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The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has acknowledged that it used circular reasoning and lacks documentation to support its explanation why there is a high number of Yellow Card reports related to covid injections. The agency asserted that the increase in reports is due to heightened public awareness, resulting in more people submitting reports than usual.

The MHRA has previously claimed there were a high number of Yellow Card reports relating to covid injections due to a high level of public awareness on reporting the ill effects.

In a recent article, Stephen Feldman highlighted a response to a Freedom of Information Act (“FoI”) request that revealed the MHRA used circular reasoning to make this claim.  On 9 February, the FoI Team for the MHRA’s Safety and Surveillance said:

The statement made by the MHRA concerning high public awareness of the Yellow Card scheme and the reporting of suspected reactions was inferred from the number of Yellow Cards received reporting suspected side effects to the covid-19 vaccines.

FOI 24/099, MHRA, 9 February 2024

The MHRA has admitted that they began with what they are trying to end with.  They wanted the high level of Yellow Card reports to be due to the high level of public awareness.  So, they used the high level of Yellow Card reports to claim there was a high level of public awareness, which resulted in a high level of Yellow Card reports – circular reasoning.

The MHRA’s Yellow Card scheme is a mechanism by which anybody can voluntarily report any suspected adverse reactions to covid injections. Reports to the scheme are known as suspected adverse drug reactions (“ADRs”). Its purpose is to provide an early warning that the safety of a product may require further investigation. Reports can be made for all medicines including vaccines, blood factors and immunoglobulins, herbal medicines and homeopathic remedies, and all medical devices available on the UK market.

Since January 2023, the MHRA revised the format of the Summary of Yellow Card reporting to focus on the covid “vaccines” administered from the beginning of the Autumn 2022 booster campaign.

There are two important aspects to keep in mind as we work through the MHRA correspondence: the staggering number of Yellow Card reports and the degree of under-reporting.

In response to a FoI in December 2020, the FoI Team for the MHRA’s Vigilance and Risk Management of Medicines Division team said:

Our past experience with other new immunisation campaigns is that we tend to receive around 1 Yellow Card report per 1,000 doses administered and we are preparing our surveillance systems on that basis.

 FOI 20/461, MHRA, 9 December 2020

Up to and including 23 November 2022, the MHRA “received and analysed” 177,925 (Pfizer/BioNTech), 246,866 (Oxford/Astra Zeneca), 47,045 (Moderna), 52 (Novavax) and 2,130 (brand not specified). The total Yellow Card reports received by the MHRA was 474,018. (Note: this is the number of Yellow Card reports.  A single report may contain more than one symptom or suspected reaction that a particular person is experiencing).

According to the MHRA, by 11 September 2022, 53,813,491 had received one dose and 50,762,968 had received a second dose.  As of 23 November 2022, 40,528,279 had received at least one booster dose.  The maximum number of people who received a covid injection was 53,813,419. The total number of doses administered to a maximum of 54 million people was 145,104,738 doses.

Based on the number of people who had received a “vaccine,” 8 people per 1,000 people vaccinated submitted a Yellow Card report. Based on the total doses, there were 3 Yellow Card reports per 1,000 doses. 

However, according to the MHRA, previous immunisation campaigns had shown around 1 Yellow Card report per 1,000 doses administered. So, as Stephen Feldman noted, that put the MHRA in a real corner.

As early as August 2021, the MHRA began re-framing the high level of Yellow Card reports as being under-reported by an “unknown” amount and “influenced by public awareness.” 

In response to a FoI, the FoI Team for the MHRA’s Vigilance and Risk Management of Medicines Division said:

Although some historical studies have estimated only 10% of ADRs are reported, the actual rate is unknown and variable because it is influenced by public awareness and seriousness of the event. These estimates should not be used as indicators of the reporting rate for covid-19 vaccines, for which there is high public awareness of the Yellow Card scheme and the reporting of suspected reactions.

The MHRA has in place a Yellow Card Strategy to promote the scheme and raise awareness amongst healthcare professionals and patients alike … We have worked to ensure that people know to report suspected side effects to the Yellow Card scheme. In addition to social media campaigns, we have issued a Drug Safety Update, a press release, and embedded information about Yellow Card reporting into healthcare professionals training materials to enable us to rapidly identify new and emerging side effects. The general public have also been encouraged to report any suspected side effects to the vaccine to the MHRA via a Yellow Card on the recent televised press briefings and vaccination materials signpost individuals to the Coronavirus Yellow Card reporting site.

FOI 21/872, MHRA, 20 August 2021

The estimated 10% of ADRs reported that MHRA is referring to relates to serious ADRs.  In May 2019, the MHRA published a request to help reverse the decline in reporting of suspected ADRs.  It stated:

It is estimated that only 10% of serious reactions and between 2 and 4% of non-serious reactions are reported.

Yellow Card: please help to reverse the decline in reporting of suspected adverse drug reactions, MHRA, 17 May 2019

Stephen Feldman wrote that there have been over 360,000 injuries reported to the Yellow Card scheme that are classified as serious. “That presented a problem [for the MHRA],” he said.

We haven’t verified the total number of serious ADRs reported but to gauge the accuracy of the figure Feldman quoted, below is a graphic of “serious” and “serious with a fatal outcome” for the Pfizer/BioNTech covid “vaccine” alone.

Because of the 90% under-reporting, if 360,000 serious ADRs have been reported to the Yellow Card scheme, and that number represents only 10% of serious ADRs, then somewhere in the region of 3.6 million serious ADRs could have actually resulted from covid “vaccines.”

To overcome that the 360,000 serious ADRs reported may indicate 3.6 million serious ADRs according to their estimates, the MHRA reasoned that the reported number for covid vaccines is high due to the high level of public awareness and reporting of suspected reactions.

“People were not being injured in these huge numbers according to the MHRA, they were just reporting more,” Stephen Feldman wrote.

Unfortunately for the MHRA, their response on 9 February 2024 to FOI 24/099 has revealed their excuse as faulty. 

Beginning with a quote from a previous response from the MHRA to Dr. Tess Lawrie, the FoI requested:

“With regards to your points on under-reporting in pharmacovigilance data, the reporting rate for ADRs is variable and can depend on a multitude of factors. These estimates should not be used as indicators of the reporting rate for covid-19 vaccines, for which there is high public awareness of the Yellow Card scheme and the reporting of suspected reactions.” [Quoted from a previous response from Dr. June Raine, MHRA Chief Executive Officer, to Dr. Tess Lawrie on 22 July 2021]

Where the MHRA claims “there is high public awareness of the Yellow Card scheme and the reporting of suspected reactions” please provide the evidence held by the MHRA at the time of the letter (up to 22 July 2021) in support of this claim.

FOI 24/099, MHRA, 9 February 2024

The MHRA responded:

The MHRA do not hold a specific document for disclosure that could be provided in response to this request. The statement made by the MHRA concerning high public awareness of the Yellow Card scheme and the reporting of suspected reactions was inferred from the number of Yellow Cards received reporting suspected side effects to the covid-19 vaccines.

FOI 24/099, MHRA, 9 February 2024

The MHRA has no documentation to support its claim because the MHRA simply inferred a high level of reporting due to a high level of public awareness, which in turn was the cause of the high level of reporting. As we said at the beginning of this article, it’s circular reasoning. The MHRA has admitted that they began with what they are trying to end with.

In Stephen Feldman’s opinion, “The high public awareness and the reporting of suspected reactions was not inferred, it was chosen. Their narrative has now been demolished. It is now time to hold the MHRA and their staff to account.”

We might add: How the hell did they think they would get away with this?

You can read Stephen Feldman’s article HERE.

Featured image: June Raine made DBE in New Year Honours, University of Oxford (right)