In August 2023 we published this article describing Cheryl Grainger’s tenacious attempts to get MHRA to release the data it has been holding for 3 years now about the 2000 pregnant women who were vaccinated in the first half of 2021 who the MHRA were supposed to have been monitoring. The MHRA refused to release the data, citing exemption under Section 22 of the FOI Act; this exemption applies when a ‘future’ report is ‘planned’ to be issued containing the relevant information. They provided no date for when this ‘future’ report might be published. Consequently Cheryl wrote the following letter of complaint to the Information Commissioner’s Office:
RE: Challenge of MHRA & FOI 23/280
I originally sent a FOI Request to the MHRA on 13th April 2023, which received a belated response on 19th July, claiming exemption under Section 22 (information held with a view to its future publication). I replied asking when and where the MHRA were publishing these results.
I sent an Application for Internal Review on August 30th, and it was dated 20th September 2023, but I did not receive until 25th September 2023. I attach these documents.
I remain dissatisfied with the outcome of the internal review and am applying directly to the Information Commissioner for a decision.
The special case for drug use in Pregnancy.
Thalidomide and the teratogenicity caused, forced governments and medical authorities to review their pharmaceutical licensing policies. As a result, changes were made to the way drugs were marketed, tested, and approved both in the UK and across the world. There were two key changes with drugs intended for human use:
They could no longer be approved purely based on animal testing.
Drug trials for substances marketed to pregnant women had to provide evidence that they were safe for use in pregnancy.
The 1968 Medicines Act was passed because of the thalidomide scandal and eventually leading to the formation of the MHRA which replaced the Medical Control Agency and Medical Devices Agency, in 2003.
The Yellow Card Scheme, run by the MHRA, originally for health care professionals and now including the public, to share side effects of medications prescribed through paper forms or online. The MHRA publish regularly the Yellow Card Data and the purpose of the scheme is to provide an early warning that the safety of a product may require further investigation.
The MHRA’s responsibilities
Regulates medicines with standards of safety, quality, and efficacy.
Promotes international standardisation & harmonisation to assure the effectiveness and safety of biological medicines.
Educates about risks and benefits, leading to safer & more effective use.
The Covid-19 vaccines were first used in December 2020 and the Yellow Card Scheme was reporting in summary every two weeks until September 2022 and then changed to the Interactive Analysis Print (IAP). Pharmacovigilance is an important role of the MHRA.
MHRA state the following, without investigation or proof of causality:
The existence of an adverse reaction report does not necessarily mean that the vaccine has caused the reaction.
Sometimes, reactions can be part of the condition being treated rather than being caused by the vaccine.
Many factors have to be considered when assessing whether a vaccine has caused a reported adverse reaction.
It is important to note that most people receive vaccinations without having any serious side effects.
Causality of adverse drug reactions and death to the Covid-19 vaccines can be shown by meeting all Bradford-Hill criteria. The MHRA have not done this.
FOI 23/280 referred specifically to the Yellow Card Vaccine Monitor (YCVM). Unlike the Yellow Card, this Monitor has the participant’s data, detailed vaccination data, recordings of any symptom related to the vaccines, recorded over regular follow-up dates.
The Monitor states on sign up:
Register by providing your details. Please fill in as much information as possible. If you don’t know the exact details, please provide what you can to help us with our analysis.
Once you’ve been vaccinated, we will ask you to tell us the COVID-19 vaccine brand name and batch number. Please write down these details, if you can, when you receive the vaccine. You can still participate if you do not know this information.
We will then contact you by email, SMS or pop-up notification to ask if you’ve had any symptoms that you believe are related to the vaccine.
We will follow up with you every few weeks to begin with and we will follow-up with you less frequently after.
The YCVM is part of our long-established UK Yellow Card system for collecting and monitoring information on suspected safety concerns involving medicines and medical devices. This links into Yellow Card data which it appears to be a part of as the privacy policy shows. MHRA refer to the YCVM as a novel technology and methodology – it might be to them but many have used monitoring processes for years.
Normally, for any medication to be used in pregnancy it must be tested thoroughly and over the long-term. There was no long-term data for the Covid-19 vaccines for anyone, let alone pregnant women.
The present position stated by the MHRA is that the MHRA closely monitors the safety of COVID-19 vaccine exposures in pregnancy, including published (8.3.23) information as well as Yellow Card reports for COVID-19 vaccines used in pregnancy.
The current advice of the Joint Committee on Vaccination and Immunisation (JCVI) is that the COVID-19 vaccines, including booster doses, should be offered to those who are pregnant as a clinical risk group in the COVID-19 vaccination programme and can be given at any stage in pregnancy.
Contrast this with the information presented for license for Pfizer Covid-19 vaccine. The Pfizer Document Analysis on court released data submitted for license application by the FDA, shows that at application there were known effects on fertility, pregnancy, embryo, or offspring development. This license application data is the same information the MHRA received in September 2020.
In reply to my FOI request, the MHRA have sent an interim report on the full YCVM, including pregnant women, that they presented to the Pharmacovigilance Expert Advisory Group (PEAG) in July 2021. These are results that they have known for 2.5years.
Statement: The use of the YCV Monitor, especially for Pregnant Women, has thrown up vital information re ADRs reported in pregnancy.
This interim review has been analysed by Prof Norman Fenton, a mathematician who is a world leading expert on risk assessment and statistics with a focus on Bayesian probability. His report shows that the MHRA data supplied includes 1366 pregnant women in the YCVM and 565 reported Adverse Drug Reactions (ADRs). “Of those who received the Astra-Zeneca vaccine a whopping 66% (124 out of 203) reported at least one ADR; 38% of the Pfizer recipients and 61% of the Moderna recipients reported at least one ADR”.
These results were known by MHRA in July 2021, over two years ago, and contradicts the SmPC which MHRA updated on 5/6/2023: “There were no vaccine-related effects on female fertility, pregnancy, or embryo-foetal or offspring development.”
Why has the YCV Monitor data not been published in the same way that Yellow Card Reports are published regularly by the MHRA on their website.
Why does it need a peer review, which is used to validate research when this is real time data?
Why does the MHRA not acknowledge the high level of ADRs in this Monitored pregnancy group (a vulnerable, special group that needs protecting), as a strong signal that needs investigating?
Why is it acceptable for pregnancy data to not be disclosed, analysed, and acted on until after publication (which could be more than 3+years) after the data was known?
Why do they feel the need to publish in a peer reviewed journal?
What happens if the data never gets published? This is now taking the time it took to identify the injuries and deaths of Thalidomide and that was before the digital age.
Why is this information not available like the Yellow Card Reports which are published on the MHRA’s website regularly.
How can it be right that it is sufficient for there to be an ‘intent to publish’ to refuse the request and with-hold this information from pregnant women that they are charged to protect? They are therefore hiding pregnant women’s data, that is indicating potential harm, which is scandalous.
How many pregnant women have been vaccinated whilst we wait for the results to be published? We are talking about the % chances of damage to pregnant women, foetuses, and babies.
They state that the Monitor shows answers to all the pregnancy outcome information I requested but because of the timing of the report to the PEAG there is only minimal information on the pregnancy outcomes (only 6 births in total had been recorded by 30 June 2021). We need to see the answers to each of my questions.
What has happened to pharmacovigilance when the MHRA are stating that pregnant women should still be vaccinated even though they have their own Monitor data that indicates harm?
Finally, their Internal Review states: “The response explained that it was reasonable and not in the public interest to release this data ahead of publication because information on use of covid-19 vaccines during pregnancy is already in the public domain in our Summary of Yellow Card reporting publication”. Comments on safety in specific populations 8.3.23
How can this be right when the data they have from the Monitor by its very nature more accurate than information randomly received via Yellow Card, is showing very strong patterns of adverse drug reactions in high percentages of patients?
I believe there is a very strong public need to have this information which is available, released for the protection of anyone who is pregnant and to update the advice given, based on this available data.
Yours sincerely
Cheryl Grainger BSc
Cheryl has finally received the following disgraceful response from the Information Commissioner’s Office:
So, although the ICO (in point 27) rapped MHRA’s knuckles over their failure to respond within the mandatory period required for FOI’s, the ICO upheld the MHRA response to delay publication until it is ‘peer reviewed’ (something that is by no means guaranteed to ever happen). Yet this data should be more accurate than their normal Yellow Card data, which they didn’t have any problems publishing.
Cheryl questions some specific points in the response:
17. It added that it already has publicly available information on its position on the use of COVID-19 vaccines for those who are pregnant, and that this position was based on analysis of all Yellow Card data, as well as relevant data from other sources, rather than only on the subset of data for the YCVM to which the request relates. But it contradicts the information that the more accurate interim report shows that we analysed earlier.
19. “…….the first time Yellow Card Vaccine Monitor (‘YCVM’) has been used, and it is a novel technology and methodology.”
They anticipated that the requested information would be published in late 2023 or 2024. V-safe in the US was the same technology, and it has been made to be released. Why did they shut down the Monitor within 7 months? This data has been recorded since mid 2021.
20. Independent peer review? Who?
If the reports are as bad as in the interim report these vaccines should not be used in the pregnant and then the MHRA should stop it.
There was information in the Pfizer Document Analysis Reports 7,13,40,46,48,83 (https://www.ukcolumn.org/series/uk-situation-room-pfizermoderna-document-analysis), which MHRA should have been aware of on analysis of data for license.
21. My fault as I asked, in their opinion for answers to too specific questions! They said most of my questions could be answered yes or no – I disagree.
It explained that the disclosure of aggregate data and answers to narrow questions in isolation without a full discussion of the methods of data capture and the limitations of the data provided could lead to misinterpretation, which could in turn lead to unnecessary concern on the safety of vaccination within a vulnerable population. Isn’t this what they have done – they have released an interim report without the details?
22. Is the availability of safety data on pregnant women already in the public domain to support healthcare professionals and members of the public to make informed decisions regarding use of Covid-19 vaccines? I challenge that the MHRA safety data in pregnancy already published and distributed is not accurate and the MHRA is supposed to provide evidence that they were safe for use in pregnancy (Key point Medicines Act 1968). Again see 20.
25. “There is a public interest in transparency but, in this case, there’s greater public interest in allowing the MHRA to publish the requested information to its planned schedule……to reduce the risk of misinformation and people becoming concerned unnecessarily.” I have no words!!!!!
The public are being misinformed as they are not being given up to date information as it is being withheld and when they find out the risks in pregnancy, they will be very concerned and annoyed they were not informed.
It is not clear if there is any point in taking this further to appeal, but the public needs to know about the continued refusal by MHRA to release this data and whether they are hiding something.
Click this link for the original source of this article.
Author: Norman Fenton
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