Freedom of Information request about adverse drug reactions (ADR) to COVID-19 vaccines (FOI 21-143)
Published 28 April 2021
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Thank you for your email dated 3rd February 2021, where you asked:
“Please could you provide an overview of your surveillance methods used, and how you came to the conclusion that the COVID 19 vaccines did not contribute to their deaths”
One of MHRA’s main roles is to continually monitor safety of medicines and vaccines during widespread use, and we have in place a proactive strategy to do this for COVID-19 vaccines. Through this strategy we are able to rapidly detect, confirm, and quantify any new risks and weigh these against the expected benefits. We can then take any necessary action to minimise risks to individuals.
Regarding the tragic deaths of 22 residents in a Basingstoke care home, we have received confirmation from North Hampshire Clinical Commissioning Group that these deaths were unfortunately due to a COVID-19 outbreak. These were not reported to the Yellow Card scheme.
Vaccine efficacy progressively increases after initial vaccination and at least 2 weeks are needed before any immune response is expected. Therefore, even if a large number of elderly were vaccinated they are still susceptible to COVID-19 infection in the two weeks following vaccination, and some degree of protection is expected after the third week. Outbreaks of infection in the week or two after the vaccine has been rolled out to residents are possible as the vaccines do not offer immediate protection. Even after this period of time vaccine efficacy is not 100% and therefore there is still a chance that individuals can contract COVID-19.
Those at the highest risk of COVID-19 complications, whether due to their elderly age and/or underlying chronic illnesses, are currently 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.
The information is thoroughly analysed for patterns or evidence which might suggest a causal link between the vaccination and the death. All reports from the UK vaccination campaign undergo robust scientific evaluation by the MHRA alongside data available from international sources. This is further considered by the Commission on Human Medicine and its Expert Advisory Groups. These analyses do not suggest that COVID-19 vaccination has contributed to any deaths reported to us.
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