The “third dose yes or no” TOPIC for mRna vaccines is one of the hot topics of these days, because a decision will have to be made quickly. If you decide yes, it is very likely that among the first in line at the vaccination centers there will be the so-called “fragile” people. And, among these, some of the cancer and immunological patients being treated. Data on their response to the two doses of the vaccine are still scarce. The latest in chronological order come from the Immuno-Oncology Center (CIO) of the Sienese University Hospital, which investigated how the immune response to vaccination during therapy varies, and whether there are differences based on the anti- cancer used. Up European Journal of Cancer Michele May, director of the IOC, Maria Grazia Cusi e Anna Maria Di Giacomo report that, unlike those on immunotherapy – where the vaccine response is optimal in terms of antibody production – with chemotherapy vaccination does not always lead to a robust antibody response. “A fact – underline the authors – to keep in mind in view of a possible third dose in this particular group of patients”.
Now there is the confirmation: the double dose of vaccine protects against the disease
by Simone Valesini
Who responds least to the vaccine?
The study considered 131 patients: 70 treated with immunotherapy, 28 with chemotherapy, 23 with molecular target therapies and 10 with combination of target therapies and immunotherapy. In these groups, the production of antibodies underwent significant variations: “Patients treated with immunotherapy have a significantly higher average amount of antibodies than those treated with chemotherapy or target therapy, and even higher than that observed in healthy donors” , says Maio: “A possible explanation lies in the fact that immunotherapy, by removing the brake on the activity of the patient’s immune system, frees the defense cells to respond more strongly not only to the tumor but also to the Sars vaccine. Cov-2 “. On the contrary, the antibody response in patients treated with chemotherapy or target therapy was not so robust, probably due to the immunosuppressive effect of these therapies “.
Covid vaccine, third dose around the corner. Pregliasco: “It is necessary, the virus will remain for another three years”
by Donatella Zorzetto
Contradictory information
However, the data presented in another study conducted by researchers from the United States (from the Mays Cancer Center at UT Health San Antonio MD Anderson) and from Switzerland (from the Swiss Cancer Center Leman), published on Cancer Cell. Also in this case, 131 patients were considered, and as many as 94% developed an immune response after the second dose with mRna vaccines, as strong as that of the general population. For seven of them, however, the answer was not there: in particular they were people with haematological tumors, such as myeloma and Hodgkin’s lymphoma, or treated with rituximab, a monoclonal antibody used in the treatment of some haematological tumors and autoimmune diseases. . “The population studied that does not respond to vaccination is very particular, precisely because it is less sensitive to the immunological stimulation of vaccination. These results were therefore predictable, ”he explains Saverio Cinieri, elected president of the Italian Association of Medical Oncology (Aiom) and director of the Medical Oncology and Breast Unit of the ‘Perrino’ Hospital in Brindisi. But how to assess, patient by patient, if and when a third dose is needed? “This is still under discussion, not only in Italy, but all over the world, because it is not yet clear if the ‘count’ of anti-spike antibodies is a valid measure and there is no validated rapid method”, he replies. Cinieri.
What should someone who cannot get vaccinated do?
Who needs the third dose? The answer may soon come from an Italian studio
Clearer information could come from a large national study underway to evaluate the efficacy of mRna vaccines in the most fragile cancer patients, who have immunological diseases or who are taking immunosuppressive therapies. Is called Vax4Frail, is funded by the Ministry of Health and started several months ago, exactly when vaccination began, giving them priority. The results of the double dose effect for this particular category of patients will arrive by the summer. But not only that: if you decide to proceed with the third dose starting with these people, the study would allow you to quickly collect new data and verify whether it is really useful or not. Fundamental data, which are not found in the registration studies of pharmaceutical companies, where the percentage of patients with oncological and immunological diseases is usually negligible.
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The study involves 11 IRCCS institutes, including theSpallanzani National Institute of Infectious Diseases of Rome, which collects and analyzes all samples in a centralized way. The trial is coordinated by Giovanni Apolone scientific director of the National Cancer Institute of Milan, Alberto Mantovani, scientific director of the Humanitas Research Hospital of Rozzano, e Massimo Costantini, scientific director of the Institute of Advanced Technologies and Care Models in Oncology of the USL of Reggio Emilia. They also participate in the scientific committee Franco Locatelli, one of the leading experts in childhood hematological cancers and president of the Higher Health Council.
“When we started vaccinating so-called ‘ultrafragile’ people, who we think may be at particular risk of developing a severe form of the disease if infected, several centers were starting to do studies on the effectiveness of vaccines in this population, because they were starting to evidence emerged that above all the onco-haematological patients did not respond like the others, neither for the production of antibodies nor for the activation of the immunity mediated by lymphocytes “, explains Apolone:” We then decided to join forces and coordinate to make one single, centralized clinical study “.
600 patients, 12 groups
The study currently involves about 600 patients divided into 12 subgroups, not only oncology. All samples are sent to Spallanzani, which also analyzes the ability of the antibodies produced in response to the vaccine to neutralize the virus in the laboratory. It must be said, in fact, that the measurement of antibodies in the blood is not by itself a valid method to establish whether a person is protected from the virus or not: both because the tests used have different sensitivities, and because other components come into play in the immune response. . These investigations will instead try to understand if the antibodies produced are “neutralizing” and if they maintain this ability at different times within a year from the second dose, to also understand how the effectiveness of the vaccine changes over time. The first results will be available shortly, while it will be necessary to wait a little longer for the complete data, one year after the first vaccination.
Covid vaccine, third dose around the corner. Pregliasco: “It is necessary, the virus will remain for another three years”
by Donatella Zorzetto
Defenses seem to subside after 6-8 months
Some studies conducted to date, usually on small series, show that the defenses against the coronavirus begin to decline after 6-8 months from the second dose. And this is why we are thinking about the third. “For now we are collecting data on the effectiveness of the first and second dose but, by the time we start with the third, we will be ready to analyze the response of these patients and produce immediately transferable knowledge in a few months”, continues Apolone: ”We are in fact, to request a modification of the study protocol from the Italian Medicines Agency. Not only to evaluate the effectiveness of the possible third dose, but to include other categories of poorly studied cases, such as transplant patients “.
Vaccine, Crisanti: “Third dose? In a month we will understand from the data”. Rezza: “Still undecided, but probable for the most fragile”
The first study in transplant patients
On people who had transplants, a study conducted in France and published in the New England Journal of Medicine measured the effectiveness of the third dose in about 100 patients. The percentage of antibodies against Sars-Cov-2 was on average 4% before the second dose, 40% before the third dose and 68% at 4 weeks after the third dose. The people with the least response were the older or those severely immunosuppressed. At the time of the study’s publication (last June) none of them had contracted Covid-19 and no serious adverse events to the vaccine occurred.
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