Misinformation Monitor (Part 1)
For 4 years the MHRA, our pharmacovigilance agency, have ignored signals from Yellow Card Reports and hidden the Yellow Card Monitor, putting the public at significant risk, failing to protect them.
Cheryl Grainger
"Those who make you believe absurdities can make you commit atrocities".
The Background Story
In November 2022, Dame Raine, former CEO MHRA, presented in Wales and covered the 4 strands of the MHRA's Pharmacovigilance, one being the Yellow Card Vaccine Monitor (YCVM), in which she boasted they had 2000+ pregnant women giving them a denominator for their data analysis.
Curious to know what the pregnancy data showed, I filed an FOI in April 2023, asking the MHRA for the Monitor's pregnancy data via a series of questions. The MHRA refused on the grounds of s22 which was their intension to peer review and publish (with no date given). This led me through the full FOI process which culminated in a First-Tier Appeal of the ICO with the MHRA becoming the Second Respondent.
Why does it need a peer review, which is used to validate research when this is real time data?
There is a special case for drug use in Pregnancy. Pregnancy should be significant to the MHRA. Thalidomide and the teratogenicity caused, forced governments and medical authorities to review their pharmaceutical licensing policies. The resulting 1968 Medicines Act, eventually lead to the formation of the MHRA in 2003. An important change was that drug trials for substances marketed to pregnant women, had to provide evidence that they were safe for use in pregnancy.
2021 was the first time a novel treatment (Covid-19 "vaccines") had been rolled out to the pregnant, at the same time as those who were not pregnant.
The Information Received
PRE-PRINT OF THE MONITOR ANALYSIS
MHRA describes the Monitor as:
Real-time, targeted active monitoring of vaccinees.
With enrolment prior to vaccination and recording of ADRs at set intervals.
Helping to estimate the frequency and long-term outcomes of side effects.
A novel technology and methodology
MHRA state, "The YCVM has played a role in our strategy to rapidly detect, confirm, characterise and quantify new risks, communicating on these as necessary."
Their Pre-Print shows otherwise.
The Monitor completed in December 2022, and the public interest in making this dataset available for unbiased scrutiny is undeniable. The Monitor data should be more accurate than information randomly received via Yellow Card Reports.
How can it be right to take 4 years to Pre-Print the Monitor data, by its very nature more accurate than Yellow Card data, when it is showing very strong patterns of ADRs in high percentages of patients?
My FOI (23-280), resulted in the MHRA publishing their interpretation of the results of the YCVM as a Pre-Print in MedRxiv on 13th November 2024, just before the Appeal hearing date. The information related to the whole of the Monitor and not just the pregnant. The front page:
The MHRA offered answers to my FOI questions, referring to the Pre-Print:
The Monitor Pre-Print does not substantiate the MHRA’s statements, provided as answers to my questions, but highlights significant gaps in the information.
The Pre-print does not provide the evidence of safety.
The Monitor is evidence of potential harm disproportionately affecting a specific group, pregnant women.
The information & interpretation the MHRA provides is misleading, meaningless, underestimated (using estimates instead of actuals) and obfuscated with serious omissions.
The standardisation, systemisation and tracking of participants is lacking.
All the Pre-Print authors are MHRA employees, 86% funded by Pharma. No Conflict of Interests are declared.
Why has the YCV Monitor data not been regularly published in the same way of Yellow Card Reports?
If the MHRA's conclusion is that the vaccines are safe and effective even in pregnancy, then why are the MHRA not publicising their Pre-Print Monitor information?
Why are the MHRA not being transparent as they are withholding this information from pregnant women that they are charged to protect?
THE PUBLISHED MONITOR PRE-PRINT
MHRA’s Claimed Results:
36,604 individuals registered, with 30,281 reporting vaccination.
Median [IQR] follow-up was 184 days [14-367].
15,764 (52.1%) of those reporting vaccination, reported experiencing at least one adverse reaction. But as the MHRA often states, were "expected, acute reactions".
**BUT CAN YOU BELIEVE THEY ACTUALLY STATE...........................
ONLY 4,134 (13.7% = 1 in 7) reported an event considered medically serious.
Please note the Monitor had a sub-cohort of pregnant and breast-feeding patients and also specifically conducted analyses to support regulatory assessment of two safety signals, menstrual disorders, and tinnitus. They state in summary:
The data raised no safety concerns in pregnant and breast-feeding patients.
Reporting of menstrual disorders appeared stimulated by media interest, as seen in spontaneous reporting systems.
Data on the incidence of tinnitus were used to support regulatory action on this signal.
MHRA statement :
The technology developed has enhanced regulatory vigilance options and could be valuable in the future for actively monitoring the safety of innovative products used in small populations.
How many pregnant women have been vaccinated whilst we wait for these results to be published? We are talking about the % chances of damage to pregnant women, foetuses, and babies.
A REVIEW OF MISSING DATA & MISINFORMATION in the MONITOR, negating the MHRA's analysis:
1. Missing and Unreliable Data:
Pregnant Women Follow-up: Pregnant women were only followed up for 73 days (range 5-244), far short of the expected 280+ days.
Trimester Information Missing: In 762 (30%) of cases, the trimester of pregnancy could not be estimated or was unknown.
Spontaneous Abortions: In 2,514 pregnancies, the expected number of spontaneous abortions is 106, but only 19 were known in the Monitor.
Congenital Malformations: No reports of congenital malformations were found in the relevant category (Congenital, Familial, and Genetic SOC).
Serious ADRs: "Only" 13.7% (1 in 7) of adverse drug reactions (ADRs) were reported as serious, downplaying the severity.
Pre-term Births: No pre-term births were reported, but 4 premature births were found in free text fields, the only time free text fields were mentioned.
Breastfeeding ADRs: 53.5% of vaccinated, breastfeeding mothers reported 900 ADRs.
Missing Participants: 1,421 women were missing from the data. They assumed that non-responders experienced no ADRs.
Completeness of Data: Lack of completeness makes it impossible to medically confirm self-reported ADRs.
Monitoring Timelines: Follow-ups occurred only at 1 week, 1 month, 6 months, and then 10 weeks after birth, showing significant gaps in the data.
Loss to Follow-Up: The loss of half of the participants to follow-up is a critical failure.
Inferential Statements: The abstract states, “The data raised no safety concerns,” but given the data gaps, such statements are misleading.
Bias and Self-Selection: The study did not adequately account for potential bias, including self-selection and self-reporting.
Free Text Fields Ignored: Free text field reports were intentionally ignored in the analysis.
Study Design Issues: The study appears to be intentionally designed to under-identify ADRs from an already underreported database.
2. Misrepresentation of Data:
Reported ADRs by Dose:
Doses 1 & 2: After the first dose, 2,156 pregnant women reported 750 ADRs. After the second dose, 991 pregnant women reported 271 ADRs (46% drop).
Dose 3: Only 25 reports after the third dose.
Doses 1 & 2: The same women likely reported for both doses, as pregnancy lasts about 9 months. The total should be 2,555 but the report shows 139 more.
Outcome Reporting Bias: There is an issue with outcome reporting bias, leading to misrepresentation of the risk-benefit ratio of the vaccines. Concealing this information and suppressing public discourse is illegal.
3. Issues of Failure:
Incomplete Data: Information provided in the manuscript does not satisfactorily answer the FOI23/280 questions.
Failure to Collect Critical Data: The manuscript fails to address missing or incomplete data.
Obfuscation of Data: The MHRA continues to obscure data and avoids addressing gaps in reporting.
4. Questions and Concerns Raised:
MHRA’s Failure to Report: The MHRA does not adequately report or evaluate the data collected, which is a public authority duty.
Inadequate Reporting of Research: The data and the way it is reported provide a misleading view of the safety of vaccines during pregnancy.
Misunderstanding of Research Nature: The MHRA treats the study as an extension of spontaneous reporting, not a clinical trial, ignoring warning signals related to women's health.
Public Interest in Data: There is a public interest in obtaining meaningful data to substantiate claims regarding vaccine safety in pregnancy.
Inadequate Pregnancy Data: The pregnancy data presented is incomplete and does not satisfy the FOI23/280 questions.
5. Missing Information in the Report:
Focus on Technology, Not Data: The manuscript focuses more on the technology used for data collection than on the data itself.
Lack of Transparency: There is no clear explanation of how the relevant information was gathered, evaluated, and recorded, leading to a lack of understanding of the data.
YCVM and MHRA Data Interpretation: The MHRA's interpretation of the YCVM data is inadequate and does not answer the original FOI questions.
6. Exemption of Personal Data:
Section 40 and 41 Exemptions: MHRA argued that individual case data may be subject to personal data exemptions (FOIA Sections 40 and 41).
Anonymisation: The data can be easily anonymised and released without breaching data protection laws.
7. Free Text Data Issues:
Free Text Data: The free text data, which contains valuable details, is ignored in the Pre-Print. This data can be anonymised and should be included in the study for completeness.
Risk of Re-identification: MHRA claims that free text data may contain identifiable information, but this data can be anonymised without compromising its value.
8. Loss of Follow-Up Data:
Importance of Follow-Up: Follow-up data, particularly birth outcomes, is critical for understanding vaccine safety during pregnancy.
Half the Participants Lost: Losing half the participants to follow-up is a significant failure and undermines the study’s conclusions.
9. YCVM Warning Signals on Women:
Higher ADRs in Women: Women report more ADRs than men (76% of both serious and non-serious ADRs).
Reproductive System Disorders: Women have significantly more disorders related to the reproductive system than men (98% of such disorders are in women).
Overrepresentation of Women of Childbearing Age: Women aged 20-49 are overrepresented in both serious and non-serious ADR reports.
10. Causality:
Only look at causality if not linked to vaccines: Menstrual disorders are linked in their opinion, to reports in the media.
Tinnitus: will only use the observed : expected measures.
e.g. AZ analysis of tinnitus safety signal:
3,142 cases within 14days of vaccination (38% within 1day) but 10,597 calculated expected cases
Conclusion = No pattern/cluster suggesting any causal association. Therefore, no potential safety concerns.
These absurd calculations stopped recognition till August 2022 (by EMA).
This discussion concludes in Misinformation Monitor (Part 2)