Questions for MHRA

Our report raises a huge number of questions about MHRA’s Regulation and safety management of the Covid vaccines.  We are surprised that MPs and the Media are not challenging the Government and MHRA about them. 

Here are just a few :

1Why did MHRA regulate the mRNA products as vaccines when the manufacturers themselves (Biontech and Moderna in SEC submissions in 2020) regarded them as gene therapies which require a wider range of testing? Who decided this and when ?The consequential lack of pharmacokinetic and toxicity testing appears material given the high serious adverse event rate.
2What is MHRA’s assessment of where the synthetic mRNA goes in the body and for how long it persists ? When did MHRA make this assessment ? What is the evidence relied upon ?Independent evidence is that mRNA distribution is more widespread, and persists longer, than MHRA claims.
3What was MHRA’s assessment of ‘Number Needed to Vaccinate’ (NNV), by age group, in December 2020 ?NNV is extremely important when assessing the benefit/risk ratio (and therefore the safety) of a vaccine. The published NNV in Spring 23 were very high for younger age groups – ie little/no benefit
4What is MHRA’s quantitative benefit/risk assessment in relation to licensing Covid vaccination of children, pregnant women and those of reproductive age ? [For the avoidance of doubt, this is about MHRA’s licensing as safe (‘benefits outweigh the risks”), not what the JCVI might subsequently decide]Younger age groups were at extremely low absolute level of risk from Covid. The Covid vaccines were licensed for pregnant women with no long term safety data and contrary to precedent.
5When did human testing start of Pfizer’s ‘Commercial Supply’ ‘Process 2’ product which was given Temporary Authorisation on 2 December 2020 ? On what evidence did MHRA assess its safety and effectiveness for Temporary Authorisation given that Pfizer’s clinical trials to that point used product manufactured using ‘Clinical Supply’ ‘Process 1’ ? What is/are the reference of the Pfizer report(s) on which MHRA based that assessment?Temporary Authorisation of the Pfizer Covid vaccine (specifically only Batch EJ0553) was given on 2 Dec 20. Batch EJ0553 was produced in Sep 20 using manufacturing ‘Process 2’ whereas Pfizer’s clinical trials had used product manufactured by ‘Process 1’. The implication is that MHRA approved a product made using a different process (P2) from that used in the clinical trials (P1) which would breach pharmaceutical safety requirements and lead to misleading effectiveness data.
6Why was MHRA slower than other national Regulators to react to problems with the AstraZeneca Covid vaccine ? Why did MHRA subsequently give the AZ Covid vaccine Conditional Marketing Approval despite it no longer being in use in the UK? Why has MHRA not withdrawn the license for the AZ Covid vaccine ? Does MHRA still regard it as safe (ie “benefits outweigh the risks”) ?The Minister promised to answer this question (Q9 here)
The implication is that MHRA still regard the AZ Covid vaccine as safe. Is that correct ?
7Why won’t DHSC/MHRA publish the minutes of the Commission on Human Medicines’ Covid-19 Benefit/Risk Expert Working Group and Covid-19 Safety Surveillance Methodologies Expert Working Group ?The minutes should describe MHRA and CHM views about, inter alia, a) the benefit/risk balance for younger ages, effect on transmission, and waning; and b) the effectiveness of its safety surveillance of Covid-19 vaccines. They should be in the public domain for transparency and should certainly be available to the Covid Inquiry.
8Why don’t MHRA define (at the point of licensing) an absolute tolerable rate of fatal/serious adverse events and/or tolerable benefit/risk ratio ?This is best practice in other safety critical sectors.
9Why doesn’t MHRA investigate all individual fatal/serious/paediatric/pregnancy Yellow Card reports for any medicine ? And for all such Yellow Card reports: how many has MHRA investigated ? If batch data, subject age, medical history and/or time interval since administration of the medicine are not included, what steps does MHRA take to obtain this information ? What steps does MHRA take to obtain health records ? Why doesn’t MHRA make any causality assessment ?Investigating individual fatal and serious safety incidents is a fundamental part of safety management in other safety critical sectors.
10What steps has MHRA taken to review data from, inter alia, post-mortem results, NHS data for 999 calls/ICU/Inpatients, cancer registration, pregnancy to investigate any correlation with vaccination status ?Those who have looked find some ‘interesting’ correlations with vaccination status.
11When was the ‘Black Triangle’ added to the Patient Information Leaflets for the Pfizer, AstraZeneca and Moderna Covid vaccines ? If not from Day 1, why not?The black triangle appears not to have been added until months after Covid vaccination started : lack of informed consent. [‘Black Triangle’ means “additional monitoring” – applied to all new drugs, usually for the first 2 years.]
12The FDA reported (page 23 here) : From Dose 1 through the March 13, 2021, there were a total of 38 deaths, 21 in the COMIRNATY group and 17 in the placebo group. None of the deaths were considered related to vaccination.” What was MHRA’s assessment of the causes of death ?Did MHRA check ?
13What advice did MHRA provide to CMO(England) & DepCMO(England) in relation to Temporary Authorisation of each of the Covid vaccines ?MHRA says that it can’t find Dame June Raine’s replies to the letters from DepCMO(E) Prof Van Tam which sought that advice. Yet they are fundamental parts of the audit trail leading to Regulation 174 approval.
14What steps has MHRA taken to re-examine the Yellow Card database for the safety signals missed prior to its changes in Disproportionality Analysis in 2022 for both non-Covid vaccines and Covid vaccines (documented here)MHRA changed its statistical analysis methods in 2022 after realising it had missed potential safety signals.
15Did MHRA or DHSC conduct any safety impact assessments of MHRA’s Operational Transformation Programme (including the associated reorganisation and manpower reduction) ? Similarly for MHRA’s 20% vacancy rate in 2022 ?Safety impact assessments are best practice in other safety critical sectors when the organisation makes significant changes.
16Does the MHRA think that any of the following would improve its safety management: An independent safety audit (not the Quality audit it relies upon) Removing organisational separation between Licensing and Pharmacovigilance Introducing senior management governance of safety of products Introducing personal safety delegations to individuals responsible for signing off drug licenses Organisational separation between those responsible for a) Regulatory standards (rule-making/enforcement) and b) product licensing and pharmacovigilance (ie not both under MHRA)Those principles are best practice in other safety critical sectors. What is MHRA’s justification for not doing them ?
17Why is MHRA not part of the process for assessing claims under the Vaccine Damage Payment Scheme? For how many claims under the VDPS are there corresponding YC reports? If the answer is less than 100%, does MHRA agree that there is potential for missed safety signals from its Disproportionality Analysis ?It seems odd that the body which licenses medicines on behalf of the Secretary of State for Health has no involvement in assessing claims against the vaccine.