FOI release

Freedom of Information request on questions relating to COVID-19 vaccinations (FOI 21/490)

Published 28 June 2021

28th May 2021 FOI 21/490

Dear

Thank you for your email dated 29th April 2021 where you asked a number of questions related to COVID-19 vaccinations to which we have responded below.

1. On what date will the iDAPs be published and provided?

Unfortunately, we are unable to provide an exact date as to when iDAPs (interactive Drug Analysis Profiles) will be published. We recognise that there is strong interest in seeing this data and accept it should not be withheld. Please be assured that we will send you the link to the iDAPs as soon as they are available. In the meantime, you may wish to view the COVID-19 vaccines summary of Yellow Card reporting alongside the Vaccine Analysis Prints which contain a complete listing of all suspected adverse reactions that have been reported to the MHRA via the Yellow Card scheme for COVID-19 vaccines.

1. Is anyone monitoring the combined deaths and severe reactions data of the USA, the UK, and the European Union, associated with the temporary emergency vaccines due for full research outcomes at the end of December 2022/January 2023? If not, why are we not accurately monitoring this information and why is this not being fully published in the UK?

The MHRA is working closely with its international counterparts including the EMA (European Medicines Agency) to monitor the global safety experience of COVID-19 vaccines. During our signal detection activities, we take into account the international experience based on data from other countries using the same vaccines. For further information on how we use and assess the data we collect please view our COVID-19: vaccine surveillance strategy - GOV.UK (www.gov.uk).

Additionally, the MHRA is only able to publish data that we collect and hold, therefore we would be unable to publish other international regulators’ data.

1. At what medical research stage and mathematically is it calculated decided by the MHRA that the risk of very severe outcomes and death in the UK far out ways the medical benefits of the COVID-19 vaccines?

2. At what medically calculated threshold has this been already assessed, agreed, set and calculated?

Following a thorough review of safety, quality and efficacy information from clinical trials, the vaccines showed very high levels of protection against symptomatic infections with COVID-19. Following widespread use of these vaccines across the UK, the vast majority of suspected adverse reaction reports so far confirm the safety profile observed in clinical trials.

There is currently no defined threshold at which a medicine or a vaccine would be removed from use as many factors have to be taken into account.

Yellow Card reports of suspected ADRs 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 expected, based on what is known on background rates of illness in the absence of vaccination. This aims to account for factors such as coincidental illness. We also consider the clinical characteristics to see if new patterns of illness are emerging that could indicate a new safety concern.

We supplement this form of safety monitoring with other epidemiology studies including analysis of data on national vaccine usage, anonymised GP-based electronic healthcare records and other healthcare data to proactively monitor safety. These combined safety data enables the MHRA to detect side effects or safety issues associated with COVID-19 vaccines. Further information on our strategy to continually monitoring safety of COVID-19 vaccines can be found in the link provided in answer to question 2.

We also work closely with our public health partners in reviewing the effectiveness and impact that the vaccines are having to ensure benefits continue to outweigh any possible side effects. As previously mentioned, we work with our international counterparts to gather information on the safety of vaccines in other countries. We now have very clear evidence from Public Health England (PHE) that both vaccines are highly effective and are contributing to an 80% reduction in hospitalisations.

1. Who in the UK makes these medical decisions, I presume the executive board?

The MHRA is advised by the Commission on Human Medicines, an independent public body that advises ministers on the safety efficacy and quality of medicinal products. The Chair and Commissioners are appointed in accordance with the Code of Practice for Ministerial Appointments to Public Bodies, issued by the Commissioner for Public Appointments. The Chair and Commissioners follow a code of practice, in which they are precluded from holding personal interests.

The CHM is advised by a COVID-19 Vaccines Benefit Risk Expert Working Group and the member ship of the Group is also published in the link provided above.

1. Is this based on world data on Pfizer, Moderna and AstraZenica adverse reactions and deaths or just on UK outcomes?

See response to question 2-5.

1. Please provide me with the number of deaths of vaccinated UK citizens who died within 28 days of their first or second vaccination at home and in hospitals? Also, the age of those persons and vaccine administered, cause of death.

2. Can you advise me if a rolling data review of these persons will be kept during the vaccine research programmes up to December 2022 and January 2023 and beyond?

The MHRA does not hold this information. The MHRA collects information on adverse reactions as well as fatalities to medicines including COVID-19 vaccines. Information on data received via the Yellow Card scheme is published weekly in the link provided in response to question 1. We would suggest these questions be directed to the Office for National statistics (ONS).

Reports received via the Yellow Card scheme can be reported at any time after a suspected side effect has occurred. Additionally, the time frame from when the patient received the vaccine to experiencing a suspected side effect is not always provided by the reporter. We review all reports of death regardless of the time to onset from receiving a medicine or vaccine. All reports including fatalities are kept under continual review throughout the lifecycle of a medicine or vaccine.

1. Please advise me if all the individual consent forms are individually matched against the deceased register data and UK hospital deaths data. Also recording date of death, age, cause of death including Covid 19 and vaccine type administered as a rolling review. If not can you explain why this is not done?

As the MHRA do not hold this information (see response to question 10), we cannot answer this further. Additionally, Public Health England (PHE) are responsible for the vaccine deployment programme which includes consent to vaccinate.

1. Are autopsies being completed on all suspected vaccine linked deaths when doctors enter this as probable cause of death on a medical certificate? Can we have published data on all suspected vaccine linked deaths? If this is not being recorded for research and public data information can you explain why not?

As you will know from the above responses, the MHRA collects data on adverse reactions where a reporter has a suspicion that the medicine or vaccine was the cause. The MHRA routinely follows up on all fatal cases which are reported through the Yellow Card scheme where permission to do so is provided. If a post-mortem is not provided with an initial report, then this request for the information is made where appropriate. All fatal reports submitted via the Yellow Card scheme in association with COVID-19 vaccines are included in the figures presented in the weekly publication and detailed in the analysis prints (link in question 1).

1. Can you please advise me if and when all the above data sets will be published on gov.uk?

As detailed above, there is unfortunately some data we do not hold. We are working hard to make the data on Adverse Drug Reactions to COVID-19 vaccines available and accessible for members of the public. We hope to be able to publish further breakdowns on this data soon along with making iDAPs available for all COVID-19 vaccines currently in use.

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