to attribute responsibility to the disease itself or to the immunosuppressive therapies used in their treatment, or whether it is attributable to both. Furthermore, a significant percentage of patients with autoimmune disease on immunosuppressive therapy did not respond or did not respond satisfactorily to the anti-Covid vaccination course with mRna vaccines or with Johnson & Johnson.
Vaccines: third dose for frail patients? Here is what data we have
by Tiziana Moriconi
I study
An unacceptable situation for the Niaid (Nih), whose director Anthony Fauci said he was determined to find ways to elicit a protective immune response to vaccines in this population. The study called ‘COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders’ goes in this direction, which aims to evaluate the antibody response to an extra dose of COVID-19 vaccine, also investigating the weight of immunosuppressive therapy in response development.
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Approximately 600 participants aged 18 and over will be involved, followed in 15-20 centers across the US. Patients have multiple sclerosis, pemphigus, rheumatoid arthritis, systemic sclerosis, and lupus erythematosus, and are taking immunosuppressive therapies such as mycophenolate mofetil (MMF) or mycophenolic acid (MPA), methotrexate (MTX), drugs that reduce B cells. developed an unsatisfactory immune response at the end of the anti-Covid vaccination course.
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The trial provides for the administration of an extra dose of vaccine, the same previously received, to all participants, who will then be divided into two groups at random: one group will be asked to continue their immunosuppressive therapy, the other to interrupt it for a short period of time to determine the percentage of participants who, four weeks after administration, will have a significantly better antibody response.
The patients will be followed for 13 months and the first results should be communicated in November 2021. The experts, however, are optimistic about the success of the extra dose of vaccine for immunosuppressed people, also the data that are coming from the trials – the latest published in the New England Journal of Medicine – with patients who have undergone an organ transplant and who are following immunosuppressive therapies, which see all immunological parameters improve.
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