FOI release

Freedom of Information request on the regulatory approval on the COVID-19 vaccines (FOI 21/956)

Published 20 January 2022

27th August 2021

FOI 21/956

Dear Enquirer,

Thank you for your request of 18 August 2021.

Our responses to your questions are provided below:

Under the Freedom Of Information Act I would like to know what health & safety risk assessments were carried out before the vaccine roll out…?

The steps taken to authorise the Covid-19 vaccines are covered in the Public Assessment Reports which are available on our website at the links below.

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

COVID-19 Vaccine Janssen: https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-janssen

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

Spikevax (formerly COVID-19 Vaccine Moderna): https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna

Your question refers to the “vaccine roll out”, so if you are referring to any assessments conducted around the logistics of setting up vaccination centres, delivering vaccine supplies and the associated steps to invite individuals to receive a vaccine, this is not something which we are involved in. If your request does relate to this then we recommend you contact Public Health England via: enquiries@phe.gov.uk

In addition I would like to specifically know why in 1976 the USA halted their national swine flu vaccine rollout after 33 deaths yet the UK as reported on the Yellow Card Scheme is plowing ahead with the Covid vaccine rollout after 1500 deaths plus…?

We strongly encourage healthcare professionals and patients to report any suspected side effects to any medicinal product, including the COVID-19 vaccines, to the Yellow Card scheme. The reporter does not have to be sure of a causal association between the vaccine and reactions, and are encouraged to report on the basis of suspicion.

It is important to note that vaccination is the single most effective way to reduce deaths and severe illness from COVID-19 infection. All vaccines and medicines have some side effects. These side effects need to be continuously balanced against the expected benefits in preventing illness. Following widespread use of these vaccines across the UK, the vast majority of suspected ADR reports so far confirm the safety profile seen in clinical trials.

We fully evaluate all reports of serious suspected side effects as soon as they are received to consider whether the vaccine may have caused the event, or whether the event was likely to be purely coincidental. It is our role to continually monitor safety during widespread use of a vaccine. It may be useful for you to be aware that we have in place a proactive strategy to do this. Please be reassured that we are working in collaboration with partners in the health system to rapidly assess all available safety data in real time and communicate any emerging issues, as necessary. Additionally, we apply statistical techniques that can tell us if we are seeing more events than we would expect to see, based on what is known about background rates of illness in the absence of vaccination. This aims to account for factors such as coincidental illness. We also look at the clinical characteristics to see if new patterns of illness are emerging that could indicate a new safety concern.

Please note that we are not in a position to comment on any steps taken in the USA.

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

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 you receive this response and addressed to: info@mhra.gov.uk

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