FOI release

Freedom of Information request about data on COVID-19 vaccines (FOI 21/203)

Published 7 May 2021

Thank you for your email dated 20th February 2021 regarding the data published by the MHRA on the COVID-19 vaccinations.

Please see table 1 below which displays aggregated age groups for all the ADR reports received by the MHRA up to and including 28thFebruary.

Table 1: Number of fatal ADR reports associated with COVID-19 vaccines by reported patient age up to and including 28th February.

Number of reports

Age group	Pfizer	AstraZeneca
18-35	5	6
36-65	21	22
66+	182	225
Unknown	15	15

The figures in the table are currently in line with what we would expect given the majority of vaccinations so far in the campaign have been administered to the elderly population. We are planning to include further breakdowns like age in our weekly publication soon. We know from the trials that both vaccines can be associated with broadly similar types and rates of side effects. But no head to head trials have been done so we can’t directly compare the vaccines. There are a range of factors that can lead to increased reporting of one vaccine over another, for instance socio-demographic factors of vaccine recipients or whether or not they have been encouraged by information, or a healthcare professional, to make a report .No robust inferences can be drawn from such comparisons.

Regarding the threshold level at which the MHRA would revoke use of the vaccine –there is currently no defined threshold at which a medicine or a vaccine would be removed from use as many factors have to be taken into account.

Yellow Card reports of suspected ADRs are evaluated, together with additional sources of evidence, by a team of safety experts to identify any new safety issues or side effects We apply statistical techniques that can tell us if we are seeing more events thanwe 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.

We supplement this form of safety monitoring with other epidemiology studies including analysis of data on national vaccine usage, anonymised GP-based electronic healthcare records and other healthcaredata to proactively monitor safety. These combined safety data enables the MHRA to detect side effects or safety issues associated with COVID-19 vaccines. As well as confirming new risks, an equally important objective of monitoring will be to quickly rule out risks –in other words to confirm that the vaccine is not responsible for a suspected side effect and to provide reassurance on its safety. Further information on our strategy for continually monitoring safety of COVID-19 vaccines can be found here: Report of the Commission on Human Medicines Expert Working Group on COVID-19 vaccine safety surveillance -GOV.UK (www.gov.uk)

We also work closely with our public health partners in reviewing the effectiveness and impact that the vaccines are having to ensure benefits continue to outweigh any possible side effects. In addition, we work with our international counterparts to gather information on the safety of vaccines in other countries. We now have very clear evidence from Public Health England (PHE) that both vaccines are highly effective and are contributing to an 80% reduction in hospitalisations.

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

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