On Friday March 17th 2023, there was an Adjournment debate in the House of Commons about the Covid vaccines. Here are the video and transcript.
Andrew Bridgen MP used the Government’s own data about the ‘number needed to vaccinate to prevent a COVID-19 hospitalisation’ to demonstrate that the Covid vaccines are not safe, effective or value for money.
It was damning. Given the serious adverse event rate from the vaccines of one in 800, the Government’s own data showed that for all healthy people and all those considered at risk under 70, the probability of being seriously harmed by Covid is significantly outweighed by the risks associated with the Covid vaccines. And for over-70s with health problems, the risk from Covid is the same as the risk from the vaccine – they are just switching one risk for another.
Will Quince MP replied for the Government. He swerved Bridgen’s reference to vaccine harms and trotted out the usual narrative: “Countless studies have shown that vaccinated people are less likely to die or become seriously ill from the virus.” His only attempt to rebut Bridgen’s reference to vaccine harms was to laud the drugs regulator the MHRA.
I have been very critical of the MHRA over the last eight months so I want to dissect what Will Quince MP said about MHRA.
Will Quince MP is the Minister of State in the Department of Health and Social Care responsible, amongst other things, for “medicines and medicines regulation”. So Andrew Bridgen MP was actually wrong to say that his speech “is neither his (Quince’s) area of responsibility nor his area of expertise”. It absolutely is his area of responsibility.
Will Quince MP defended the Covid vaccines saying “all the vaccines used in the U.K. COVID-19 vaccination programme have been through a vigorous approval process. The U.K. has some of the highest safety standards in the world, and the independent Medicines and Healthcare products Regulatory Agency is globally recognised for requiring high standards of quality, safety and effectiveness.”
“A vigorous approval process” is a bit of a stretch, to say the least. Here are just three issues:
- MHRA approved the first Covid vaccine in December 2020 after about only 10 months of clinical trials when new medicines typically take 5-10 years to get to market;
- MHRA ignored new draft regulations for mRNA products. Instead, it used the same regulations as traditional vaccines. This lowered the regulatory requirements, resulting in limited evaluation of pharmacodynamics, pharmacokinetics and toxicology;
- Even the manufacturers were surprised (and, I assume, saw dollar signs). For example:
- in March 2020, Pfizer said (page 14): “Other jurisdictions may consider our mRNA-based product candidates to be new drugs, not biologics or gene therapy medicinal products, and require different marketing applications.”
- in August 2020, Moderna said (page 70): “Currently, mRNA is considered a gene therapy product by the FDA. … In addition, because no product in which mRNA is the primary active ingredient has been approved, the regulatory pathway for approval is uncertain. … Moreover, the length of time necessary to complete clinical trials and to submit an application for marketing approval for a final decision by a regulatory authority… may be difficult to predict.”
Quince also said that MHRA is “globally recognised for requiring high standards of quality, safety and effectiveness”. I worked for 20-plus years in another safety critical sector so I know good safety management when I see it. In reality, MHRA has major shortcomings against best practice, including:
- Responsibility and Accountability. Unlike other safety critical sectors, MHRA does not have a process for delegating authority from the Secretary of State for Health to MHRA individuals to approve medicines for public use. Medicines are assessed by groups of individuals (Section 2) and no single person within the MHRA is responsible for the decision to authorise (Section 3). Moreover, MHRA is organised functionally, with licensing and pharmacovigilance as two separate divisions, which further dilutes responsibility.
- Yellow Card investigation. Unlike other safety critical sectors, MHRA does not have a process for investigating individual Yellow Card (safety incident) reports. It says it tries to investigate individual fatal/serious Yellow Card reports but it does not know how many it has investigated.
- Safety Audit. MHRA has never had a safety audit. It has a biennial quality audit of its pharmacovigilance. However, there is world of difference between a quality audit and a safety audit, and the quality audit does not even look at licensing.
- Risk Assessment and Safety Targets. MHRA does not define the level of risk which is ‘acceptable’ as the basis of “acceptably safe”. Instead, the MHRA defines “acceptably safe” in relative terms: “For a medicine to be considered safe, the expected benefits of the medicine will be greater than the risk of suffering harmful reactions.” Yet post-approval risks will often turn out to be higher in practice due to the inherent limitations of clinical trials and lack of long term safety data. In contrast, other safety critical sectors have clear, documented processes for assessing safety risks (both as part of the approval and usage) against absolute safety targets and baseline risk assessments. Amongst other things, this provides a clear threshold for action if subsequent evidence undermines the original safety risk assessment.
- Monitoring Usage. MHRA relies mainly on statistical analysis of Yellow Card reports to assess drug safety, comparing the frequency of side-effects for a new drug with those of other drugs. No other safety-critical sector monitors safety on a relative basis. It is like the nuclear regulator saying “his nuclear power station is safe because he gets no more contaminated water leaks than the other ones”.
I am co-authoring a long report which goes into far more detail about MHRA’s failures in regulation of the Covid vaccines – both the licensing and monitoring of them. It should be published shortly. I hope Will Quince MP will read it.
Until Nick retired a few years ago, he was a Senior Civil Servant in a Government Department.
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