UK PETITION: INVESTIGATE THE MHRA
(Note: Only UK votes count and I refrain from comment due to my previous experience of that organisation)
Image: The Crown & Portcullis is the symbol of the UK Parliament.
https://petition.parliament.uk/petitions/628165
Petition: Launch a Public Inquiry into the approval process for covid-19 vaccines
We want the Government to launch a Public Inquiry to investigate the MHRA's process for approving covid-19 vaccines.
This should consider all aspects of the approval process, including how approval was expedited and the drivers for expedition, and any potential conflicts of interests.The MHRA are primarily funded by fees from the pharmaceutical industry.
An expedited rolling review was used to grant temporary authorisations for the use of covid-19 vaccines.
Initial covid-19 vaccines were approved based on efficacy reducing illness from covid-19, whereas bivalent boosters have been approved based on immune response. Moderna Bivalent booster was approved despite lower efficacy than the original vaccine, and Pfizer BA.4-5 booster was approved using BA.1 data.
Public Assessment Reports for bivalent boosters have only been published months after the boosters were approved.
Please Sign this petition if you are UK resident.
25,090 signatures so far!
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Government responded on 20 December 2022
The Government is confident that the approval processes of the medicines regulator are robust. It is a matter for the COVID-19 public inquiry whether it wishes to pursue any of these issues.
Public Inquiry
On 28 June 2022 the Prime Minister published the Terms of Reference (ToR) for the UK COVID-19 Public Inquiry.
The ToR set out that the Inquiry will look at the development, delivery and impact of therapeutics and vaccines. The Inquiry is independent of the Government, the Department of Health and Social Care cannot comment on when, or to what extent, the Inquiry will focus upon vaccines.
An exercise to listen to experiences of the pandemic has been launched and any person or organisation are encouraged to visit the COVID-19 Inquiry website for further details.Approval Process for COVID Vaccines
The Medicines and Healthcare products Regulatory Agency (MHRA) authorised Pfizer, AstraZeneca and Moderna COVID-19 vaccines under Regulation 174 (R174) of the Human Medicines Regulations 2012 between November 2020 and January 2021. R174 is a temporary authorisation for supply of an unlicensed medicine in response to certain public health threats, such as a pandemic. Once data shows that benefits outweigh the risks R174 is triggered by the government.
The three vaccines were assessed via an expedited rolling review. This allowed MHRA to review data as it became available and meant good progress had been made before the last submission of data was received. Each vaccine’s data package was reviewed by MHRA teams of scientists and clinicians who rigorously evaluate the quality, safety and effectiveness of the vaccines.
The data was scrutinised by the COVID-19 Vaccines Benefit Risk Expert Working Group (VBR EWG). This was established to advise MHRA and the Government’s independent advisory body, the Commission on Human Medicines (CHM), on the benefits and risks of COVID vaccines. The CHM critically reviewed the data before advising the UK government on the safety, quality and effectiveness of the vaccines. No vaccine would be authorised for supply in the UK unless the expected standards were met.
The R174 authorisations of the Pfizer, AstraZeneca and Moderna vaccines were replaced by marketing authorisations (MAs) in December 2020, June and March 2021. Initially these were conditional MAs with specific obligations on the marketing authorisation holders to provide longer term data. The MA of Comirnaty has now been converted to a full MA as there are no outstanding specific obligations.
Bivalent Boosters
The approved bivalent booster vaccines met the MHRA’s expected standards of safety, quality and effectiveness. The decisions were endorsed by the CHM after a careful review of the evidence.
Neutralising antibodies prevent the SARS-COv-2 virus entering the body’s cells. A neutralising antibody response has been shown to correlate with vaccine efficacy, allowing an estimate of effectiveness over a shorter period.
The clinical study of the Moderna bivalent booster was not designed to compare the efficacy of the original and bivalent boosters. The results of the study showed that both the original Spikevax vaccine and the updated bivalent vaccine elicited a significant immune response against the ancestral strain and Omicron. While the immune response against the ancestral strain did not differ much between the vaccines, the bivalent vaccine triggered a superior antibody response against Omicron BA.1.
The Pfizer bivalent Original/Omicron BA.4-5 vaccine and the Original/Omicron BA.1 bivalent vaccine have the same composition, apart from containing mRNA which matches different, but closely related, Omicron subvariants. The MHRA’s decision to approve the Pfizer BA.4-5 booster was based on all available evidence on the original Pfizer/BioNTech COVID-19 vaccine and its adapted vaccines. This included extensive safety and effectiveness data for the original vaccine, clinical data from the bivalent original/Omicron BA.1 vaccine and safety data from an on-going clinical trial of the bivalent original/Omicron BA.4-5 vaccine.
MHRA Funding and Operational Independence
MHRA retains operational independence and the pharmaceutical industry does not play any part in the independent decisions made by MHRA. Fees charged to the regulated industry funds MHRA’s medicines regulation work according to the full cost recovery rules as set out in His Majesty’s Treasury’s Managing Public Money.
The majority of the MHRA’s income comes from the pharmaceutical industry through fees, e.g., all Marketing Authorisation applicants have to pay a fee. For further information, click here: https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-21-june-2021/freedom-of-information-request-on-whether-the-mhra-receives-funding-from-the-bill-and-melinda-gates-foundation-foi-21-624
MHRA staff members are required to make annual conflict of interest declarations, and immediately declare any financial or other interests as and when they arise. Staff members cannot hold direct financial interests in the pharmaceutical and healthcare (medical devices) industries. (Department of Health and Social Care)
At 100,000 signatures...
At 100,000 signatures, this petition will be considered for debate in Parliament.
Note the use of the word “considered”….. it is not necessarily a foregone conclusion that our MPs will discuss this matter and, furthermore, when they DO discuss petitions it is in a cosy little anteroom at Parliament and nothing is ever gained from it. (Sorry, I know I said that I would refrain from comment but I just could not let that fly by unchallenged!)
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Why would the people at the MHRA be any more virtuous then the people at the CDC or FDA.
Big Pharma/Government pays their bills through fees and I’m sure a whole lot more. I would think that those are fees of influence. I have owned companies that had to pay fees to belong and be approved by regulatory agencies. I’m small potatoes, but you do get to talk with people at the agency’s especially if all your fees are up to date. I never used it to swing their decision making process, but I can see how easily it can be done. It’s pretty apparent that most and by most I’m going out on a limb and say 95% of the government officials have been bought and paid for in the western world. It could possibly be higher then that number. It’s why we’re in the mess that we’re in. That and the fact that the majority of people are playing ostrich’s right now. Until we as a society take big money out of politics, we’re screwed.
Do you believe any virus exists?
I’m now at the conclusion no virus exists, or what they see and call a virus is merely part of a cell process, and that nearly every disease is caused by toxicity of the body, which could be hastened by emfs chemtrails etc.