In view of the urgency of the situation, we request that you reply to this email within seven days and address all our concerns substantively. Should you choose not to comply with this reasonable request, we will make this letter public
This email is copied to:
Charles Michel, President of the Council of Europe
Ursula von der Leyen, President of the European Commission.
https://doctors4covidethics.medium.com/urgent-open-letter-from-doctors-and-scientists-to-the-european-medicines-agency-regarding-covid-19-f6e17c311595
This email is copied to:
Charles Michel, President of the Council of Europe
Ursula von der Leyen, President of the European Commission.
https://doctors4covidethics.medium.com/urgent-open-letter-from-doctors-and-scientists-to-the-european-medicines-agency-regarding-covid-19-f6e17c311595
Medium
Urgent Open Letter from Doctors and Scientists to the European Medicines Agency regarding COVID-19 Vaccine Safety Concerns
Emer Cooke, Executive Director, European Medicines Agency, Amsterdam, The Netherlands
"Targeting the Davos, Switzerland-based World Economic Forum and its devotees among global political leaders, attorney Reiner Fuellmich says they are guilty of crimes against humanity for their perpetration of COVID-response policies that led to forced shutdowns, destroyed businesses, impoverished families, broken lives and a spike in suicide rates.
He has formed the German Corona Investigative Committee to pursue civil charges against the main perpetrators, among them being the head of the United Nations World Health Organization Dr. Tedros Adhanom. He hopes a successful class-action lawsuit will also lead to criminal charges."
https://humansarefree.com/2021/03/legal-team-wants-second-nuremberg-tribunal-to-try-global-lockdown-promoters-for-crimes-against-humanity.html
He has formed the German Corona Investigative Committee to pursue civil charges against the main perpetrators, among them being the head of the United Nations World Health Organization Dr. Tedros Adhanom. He hopes a successful class-action lawsuit will also lead to criminal charges."
https://humansarefree.com/2021/03/legal-team-wants-second-nuremberg-tribunal-to-try-global-lockdown-promoters-for-crimes-against-humanity.html
Humans Be Free
Legal Team Wants ‘Second Nuremberg Tribunal’ to Try Global Lockdown Promoters for Crimes Against Humanity
Mike Yeadon
Robin, anyone, please share this press release on concerns for serious adverse effects from Covid19 vaccinations: PRESS RELEASE - FOR IMMEDIATE RELEASE BREAKING NEWS: Doctors and Scientists Write to European Medicines Agency Warning of COVID-19 Vaccine Dangers…
Is it a coincidence I am suspended from twitter for no valid reason the week they knew this letter was going to come out, and my appeal has received no response? Is it a coincidence that a fake Mike Yeadon account appeared on twitter the day before just as I was sharing Mike's posts from Telegram to twitter?
BOT is doing good work out there. 🤖 https://twitter.com/robinmonottibot/status/1369715800177848320?s=19
Twitter
Robin Monotti Bot 🤖
PRESS RELEASE from Mike Yeadon: A group of scientists and doctors has today issued an open letter calling on the European Medicines Agency (EMA) to answer urgent safety questions regarding COVID-19 vaccines, or withdraw the vaccines’ authorisation. http…
The Truth Behind The Vaccine Trials - Documentary Film 2021
https://rumble.com/vebrjv-the-truth-behind-the-vaccine-trials-documentary-film-2021.html
https://rumble.com/vebrjv-the-truth-behind-the-vaccine-trials-documentary-film-2021.html
Rumble
The Truth Behind The Vaccine Trials - Documentary Film 2021
So the vaccine is not technically licensed as the clinical trials will not be completed until 2023, yet the vaccine promotion campaign is rampant everywhere. The government, corporations, and celebrit
FDA Approval requires minimum 1 year of Phase 3 clinical trials. Phase 2 trials of Pfizer completed on 19th June 2020, which means Phase 3 needs to last at the very least until 19th June 2021 to be even considered for approval by the FDA.
At the same time, the EUA authorization is only valid if there is a pandemic emergency.
Which means they need to keep the "pandemic" going at least until June. That is why roadmaps to reopening are so slow.
https://www.fda.gov/patients/drug-development-process/step-3-clinical-research#Clinical_Research_Phase_Studies
https://www.patreon.com/robinmonotti
At the same time, the EUA authorization is only valid if there is a pandemic emergency.
Which means they need to keep the "pandemic" going at least until June. That is why roadmaps to reopening are so slow.
https://www.fda.gov/patients/drug-development-process/step-3-clinical-research#Clinical_Research_Phase_Studies
https://www.patreon.com/robinmonotti
⚠️In the EU, clinical studies approval timing laws are under the rules of the country the studies take place in, not under EU EMA rules⚠️
https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/vaccines-covid-19/covid-19-vaccines-studies-approval#what-types-of-studies-are-needed-to-approve-a-covid-19-vaccine?-section
https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/vaccines-covid-19/covid-19-vaccines-studies-approval#what-types-of-studies-are-needed-to-approve-a-covid-19-vaccine?-section
Robin Monotti + Cory Morningstar
⚠️WARNING⚠️ https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/vaccines-covid-19/covid-19-vaccines-studies-approval#what-studies-are-needed-after-approval?-section
Mike Yeadon: "This is completely contrary to medical ethics, without any question.
I dismiss all false equivalencies with influenza, for example.
Even trialling new technology medical interventions at scale is reckless enough.
Administering these to anyone not at risk, arguing that they’ll help protect others, is wrong on a number of levels.
Though this is part of the rationale for flu mist vaccination in kids, it’s often forgotten that young kids are at much greater risk from flu than are healthy adults (until quite late in life).
In this basis, I’d like to see the ethical review board’s conversations ahead of such paediatric vaccination trials."
I dismiss all false equivalencies with influenza, for example.
Even trialling new technology medical interventions at scale is reckless enough.
Administering these to anyone not at risk, arguing that they’ll help protect others, is wrong on a number of levels.
Though this is part of the rationale for flu mist vaccination in kids, it’s often forgotten that young kids are at much greater risk from flu than are healthy adults (until quite late in life).
In this basis, I’d like to see the ethical review board’s conversations ahead of such paediatric vaccination trials."
EU: Even the efficacy studies are ongoing: "The efficacy studies may continue for two years or more" https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/vaccines-covid-19/covid-19-vaccines-studies-approval#what-types-of-studies-are-needed-to-approve-a-covid-19-vaccine?-section
The problem here is the small amount of people who caught the disease even in the placebo group and the case definition they used: 1 positive RT-PCR test at astronomically high cycle thresholds and one mild symptom which could be a headache.
https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/vaccines-covid-19/covid-19-vaccines-studies-approval#what-types-of-studies-are-needed-to-approve-a-covid-19-vaccine?-section
https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/vaccines-covid-19/covid-19-vaccines-studies-approval#what-types-of-studies-are-needed-to-approve-a-covid-19-vaccine?-section
⚠️ EU EMA confirms 1 year is required for safety trials, that is why they are pushing the pandemic into late June ⚠️
https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/vaccines-covid-19/covid-19-vaccines-studies-approval#what-types-of-studies-are-needed-to-approve-a-covid-19-vaccine?-section
https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/vaccines-covid-19/covid-19-vaccines-studies-approval#what-types-of-studies-are-needed-to-approve-a-covid-19-vaccine?-section
The US gives an Emergency Use Authorization (EUA), whereas the EU gives a Conditional Marketing Authorization (CMA). ⚠️ NONE OF THESE ARE ACTUAL VACCINE APPROVALS ⚠️
https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/vaccines-covid-19/covid-19-vaccines-development-evaluation-approval-monitoring
https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/vaccines-covid-19/covid-19-vaccines-development-evaluation-approval-monitoring
ema-considerations-covid-19-vaccine-approval_en.pdf
205.3 KB
ema-considerations-covid-19-vaccine-approval_en.pdf
HERE WE GO, THIS IS WHY THEY NEED THE PANDEMIC GOING AT LEAST TIL LATE JUNE. CURRENT VACCINE AUTHORIZATION (NOT APPROVAL) IS TEMPORARY PENDING CONCLUSION OF CLINICAL SAFETY TRIALS WHICH MUST BE AT LEAST ONE YEAR IN DURATION. NO PANDEMIC AND AUTHORIZATION CAN BE CHALLENGED.
ICMRA JULY 2020:
"Follow-up of study participants for COVID-19 outcomes should be long enough (i.e., 1 year or longer post-vaccination) to evaluate safety, duration of immune response and risk of disease enhancement as antibody titers wane."
ICMRA SARS-CoV-2 Vaccines Workshop #2 - Summary | International Coalition of Medicines Regulatory Authorities (ICMRA)
http://www.icmra.info/drupal/news/22june2020/summary
https://www.patreon.com/robinmonotti
ICMRA JULY 2020:
"Follow-up of study participants for COVID-19 outcomes should be long enough (i.e., 1 year or longer post-vaccination) to evaluate safety, duration of immune response and risk of disease enhancement as antibody titers wane."
ICMRA SARS-CoV-2 Vaccines Workshop #2 - Summary | International Coalition of Medicines Regulatory Authorities (ICMRA)
http://www.icmra.info/drupal/news/22june2020/summary
https://www.patreon.com/robinmonotti
Patreon
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