Something moved after Sunday we hosted a document of the Critical Conscience University Teaching Group, contrary to the recommendations expressed by the health authorities, not only in our country, to indiscriminately vaccinate pregnant women at any time during pregnancy. These recommendations – as is well known – this summer presupposed a modification of the guidelines expressed up to June by those same authorities, initially cautious on the subject. The same caution that, for example, last year imposed on the producers of anti-Covid vaccines to exclude from trials pregnant and lactating women.
What scientific data was this international change of course based on?
The statements of public health managers at various levels have substantially supported two arguments:
1) the admissions to intensive care of some pregnant women affected by Covid;
2) the data accumulated by the Registry v-Safe of the Center for Disease Control and Prevention (CDC), the US public health supervisory body.
Let’s deal with the first point first. How big was the phenomenon when the guidelines changed in June? Undoubtedly differentiated according to geographic areas: the British – struggling with the “English” variant – reported 277 cases between September and March, but incredibly demeaned their research by recognizing that those data were invaluable, not having been able to calculate the percentage of women pregnant women with Covid in that period (!?!), as well as – we add – not having done one screeneng by ethnic groups, some of which are notoriously more exposed to complications in the case of Covid due to congenital vitamin deficiencies.
In Italy the situation was limited to a few units. If we calculate that in the 20 months of the pandemic in a basin such as that of the Monza and Brianza area (which has a Covid pregnancy ward at the S. Gerardo Hospital) we had 5 pregnant women hospitalized in intensive care, three of which are non-EU and therefore more at risk , out of an estimated order of approximately 10,000 pregnancies, one can understand how the problem could be further limited before June.
The INTERCOVID Multinational Cohort Study (7 Italian hospitals involved) had indeed warned that the risk of maternal mortality in pregnant women with Covid was 22 times greater than in non-infected women, but the reliability of this study was undermined by two serious limitations: half of the sample of pregnant women it was already at high risk (also for clinical history) regardless of Covid and finally the deaths were concentrated in countries with low health efficiency (Ghana, Macedonia, Egypt, Pakistan, Nigeria, India). There was no change instead compared to the rest of the population for asymptomatic pregnant women.
Therefore, with the exception of individual cases for which the vaccine would still constitute a necessary risk, if these were the proportions of the phenomenon, to speak of a health emergency would be completely out of place; to what other order of data did the Italian and international health authorities then resort to?
Likewise it cannot have been the Registry itself v-Safe of the CDC, the US public health supervisory body, to have inspired the certainty in the health authorities that there were no contraindications to recommending the vaccine at any gestational age. We say that we are aware, however, that precisely the data obtained from there (passive surveillance and on a voluntary basis, let us remember) have given way to a change of position in international and national medical and political organizations. It’s a pity that in the only validated scientific evaluation of those data (for the December-February quarter) published in the New England Journal of Medicine, the same team of researchers (Shimabukuro and others, June 17, 2021) has already defined it in the title Preliminary and he had to denounce its serious limitations by exposing himself to various criticisms and complaints from the editorial committee of the magazine for having ventured – even with these shortcomings – reassuring conclusions about the physiological course of pregnancy for those who had been vaccinated.
Even worse went to another group of researchers (Zauche et al, August ’21) who drew similar conclusions on a broader chronological basis (7 months) in the Registry. But when their preprint ended up on the Net were harshly challenged by colleagues and by the same women who volunteered for research (several of them had spontaneously aborted after being vaccinated and were never contacted by public officials: did they enter the account?) and had to subsequently point out all the shortcomings of their research. An editorial of the New England Journal of Medicine (June 17) he had photographed the situation in this way: unfortunately registered vaccinated pregnant women are only 4.7% of the total (and many of them may have been ignored, as we have seen in their comments). It is impossible to draw firm conclusions on such a small sample.
Even the heralded opinion of Joint Committee on Vaccination and Immunisation British (“there were no safety problems from any brand of vaccine in relation to pregnancy”, April ’21) was based on the limp American data and in any case recommended vaccination only for pregnant women at greater risk of serious outcomes from Covid, while he urged the others “to discuss the risks and benefits of vaccination with their doctor”. Exactly as the leaflets of the anti-Covid vaccines say. If anything, the Journal of the American Medical Association (Kharbanda, 8 September ’21) a few days ago highlighted a higher rate of spontaneous abortion in a group of vaccinated women between 16 and 24 years compared to those not vaccinated, but the reference basin still remains the sieve and deficient one of the American registry.
In conclusion: it could also be true that vaccination does not alter the physiological course of pregnancy, especially in the final semester, but if the data referred to so far are these, it is absolutely impossible to draw this conclusion, or others of opposite sign, therefore it would be better for the health authorities to maintain that caution that they inexplicably have instead abandoned out of the blue.
Just in these hours, the Higher Institute of Health has rectified the directive of this summer “vaccinating during pregnancy always and in any case!”, Limiting it to the final semester. Does this mean that the ideological hangover is finally giving way to a more realistic and honest evaluation of the data available, alas, still incomplete? It’s not for sure! But it is a step. Moreover, it is urgent to remove even the suspicion that the logics of organizational-health sustainability or, worse still, economic interests prevailed over the scientific ones.
PS A reader of the Subsidiary, specializing in Internal Medicine, Thomas Teatini, wrote to us contesting the correctness of the calculation made by the Critical Conscience University Teaching Group on the rate of spontaneous abortions in the first quarter of vaccinated pregnant women registered in the American Register: percentages “totally false” – he claims -, ” a deeply wrong methodological approach, which looks at the data not for what they say – perhaps we still don’t know enough – but to make them say something else, I would almost dare to say in an ideological way “. The reply from the Teaching Group defines that calculation resulting from the method that a Belgian researcher from Antwerp suggested as a correction to American scholars in a correspondence hosted on the New England Journal of Medicine, correction admitted by the interlocutors themselves. As if to say, in short, that the accusation – if it were founded – should if anything be turned to the authors of the research: “we certainly do not mean us first” – conclude the teachers – “to consider our estimate of an increase of over 80% as conclusive of the risk of miscarriage in the first twenty weeks, but emphasize how a today the data produced by the published observational studies are far from reassuring and indeed give rise to more than a few worries ”.
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