The following is an email response from the MHRA regarding a series of questions I posed them about vaccine injuries and deaths. Their answers (below) have prompted a follow-up email to them which is also included in this blog post.
Subject: Freedom of Information Act Request
From: Bob Fiddaman
To: info@mhra.gov.uk
According to your weekly records, accessed 21 Dec, 2021 -
https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting
As of 8 December 2021, for the UK, 141,866 Yellow Cards have been reported for the COVID-19 Pfizer/BioNTech Vaccine, 239,314 have been reported for the COVID-19 Vaccine AstraZeneca, 22,270 for the COVID-19 Vaccine Moderna and 1,333 have been reported where the brand of the vaccine was not specified.
For the COVID-19 Pfizer/BioNTech Vaccine, COVID-19 Vaccine AstraZeneca and COVID-19 Vaccine Moderna the overall reporting rate is around 3 to 7 Yellow Cards per 1,000 doses administered.
In the week since the previous summary for 1 December 2021 we have received a further 2,603 Yellow Cards for the COVID-19 Pfizer/BioNTech Vaccine, 673 for the COVID-19 Vaccine AstraZeneca, 1,750 for the COVID-19 Vaccine Moderna and 26 where the brand was not specified.
*1.* Of the 141,866 Yellow Cards have been reported for the COVID-19
Pfizer/BioNTech Vaccine, how many have been:
A: Fatal
B: How many of the fatal reports did the MHRA follow-up with the reporter
C: What test, if any, was carried out to determine whether or not the
vaccine was the cause of death or not
*2.* Of the 239,314 that have been reported for the COVID-19 Vaccine
AstraZeneca, how many have been:
A: Fatal
B: How many of the fatal reports did the MHRA follow-up with the reporter
C: What test, if any, was carried out to determine whether or not the
vaccine was the cause of death or not
*3.* Of the 22,270 that have been reported for the COVID-19 Vaccine
Moderna, how many have been:
A: Fatal
B: How many of the fatal reports did the MHRA follow-up with the reporter
C: What test, if any, was carried out to determine whether or not the
vaccine was the cause of death or not
*4.* Of the 26 that have been reported where the brand was not
specified, how many have been:
A: Fatal
B: How many of the fatal reports did the MHRA follow-up with the reporter
C: What test, if any, was carried out to determine whether or not the
vaccine was the cause of death or not
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*Bob Fiddaman*
Author/Blogger/Researcher
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From: Pharmacovigilanceservice <Pharmacovigilanceservice@mhra.gov.uk>
To: "fiddamanwork@gmail.com" <fiddamanwork@gmail.com>
CC: MHRA Customer Services <MHRACustomerServices@mhra.gov.uk>, FOI_Policy <FOI_Policy@mhra.gov.uk>
Subject: RE: FOI 21/1342 CSC 81313 Freedom of Information Act Request
Dear Mr Fiddaman,
Thank you for your FOI request dated 21st December 2021.
The number of fatal reports is included in the Vaccine Analysis Prints published each week. Please note that a report of a suspected ADR to the Yellow Card scheme does not necessarily mean that it was caused by the vaccine, only that the reporter has a suspicion it may have. Underlying or previously undiagnosed illness unrelated to vaccination can also be factors in such reports. The relative number and nature of reports should therefore not be used to compare the safety of the different vaccines. All reports are kept under continual review in order to identify possible new risks.
https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions
All Yellow Card reports we receive are promptly entered onto the MHRA's Adverse Drug Reaction (ADR) database so that they are available for a process called signal detection. During signal detection, reports are evaluated, together with additional sources of evidence, by a team of safety experts to identify any new safety issues or side effects. We apply statistical techniques that can tell us if we are seeing more events than we would expect to see, based on what is known about background rates of illness in the absence of medication or vaccination. This aims to account for factors such as coincidental illness. We also look at the clinical characteristics to see if new patterns of illness are emerging that could indicate a new safety concern.
For the COVID-19 vaccines, we supplement this form of safety monitoring with other epidemiology studies, including data analysis on national vaccine usage, anonymised GP-based electronic healthcare records, and other healthcare data to proactively monitor safety. These combined safety data enable the MHRA to detect side effects or safety issues associated with COVID-19 vaccines. As well as confirming new risks, an equally important objective of monitoring will be to quickly rule out risks - in other words, to confirm that the vaccine is not responsible for a suspected side effect and to provide reassurance on its safety. We also take into account the international experience based on data from other countries using the same vaccines. For further information on how we use the data we collect, please view our COVID-19: vaccine surveillance strategy.
As with any serious suspected ADR, reports with a fatal outcome are fully evaluated by the MHRA to consider whether the medicine or vaccine may have caused the event or whether the event and fatal outcome were likely to be purely coincidental and due to underlying illness. To ensure the comprehensive assessment of fatal reports, we follow-up all fatalities where necessary for further information.
As mentioned above, for all the fatal reports concerning COVID-19 vaccines, a follow-up letter is sent to the reporter to request further information, including a copy of the Post Mortem (PM) report and the certified Cause of Death. Once we receive this follow up information, it may change the classification of the case. In some instances, the reporter may not consider the death to be related to the COVID-19 vaccine. The classification of these cases would therefore be amended within our database and these updates reflected in the following weekly Coronavirus ADR publication.
Kind regards,
FOI Team
Vigilance and Risk Management of Medicines Division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
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Follow-Up response
From: Bob Fiddaman
To: Pharmacovigilanceservice <Pharmacovigilanceservice@mhra.gov.uk>
Thank you for this information.
As a follow-up question, I am interested in the following paragraph you wrote me:
"As mentioned above, for all the fatal reports concerning COVID-19 vaccines, a follow-up letter is sent to the reporter to request further information, including a copy of the Post Mortem (PM) report and the certified Cause of Death. Once we receive this follow up information, it may change the classification of the case. In some instances, the reporter may not consider the death to be related to the COVID-19 vaccine." "The classification of these cases would therefore be amended within our database..."
Questions under the terms of the FOIA
1. Is a follow-up question/s sent to every single person who reports (via the yellow-card reporting system) an adverse reaction to the vaccine?
2. Is it the position of the MHRA that a UK citizen can determine whether or not an injury was caused by a pharmaceutical product?
Sincerely,
Bob Fiddaman
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I'll let you know when/if they respond
Bob Fiddaman
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