Have almost 50 people died in NI because of a Covid-19 vaccine?

• This claim misrepresents data from the Yellow Card reporting system for suspected adverse reactions to Covid-19 vaccines

• A Yellow Card report about a fatal outcome is NOT the same as a death where vaccines have been confirmed as a factor

• However, a closer look at official figures reveals how confusing and incomplete publicly-available information can be

On 10 January, DUP MLA Paul Frew tweeted:

“[We] know, according to MHRA that 47 people in NI died from vaccine injury up to 29th sept 22 this may be under reported as suggested by MHRA”

Mr Frew based his claim on information that was released following a Freedom of Information request made to the Medicines and Healthcare products Regulatory Agency (MHRA).

However, the MLA incorrectly presented what the data said due to a misrepresentation about what the Yellow Card scheme is and does – namely, that it is a system that allows any individual or family to self-report suspected adverse reactions to a Covid-19 vaccine.

A Yellow Card report is not confirmation of any incident of vaccine injury including, as with these cases, any deaths where the vaccine may have been an underlying factor.

For that reason, this claim is inaccurate.

FactCheckNI also took a closer look at what information is publicly available from MHRA. The organisation makes a large amount of data available, but could present it more clearly.

Misrepresentation

Following the claims made by Mr Frew, the MHRA said:

“As of 29 September 2022, 47 reports from Northern Ireland of possible reactions relating to the COVID-19 vaccines had been submitted to us where there was a fatal outcome.”

“These reported reactions have not been proven to be related to the vaccine and should not be interpreted as such. While each fatal report is evaluated in depth, we do not determine the cause of death and this is instead the responsibility for a Coroner.”

“We also did not state that there had been under-reporting of possible fatalities relating to the COVID-19 vaccines, only that Northern Ireland may not have been labelled correctly as a location on some of the reports submitted to us and therefore would not have been included in the number of reports provided for Northern Ireland specifically.”

This statement was issued to Northern Ireland journalist Amanda Ferguson shortly after Mr Frew made his claims. The inaccuracy of the MLA’s claim was subsequently reported widely in local media.

FactCheckNI decided to dig deeper into what information is made available by MHRA, including comparing the figures within the FoI to data the organisation itself makes publicly available.

Available information

MHRA has a dedicated webpage about its Yellow Card scheme and includes a clear explanation of why incidents recorded via this scheme should not be taken as a confirmed case of vaccine injury or death.

The same page also contains some data about Yellow Card reports “with a fatal outcome” – i.e. suspected adverse reactions (ADRs) where an individual has died at some point following receipt of a vaccine dose. At the time of writing (14 February), the latest version of the report states:

“The MHRA has received 23 UK reports of suspected ADRs with a fatal outcome to the bivalent COVID-19 Pfizer/BioNTech vaccine and 40 reports of suspected ADRs with a fatal outcome for the bivalent COVID-19 vaccine Moderna . The MHRA has received no UK reports with a fatal outcome for COVID-19 Vaccine Novavax.”

These figures indicate that a total of 63 ADRs with a fatal outcome have been received by MHRA from across the UK. However, these data in fact only covers a relatively short period since the Yellow Card summary reporting changed at the beginning of this year “to focus on the COVID-19 vaccines administered from the beginning of the Autumn 2022 booster campaign”.

To get a complete overall picture, these newer updates can be placed alongside data from the final summary report in the previous format or via archive analyses.

The final report in the previous format, published December 2022, has a more in-depth look at ADRs including comparative tables where different types of suspected ADRs are broken down by various other factors, such as age. That report also notes:

“The MHRA has received 857 UK reports of suspected ADRs to both COVID-19 Pfizer/BioNTech Vaccines in which the patient died after vaccination, 1,334 reports for the COVID-19 Vaccine AstraZeneca, 111 reports for both COVID-19 Vaccines Moderna and 60 reports where the brand of vaccine was unspecified. The MHRA has received no fatal UK reports for COVID-19 Vaccine Novavax.”

Those figures indicate a total of 2,362 Yellow Card reports involving a fatal outcome were received prior to the Autumn 2022 booster programme – meaning, when combined with the latest summary reports, a total of 2,425 ADRs with a fatal outcome have been received by MHRA.

This information could be presented both more simply and in a more accessible fashion, without the need to juggle various websites to build a comprehensive picture.

The data itself relies on an open system where anyone can make a report. Individual reports themselves can come with incomplete information. This can make both representing or analysing this data more difficult.

MHRA does not routinely publish figures from ADRs with a fatal outcome broken down by the four different nations within the UK. We asked about the reason for this, and MHRA  said:

“… we do not break down every analysis by country because the accuracy of regional data relies on the postcode being correctly provided by the reporter in the original Yellow Card. A postcode is not mandatory when submitting a report, so it is not available for all reports. Additionally, reports received indirectly from pharmaceutical companies do not include the reporter address details and therefore are not included in this regional data.”

MHRA provided FactCheckNI with a geographical breakdown of ADRs with a fatal outcome, correct for the period up to 25 January this year:

This lists a total of 2,081 ADRs with a fatal outcome – meaning that another 344 (out of the total of 2,425) were not geographically attributable.

Analysing MHRA data for ADRs with a fatal outcome could be easier. However, some of the fuzziness in the data stems from the nature of Yellow Card reporting itself – which is designed to be a quick reporting mechanism, usable by anyone.

Wider context

To illustrate the comparison between Yellow Card reports with a fatal outcome and actual deaths where a Covid-19 vaccine is a factor, it is useful to consider this February 2022 analysis from the Office of National Statistics (ONS) and contemporaneous Yellow Card reporting. At that time, more than 2,000 ADRs with a fatal outcome had been reported to MHRA but in England and Wales – home to a large majority of the UK population – only 15 deaths had occurred where a Covid-19 vaccine was listed as a factor.

In the first six months of the vaccination programme (to June 2021), one death was recorded in Northern Ireland with the vaccine as an underlying cause.

After approval of the first Covid-19 vaccination (1.2), the UK Government amended by regulation the 1979 Vaccine Damage Payments Act to allow for payments under the Scheme for the first time to people aged 21 or over; this specifically provided for a blanket payment of £120,000 (the maximum under the Act) for “probable damage” arising from vaccines against COVID-19. However, “probable damage” requires evidence of meeting 60% of disability criteria, so does not equate directly to injury or harm arising from vaccines.

The British Medical Journal emphasised that establishing a causal link between the vaccines and subsequent harm “is not a straightforward matter”. With regards to assessing fatal outcomes after a report of “vaccine injury”, this is extremely difficult not least because elderly people account for a disproportionate number of vaccines.