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Janssen vaccine. Photo supplied
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EMA: Almost a third of Covid vaccination side effects are severe

The reported suspected side effects for the four Covid vaccines, which have only been conditionally approved in the EU, are record-breaking after just 8 months. Serious side effects have been reported.

Published: September 14, 2021, 10:57 am

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    The European Medicines Agency EMA currently lists 904 534 personal suspected cases with a total of 3 478 979 individual side effects for the Covid vaccines (as of September 3, 2021). Almost a third of them are categorized as serious. Thus 262 383 of the 904 534 the cases are severe.

    The four Covid vaccines have only received limited approval and the final evaluation reports are not expected until the end of 2022 or 2023.

    In the EMA EudraVigilance database, the data for the following vaccines are listed:

    Covid-19 mRNA Vaccine Pfizer-Biontech (Tozinameran)

    Covid-19 Vaccine Astrazeneca (Chadoxi NCoV-19)

    Covid-19 mRNA Vaccine Moderna (CX-024414)

    Covid-19 Vaccine Janssen (AD26.CoV2.S)

    The total number of all suspected cases reported to the EMA increased by over 80 percent in the period May 29, 2021 to September 3, 2021. Contrary to some rumours, the majority of the reports are submitted by personnel from the health sector such as clinics or medical practices. With Biontech it is around 46 percent that are reported by EU medical practices or clinics.

    This speaks for a solid database. Added to this are the control and monitoring mechanisms of the EMA, which have been tried and tested over many years, in order to secure the best possible data sets.

    The reports are usually first sent to the national competent authorities (Germany PEI). These cases are often filtered and then reported to the EMA.

    What proportion do the reported suspected cases of Covid vaccinations make up in the EMA database?

    If one follows the information in the 2020 annual report, the 904 534 suspected Covid vaccination cases in the period of just 8 months from 2021 account for almost exactly 50 percent of the 1 821 211 suspected side effects of all 5 042 substances listed for drugs as well as vaccinations in 2020.

    That is incredibly high.

    France singles out Janssen’s product as a problem

    A “significant number” of injuries as a result of Janssen’s Covid-19 vaccine, which works with a single dose, has been noted in France, said the Medicines Agency (ANSM) on Monday, which said it would be carrying out more investigations.

    “A large number of cases of failure of the Janssen vaccine has been reported, with in particular serious forms (death, resuscitation) as well as an over-representation of patients vaccinated by Janssen in intensive care” in Marseille and Tours, noted the ANSM in its periodic vaccine surveillance report.

    Since April, around one million injections of this vaccine (the only one to be administered with a single dose) have been carried out in France. Among all these people vaccinated with Janssen, 32 cases of Covid-19 infection have so far been reported (a rate of 3,78 per 100 000).

    Of these 32 cases, 29 were serious and 4 deaths were recorded (people aged 73 to 87). For the 17 cases of infection where the variant was known, it was the Delta variant in each case.

    Hospitalized in intensive care despite vaccination

    In addition, two hospitals reported an unusually high number of patients vaccinated with Janssen among people hospitalized in intensive care despite vaccination.

    In Marseille, out of 7 patients who were fully vaccinated but still admitted to the ICU (that is to say seriously affected), 4 had been jabbed with Janssen. In Tours, this proportion was  50 percent.

    All these elements justify “additional investigations” to check whether the failures are more important with Janssen than with the other vaccines available in France.

    On August 24, the French National Authority for Health (HAS) recommended that people vaccinated with Janssen receive a booster dose with an mRNA vaccine (Pfizer or Moderna) from four weeks after their vaccination.

    Several real-life studies have indeed shown that the first dose of Pfizer or AstraZeneca vaccine provided insufficient protection. No data on this point is available for Janssen, but the HAS considered it likely that this is also the case.

    The risk/reward ratio of Covid-19 vaccines is appalling

    As the graphs in these tweet shows, there are no valid reasons for pursuing mass vaccination against Covid-19.

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