FOI release

Freedom of Information request about mRNA COVID-19 vaccines (FOI-21-174)

Published 7 May 2021

9th March 2021

Dear ,

Our Ref: FOI 21/174

Thank you for your email dated 8th February 2021, where you asked:

“Question 1 We are told by the MHRA that DNA-mRNA genomes in the 2 UK Covid-19 “vaccines” come from computer generated models and NOT from an “isolated virus” taken from an infected person (Human). Why then are both the Pfizer Bio-NTech and Astra Zeneca Oxford “solutions” called Covid- 19 Vaccines when they offer NO live active Covid-19 virus to illicit an immune response ?

Question 2 MHRA statement in the Romsey Advertiser regards to an increase in deaths of the elderly in care homes alluding to the “Deaths that have occurred post vaccination are not linked to the vaccines but to other underlying conditions that those given the vaccine may have had or since taking the vaccine become ill”. Why were these same patients relatively well prior to their vaccination and What evidence do you have for this statement.”

In answer to your first question, the definition of a vaccine is ‘a substance used to stimulate the production of antibodies and provide immunity against one or several diseases, prepared from the causative agent of a disease, its products, or a synthetic substitute, treated to act as an antigen without inducing the disease.’ According to this definition, a vaccine does not have to be a live, active virus, and it can be an inactivated version of the virus or a synthetic substitute. The key factor is that it stimulates the production of antibodies and provides immunity, without causing the disease itself.

Secondly, you have raised concerns regarding a number of deaths in the elderly in care homes which had been reported in the media. Please be assured that the MHRA carefully monitors reports of deaths following vaccination with the COVID-19 vaccines, as with all medicines in the UK.

It is important to note that those at the highest risk of COVID-19 complications, whether due to their elderly age and/or underlying chronic illnesses, have been prioritised for vaccination. It is not unexpected that some of these people may naturally fall ill due to their age or underlying conditions shortly after being vaccinated, without the vaccine playing any role in that. That being said, the MHRA takes all reports of fatal events in patients who have received a COVID-19 vaccine very seriously. Where these events are reported to us, we follow up to find out full details of the events and the cause of death and, where applicable, further information of any post-mortem findings.

We also monitor death rates over time, to determine if any specific trends or patterns are occurring that might indicate a vaccine safety concern or a possible link between the vaccination and any serious side effect, including death. We also receive independent advice from the Commission on Human Medicines on the impact of any safety issues, including fatal cases, on the balance of risks and benefits of COVID-19 vaccines.

To date, the MHRA has concluded that no safety concerns have been raised based on the fatal cases received to date. The MHRA will continue to monitor this carefully and will take appropriate action should any concern be identified.

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.

Yours sincerely,

FOI Team Vigilance and Risk Management of Medicines Division