FOI release

Freedom of Information request on how many of these deaths does your team consider were primarily caused by a COVID vaccine (FOI 21/1239)

Published 31 May 2022

FOI 21/1239

15th December 2021

Dear

Thank you for your follow up email dated the 16th November and please accept my apologies that you do not feel we fully answered your questions in our original email.

1) How many of these deaths does your team consider were primarily caused by a covid vaccine? None? One? Two? Or more? Is anyone connected to MHRA actively researching the causes of these deaths or are you all simply passively monitoring these numbers?

The Yellow Card scheme is a mechanism by which anybody can voluntarily report any suspected adverse reactions or side effects to any medicine or vaccine. It is very important to note that submission of a Yellow Card report does not necessarily mean the medicine or vaccine caused that reaction or event. We ask for any suspicions to be reported, even if the reporter isn’t sure if it was caused by the vaccine. Reports to the scheme are known as suspected adverse drug reactions (ADRs).

Many suspected ADRs reported on a Yellow Card do not have any relation to the vaccine or medicine and it is often coincidental that symptoms occurred around the same time as administration. Please be assured that all reports are continually reviewed to detect possible new side effects that may require regulatory action, and to differentiate these from things that would have happened regardless of the vaccine or medicine being administered, for instance due to underlying or undiagnosed illness.

It is therefore important that the suspected ADRs described in the weekly summary are not interpreted as being proven side effects of COVID-19 vaccines and that any deaths are not proven to be related. Details of our proactive vigilance strategy for COVID-19 vaccines can be found here.

The majority of the fatal reports were in elderly people or people with underlying illness. Usage of the vaccines has increased over the course of the campaigns and as such, so has reporting of fatal events with a temporal association with vaccination. However, this does not mean that there is a link between vaccination and the fatalities reported. Review of specific fatal reports is provided in the summaries here https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting. The pattern of reporting for all other fatal reports does not suggest the vaccines played a role in these deaths.

Part of our continuous analysis includes an evaluation of natural death rates over time, to determine if any specific trends or patterns are occurring that might indicate a vaccine safety concern. Based on age-stratified all-cause mortality in England and Wales taken from the Office for National Statistics death registrations, several thousand deaths are expected to have occurred, naturally, within 7 days of the many millions of doses of vaccines administered so far, mostly in the elderly.

Whilst all reports with a fatal outcome are fully and continuously evaluated by the MHRA, we do not assign each report a category as to whether the death has been caused by the vaccine therefore we are unable to provide you with this figure.

2) How many reports of fatalities need to occur before you recommend that these injections are paused or halted?

There is currently no defined threshold at which a medicine or a vaccine would be removed from use as many different factors have to be taken into account. The MHRA assesses the benefit risk balance of all medicines and vaccines at the time of initial licensing and throughout their use in clinical practice. The safety of all medicines and vaccines is actively monitored by the MHRA on an ongoing basis through various channels, including the Yellow Card scheme, and the Product Information of the drug is routinely updated with any new relevant information. Where the benefit-risk balance is positive in the approved indication the medicine will retain its market approval.

3) How many reports of fatalities occurred with previous vaccines before those medical interventions were paused or halted?

No vaccine has ever been removed from the UK market due to excessive fatalities. As discussed above, it is not possible to assign a specific number of suspected ADRs or fatal reports which would result in the MHRA taking action due to a number of factors needing to be considered.

4) With regard to children specifically, how will you be monitoring injury and death among children unless you routinely collect and PUBLISH data on ages for every Yellow Card report?

The MHRA collect Yellow Card reports associated with patients of all ages, including children. Age is one the available fields a reporter may fill in when completing a Yellow Card report. In addition to this our assessors routinely follow up for the age of patients where it is helpful for their assessment. The MHRA looks for patterns of adverse drug reactions in the whole population receiving a medicine as well as in indidual subsets including age groups.

Please be assured that the MHRA has a comprehensive surveillance strategy in place for monitoring the safety of the COVID-19 vaccines in children.

Information surrounding suspected side effects reported in individuals under 18 years old can be found in our weekly summary of Yellow Card reporting. We intend to publish all suspected reactions reported in association with available COVID-19 vaccines in an interactive format as interactive drug analysis profiles (iDAPs), along with our ADR summary that is published each week. The use of iDAPs will enable users to view the data by categories of their choice such as age, sex and seriousness of reports, and will be available for each of the COVID-19 vaccine in use in the UK.

5) In your considered opinion as pharmacovigilance experts, how many dead children are too many? Given that perhaps 9 children with no pre-existing comorbidities died of covid in the UK, how many need to die of covid vaccine injury before the risks clearly outweigh any benefit? What is the number of above-average fatalities among children that you will tolerate before you recommend that children should no longer be receiving covid vaccinations?

Please see response to question 2.

I hope the information provided is helpful, but if you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division