Ryhmä juristeja ja lääkäreitä on tehnyt koko viime vuoden työtä sen eteen, että Euroopan lääkevirasto (EMA) vapauttaisi mRNA-koronarokote Comirnatyn kaikki turvallisuusraportit. EMA joutui taipumaan, kun joukko eurooppalaisia juristeja ja lääkäreitä yhdistivät tietotaitonsa.
Kiitos itävaltalaisen asianajaja Silvia Behrendt’n1 pitkäjänteisen suunnitelman tavoite saavutettiin. Aluksi ryhmä eurooppalaisia lääkäreitä lähtivät vaatimaan, kukin yksityishenkilönä, EMA:lta kaikki heillä olevat turvallisuusraportit (PSUR:t) nähtäväkseen. EMA vapautti kuitenkin vain osan hallussaan olevasta turvallisuusdatasta. Niinpä Silvia Behrendt yhdessä espanjalaisen kollegansa, Luis Pardon kanssa jatkoi neuvotteluja EMA:n kanssa. Merkittävä läpimurto tapahtui syyskuussa 2023 etänä pidetyssä palaverissa, joka käytiin EMA:n lakiasiain johtajan Stefani Mauron ja muiden EMA:n edustajien kanssa. Jostain syystä EMA oli jättänyt julkaisematta neljännen turvallisuusraportin, mutta sekin on nyt saatu Silvia Behrendt’n konsultoitua Euroopan oikeusasiamiestä.
Vapautetut turvallisuusraportit löytyvät täältä2 (skrollaamalla ruutua alaspäin) ja tarkemmat kuvaukset tapahtumien kulusta ovat luettavissa liitteenä olevasta Silvia Behrendt’n työryhmälle lähettämästä sähköpostista, joka julkaistaan hänen luvallaan.
Työtä riippumattoman tieteen puolesta on tästä hyvä jatkaa.
- Global Health Resbonsibility
- PSUR-TIETOJEN ARKISTO Comirnatysta, Vaxzevriasta, Nuvaxovidista ja Spikevaxista – uusia päivityksiä Vaxzevriasta ja Valnevasta
Sähköpostiviestit asianajaja Silvia Behrendt’lta työryhmälle
Sähköposti 24.1.2024:
Although it is late in January, I still wish you all a happy new and blessed year 2024!
The PSUR-initiative was a great success in 2023 and I believe that it is a crucial part of an important evidence that is needed urgently and will accompany us in 2024!
It is certain that EMA became quite pressured by you all and that they were overwhelmed by the amount of doctors and lawyers – EMA never experienced something like this before!
Luis Pardo and me, we had a virtual meeting in September 23′ questioning why some issues are still not resolved and why particularly the 4th PSUR of Comirnaty has not yet been released. I never heard from them again, therefore I filed a claim against EMA with the European Ombudsman in Dezember – only some days after that, the 4th PSUR of Comirnaty has been published at the product website.
Due to our pressure, EMA publishes now all PSURs and PRACs at the product websites of EMA – they decided this in a special meeting during the summer.
The entire set of documents so far received has been published at the German blogger site TKP and all the documents have been coverted to an OCR format, so they are searchable, which is highly important for doing research! And please spread the documents all over the world to researchers!
See here https://tkp.at/2024/01/17/psur-datenarchiv-zu-comirnaty-vaxzevria-nuvaxovid-und-spikevax-neue-updates-zu-spikevax-und-vaxzevria/ so if you are intending to use the documents at other websites please use the OCR format only available under the above link.
As of now, we still await a lot of documents from EMA, but there is already a good basis to work for researchers and all people interested. So keep alerted!
I greatefully thank everybody who made this success possible and also especially the ones who still forward me the EMA-eMails, so I know what is going on, even if I normally don’t reply.
Best and take care, Silvia
PSURs4doctors/Transparency4vaccines <vaccine_transparency@proton.me> schrieb am Dienstag, 12. September 2023 um 22:03:
Hello everybody,
thanks for being part of this initative and thanks to everybody for constantly forwarding the documents from EMA, which are sent to us in small pieces.
Last Monday, Luis Maria Pardo from Spain and me had a virtual meeting with the boss of the legal department, Stefano Mauro, and other representatives from EMA which verfied that EMA takes this initiative extremely serious and attributes the highest attention to it. Not only the meeting but the entire initiative is a huge, huge success because hidden pharmacovigilance data were revealed and EMA is pressured to release them on an ongoing basis – and they also talk to us, although they do not like to talk to anybody outside the pharmaceutical companies about the adverse events.
As of now, EMA released through this initative:
Comirnaty:
- finished: #3 and #2 PSURs incl. PRAC AR and annexes (almost 1000 pages each)
- unfinished/ongoing: #1 PSUR – PRAC and some annexes are still missing
- not started: #4PSUR
Spikevax
- unfinished #3PSUR, missing PRAC AR and Annex 1-565 (?)
Jcdoven: the release has been stopped and replaced with Spikevax upon our request
As final outcome of the meeting, EMA agreed to provide us with the details of re-releases of the documents, which were 11 altogether and a legal opinion whether we can upload the documents publicly, because they are not uploading them at the EMA homepage. We are still waiting for this to happen.
In addition, I asked to establish a “pharmacovigiliance Roundtable” for Covid-vaccines (and any future pandemic vaccines) – this project requires further elaboration, but they took notice of it. Within the last days, EMA sent an urgent request that a wrong document titled ‘R – tozinameran (COMIRNATY) COMIRNATY PSUSA-10898-202206 – PRAC AR.pdf’ (see attachement) has been released to us and it should be deleted immediately. Instead, we should use this document
– however, it is perfect to argue that this situation is one of the reasons why this way of release is highly ineffectiv, if they had a central place, it would be very easy for them to replace it (but not good for our purposes, exceptionally). However, EMA now asks us to delete the released document and confirm it. The reason remains unclear as well as the question what kind of secrecy is behind the officially released document. I will ask back and seek clarification from EMA for this unususual behaviour.
As of now, I am again ready and available to push this pharmacovigiliance initiative! Please stay in touch,
Best, Silvia
