FOI release

Freedom of Information request on the adverse reactions and death statistics relating to the COVID-19 vaccines (FOI 22/373

Published 31 May 2022

FOI 22/373

15th February 2022

Dear

Thank you for your email.

Please find below answers to the questions you have raised below;

1) How many deaths have there been in the UK from all COVID-19 vaccines?

Unfortunately we do not hold this information as we do not collect complete fatality data. The Office of National Statistics may be able to help with this request. Reports received through our Yellow Card scheme include some fatality reports and these can be viewed by following the link below: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions

2) Are vaccinations for coronavirus still in trial?

The main efficacy and safety results for the Phase I, II and III trials for all authorised vaccines have been submitted to MHRA, sufficient that these vaccines can be authorised for use in the patient populations stated in the Information for Healthcare Professionals/Summary of Product Characteristics for each vaccine. These studies are currently ongoing to follow-up vaccine recipients to collect additional safety data, in the same way that all clinical trials for new medicines follow up their study subjects after the main results of the study have been reported. Other studies that are currently in progress are to investigate the use of vaccine outside of the current authorisations (such as giving different brands of vaccine for the first and second doses).

The estimated dates for the end of completion of the clinical trials are as follows:

AstraZeneca Phase I/II Estimated Study Completion Date: November 15, 2021 https://clinicaltrials.gov/ct2/show/NCT04568031

AstraZeneca Phase III Estimated Study Completion Date: February 14, 2023 https://clinicaltrials.gov/ct2/show/NCT04516746

Pfizer/BioNTech PHASE 1/2/3, Estimated Study Completion Date: April 6, 2023 https://clinicaltrials.gov/ct2/show/NCT04368728

Moderna Phase 2a Estimated Study Completion Date: November 1, 2021 https://clinicaltrials.gov/ct2/show/NCT04405076

Moderna Phase 3 Estimated Study Completion Date: October 27, 2022 https://clinicaltrials.gov/ct2/show/NCT04470427

3) What are the chances of having any adverse reaction from a coronavirus vaccination?

The Summaries of Product Characteristics and Patient Information Leaflets for each vaccine describes the adverse events that can occur with administration of that vaccine and the frequency of occurrence for each event and these are available through the MHRA website, a link to these is provided below:

https://www.gov.uk/guidance/find-product-information-about-medicines

Unfortunately, it is impossible to accurately predict how different individuals will react to a medicine or vaccine. Whilst medicines and vaccines can be safe and effective in thousands of patients, other individuals seem to be particularly susceptible to side effects and it is very unfortunate that it is impossible to predict who will experience side effects to a medicine prior to use. It is also true that an individual may suffer no ill effects from one dose of a vaccine but may suffer them from another.

It is known from the clinical trials that the most common side effects for all vaccines can occur at a rate of more than one per 10 doses (such as local reactions, symptoms resembling transient flu-like symptoms).

For all COVID-19 vaccines, the overwhelming majority of Yellow Card reports relate to injection-site reactions (sore arm for example) and generalised symptoms such as ‘flu-like’ illness, headache, chills, fatigue (tiredness), nausea (feeling sick), fever, dizziness, weakness, aching muscles, and rapid heartbeat. Generally, these happen shortly after the vaccination and are not associated with more serious or lasting illness.

4) Have you got any evidence that the vaccine is effective in preventing the transmission of coronavirus?

We suggest you review the following UKHSA link Monitoring reports of the effectiveness of COVID-19 vaccination - GOV.UK (www.gov.uk)

5)  A report of the trials and adverse effects reported in clinical trials for vaccinations for coronavirus?

Public Assessment Reports (PARs) have been published by MHRA and the EMA that present assessments of the vaccines and their positive benefit/risk in clinical trials. Links to these PARs are provided below:

https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19

https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca

https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna

https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty

https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-moderna

https://www.ema.europa.eu/en/medicines/human/EPAR/vaxzevria-previously-covid-19-vaccine-astrazeneca

If you have a query about the information provided, please reply to this email.

If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Yours sincerely

MHRA Customer Experience Centre