3,631 reports of miscarriages and fetal deaths in Europe

More Pagina UM (Portugal) reporting on the genetic COVID vaccine adverse reactions

Machine Translated. Reprinted by permission.

PÁGINA UM (Portugal), Reported by Pedro Almeida Vieira on February 13, 2023

EXCLUSIVE: ADVERSE REACTIONS OF VACCINES AGAINST COVID-19

There are already 3,631 reports of miscarriages and fetal deaths in Europe. Isn't it time to talk to pregnant women yet?

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PAGE ONE (Pagina UM) scoured thousands and thousands of records of adverse reactions to vaccines against covid-19 in pregnant women. Despite the widespread obscurantism, which makes statistical analyzes difficult and does not even allow calculating the incidence, the PAGE UM survey found the existence of more than 5,300 cases of reactions considered serious, including 3,385 abortions and 246 fetal deaths. Vaccination of pregnant women, carried out on a massive scale, was not preceded by clinical trials and the European Medicines Agency wrote last December that it is still in the monitoring process, but not a word about the thousands of cases already notified in the database of the EudraVigilance. Here in Portugal, Infarmed does not say a word about the subject, preferring to fight in the Administrative Court of Lisbon for the maintenance of obscurantism. Isn't it time to talk with and about pregnant women?

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Pharmacovigilance, according to the concept defined by Infarmed, “aims to improve the safety of medicines, in defense of the user and Public Health, through the detection, evaluation and prevention of adverse reactions to medication(s)”. And for that, the national regulator, chaired by Rui Santos Ivo, has a National Pharmacovigilance System to “monitor[r] the safety of medicines with authorization for introduction on the national market, assessing any problems related to adverse reactions to medicines and implementing security measures where necessary.”

Thus, in principle, we should be reassured when, reading the most recent Pharmacovigilance Report on the monitoring of the safety of vaccines against covid-19 in Portugal, regarding the data received until the end of 2022, it is guaranteed that “several studies prove that the vaccines against covid-19 are safe and effective”. It is true that, later on, figures on adverse reactions appear, with 8,518 reports classifying them as serious, indicating that 886 also led to hospitalization, 309 were life-threatening and there were even 143 deaths. Infarmed, in the latter case, only indicates the median (72 years), which means that it does not accurately inform the age of the victims.

For a disease to which a little more than 26,000 deaths are already attributed in Portugal alone, terms such as “secondary effect” of vaccines, “friendly fire”, 143 deaths, could even be socially acceptable. Even more so if what epidemiologists like Henrique Barros assert were true: that in 2021 vaccines “saved” 2,300 lives, and that by the end of 2022, there were already 12,000 lives. But concrete studies of these miracles, no one has ever publicly seen them.

In fact, there are still strong doubts about the rigor and accuracy of the Infarmed report. The gaps and the biased way in which the numerical data are presented prove to be more serpentine than the medicine inserts written by the pharmaceutical companies and authorized by the regulator.

Indeed, neither in the others nor in this most recent Infarmed report – which is announced to be the last, in an attempt to bury controversies, claiming that there is already “a more robust knowledge of the safety profile of these vaccines”, the which is a criminal falsehood – a single reference to “pregnant women”, “abortion” or “fetal death”. It could be the case that, finally, it is an irrelevant question. It is not, on the contrary: it has been exclusively in the phase of pharmacovigilance that the adverse effects of drugs on pregnant women and fetuses can be observed.

As mentioned in the introduction to a recent review article in the scientific journal Obstetrics, suggestively titled “Covid-19 vaccination in pregnancy: need for global pharmaco-vigilance”, for “ethical reasons, clinical trials could not be conducted to study the effects of the vaccine against covid-19 during pregnancy”. Thus, despite the fact that the authors of the article are even in favor of vaccinating pregnant women, they do not present any cost-benefit analysis and admit that mass vaccination began with safety information coming only from a few women who participated in the trials without knowing their state.

For all this, it can only, at the very least, be strange that Infarmed does not expressly clarify – this will be, one would hope, its function – whether or not cases of abortions and fetal deaths associated with vaccines against covid-19 have been reported. 19 in Portugal. But there is not a single line. A zero. Anything.

And there will be. There can only be. Statistically, with around 5 million pregnancies per year in the European Economic Area – already including those that are not completed –, only a strange miracle would prevent serious adverse reactions associated with vaccines against covid-19 from being reported in pregnant women on Portuguese soil, because Portugal accounts for 2% of all births (and pregnancies) in this European region. Therefore, it would be sensible to admit that 2% of pregnancies will correspond to 2% of serious adverse reactions, or values not far from this; unless, of course, there are miracles.

Number of serious adverse reactions per year (2023 only until the first week of February) in the European Economic Area by type of vaccine. Source: EudraVigilance.

Analysis: PAGE ONE.

And it is evidence that these serious reactions exist, because they have been reported. In fact, according to an exhaustive analysis carried out by PÁGINA UM of all notifications received from 2021 until the first week of February this year by Eudravigilance – the system that receives notifications, and validates them, about the adverse effects of different drugs – , there are a total of 5,336 cases considered serious of adverse reactions associated with the various covid-19 vaccines during pregnancy, puerperium and perinatal conditions. These numbers include the countries of the European Union and also Norway, Iceland and Liechtenstein.

It should be noted that, as a rule, the insertion of these notifications of cases classified as serious (serious, in the terminology used by the EMA) is done by health professionals and, in most cases, by the pharmaceutical companies themselves. That is, there is clinical evidence for a very strong suspicion of an adverse reaction caused by vaccines against covid-19, and not a mere casual relationship, not a mere coincidence.

At the European level, according to EMA data, the year 2021 was the year with the highest number of serious cases, with a total of 3,020, almost all from March, as the elderly were a priority in the first phase of vaccination programs in most European countries. In Eudravigilance, therefore, there are only 27 records of serious adverse reactions in January and February 2021. But even though there are already serious adverse reactions, it was decided to go for a massive vaccination of pregnant women never seen before.

It should be noted that, in June 2022, a scientific review and meta-analysis article published in the American Journal of Emergency Medicine concluded that, although there is an increased risk of hospitalization in intensive care units and ventilation in case of covid-19 infection, the mortality rate in pregnant women was not statistically higher compared to non-pregnant women.

In 2022, the number of serious adverse reactions in pregnant women dropped to 2,244, ignoring whether this was due to a lower number of vaccines administered in this specific group. This year there were only 72 cases, which may indicate that the number until December will be much lower than in previous years, but it is not yet known whether this is due to the much smaller number of pregnant women wanting to be vaccinated or to the better safety profile of bivalent vaccines.

As with everything that has been seen in this vaccination process, a lot of information is still being collected, it seems that we are witnessing a mega-clinical trial in real time to find out if everything is going well or not.

At European level, according to EMA data, the year 2021 was the year with the highest number of serious cases, with a total of 3,020, almost all from March, as the elderly were a priority in the first phase of vaccination programs in most European countries. In Eudravigilance, therefore, there are only 27 records of serious adverse reactions in January and February 2021. But even though there are already serious adverse reactions, it was decided to go for a massive vaccination of pregnant women never seen before.

It should be noted that, in June 2022, a scientific review and meta-analysis article published in the American Journal of Emergency Medicine concluded that, although there is an increased risk of hospitalization in intensive care units and ventilation in case of covid-19 infection, the mortality rate in pregnant women was not statistically higher compared to non-pregnant women.

In 2022, the number of serious adverse reactions in pregnant women dropped to 2,244, ignoring whether this was due to a lower number of vaccines administered in this specific group. This year there were only 72 cases, which may indicate that the number until December will be much lower than in previous years, but it is not yet known whether this is due to the much smaller number of pregnant women wanting to be vaccinated or to the better safety profile of bivalent vaccines.

As with everything that has been seen in this vaccination process, a lot of information is still being collected, it seems that we are witnessing a mega-clinical trial in real time to find out if everything is going well or not.

Number of abortions and fetal deaths per year (2023 only until the first week of February) in the European Economic Area by type of vaccine. Source: EudraVigilance.

Analysis: PAGE ONE.

This absolute evolution of severe cases has little meaning even for tracing the safety profile of vaccines against covid-19 in pregnant women, in general, and of the different brands, in particular. No information can be found at the EMA or any other European organization on the number of doses administered to pregnant women per year, much less the numbers per brand. The lack of information is intentional: this makes it impossible to calculate the incidence of serious effects.

The European regulator's safety report of last December 8 dedicates a brief final reference to pregnant women in a single sentence, by the way the last of a nine-page text: “Furthermore, the EMA is coordinating observational studies in the Member States , analyzing real-world data from clinical practice to monitor the safety and efficacy of COVID-19 vaccines, including in pregnant women” [“In addition, EMA is coordinating observational studies in EU Member States looking at real-world data from clinical practice to monitor the safety and effectiveness of COVID-19 vaccines, including in pregnant women”].

This lapidary sentence, full of nothing but uncertainty, written two years after the start of vaccination, says a lot, or too much, of the blind way in which the doses were administered to pregnant women – even more so without ever showing that these were a particularly at risk group, not least because the generality is young and healthy.

For this reason, it is misleading even to directly compare the number of adverse reactions between different pharmaceuticals. For example, although Pfizer's vaccines, especially the first one (Tozinameran), are suspected of causing 3,297 serious adverse reactions (62% of the total), their safety profile may even be better than that of other vaccines, since that 73.3% of all nearly 934 million doses administered in the European Economic Area were from this US drugmaker. Furthermore, it would be necessary to know specifically the number of pregnant women who took each of the vaccines, and in what years, as well as their ages and health conditions, confronting the incidence of adverse reactions.

Even with this absurd lack of information – and the pregnant women themselves will be even more ignorant – it is astonishing to observe that the AstraZeneca vaccine caused 756 serious adverse reactions in this group of women. This is knowing that only 68.8 million doses were administered in all ages (never the smallest), a value that contrasts with the 685 million doses of Pfizer (almost 10 times more) and the 161 million doses of Moderna ( 134% more overall, but “only” 50% more serious adverse reactions in pregnant women).

In short, the brand of vaccine administered will not have been indifferent to pregnant women, from the point of view of risk. Did the pregnant women (and other people) know? No. Were they given a choice? No.

The range of serious reactions detected by PAGE UM in the EudraVigilance database is vast and not always easy to catalogue. However, in the case of pregnant women, in addition to the risk of their own death, the most serious of the serious adverse effects reported in the EMA seems obvious: the death of the “child” in formation, or technically, the fetus.

And then, despite the Portuguese regulator chaired by Rui Santos Ivo – who, since December 2021, has been fighting tenaciously, now in the Administrative Court, not to give PÁGINA UM the administrative data of the RAM Portal with anonymized information – does not even deign to do reference to adverse reactions in pregnant women and fetuses (perhaps because it considers them without legal personality), and the EMA postponed the matter to the calends, the Eudravigilance records show the cold numbers of lives lost.

According to PÁGINA UM's individual analysis of the 5,336 serious reactions in pregnant women since 2021 – the Eudravigilance database only allows a summary of notifications to be downloaded in spreadsheet format –, 3,385 abortions appear (the overwhelming majority with the indication of being spontaneous) and 246 more fetal deaths since January 2021. Distribution by country is ignored.

More than two out of three serious adverse reactions (68%) in pregnant women thus resulted in the loss of the child – let's call it that for dignity. Also here, 2021 was the worst year, with records of 2,039 abortions and 144 fetal deaths.

The weight in the total number of reactions considered serious was, however, higher (72%) than the average. In 2022, that percentage dropped to 62%, that is, 1,305 abortions and 96 fetal deaths were reported for a total of 2,244 serious cases. This year still has few cases to draw a trend, but the proportion is, for now, close to that of previous years.

Once again, as mentioned for total severe cases, it is not possible to assess any sign of the safety profile of each of the vaccines, but it seems that there are significant differences. On the other hand, apparently, the decrease in deaths of children before birth between 2021 and 2022 should be more associated with a lower demand for reinforcements in this second year than with an improvement in safety. However, it is reiterated: without the availability of reliable data, speculation will always remain.

If speculation is not advisable, the lack of data – due to the intentional obscurantism of public entities and the Ministry of Health – should also not cause a complete absence of debate. And one thing seems so clear: with the figures for abortions and fetal deaths in the countries of the European Economic Area, it will be statistically impossible for pregnant Portuguese women not to have been affected by vaccines against covid-19.

Indeed, if we estimate the occurrence of 100,000 pregnancies per year in Portugal (a figure that already considers spontaneous abortions in natural conditions), it means that our country has a weight of around 2% in total pregnancies in the European Economic Area . Now, if that weight is applied to all adverse effects, then in Portugal there will have already been 108 serious cases of adverse reactions in pregnant women, of which 61 in 2021, plus 46 last year and just one this year.

Considering the fatalities, it will then be assumed that – unless Santo Ivo, the patron saint of lawyers comes to argue with a miracle – have occurred 68 abortions and four fetal deaths in Portugal since 2021. Estimates can be made by pharmacists.

Can this number, in absolute terms, and from a strictly Public Health point of view, be considered an acceptable number? It depends. First, whatever that value may be, they are individual lives that were lost, dramas that were experienced.

Second, an essential question has to be asked: were these lost lives worth it or were they in vain? How many pregnant women were saved by this massive vaccination program for a group where there were no (and continue to be scarce) safety studies on vaccines against covid-19? How many deaths of pregnant women were there in Portugal from covid-19 before vaccines? Let it be said, but no lies.

And, above all, make this information available to pregnant women. Informed consent can only be exercised with information. Not with intentional omissions, not with deliberate obscurantism, not with outright falsehoods.

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PAGE ONE discloses the individual records (obviously anonymized) of the notifications since 2021 of the serious adverse effects of the Eudravigilance database, managed by the EMA, related to pregnant women. It was decided to group the data by pharmaceutical company, with each file containing all the records by year and by vaccine (three from Pfizer and three from Moderna). The Valneva and Sanofi / GlaxoSmithKline files were not included, since, as they are still little used, they do not yet account for serious adverse reactions. In column N of each spreadsheet there are direct links to the Eudravigilance database where the respective notification record can be consulted.

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