In the thrill of pharmacovigilance
A recent post entitled “How to help improve the safety and correct use of COVID-19 vaccines?” on the Ministry of Health’s blog[1], which was also promoted on Facebook, seemed a little disconcerting. Was the point here, after an 18-month vaccination campaign, once again to appeal to the population to report any side effects of the Covid-19 vaccines to the pharmacovigilance system, or was it to channel a new argument for the safety of vaccinations into the public consciousness? In the article, we read that:
The COVID-19 vaccination campaign, which started on 28 December 2020, resulted in an unprecedented avalanche of pharmacovigilance reporting for 2021. That year saw no less than 2,158[3] pharmacovigilance reports submitted to the competent authorities, compared to a mere 92 for 2020. The information and awareness campaign for pharmacovigilance with regard to COVID-19 vaccination explains, among other things, this increase in adverse event reports.
We also learn that 98% of these reports are due to the Covid-19 vaccines[2].
Our pharmacovigilance services thus assume, theoretically and even before any reporting, that the number of reports on side effects will be meaningless because of the awareness campaign. While over the past 2,5 years, the political authorities stubbornly dismissed the argument that more testing leads to more positive results as disinformation, here, in the case of side effects, they fall back on exactly this argument: more reports simply arise from the successful awareness campaign and say nothing about the real situation.
A bold claim, considering that scientific proof would be needed to show that the majority of these reports are not related to vaccination.
A clue as to whether this idea was dreamed up by the Ministry of Health itself or inspired by other parties, can be found at the Uppsala Monitoring Centre (UMC) which is mentioned in the article.
The Uppsala Monitoring Centre (UMC)
The UMC is responsible for pharmacovigilance and drug safety within the framework of the WHO and maintains the VigiBase database in which the reported adverse reactions to drugs and vaccines are recorded. The UMC was founded by the WHO and the Swedish government in 1978 and has the status of an independent, non-profit organisation that is purportedly self-financing[3]. However, on closer inspection, this “self-financing” begins to look a little different. On the UMC’s website, for example, under “Governance and funding”[4]:
UMC is independent and self-funded. We finance our operations by selling pharmacovigilance products and services to a range of external bodies, most notably the WHODrug Global portfolio of products. […] We do not receive other funding from external sources, except for specific project grants.
Also, the question arises as to what extent the WHO’s pharmacovigilance agency can be “independent” when the largest private sponsor of this international organisation, the Bill & Melinda Gates Foundation (BMGF), is simultaneously a major shareholder in BioNtech[5].
But, referring back to the explanation discussed at the beginning, as to why there are so many reports of side effects of the Covid-19 vaccine. The UMC publishes the Uppsala Reports at irregular intervals, approximately two to three times a year. Let’s take a look at the latest issue from November 2021[6].
On page 7 there is a Q&A section, managed by VigiBase Manager Helena Sköld. In reply to the question:
There has been a surge in reports of adverse drug reactions related to COVID-19 vaccines. Should we be worried?
the agency stated:
No, quite the contrary. Because this is the biggest mass vaccination programme in history, it makes sense that there would be a large number of reports anyway. But also because these are new vaccines, and they are so important to stopping the pandemic, health authorities at national and international level have been actively encouraging reporting. […]
The Luxembourg Ministry of Health offers the same pre-emptive defence arguments, by cutting and pasting from the UMC. Like the UMC, but without citing the source, our ministry declares that an increase in side effects is simply due to more reports. Not a problem for the vaccination campaign, but a great success for an awareness campaign that consequently unearths quantitatively useless data.
The claim that the high number of reported adverse reactions to the Covid-19 vaccine is due to the number of doses administered can be easily refuted: as we have already pointed out in an earlier article: polio has been administered about 3 billion times since 1968, but no more than about 123,000 adverse reactions have been reported[7].
On vaccine hesitants and opponents
That such covert adopting of arguments in fact amounts to a pre-emptive defence technique can easily be gleaned from another article in this publication of the UMC: here it becomes apparent that it is mainly about pre-emptive action to take the wind out of the sails of vaccine-hesitant people and vaccine opponents. Exactly what an article entitled “Countering narratives of distrust key to convincing the vaccine hesitant” has to do with a publication by a pharmacovigilance body is not clear. The article on page 24 consists mainly of quotations from a certain Dr Tom Aechtner, who lectures at the Faculty of Human and Social Sciences at the University of Queensland/Australia.
Aechtner offers the online course “Antivaccination and Vaccine Hesitancy” on the education platform edX[8]. Some excerpts from the short description:
In 2019 the World Health Organization listed vaccine hesitancy as one of the top ten threats to global health. […] You will engage with the science of vaccination and learn crucial information about why vaccines are safe and effective. Additionally, the course examines the most well-known vaccine myths and antivaccination persuasion strategies. These myths include stories about vaccines causing autism, questions about whether too many vaccines can overload a child’s immune system, as well conspiratorial claims that vaccines are major money-makers for Big Pharma, government and doctors.
As partners of edX we find many global players such as Microsoft, IBM, Google, or Amazon Web Services. Somewhat more discreetly, the BMGF is also listed under “Friends of edX” alongside other foundations[9].
It is probably somewhat naïve to think that a pharmacovigilance agency collects reports on side effects and then evaluates them without bias. At the UMC, they seem to assume that drugs and vaccines are safe a priori and that this only needs to be confirmed via the data collected.
Ministry of Health reports on adverse side effects
A serious pharmacovigilance service should publish statistics on reported adverse reactions at regular intervals. The list of the 11 reports so far can be found on the “infoVAXX” page of Covid19.lu[10].
From April 2021 to February 2022, this also happened more or less regularly every month. Since February 2022, however, only one report has been published, on 13 April. For reasons that cannot be explained, the date in the link was changed from “13/04/2022” to “02/06/2022” sometime after 1 June, without the linked PDF having changed.
Screenshot of the website archived by Wayback Machine on 1 June 2022[11]:
Current screenshot of the page from 15 June:
Is the intention here to create the impression that, at least at first glance, there is an up-to-date report?
Update 17.06.2022: Oddly enough, this change has since been reversed in the French version, but not yet in the other two languages. Here is the link to the archived page with the date of 2 June.
Incidentally, the parallels with the German Paul Ehrlich Institute (PEI) are remarkable: here, the frequency with which the COVID-19 vaccine safety reports were published has decreased in a very similar way: the last report here is dated 04/05/2022[12]. The corresponding database was taken offline on 14 April, allegedly because it “no longer met the high IT security requirements of the Federal Office for Information Security (BSI)”[13].
Will Luxembourg’s reports of adverse side effects soon suffer the same fate as the incidence rates by vaccination status[14]?
The publication of deaths as a cumulative figure, which for two and a half years now has worked so well for deaths “from and with Covid” to increase the drama, may in retrospect have proved rather disadvantageous in this context.
Karma bites back.
Sources
[1] Covid19.lu (09.06.2022): Wie kann man zur Verbesserung der Sicherheit und korrekten Anwendung von Impfstoffen gegen COVID-19 beitragen?
https://covid19.public.lu/de/blog/impfung/pharmakovigilanz.html
[2] Uppsala reports (04.05.2022): Luxembourg’s PV culture: A lesson in the benefits of cross-pollination
https://uppsalareports.org/articles/luxembourg/
[3] UMC: Get to know UMC
https://who-umc.org/about-uppsala-monitoring-centre/
[4] UMC: Governance and funding
https://who-umc.org/about-uppsala-monitoring-centre/governance-and-funding/
[5] BioNtech Press Release (04.09.2019): BioNTech Announces New Collaboration to Develop HIV and Tuberculosis Programs
https://investors.biontech.de/news-releases/news-release-details/biontech-announces-new-collaboration-develop-hiv-and
[6] Uppsala reports: Issue 85 (November 2021)
https://view.publitas.com/uppsala-monitoring-centre/uppsala-reports-85
[7] Transparenztest: WHO VigiAccess Datenbank: 2.727.041 Reports mit 6.552.626 einzelnen Impf Nebenwirkungen gemeldet
https://www.transparenztest.de/post/who-vigiaccess-datenbank-2727041-reports-mit-6552626-einzelnen-impf-nebenwirkungen-gemeldet
[8] edX: Antivaccination and Vaccine Hesitancy
https://www.edx.org/course/antivaccination-and-vaccine-hesitancy
[9] Friends of edX
https://www.edx.org/friends-edx
[10] Covid19.lu: infoVAXX
https://covid19.public.lu/de/impfung/infovaxx.html
[11] Covid19.lu: infoVAXX archiviert am 01.06.2022 auf Wayback Machine
https://web.archive.org/web/20220601022450/https://covid19.public.lu/de/impfung/infovaxx.html
[12] PEI: Sicherheit von COVID-19-Impfstoffen
https://www.pei.de/DE/newsroom/dossier/coronavirus/arzneimittelsicherheit.html
[13] PEI: Datenbank zu Arzneimittelnebenwirkungen
https://www.pei.de/DE/arzneimittelsicherheit/pharmakovigilanz/uaw-datenbank/uaw-datenbank-node.html
[14] Expressis Verbis (29.05.2022): Malen nach Zahlen
https://www.expressis-verbis.lu/2022/05/29/malen-nach-zahlen/
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