FOI release

Freedom of Information request on the total numbers of deaths for COViID-19 vaccine from December 2020 to date and the number of recorded deaths within 28 days of a COVID-19 vaccine (FOI 21-778)

Published 29 December 2021

13th July 2021 FOI 21/778

Dear

Thank you for your email.

Regarding your request for: 1. the total numbers of deaths recorded within 28 days of a Covid vaccine Please include the numbers from when the vaccinations started back in December to date. 2. The total number of deaths recorded where Covid vaccination was the cause of death from December 2020 to date.

The MHRA does not hold this data as such we would advise you to contact the Office for National Statistics which can be done so here: Contact us - Office for National Statistics (ons.gov.uk). The Yellow Card scheme is run by the MHRA and is the UK system for collecting and monitoring information on safety concerns such as suspected side effects or adverse incidents involving medicines and medical devices. Reports received through our Yellow Card scheme include some fatality reports and these can be viewed by following the link below: [Coronavirus (COVID-19) vaccine adverse reactions] (https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions.)

1. The reasoning behind vaccinating people who have over 99.99% survive rate from “Covid 19”. Regarding the MHRA approval of the Pfizer/BioNTech and the Oxford/AstraZeneca COVID-19 vaccines, further information (including information for physicians and recipients of the vaccine, and Public Assessment Reports [PARs] for each vaccine) are available on the MHRA website. Links to these are provided below: Regulatory approval of Pfizer/BioNTech vaccine for COVID-19

[Regulatory approval of Vaxzevria (previously COVID-19 Vaccine AstraZeneca] (https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca)

Regulatory approval of Spikevax (formerly COVID-19 Vaccine Moderna)

Please note that a marketing authorisation was granted for the Pfizer/BioNTech vaccine (Comirnaty) following a European Commission (EC) decision on 21 December 2020 (PLGB 53632/0002). Further information is available on the European Medicines Agency (EMA) website, a link to this is provided below: Comirnaty

Please also note that a marketing authorisation was granted for the Moderna vaccine on 31 March 2021 following an EC Reliance Procedure (PLGB 53720/0002). Further information is available on the MHRA website and the EMA website, links to these are provided below:

Regulatory approval of Spikevax (formerly COVID-19 Vaccine Moderna)

Spikevax (previously COVID-19 Vaccine Moderna)

A marketing authorisation has been granted for the Janssen Covid-19 vaccine on 28 May 2021. Further information is available via the below link:

Regulatory approval of COVID-19 Vaccine Janssen

In addition, a marketing authorisation was granted for the Oxford/AstraZeneca vaccine on 24 June 2021 following an EC Reliance Procedure (PLGB 17901/0355). Further information is available on the MHRA website and the EMA website, links to these are provided below:

Regulatory approval of Vaxzevria (previously COVID-19 Vaccine AstraZeneca)

Vaxzevria (previously COVID-19 Vaccine AstraZeneca)

1. The reasoning behind vaccinating children with a 100% survival rate from Covid 19. The MHRA’s assessment of the use of the Pfizer/BioNTech vaccine in adolescents is available in Annex 1 of the below-linked Public Assessment Report (PAR):

Summary of the Public Assessment Report for COVID-19 Vaccine Pfizer/BioNTech

Furthermore, the study of the safety, immunogenicity, and efficacy of the Pfizer/BioNTech vaccine is published in a peer-reviewed journal, the link to this is also provided below: [Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents] (https://www.nejm.org/doi/full/10.1056/NEJMoa2107456)

You may be interested to know that other regulatory authorities around the world, including the European Medicines Agency (EMA), US FDA and Health Canada, have also approved the use of the vaccine in 12 – 15 year olds. Nearly 5 million 12 – 15 year olds in the USA have now received the vaccine, of whom 3.5 million have received both doses CDC COVID Data Tracker . In Canada, 1.5 million 12 – 17 year olds have received the vaccine COVID-19 vaccination coverage in Canada - Canada.ca

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.

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

Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices

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 Service Centre

Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU Telephone 0203 080 6000