⚠️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
Get more from Robin Monotti Graziadei on Patreon
creating education.
OUR BEST WEAPON IS THE EDUCATION OF THE GENERAL PUBLIC. WE HAVE AN ACTIVE ROLE IN THIS. WE ARE NOT PASSIVE BYSTANDERS.
How to use this channel as a search engine. Step 1. Find the three dots at the top right. Step 2. Click on them. Step 3. Click search then enter search term, eg. Masks. Step 4. Click arrows up and down to toggle between results.
Robin Monotti + Cory Morningstar
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…
Vaccine phase 2 efficacy trials completed around 20th June 2020 (see Pfizer). Phase 3 safety trials need one year post phase 2, before that year passes they need emergency use to justify authorization before they can legally be approved.
Does this make sense now?
" No earlier than 21 June
Remove all legal limits on social contact.
Reopen the remaining closed settings and enable large events above the capacity restrictions"
Does this make sense now?
" No earlier than 21 June
Remove all legal limits on social contact.
Reopen the remaining closed settings and enable large events above the capacity restrictions"
Forwarded from World Doctors Alliance
https://youtu.be/WyLNpbN7P1g Numbers, p@ssports, the V-word, meditations, pr0tests and equinoxes.
*
The People’s Lawyer Telegram group - ‘Combating Medical Tyranny’ :
https://t.me/thepeopleslawyerchannel.
LETTER TEMPLATES TO CHALLENGE MASKS, & DECLINE TESTING & VACCINES
This is from Miri Anne Finch, Lawyer. UKMFA:
Let’s empower ourselves with legal ways of refusing such tyranny!
LETTER TEMPLATES: A USER'S GUIDE
LETTERS CHALLENGING MASK MANDATES:
https://miriaf.webs.com/employer-mask...
https://miriaf.webs.com/mask-risk-ass...
https://miriaf.webs.com/pub-mask-refusal
https://miriaf.webs.com/airline-mask-...
https://miriaf.webs.com/masks-small-b...
https://miriaf.webs.com/shopping-cent...
https://miriaf.webs.com/leisure-centr...
https://miriaf.webs.com/exercise-mask...
https://miriaf.webs.com/council-shops...
https://miriaf.webs.com/doctor-smear-...
LETTERS DECLINING COVID TESTING
https://miriaf.webs.com/school-consen...
https://miriaf.webs.com/covid-test-da...
https://miriaf.webs.com/school-corona...
https://miriaf.webs.com/hospital-covi...
https://miriaf.webs.com/hospital-work...
LETTERS DECLINING VACCINES
https://miriaf.webs.com/school-consen...
https://miriaf.webs.com/custody-conse...
https://miriaf.webs.com/hospital-work...
ALL OTHER LETTERS:
https://miriaf.webs.com/site-index
Kindly share WIDELY
Register for the V-Stop No Vaccine UK Festival, 24th July 2021
https://www.vstopfestival.com/?fbclid...
Stop 5G protest event, 19th March, for those in Southern California:
https://stop5ginternational.org/5g-sp...
Human rights: Vaccination and public/private coercion:
https://ukhumanrightsblog.com/2021/02...
*
The People’s Lawyer Telegram group - ‘Combating Medical Tyranny’ :
https://t.me/thepeopleslawyerchannel.
LETTER TEMPLATES TO CHALLENGE MASKS, & DECLINE TESTING & VACCINES
This is from Miri Anne Finch, Lawyer. UKMFA:
Let’s empower ourselves with legal ways of refusing such tyranny!
LETTER TEMPLATES: A USER'S GUIDE
LETTERS CHALLENGING MASK MANDATES:
https://miriaf.webs.com/employer-mask...
https://miriaf.webs.com/mask-risk-ass...
https://miriaf.webs.com/pub-mask-refusal
https://miriaf.webs.com/airline-mask-...
https://miriaf.webs.com/masks-small-b...
https://miriaf.webs.com/shopping-cent...
https://miriaf.webs.com/leisure-centr...
https://miriaf.webs.com/exercise-mask...
https://miriaf.webs.com/council-shops...
https://miriaf.webs.com/doctor-smear-...
LETTERS DECLINING COVID TESTING
https://miriaf.webs.com/school-consen...
https://miriaf.webs.com/covid-test-da...
https://miriaf.webs.com/school-corona...
https://miriaf.webs.com/hospital-covi...
https://miriaf.webs.com/hospital-work...
LETTERS DECLINING VACCINES
https://miriaf.webs.com/school-consen...
https://miriaf.webs.com/custody-conse...
https://miriaf.webs.com/hospital-work...
ALL OTHER LETTERS:
https://miriaf.webs.com/site-index
Kindly share WIDELY
Register for the V-Stop No Vaccine UK Festival, 24th July 2021
https://www.vstopfestival.com/?fbclid...
Stop 5G protest event, 19th March, for those in Southern California:
https://stop5ginternational.org/5g-sp...
Human rights: Vaccination and public/private coercion:
https://ukhumanrightsblog.com/2021/02...
Why Denmark and Iceland have Stopped Using the AstraZeneca COVID Vaccine
"The health authorities have, due to precautionary measures, suspended vaccination with AstraZeneca following a signal of a possible serious side effect in the form of fatal blood clots ."
https://www.newsweek.com/covid-vaccine-astrazeneca-denmark-stopped-using-side-effects-1575342
"The health authorities have, due to precautionary measures, suspended vaccination with AstraZeneca following a signal of a possible serious side effect in the form of fatal blood clots ."
https://www.newsweek.com/covid-vaccine-astrazeneca-denmark-stopped-using-side-effects-1575342
Newsweek
Why Denmark and Iceland have stopped using the AstraZeneca COVID vaccine
Denmark's health minister said there were concerns about side effects days after the country approved the jab.
"Icelandic health authorities are temporarily suspending use of the AstraZeneca COVID-19 vaccine while the European Medicines Agency researches whether there is a causal link between the drug and blood clots reported among recipients outside of Iceland. In a briefing in Reykjavík today, Chief Epidemiologist Þórólfur Guðnason stated.."
https://www.icelandreview.com/society/covid-19-in-iceland-authorities-temporarily-suspend-use-of-astrazeneca-vaccine/
https://www.icelandreview.com/society/covid-19-in-iceland-authorities-temporarily-suspend-use-of-astrazeneca-vaccine/
Iceland Review
COVID-19 in Iceland: Authorities Temporarily Suspend Use of AstraZeneca Vaccine
Icelandic health authorities are temporarily suspending use of the AstraZeneca COVID-19 vaccine while the European Medicines Agency researches whether there is a causal link between the drug and blood clots reported among recipients outside of Iceland. In…
"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..The letter describes serious potential consequences of COVID-19 vaccine technology, warning of possible autoimmune reactions, blood clotting abnormalities, stroke and internal bleeding, “including in the brain, spinal cord and heart”. The authors request evidence that each medical danger outlined “was excluded in pre-clinical animal models with all three vaccines prior to their approval for use in humans by the EMA.”
https://pressat.co.uk/releases/breakig-news-doctors-scientists-write-to-ema-re-covid-19-vaccine-safety-be11df3b8f9d599b2560dea639700355/
https://pressat.co.uk/releases/breakig-news-doctors-scientists-write-to-ema-re-covid-19-vaccine-safety-be11df3b8f9d599b2560dea639700355/