US Separation of Powers – Federal v States h/t EmilyPeter’s Newsletter is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber. Big government does, of course, imply greater Federal control and lower control by the States. It reaches to the heart of the US constitution. How far can Federal law impinge and dictate States law, beyond the protection of basic human rights granted to all human beings that the States cannot infringe upon.
Feel free to pass this on to whatever contacts you have in MSM, journalists, lawyers working on the court cases, medical people fighting mandates and so on.
But if they ask where it came from to fact check then pass on my contacts and I will supply them the original for their due diligence.
MHRA answered me this morning . Strange for them to send out e-mails on a Sunday, normally it’s a Friday afternoon, answering these 2 questions:
Can you please supply: - the metric or standard that is used by the MHRA to quantify the term “safe” with regards/reference to a “covid vaccine” authorised for use by the MHRA?
- the metric or standard that is used by the MHRA to quantify the term “effective” with regards/reference to a “covid vaccine” authorised for use by the MHRA?
What an answer - they have no definitive standard to measure either safety nor effectiveness of any medicine or vaccine.
So how do they know something is “safe” or “effective”?
It is because they, or the manufacturer, say it is!!!
Here is their actual answer:
There is no ‘metric or standard’ used by the MHRA to quantify ‘safe’ in terms of a COVID-19 vaccine, or any other medicinal product. (my highlighting). No medicine is completely risk-free. For a medicine to be considered acceptably safe, its expected benefits should be greater than any associated risks of harmful reactions (my highlighting). This can be determined based on the data submitted with an application for a marketing authorisation for a medicinal product such as a COVID-19 vaccine. But the balance of benefits and risks for any product can change at any time during its marketed life, for example if a serious new side effect is established.
For this reason the MHRA continually monitors the safety of all medicinal products authorised in the UK, including the COVID-19 vaccines. The process is termed pharmacovigilance and this involves:
monitoring the use of medicines in everyday practice to identify previously unrecognised adverse effects or changes in the patterns of adverse effects
assessing the risks and benefits of medicines in order to determine what action, if any, is necessary to improve their safe use
providing information to healthcare professionals and patients to optimise safe and effective use of medicines
monitoring the impact of any action taken
You can read more about the MHRA’s safety assessments for COVID-19 vaccines here Coronavirus (COVID-19) vaccines adverse reactions - GOV.UK (www.gov.uk)
As stated above, all medicinal products are authorised based on an assessment of the benefit/risk - that is the benefit to the patient being greater than the known risks associated with taking that product. To understand the assessment of the benefit/risk for each of the Covid-19 vaccines authorised, please refer to the Public Assessment Reports (PARs) for each of the vaccines that we have provided links to in our previous responses to you.
Vaccine efficacy is usually measured in randomised controlled clinical trials. It is calculated by comparing the proportion of trial subjects that developed symptomatic COVID-19 in the vaccine arm with the proportion that developed symptomatic COVID-19 in the placebo arm. The calculation is made after a certain number of COVID-19 cases have occurred in the trial as a whole. This number is decided at the start of the trial. This means that a time period is not chosen.
More details on the measurement of vaccine efficacy are provided in the PARs that you have already received.
We hope this information is helpful.
But the PARs they mention do NOT prove the vaccines are safe nor effective when you read them.
I have read them many times and cannot find out what in them proves safety and/or effectiveness.
MHRA? Mumbling Harrumphing Rubbish Arseaches. In the tits on a bull & chocolate fireguards file.
Feel free to pass this on to whatever contacts you have in MSM, journalists, lawyers working on the court cases, medical people fighting mandates and so on.
But if they ask where it came from to fact check then pass on my contacts and I will supply them the original for their due diligence.
MHRA answered me this morning . Strange for them to send out e-mails on a Sunday, normally it’s a Friday afternoon, answering these 2 questions:
Can you please supply: - the metric or standard that is used by the MHRA to quantify the term “safe” with regards/reference to a “covid vaccine” authorised for use by the MHRA?
- the metric or standard that is used by the MHRA to quantify the term “effective” with regards/reference to a “covid vaccine” authorised for use by the MHRA?
What an answer - they have no definitive standard to measure either safety nor effectiveness of any medicine or vaccine.
So how do they know something is “safe” or “effective”?
It is because they, or the manufacturer, say it is!!!
Here is their actual answer:
There is no ‘metric or standard’ used by the MHRA to quantify ‘safe’ in terms of a COVID-19 vaccine, or any other medicinal product. (my highlighting). No medicine is completely risk-free. For a medicine to be considered acceptably safe, its expected benefits should be greater than any associated risks of harmful reactions (my highlighting). This can be determined based on the data submitted with an application for a marketing authorisation for a medicinal product such as a COVID-19 vaccine. But the balance of benefits and risks for any product can change at any time during its marketed life, for example if a serious new side effect is established.
For this reason the MHRA continually monitors the safety of all medicinal products authorised in the UK, including the COVID-19 vaccines. The process is termed pharmacovigilance and this involves:
monitoring the use of medicines in everyday practice to identify previously unrecognised adverse effects or changes in the patterns of adverse effects
assessing the risks and benefits of medicines in order to determine what action, if any, is necessary to improve their safe use
providing information to healthcare professionals and patients to optimise safe and effective use of medicines
monitoring the impact of any action taken
You can read more about the MHRA’s safety assessments for COVID-19 vaccines here Coronavirus (COVID-19) vaccines adverse reactions - GOV.UK (www.gov.uk)
As stated above, all medicinal products are authorised based on an assessment of the benefit/risk - that is the benefit to the patient being greater than the known risks associated with taking that product. To understand the assessment of the benefit/risk for each of the Covid-19 vaccines authorised, please refer to the Public Assessment Reports (PARs) for each of the vaccines that we have provided links to in our previous responses to you.
Vaccine efficacy is usually measured in randomised controlled clinical trials. It is calculated by comparing the proportion of trial subjects that developed symptomatic COVID-19 in the vaccine arm with the proportion that developed symptomatic COVID-19 in the placebo arm. The calculation is made after a certain number of COVID-19 cases have occurred in the trial as a whole. This number is decided at the start of the trial. This means that a time period is not chosen.
More details on the measurement of vaccine efficacy are provided in the PARs that you have already received.
We hope this information is helpful.
But the PARs they mention do NOT prove the vaccines are safe nor effective when you read them.
I have read them many times and cannot find out what in them proves safety and/or effectiveness.
Here they are, read them for yourselves:
https://awkwardgit.substack.com/p/the-4-official-ema-public-assessment
Many thanks for this. I hope you don't mind but I have re-posted your comment and linked to your substack. For some reason I can't Cross-Post.
Feel free to use whatever you want.
In the first paragraph of their response, “expected benefit should “. As an engineer I cringe at this use of words. Expected? Should?
This is not criteria. This is a tactic to say, you don’t have to justify anything so go ahead and do what ever you want.