FOI release

Freedom of Information request on the authorisation of COVID-19 vaccinations (FOI 22/521)

Published 22 March 2023

FOI 22/521

24 May 2022

Dear

Thank you for your email dated 06 March 2022 where you asked the following:

1. A clarification of the points raised in the following open letter published online.

2. Is there recorded date to show that Dame June Raine, as CEO of the MHRA, and hence ultimately responsible for its decisions, is fully aware of the data recorded on the Yellow Card system in relation to the Covid-19 vaccines?

3. Is there any recorded data to show whether Dame June Raine consider it necessary to present the public with a full written analysis of the 1,458,428 adverse events relating to the Covid-19 vaccines which are recorded by the Yellow Card system.

4. Is there any recorded data to show that Dame June Raine does not consider the 1,458,428 adverse events recorded by the Yellow Card system serious enough to warrant immediate withdrawal of the Covid-19 vaccines.

5. Please give the duties and obligations of MHRA and what kind of entity it is,and when it started

By way of background it may be beneficial to firstly answer your fifth question. The Medicines and Healthcare Products Regulatory Agency (MHRA) is an executive agency sponsored by the Department of Health and Social Care. The MHRA regulates medicines, medical devices and blood components for transfusion in the UK. The MHRA was formed on the 1 April 2003 after the merger of the Medicines Control Agency (MCA) and Medical Devices Agency (MDA). The MHRA’s responsibilities include ensuring that all medicines (including vaccines), medical devices and blood components meet applicable standards of safety quality and efficacy. For further details of our responsibilities please see our website.

In regard to the points raised in the letter linked in Question 1 above, it would be useful to provide the background of how the MHRA have proactively monitored the safety of the coronavirus vaccines throughout the pandemic. All COVID-19 vaccines currently in use in the UK have been authorised for supply by the MHRA following a thorough review of safety, quality and efficacy information from clinical trials. In clinical trials, the vaccines showed very high levels of protection against symptomatic infections with COVID-19. Data are available on the impact of the vaccination campaign in reducing infections and illness in the UK.

Our role is to continually monitor safety during widespread use of a vaccine. We have in place a comprehensive proactive vigilance strategy to do this. Part of our monitoring role includes reviewing reports of suspected side effects and this has been continuously carried out since the beginning of the vaccination campaign. Any member of the public or health professional can submit suspected side effects through the Yellow Card scheme.

We regularly publish our weekly summary of Yellow Card reporting to ensure the public are aware of what has been reported to the MHRA in association with the COVID-19 vaccines. The publication summarises information received via the Yellow Card scheme as well as other safety investigations we have carried out under the COVID-19 Vaccine Surveillance Strategy. When conducting the safety investigations detailed in this summary, please be assured that we take in to account the age range of the patients who experienced the side effect, any past medical history, time to onset, dose given and reaction outcomes. Within this summary, myocarditis, thrombo-embolic (blood clotting) events with concurrent low platelets, Guillain-Barré Syndrome, use in pregnancy as well as reports with a fatal outcome are discussed in further detail. Alongside the summary report, weekly Vaccine Analysis Prints are also published that contain complete listings of all suspected adverse reactions that have been reported to the MHRA for each COVID-19 vaccine.

To inform its decision-making, the MHRA seeks independent expert advice from the Commission on Human Medicines (CHM). In May 2020, the CHM established an Expert Working Group (EWG), consisting of experts in medicine, infectious disease, pharmacoepidemiology and data analytics to provide the MHRA with independent oversight and advice on its COVID-19 vaccine vigilance activities. The Agency regularly seeks advice from this group, as well as other Expert Advisory Groups (EAGs) such as the Medicines for Women’s Health EAG and Paediatric Medicines EAG when appropriate. This collaborative approach harnesses the collective expertise across the UK public health sector, and makes best use of all the information available to ensure the expected benefits of the vaccines in preventing COVID-19 and serious complications associated with COVID-19 outweigh any currently known side effects.

Vaccination and surveillance of large populations means that, by chance, some people will experience and report a new illness or events in the days and weeks after vaccination. A high proportion of people vaccinated early in the vaccination campaign were very elderly, and/or had pre-existing medical conditions. Older age and chronic underlying illnesses make it more likely that coincidental adverse events will occur, especially given the millions of people vaccinated. It is therefore important that we carefully review these reports to distinguish possible side effects from illness that would have occurred irrespective of vaccination. Fatal cases associated with extremely rare blood clots with lowered platelets are also described within the report.

Usage of the vaccines has increased over the course of the campaigns, to date over 140 million doses of COVID-19 vaccines have been given in the UK, and as such, so has reporting of fatal events with a temporal association with vaccination however, this does not necessarily indicate a link between vaccination and the fatalities reported. With the exception of specific fatal reports, such as those associated with unusual types of blood clots with lowered platelets, review of individual reports and patterns of reporting does not suggest the vaccines played a role in the vast majority of deaths.

Following widespread use of these vaccines across the UK, the vast majority of suspected adverse reaction reports confirm the safety profile seen in clinical trials. Most reports relate to injection-site reactions (sore arm for example) and generalised symptoms such as a ‘flu-like’ illness, headache, chills, fatigue, nausea, fever, dizziness, weakness, aching muscles, and rapid heartbeat. Generally, these reactions are not associated with more serious illness and likely reflect an expected, normal immune response to the vaccines.

The letter also raised concerns specifically about blindness following COVID-19 vaccination. However, our continual review of the Yellow Card reports, and safety data from the vaccine manufacturers and our international counterparts has not identified an association between any COVID-19 vaccine and blindness. However, we continue to keep reports of visual disorders under close review.

Additionally, concerns surrounding miscarriages and stillbirths were also raised. I can confirm that reports of miscarriage and stillbirth following COVID-19 vaccination are also low in comparison to how commonly these events occurred in the UK outside of the pandemic. Further details on our review can be found in our weekly summary of Yellow Card reporting. Although, like most vaccines and medicines, clinical trials of COVID-19 vaccines in pregnant women were not carried out prior to use of the vaccines in the general population, there is now growing evidence from clinical use which provides reassurance on the safety of the vaccines in pregnancy. This adds to the evidence from non-clinical studies of the COVID-19 vaccines which have not raised any concerns about safety in pregnancy. The COVID-19 vaccines do not contain organisms that can multiply in the body, so they cannot infect an unborn baby in the womb.

In the letter attached there were some concerns raised regarding underreporting. 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 televised press briefings and vaccination materials signpost individuals to the Coronavirus Yellow Card reporting site.

The actual rate of reporting is unknown and likely to be highly variable as it will be influenced by public awareness and seriousness of events as well as publicity around the use of vaccines. For the COVID-19 vaccines, there is a higher than normal public awareness of Yellow Card reporting and therefore we can expect the reporting rate for these products to be higher. Please be assured we evaluate all aspects of the data including potential variability in levels of reporting for Yellow Card data as part of our ongoing monitoring procedures. We supplement Yellow Card 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. We also take into account the international experience based on data from other countries using the same vaccines. This is particularly important for vaccinations in children when other countries have chosen to extend their vaccination programme to children at an earlier stage.

Regarding Questions 2,3 and 4, the MHRA can confirm that Dr June Raine is fully aware of the data recorded on the Yellow Card system in relation to the COVID-19 vaccines as she reviews the weekly summary of Yellow Card reporting referenced above ahead of its publication each week. The report is a cumulative summary of all of the Yellow Card reports held on the MHRA database as of that date. Attached is a recent email from Dr Raine, clearing the report for publication.

As mentioned previously the MHRA and Dr Raine, considers it vitally important to publish our analysis of the information reported to the MHRA associated with a COVID-19 vaccination. I would like to assure you that all of the information held by the MHRA is continually reviewed and carefully assessed to ensure the benefits of the vaccine continue to outweigh any risk. The MHRA consider all of the available evidence along with the independent advice from CHM and take action wherever necessary to ensure the safe use of the COVID-19 vaccines. Information is communicated to healthcare professionals and the public. The weekly summary of reporting details information on specific safety issues and where our advice has been updated.

The expected benefits of the vaccines in preventing COVID-19 and serious complications associated with COVID-19 far outweigh any currently known side effects. Over 162,719 people across the UK

have died within 28 days of a positive test for coronavirus. Vaccination is the single most effective way to reduce deaths and severe illness from COVID-19. As with all vaccines and medicines, the safety of COVID-19 vaccines is continuously monitored, and benefits and possible risks remain under review.

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: info@mhra.gov.uk. Please remember to quote the reference number above in any future communications.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division