Freedom of Information request (FOI 22/1073)
Published 17 January 2024
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16th November 2022
FOI 22/1073
Dear,
Thank you for your email, dated 29th October 2022, where you asked:
‘Could I please be provided with up to date vaccine safety information?
I can’t seem to find anything more recent than March 22. Which is before the
wave of excess deaths sweeping the country and only covered people for 12
weeks.
I have this data from the ONS.
https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarri
ages/deaths/datasets/deathsbyvaccinationstatusengland
But as they pointed out the confidence intervals are too wide as to make any
concrete conclusions making it not fit for purpose.
I’m assuming you’re doing your due diligence and monitoring the safety of
these vaccines. Please provide me with the data supporting this.’
I am pleased to provide you with the information requested.
The role of the Medicines and Healthcare products Regulatory Agency (MHRA) is to
ensure that medicinal products authorised in the UK meet acceptable standards of
safety, quality and efficacy at the time of first authorisation and thereafter. In order to
do this the MHRA has in place a comprehensive strategy to monitor the safety of
medicines and healthcare products (including vaccines). All vaccines and medicines
have some side effects. These side effects need to be continuously balanced against
the expected benefits in preventing illness.
In relation to COVID-19 vaccines, the MHRA has authorised their supply following a
rigorous review of their safety, quality and efficacy. The clinical trials of COVID-19
vaccines have shown them to be effective and acceptably safe; however, as part of
its statutory functions, the MHRA is responsible for monitoring these vaccines on an
ongoing basis to ensure their benefits continue to outweigh any risks. This
monitoring strategy is continuous, proactive and based on a wide range of
information sources, with a dedicated team of scientists reviewing information daily
to look for safety issues or unexpected, rare events including any reported fatalities.
Vaccination is the single most effective way to reduce deaths and severe illness from
COVID-19. To date approximately 93% of the population (nearly 54-million people)
have received at least one dose of one of the COVID-19 vaccines licensed in the
UK. Vaccination and surveillance of large populations on this scale means that, by
chance, some people will experience and report a new illness or events in the days
and weeks after vaccination. Older age and chronic underlying illnesses make it
more likely that coincidental adverse events, including death, will occur. At the
MHRA, we carefully evaluate 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.
The MHRA has been monitoring the safety of the COVID-19 vaccines used in the UK
vaccination programme since the first vaccine was administered in December 2020.
We also work closely with our public health partners in reviewing the effectiveness
and impact of the vaccines to ensure the benefits continue to outweigh any possible
side effects. Further details on the monitoring strategy can be found here:
https://www.gov.uk/government/publications/report-of-the-commission-on-human-medicines-expert-working-group-on-covid-19-vaccine-safety-surveillance/report-of-the-commission-on-human-medicines-expert-working-group-on-covid-19-vaccine-safety-surveillance#proactive-vigilance-for-covid-19-vaccines.
The Yellow Card scheme is one of the sources of information used in the monitoring
strategy and is the UK system for healthcare professionals and patients to report
suspected side effects or adverse reactions to medicines and vaccines. We publish a
report covering adverse reactions to approved COVID-19 vaccines, which is updated
every month and summarises information received via the Yellow Card scheme,
including a section on events with a fatal outcome. The summary can be found here:
Within the coronavirus Yellow Card scheme summary, the number of reports
received with a fatal outcome is provided as well as a breakdown of the reports by
age ranges and sex. The relative number and nature of UK reports with a fatal
outcome are subject to many factors that influence adverse drug reaction reporting.
They should therefore not be used to directly compare the safety of the different
vaccines. As part of our continuous analysis, we also evaluate natural death rates
over time, to determine if any specific trends or patterns are occurring that might
indicate a vaccine safety concern.
We take all reports with a fatal outcome in patients who have received a COVID-19
vaccine very seriously and every report with a fatal outcome is reviewed carefully,
regardless of the time period between receiving the suspect vaccine and the
reported death. A report with a fatal outcome to the Yellow Card scheme does not
necessarily mean that it was caused by the vaccine, only that the reporter has a
suspicion it may have been. Cumulatively, the Yellow Card data is thoroughly
analysed for patterns or evidence which might suggest a causal link between the
vaccination and the reported death alongside data available from international
sources. This is further considered by the Commission on Human Medicines (CHM)
and its Expert Advisory Groups.
Other relevant data is also assessed as it emerges. For example, a study published
by the Office for National Statistics (ONS) and the Office of Health Improvement and
Disparities (OHID) analysed data on COVID-19 vaccination and mortality in young
people during the coronavirus pandemic. The study found no indication of an
increased risk of death from cardiac-related or other causes in those aged 12-29
years, in the six weeks following COVID-19 vaccination. This is consistent with
findings from our rigorous safety monitoring activities. The study also suggested that
the excess in death registrations in young people in 2021 was due to delays in the
registration process and early indications of increased numbers of deaths due to
non-vaccine related external causes. The study data were reviewed by the
independent experts of the CHM’s COVID-19 Vaccines Benefit Risk Expert Working
Group who agreed with the conclusion of the report that COVID-19 vaccines were
not associated with an increased risk of death in young people.
Our continual monitoring has found that similar to most vaccines, the overwhelming
majority of reports for all COVID-19 vaccines relate to injection-site reactions (e.g.
sore arm) and generalised symptoms such as ‘flu-like’ illness, headache, chills,
fatigue, nausea, fever, dizziness, weakness, and aching muscles. Generally, these
happen shortly after the vaccination and are not associated with more serious or
lasting illness. These types of reactions reflect the normal immune response
triggered by the body to the vaccines.
Further information on the authorisation of COVID-19 vaccines, including the
information leaflets which list the recognised side effects, can be found here:
https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna
In summary, vaccines are the best way to protect people from COVID-19 and have
already saved tens of thousands of lives. Everyone should continue to get their
vaccination when invited to do so unless specifically advised otherwise. As with all
vaccines and medicines, the safety of COVID-19 vaccines is being continuously
monitored. The benefits of the vaccines in preventing COVID-19 and serious
complications associated with COVID-19 far outweigh any currently known side
effects in the majority of patients.
I hope that you find this information helpful.
Yours sincerely,
Safety & Surveillance FOI Team