Milan, April 19 (beraking latest news Salute) – In the beginning there were allergic reactions, the first rare adverse effect that ended up in the spotlight with the start of anti-Covid vaccinations. One of the first studies on the subject, published in February in ‘Jama Insights’ on Pfizer / BioNTech and Moderna mRna vaccines, censored the reports of these events in the United States from December 14 to January 18. And one figure stood out: out of 47 anaphylaxis reported post Pfizer (reporting rate of 4.7 cases per million doses administered) 44 – ie 94% – had occurred in women; 19 such events reported post-Modern (reporting rate of 2.5 cases per million doses administered), 100% women.
Then the rare thrombosis associated with low platelet levels, reported after vaccination with AstraZeneca, came under the spotlight. The European Medicines Agency Ema, in reporting on April 7 in a note the outcome of the evaluations of the Prac Pharmacovigilance Committee, spoke of “most cases reported in women under 60 years of age within 2 weeks of vaccination” , even admitting that it is not possible to identify with certainty at the moment a risk factor in age and sex. Subsequently, the data on rare thrombosis reported post J&J vaccine arrived from the USA: 6 cases (out of almost 7 million vaccinations), all involving women between 18 and 48 years old.
“What we are seeing strongly” with Covid-19 and with the mass immunization in which the world is engaged “shines a light on a historic problem: it highlights how much they weigh in the world of drugs and notoriously on vaccines, and in general about diseases, gender differences. Perhaps if we consider these differences more, starting with scientific studies, we could first catch some warning signs “. This is the vision expressed at beraking latest news Salute by two Italian scientists based in Zurich, Switzerland, who have been fighting for some time to raise awareness of the ‘pink factor’: Antonella Santuccione Chadha, doctor, clinical pathologist, neuroscience expert and of brain diseases, and Maria Teresa Ferretti, degree in Chemistry and Pharmaceutical Technologies, expert in Alzheimer’s and gender medicine.
Both are co-founders of the non-profit organization ‘Women’s Brain Project’ (Wbp) and have written a book, ‘A girl without a head’, dedicated to the theme of gender difference within the world of mental and neurological diseases. . The book will also be presented in Italy, on an important occasion, an online meeting organized by Ebri to celebrate the birth day of the Nobel Rita Levi Montalcini (April 22), who passed away in 2012. The event, ‘Writing about the brain with the heart ‘, is scheduled for April 23 at 18.30 and dedicated to the book of the two authors. “An emotion”, comments Santuccione Chadha.
In the book, the personal story of Antonella, a doctor in the psychiatric hospital of the University of Zurich, is intertwined with 9 stories freely inspired by clinical cases. With strong autobiographical hints and the red thread of a dialogue between two scientist friends, the authors propose a journey of knowledge. There is talk of diseases of the mind, but the reflection also embraces Covid-19. “It seems that a pandemic was needed to realize that sex and gender differences actually play a fundamental role, not only in infections, but in medicine as a whole,” writes Santuccione Chadha.
With Sars-CoV-2 it was seen that “women, although they represent the majority of health personnel facing Covid-19 on the front line, get less severely ill than men, and die even less”. Then the vaccines also highlighted the importance of looking at the differences. “The world has awakened and we are no longer Don Quixote,” Santuccione Chadha observes. “We know that the female immune system is activated more in response to any vaccine, and we also see this on side effects and adverse events, and it is very important to study and investigate all this. We have set up a working group, a small task force of scientists, which is working on this for anti-Covid vaccines “.
“We did a job – says Ferretti – by going to see the studies that have been published in the scientific literature on the 4 approved vaccines and also the works on which the regulators have been based, in particular the US Fda, the European Ema, the Canadian Health Canada, to approve these drugs. We found that, in fact, in the data reviewed by the agencies there is nowhere in their reports a separate analysis of the drug’s safety for men and women. It does not mean that 100% this analysis has not been done, but it has certainly not been published, it is information that is not found in the documents and we are writing an article to raise the problem “.
“Perhaps – Ferretti points out – if this type of data were always highlighted, if it were a point on the agenda, if it were structurally integrated into the approval process of a drug, some of these cases that now seem rare to us it would have been easier to spot them, especially in these young women. Vaccines have also highlighted another common problem with drug approval and it is: What do you do with pregnant and breastfeeding women, now excluded from all trials? we design the study, we could think of doing a sub-study in parallel or a post-approval register on this population, to ensure that when a vaccine is approved it is ready for everyone “.
A very critical chapter is that of pregnant women, especially in terms of drugs in use for psychiatric diseases. We have women who stop taking drugs when they discover they are pregnant, others who develop problems with the belly and often do not have drugs to treat them . There is a lack of knowledge for these populations, “Ferretti observes. On this issue of attention to gender differences “we are initiating an interview with the regulatory bodies. There was a first round table and we will continue along this path. Perhaps the recommendations should be strengthened or or it should be made mandatory that for the approval of a drug, these data should be monitored carefully and with a critical eye “.
“This type of analysis – echoes Santuccione Chadha – should be done systematically and considered when a drug is approved”. “It is not certain – Ferretti says – that in cases like those we are seeing with vaccines, everything should be stopped. It would be enough to be more careful. And doing this type of study allows us to prepare”. Precision medicine, Santuccione Chadha concludes in the book, “will only be achieved when the concept of ‘differences’ between patients, which to date continues to divide, will be supplanted by the concept of characteristics relating to each of us, making us unique and unrepeatable”.