FOI release

Freedom of Information request (FOI 22/815)

Published 17 January 2024

8th August 2022

FOI 22/815

Dear,

Thank you for your email dated 9th July 2022, where you asked questions relating to COVID-19 vaccine data, including information on the COVID-19 vaccine Pfizer/BioNTech. Please see our response to the requested information below.

1. Having administered Pfizer COVID-19 booster vaccines and subsequently found to be reported as faulty batch. How many cases are on the record/been investigated?

All potential defects are investigated, and thus far, no batches have been recalled from the UK market. The Defective Medicines Report Centre (DMRC) at the MHRA acts on issues that may affect public health. Individual complaints regarding quality defects are managed by the company in accordance with the requirements of the Rules and Guidance for Pharmaceutical Manufacturers and Distributors. The MHRA license and inspect all UK manufacturers, wholesale dealers and importers of medicines to ensure these requirements are met.

1. To date how many fatalities have been reported due to having the Pfizer COVID-19 booster vaccine and the timeline?

Confirmed death statistics are not held by the MHRA and we suggest you contact the Office for National Statistics for this information.

The MHRA has been continually monitoring the safety profile of COVID-19 vaccines licensed in the UK. This monitoring process involves the collection of information about suspected adverse reactions in patients (through the Yellow Card scheme) and assessment of any new suspicions of harmful effects. The Yellow Card scheme captures reports of suspected side effects from all users including patients and healthcare professionals alike. 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, and, if appropriate, regulatory action would be taken. This scheme is one way the MHRA carries out COVID-19 vaccine safety surveillance, and you can find out more information on our proactive pharmacovigilance strategy and how we monitor safety here.

Vaccination and surveillance of large populations means that, by chance, some people will experience and report a new illness or events in the days and weeks after vaccination. A high proportion of people vaccinated early in the vaccination campaign were very elderly, and/or had pre-existing medical conditions. Older age and chronic underlying illnesses make it more likely that coincidental adverse events including those with a fatal outcome will occur, especially given the millions of people vaccinated.

Further to your request, We can confirm that the MHRA has received a total of 153 UK spontaneous suspected adverse drug reaction (ADR) reports associated with a fatal outcome following a COVID-19 Vaccine Pfizer/BioNTech booster dose up to and including 4th August 2022.

Part of our continuous analysis includes an evaluation of natural death rates over time, to determine if any specific trends or patterns are occurring that might indicate a vaccine safety concern. Based on age-stratified all-cause mortality in England and Wales taken from the Office for National Statistics (ONS) death registrations, several thousand deaths are expected to have occurred naturally, mostly in the elderly, within 7 days of the many millions of doses of vaccines administered so far. More information can be found in our ADR report here.

You also requested information surrounding the timeline of these events. Your request is exempt from disclosure under Section 40 (personal information) and Section 41 (information provided in confidence) of the Freedom of Information Act. Providing you with the timeline of a suspected fatal adverse event following vaccination of an individual with COVID-19 Vaccine Pfizer/BioNTech could lead to patient identification.

Members of the public and healthcare professionals voluntarily submit reports of suspected side effects to the MHRA through the Yellow Card Scheme. As outlined in our Privacy Policy, the MHRA will not share the identity of anyone submitting a Yellow Card report with any person outside the MHRA without their explicit consent, unless we are required or permitted to do so by law. The Policy also states that we may receive requests for Yellow Card report data under the Freedom of Information Act. While we are legally obliged to provide some of the requested information, we only provide high-level summary information with all person-identifiable data excluded.

The MHRA has been working proactively to encourage members of the public or health professionals across the UK to immediately alert us to any concerns they have without a formal diagnosis using the Yellow Card scheme. The information and data provided to us by these third parties are shared in confidence and, as above, are personal data. Sharing the information and data received with others would not reflect the commitments in MHRA’s confidentiality agreements, potential safety signals which would be of detriment both to the application of the Agency’s regulatory function and public health more widely.

As this is personal data in relation to an individuals’ health, this would be of detriment to them and may damage the engagement with the scheme.

When considering the spontaneous ADR data provided within this response, it is important to be aware of the following points:

• A reported reaction does not necessarily mean it has been caused by the vaccine, only that the reporter had a suspicion it may have. Each year, millions of doses of routine vaccinations are given in the UK alone, and when any vaccine is administered to large numbers of people, some recipients will inevitably experience illness following vaccination. The fact that symptoms occur after use of a vaccine or medicine, and are reported via the Yellow Card scheme, does not in itself mean that they are proven to have been caused by the vaccine. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.

• It is also important to note that the number of reports received via the Yellow Card scheme does not directly equate to the number of people who suffer adverse reactions. Therefore, Yellow Card data cannot be used to determine the incidence of a reaction or compare the safety profile of different vaccines. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular drug, and may be stimulated by promotion and publicity about a drug. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time.

Furthermore, we review all reports of death regardless of the time to onset from receiving a medicine or vaccine. We follow-up all fatalities where permission has been provided to do so for further information. As with any serious suspected ADR, reports with a fatal outcome are fully evaluated by the MHRA to consider whether the vaccine (or medicine) may have caused the event or whether the event and fatal outcome were likely to be purely coincidental and due to underlying illness.

A summary of Yellow Card reporting concerning the COVID-19 vaccines is published here. The summary includes data analysis on reported suspected adverse reactions from the COVID-19 vaccines, including those with a fatal outcome. You can also find our assessment so far on particular safety topics surrounding the COVID-19 vaccinations, as well as some detail on patient demographics. In Annex 1, you will find four Vaccine Analysis Prints (VAPs). Each VAP lists all suspected adverse reactions that have been reported to the MHRA via the Yellow Card scheme and indicates if these are reported with a fatal outcome for each COVID-19 vaccine, up to and including 27th July 2022. Please consider the points mentioned above if you decide to review these VAPs.

1. Has the manufacturer of Pfizer made available information of any vaccine which fell short of the specifications required by MHRA?

This information is exempt under Section 43 due to commercial interests and an explanation follows below.

Section 43 is a qualified exemption, which means that we have considered whether the public interest in releasing the information is outweighed by the public interest in not giving the information. In favour of disclosure, we consider that there is a general public benefit from gaining insights about the quality of the vaccine batches manufactured. However, we consider that the public interest will be better served by not releasing the information as the acceptance criteria and the test results obtained are considered to be commercially confidential information (CCI). The publication of the acceptance criteria enables competitors to use the test methods for their own vaccines. This will cause material damage to the vaccine manufacturer, as competitors would be able to significantly speed up their drug development. Also, the test results/batch data are considered to be CCI. Even when the acceptance criteria of a test are publicly available, test results can be used to calculate the acceptance criteria of a test method by using a statistical approaches like reference intervals or tolerance intervals (example: For an approximately normal data set, the values within one standard deviation of the mean account for about 68% of the set; while within two standard deviations account for about 95%; and within three standard deviations account for about 99.7%. This means, the test result lies with almost certainty within the range of three standard deviations which can be then assumed to be the acceptance criteria). This approach combined with the information from e.g., ICH guidelines or EMA guidelines on specifications and release can help competitors enormously to establish acceptance criteria for the active substance or the authorised product. This will save the competitor a high amount of test method development work and lead to major business advantages for the competitor and will adversely impact the vaccine manufacturers business. Releasing the information would also prejudice the Agency’s commercial interests in this case and in future. As a market regulator, it is vital that the Agency can freely engage in dialogue with organisations about commercial activities.

1. Has there been any reported cases of the Pfizer COVID-19 booster vaccine interacting with metformin medicine?

We can confirm that the MHRA has not received any UK spontaneous suspected ADR reports associated with an interaction between metformin and COVID-19 Vaccine Pfizer/BioNTech up to and including 4th August 2022. Details of any known interactions with other medicinal products for the COVID-19 Vaccine BioNTech can be found in section 4.5 of the Product Information Leaflet (PIL). Copies of the PIL for each COVID-19 vaccine can be found on the Yellow Card coronavirus website, which you can find here. Currently, no interactions have been noted in the PIL.

We 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,

Safety and Surveillance

Medicines and Healthcare products Regulatory Agency