26 oktober 2022: zie ook dit artikel: https://kanker-actueel.nl/meer-ernstige-bijwerkingen-plus-16-procent-zoals-overlijden-en-chronische-invaliditeit-deden-zich-voor-tijdens-de-studies-van-de-mrna-vaccins-van-moderna-en-pfizer-in-vergelijking-met-de-placebogroep.html

26 oktober 2022: Bron: artsencollectief,  2022 Sep 22;40(40):5798-5805.

Uit een nieuwe studie analyse blijkt dat de kans op ernstige bijwerkingen door de mRNA vaccins van Pfizer en Moderna groter is dan dat een vaccinatie met een van de mRNA-vaccins voorkomen dat mensen in het ziekenhuis belanden door een coronavirus (Omikron-) besmetting. Het risico op een ernstige bijwerking is 1 op 800. Om te voorkomen in het ziekenhuis te belanden ligt het risico bij het Pfizervaccin op 1 op 5.000. Bij Moderna is dat 1 op 1.700. 

Het artsencollectief schreef er een kort artikel over met link naar de studie, zie onderaan abstract en referenties. Peter Doshi is o.a. hoofdredacteur van BMJ

Peter Doshi, professor farmacologie aan de universiteit van Maryland (USA) en editor van het gezaghebbende medische tijdschrift British Medical Journal vindt dat er reden is tot ernstige zorg om de veiligheid van mRNA vaccins, vooral bij mensen voor wie het risico van Covid-19 laag is.

Hij zegt dit in een interview met de Duitse televisiezender Mitteldeutsche Rundfunk (MDR) naar aanleiding van zijn onlangs gepubliceerde analyse van de oorspronkelijke Pfizer en Moderna trial data (1).

Een team van artsen en wetenschappers, waarvan hij zelf deel uitmaakte, berekende na grondige analyse dat het extra risico op een ernstige bijwerking in de trials door de mRNA vaccins één op 800 was, terwijl de preventie van ziekenhuisopnames door het virus ongeveer één op de 5.000 was bij Pfizer en één op de 1.700 bij Moderna. Daarmee was de stijging van ernstige bijwerkingen door de vaccins groter dan de vermindering van COVID-gerelateerde ziekenhuisopnames.

Geen enkele Amerikaanse televisiezender was geïnteresseerd om hem hierover te interviewen, evenmin als de grote Amerikaanse kranten.

Om het aantal van één op 800 gevaccineerden met een ernstige bijwerking gedurende de trials in perspectief te plaatsen, stelt Doshi dat dit bij andere vaccins één of twee gevallen per miljoen gevaccineerden was.

“Met dit aantal zijn in het verleden vaccins van de markt gehaald.”

Desgevraagd ziet Doshi geen rechtvaardiging voor verplichte vaccinatie, bijvoorbeeld voor bepaalde beroepsgroepen, vooral op grond van het gebrek aan overtuigende gegevens dat de vaccins de overdracht van het virus verminderen en epidemieën stoppen. Daarnaast pleit hij sterk voor het vrijgeven van de originele trialdata, waaruit de risico’s en de voordelen van de vaccins veel nauwkeuriger berekend kunnen worden.

Doshi denkt dat voor een steeds kleinere bevolkingsgroep geldt, dat de voordelen van de vaccins opwegen tegen de risico’s, zeker bij de huidige, milde virusvarianten, en dat de vaccins nauwelijks geschikt zijn om besmettingen te voorkomen.

Het volledige interview is hier terug te zien, met Nederlandse ondertiteling:

De originele Duitse uitzending is hier terug te zien.

Referentie:

  1. Fraiman J, Erviti J, Jones M, Greenland S, Whelan P, Kaplan RM, Doshi P. Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults. Vaccine. 2022 Sep 22;40(40):5798-5805. doi: 10.1016/j.vaccine.2022.08.036. Epub 2022 Aug 31. PMID: 36055877; PMCID: PMC9428332.

Abstract

Introduction

In 2020, prior to COVID-19 vaccine rollout, the Brighton Collaboration created a priority list, endorsed by the World Health Organization, of potential adverse events relevant to COVID-19 vaccines. We adapted the Brighton Collaboration list to evaluate serious adverse events of special interest observed in mRNA COVID-19 vaccine trials.

Methods

Secondary analysis of serious adverse events reported in the placebo-controlled, phase III randomized clinical trials of Pfizer and Moderna mRNA COVID-19 vaccines in adults (NCT04368728 and NCT04470427), focusing analysis on Brighton Collaboration adverse events of special interest.

Results

Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95 % CI −0.4 to 20.6 and −3.6 to 33.8), respectively. Combined, the mRNA vaccines were associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated (95 % CI 2.1 to 22.9); risk ratio 1.43 (95 % CI 1.07 to 1.92). The Pfizer trial exhibited a 36 % higher risk of serious adverse events in the vaccine group; risk difference 18.0 per 10,000 vaccinated (95 % CI 1.2 to 34.9); risk ratio 1.36 (95 % CI 1.02 to 1.83). The Moderna trial exhibited a 6 % higher risk of serious adverse events in the vaccine group: risk difference 7.1 per 10,000 (95 % CI –23.2 to 37.4); risk ratio 1.06 (95 % CI 0.84 to 1.33). Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients: risk difference 13.2 (95 % CI −3.2 to 29.6); risk ratio 1.16 (95 % CI 0.97 to 1.39).

Discussion

The excess risk of serious adverse events found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes. These analyses will require public release of participant level datasets.

Author contributions

All authors had full access to all of the data in the study (available at https://doi.org/10.5281/zenodo.6564402), and take responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: All authors.

Acquisition of data: Doshi.

Analysis and interpretation: All authors.

Statistical analysis: Jones, Greenland.

Drafting of the manuscript: Fraiman, Doshi.

Critical revision of the manuscript for important intellectual content: All authors.

Declaration of Competing Interest

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Acknowledgements

We thank Jean Rees for help identifying sources of data.

Funding

This study had no funding support.

Ethical review statement

This research was confirmed to be Not Human Subjects Research (NHSR) by University of Maryland, Baltimore (HP-00102561).

Conflicts of interest

JF, JE, MJ, SG, PW, RK: none to declare. PD has received travel funds from the European Respiratory Society (2012) and Uppsala Monitoring Center (2018); grants from the FDA (through University of Maryland M-CERSI; 2020), Laura and John Arnold Foundation (2017-22), American Association of Colleges of Pharmacy (2015), Patient-Centered Outcomes Research Institute (2014-16), Cochrane Methods Innovations Fund (2016-18), and UK National Institute for Health Research (2011-14); was an unpaid IMEDS steering committee member at the Reagan-Udall Foundation for the FDA (2016-2020) and is an editor at The BMJ. The views expressed here are those of the authors and do not necessarily reflect those of their employers.

Footnotes

1A compatibility interval is identical to a confidence interval, but relabeled to emphasize that it is not a Bayesian posterior interval (as is improperly suggested by the “confidence” label).13,14.

Appendix ASupplementary data to this article can be found online at https://doi.org/10.1016/j.vaccine.2022.08.036.

Appendix A. Supplementary data

The following are the Supplementary data to this article:

Supplementary data 1:

Data availability

All of the data in the study is available at https://doi.org/10.5281/zenodo.6564402

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