FOI release

Freedom of Information request (FOI 22/1046)

Published 17 January 2024

15th November

FOI 22/1046

Dear

What are the conditions under which the MHRA suspends or withdraws emergency use authorisation of a vaccine?

Thank you for your FOI request dated 18th October 2022, where you have asked several questions around the reporting of adverse events to the Yellow Card scheme and the criteria for the suspension or withdrawal of vaccinations by the MHRA. Please find a response to each of your questions below:

1. Does the MHRA believe that all severe adverse events (including deaths) relating to vaccines are reported to the Yellow Card Scheme? Please answer ‘yes’ or ‘no’.

2. If the answer to Q1. is ‘no’, please state the organisation’s understanding of, and agency position on under-reporting of serious adverse events (including deaths) resulting from vaccines to the Yellow Card Scheme.

Reporting to the Yellow Card scheme is voluntary, and as such, not all adverse events are likely to be reported to the Yellow Card scheme. The reporting rate for spontaneous adverse drug reactions (ADRs) is variable and can depend on a multitude of factors. The reporting rate for ADRs is influenced by public awareness and the seriousness of the event.

For COVID-19 vaccines, there is a higher-than-normal public awareness of Yellow Card reporting and therefore the reporting rate when compared to other medicines or vaccines is higher. We are currently receiving around 2 to 5 Yellow Cards per 1,000 doses of COVID-19 vaccines administered. Clearly not everyone who receives a vaccine will have an adverse experience, however we have worked to ensure that people know to report suspected side effects to the Yellow Card scheme if they were to have such an experience. At the beginning of the vaccination programme, in addition to social media campaigns, we issued a Drug Safety Update, a press release, and embedded information about Yellow Card reporting into healthcare professionals training materials to enable us to rapidly identify new and emerging side effects. The general public were also encouraged to report any suspected side effects to the vaccine via a Yellow Card on the televised press briefings, and vaccination materials signpost individuals to the Coronavirus Yellow Card reporting site.

The MHRA takes into account the variable levels of reporting across all medicines and vaccines as part of our monitoring procedures using statistical techniques. As part of its continual assessment of the safety information of medicines and vaccines, the MHRA supplement Yellow Card safety monitoring with other epidemiology studies including analysis of data on national medicine or vaccine usage, anonymised GP-based electronic healthcare records and other healthcare data to proactively monitor safety. We also take into account the international experience based on data from other countries using the same medicines or vaccines.

1. Please state precisely the MHRA’s criteria, standards and process in making a decision to suspend or withdraw emergency use authorisation of a vaccine? Please answer in detail.

2. How many confirmed vaccine deaths per 100,000 population would need to occur before the vaccine that is implicated in such deaths has its emergency use authorisation suspended or withdrawn by the MHRA?

3. How many confirmed serious vaccine injuries per 100,000 population would need to occur before the vaccine that is implicated in such injuries has its emergency use authorisation suspended or withdrawn by the MHRA?

There is currently no defined threshold or criteria at which a medicine or a vaccine would be suspended or withdrawn by the MHRA as many factors must be taken into account. In order to withdraw a vaccine from the market, the risks of being administered that vaccine would need to outweigh the benefits for the majority of people. All vaccines and medicines have some side effects. These side effects need to be continuously balanced against the expected benefits in preventing illness. The benefits of the vaccines in preventing COVID-19 and serious complications associated with COVID-19 far outweigh any currently known side effects. As with all vaccines and medicines, the safety of COVID-19 vaccines is continuously monitored, and benefits and possible risks remain under review.

As explained above, 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 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.

Regarding deaths specifically, the MHRA takes 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. All reports with a fatal outcome regardless of the time period between receiving the suspect vaccine and the reported death are reviewed. As the number of vaccine doses administered has increased, so has the number of reports with fatal outcomes following vaccination. However, this does not mean that there is a link between vaccination and the fatalities reported. Further information on MHRA analysis of these reports can be found in our coronavirus vaccine - summary of Yellow Card reporting.

It is also important to note that reporters are asked to submit Yellow Card reports even if they only have a suspicion that the medicine or vaccine may have caused the adverse reaction. The existence of an adverse reaction report on our database does not necessarily mean that the vaccine has

caused the suspected reaction. Many factors have to be considered when assessing whether the vaccine has caused a reported adverse reaction. When monitoring the safety of vaccines and medicines, MHRA staff carry out careful analysis of these factors.

Finally, please note that neither the authorisations granted under Regulation 174 nor the marketing authorisations for the COVID-19 vaccines are considered “emergency” authorisations and there has been no compromise on the safety assessment of the vaccines. The authorisations under Regulation 174 were intended for the use of specific batches of vaccine products during the vaccine rollout. The authorisations under Regulation 174 still exist; however, as the specific batches of vaccine authorised under Regulation 174 are used, these will become obsolete.

I hope that you will find this information useful. 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,

Safety and Surveillance Group