FOI release

Freedom of Information request on COVID-19 fatality data and COVID-19 vaccines (FOI 21/372 and 21/408)

Published 28 June 2021

7th May 2021 FOI 21/372 and 21/408 Dear

Thank you for your emails to MHRA customer services on 8 th and 12th April 2021, where you asked questions relating to COVID-19 data, including information on the COVID-19 vaccines. Please see our response to the requested information below and please note, we have grouped a few questions together as they either share the same topic or response from the MHRA.

1. Please provide the data regarding recovered people from COVID-19 since March 2020 and list each age group.

2. Please advise ASAP the number of people in the UK who have antibodies against COVID-19?

The MHRA does not hold information relating to the number of people who have recovered from COVID-19 since March 2020 or the number of people with antibodies against COVID-19. Public Health England typically collects and analyses data relating to public health, which would include COVID-19 data; therefore, we would recommend contacting Public Health England (PHE) with this enquiry using the email [email protected]. You can find out more details on the work PHE are currently doing using this link.

1. Please provide the fatality rate from COVID-19 since March 2020, and please list each age group.

Once again, the MHRA does not hold this information; however, you can find information regarding COVID-19-related fatalities on the UK government website using this link.

1. Please provide the data on all fatalities from COVID-19 vaccines in the UK, including the number of days after receiving the vaccines that the fatalities happened and the name of each vaccine fatality.

The MHRA has been proactively monitoring the safety of all approved COVID-19 vaccines for near real-time safety monitoring at the population level. A summary of Yellow Card reporting concerning the COVID-19 vaccines is published each week and can be found here. The summary includes data analysis on reported suspected adverse reactions from the COVID-19 vaccines, including those with a fatal outcome. 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 are therefore unable to provide the information requested. We review all reports of death regardless of the time to onset from receiving a medicine or vaccine.

We follow-up all fatalities where permission has been provided to do so for further information, including the length of time since the deceased received the vaccine if that has not already been provided. As with any serious suspected ADR, reports with a fatal outcome are fully evaluated by the MHRA to consider whether the vaccine (or medicine) may have caused the event or whether the event and fatal outcome were likely to be purely coincidental and due to underlying illness.

You can also find analysis prints which list all reactions reported for each COVID-19 vaccine and indicates if these are reported to be fatal. It is important to note that Yellow Card reports are not proof of a side effect occurring due to a vaccine but a suspicion by the reporter that the medicine or vaccine may have caused the side effect. Some events may have happened anyway, regardless of vaccination. This is particularly the case when millions of people are vaccinated. As the data in the prints do not necessarily refer to proven side effects, you should refer to the product information for these details on possible side effects of each COVID-19 vaccine, which can be found on the Yellow Card coronavirus website here.

1. Please provide the data regarding blood clots reported from all COVID-19 vaccines, and please list each age group of those cases.

2. Please return all data referring to all cases of blood clots, thrombosis, thromboembolic and blood platelet issues following any COVID-19 vaccines in the UK.

3. For each case with these issues, please advise the vaccine brand given and the age of each person.

4. Please also provide data on any people dying from having blood clots. Please include the age of each person and the vaccine brand given.

As you will see from our response to question 4, MHRA publishes a weekly summary of Yellow Card reporting, which can be found here. In this publication, you will find the specific information you have requested surrounding these case reports, including a breakdown of the age and sex of these patients and how many reports were fatal.

The estimated number of first doses of COVID-19 Vaccine AstraZeneca administered in the UK by 28th April was 22.6 million and 5.9 million estimated second doses, giving an overall case incidence of 10.5 per million doses. Taking into account the different numbers of patients vaccinated with COVID-19 Vaccine AstraZeneca in different age groups, there is a higher reported incidence rate in the younger adult age groups compared to the older groups. MHRA advises that this evolving evidence should be taken into account when considering the use of the vaccine. There is now some evidence that the reported incidence rate is higher in females compared to men, although this is not seen across all age groups, and the difference remains small. These reports have also been analysed by the Government’s independent advisory body, the COVID-19 Vaccines Benefit Risk Expert Working Group, which includes lay representatives and advice from leading haematologists.

On the basis of this ongoing review, the advice remains that the benefits of the vaccine outweigh the risks in the majority of people.

Public Health England (PHE) has provided advice on vaccination in different age cohorts in its leaflet on COVID-19 vaccination and blood clotting document: Information on vaccination.

There is currently one suspected report of thromboembolic events with concurrent thrombocytopenia for the Covid-19 Pfizer/BioNtech vaccine, and none currently reported for the COVID-19 Moderna vaccine.

Dr June Raine, MHRA Chief Executive, said:

“Over 44 million doses of vaccines against COVID-19 have now been administered in the UK, saving thousands of lives through the biggest vaccination programme that has ever taken place in this country. “No effective medicine or vaccine is without risk. These specific kinds of blood clots with low platelets reported following COVID-19 Vaccine AstraZeneca remain extremely rare and unlikely to occur. The benefits of the vaccine continue to outweigh the risks for most people. “It is still vitally important that people come forward for their vaccination when invited to do so. “We ask anyone who suspects they have experienced a side effect linked with their COVID-19 vaccine to report it to the Coronavirus Yellow Card website.”

1. Please provide proof of the informed consent they were all given before the vaccinations and if they were shown the Yellow cards reports from www.gov.uk.

The vaccination user journey is available online here. On arrival for a vaccination, recipients are checked that they do not have symptoms that would prevent them from having a vaccine. They are asked questions about their medical history and for consent for the vaccine; at this point, they have the opportunity to ask any questions they may have regarding the vaccination. Once the vaccine has been given, they will be given a leaflet that includes details on possible side effects and how to report those to the MHRA.

The product information for all approved vaccines is available to patients online: Patient Information Leaflets for the Pfizer BioNTech, Astra-Zeneca and Moderna COVID-19 vaccines. Patients are also encouraged to discuss any concerns they may have prior to receiving the vaccine with their healthcare professional.

1. Please provide the fatality rate from Swine flu and how many people were vaccinated before the swine flu vaccine was removed from the market.

Unfortunately, we do not hold this information. We would recommend contacting PHE for this information.

1. Please advise the patent owner name of all COVID-19 vaccines.

The MHRA does not hold information on patents. You might find this information from the pharmaceutical companies associated with the COVID-19 vaccines.

1. Please provide the organisation that gave the licence to Moderna to allow them to give their vaccines.

The Moderna vaccine was approved for use by the MHRA on 8th January 2021. All 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. You can find out more information on the regulatory approval of the Moderna COVID-19 vaccine using the following link: https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccinemoderna.

1. Please advise why the UK government has disabled the daily report of Yellow Card adverse returns?

This report is not produced by the MHRA. If you are referring to the following guidance, ‘Coronavirus cases in the UK: daily updated statistics’, please note the daily COVID-19 statistics are still available; the information has been moved to a different website. The link to this website is provided in question 3 and here.

1. Please advise why AstraZeneca experimental gene therapy vaccines are not banned from under 60s in the UK like so many other countries have done, including Ireland. These are countries that care about their people, unlike the UK government and your organisation, who downplay daily the adverse effects of these so-called vaccines. Investigations are being made about people and the UK government and UK organisations promoting unsafe experimental vaccines on the UK people and downplaying the adverse effects of these two-year experimental biological agents posing as vaccines. The manufacturers have legal indemnity thanks to the UK government, which leaves yourselves and the UK government accountable for all the damages done.

The Public assessment report for COVID-19 University Oxford/AstraZeneca vaccine shows that the vaccine has a positive benefit/risk and are effective in preventing deaths, hospitalisations and the spread of Covid-19. We do not agree that any COVID-19 vaccines are “experimental” as they have been thoroughly assessed by MHRA, with no stages in the vaccine development processes bypassed.

I would like to highlight that the MHRA does not advise on vaccination policy; this is the remit of the Joint Committee on Vaccination and Immunisation (JCVI). On 7th April 2021, the JCVI advised that based on the available evidence, which indicates a finer balance between the balance of risks and benefits associated with the Oxford-AstraZeneca vaccine in adults aged less than 30 years without underlying health conditions which put them at risk of severe COVID-19 disease, individuals in this age group should be offered an alternative COVID-19 vaccine.

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 this response’s date and can be addressed to this email address.

Yours sincerely, FOI Team, Vigilance and Risk Management of Medicines Division