FOI release

Freedom of Information on the MHRA’s continued endorsement of the various COVID-19 vaccinations (FOI 22/018)

Published 31 May 2022

FOI 22/018

28th January 2022

Dear,

Thank you for your email dated 30 December 2021 in which you made a complaint and Freedom of Information request regarding the MHRA’s continued endorsement of the various COVID-19 vaccinations. Under the Freedom of Information Act, you requested the following information:

1. The closest three medications causing similar numbers of adverse events to the COVID-19 vaccines authorised for use in the United Kingdom.

2. Whether the reportedly significantly lower number of vaccinated people identified in the United Kingdom by the Office for National Statistics (ONS) compared to other governmental data sources is being taken into account in the MHRA’s calculations for the benefit to risk ratio for each of the COVID-19 vaccines authorised for use in the United Kingdom.

As you have noted within your correspondence, the total number and the nature of the majority of Yellow Cards reports received so far is not unusual for a new vaccine for which members of the public and healthcare professionals are encouraged to report any suspected adverse reaction. It is the role of the MHRA to continually monitor safety during widespread use of a vaccine and as such we have in place a proactive strategy to do this. As part of this strategy we are working to increase awareness, actively promote and make reporting to the scheme more accessible for everyone. For example, invitations to be vaccinated and information leaflets provided at the time of vaccination signpost individuals to the Coronavirus Yellow Card reporting site. In addition, we have run social media campaigns informing healthcare professionals and members of the public that reporting to the Coronavirus Yellow Card reporting site will enable us to rapidly identify new and emerging side-effects.

We have also issued a Drug Safety Update, a press release, and the general public have also been

encouraged to report any suspected side-effects to the vaccine to the MHRA via a Yellow Card in

recent televised press briefings. In our collaborative work with healthcare professionals we may ask for reports of particular suspected events to be submitted. Lastly, since the launch of the national

immunisation campaign the Yellow Card Scheme has benefited from an increased spotlight and, as

such, we have seen an increase in reports received for non-COVID-19 related drugs and vaccines.

The reporting rate for spontaneous adverse drug reactions (ADRs) is variable and can depend on a multitude of factors. As you mentioned, some historical studies have estimated only 10% of ADRs are reported, however the actual rate is unknown and likely to be highly variable as it will be influenced by public awareness and seriousness of events as well as publicity around the use of vaccines. These estimates should not be used as indicators of the reporting rate for suspected reactions to COVID-19 vaccines through the Yellow Card Scheme, for which there is a higher than normal public awareness.

Regarding your request for examples of new vaccines or medicines that have generated similar levels of adverse reactions and deaths to warrant describing the COVID-19 vaccine figures as “not unusual”, I can confirm that this statement is based on information taken from previous vaccination campaigns.

Several vaccination campaigns such as those concerning human papillomavirus (HPV) and the swine flu pandemic were considered to estimate the likely ADR volumes at the start of the COVID-19 vaccination campaign. Although these earlier vaccination campaigns were used as models to estimate volumes of reports, there are key differences such as the much wider patient population who received the vaccine, greater awareness of how to report from patient leaflets given to vaccine recipients, and the influence on reporting from social media. Actual rates are dependent on the reactogenicity of the vaccine used, number of dosages, use of concurrent treatments (for instance to suppress fevers) and publicity around campaigns. These estimates were used as a baseline with the anticipation that volumes would increase depending on the nature of the campaign, such as authorisation of use in different patient populations. It is important to consider the increased work the MHRA has carried out to raise awareness around reporting suspected ADRs following COVID-19 vaccination to the Yellow Card Scheme, which has exceeded that of other vaccination campaigns.

The statement referenced in your correspondence is also based on our continual assessment of safety information from a range of sources and not only the absolute numbers of Yellow Card reports. As described in our surveillance strategy, the MHRA continually assesses data from the Yellow Card Scheme, clinical trials, and ongoing or new safety studies. Each Yellow Card report is assessed, together with additional sources of evidence, by a team of safety experts. Statistical techniques are applied to indicate if there are more events than would be expected, based on what is known about background rates of illness in the absence of vaccination, which aims to account for factors such as coincidental illness. Clinical characteristics are analysed to see if new patterns of illness are emerging that could indicate a new safety concern. We also monitor death rates over time and the information is thoroughly analysed for patterns or evidence which might suggest a causal link between the vaccination and the death.

Regarding your second request, I can inform you that the data published in the MHRA’s weekly summary of Yellow Card reporting pertaining to COVID-19 vaccines are based on data acquired from the governmental coronavirus data website. It is important to note that these data are supplemented by the ONS. Further information regarding the data can be accessed here. Whilst the MHRA uses numbers of vaccinated individuals to aid our benefit-risk assessment, several other data sources are also used as described above. The MHRA assesses the balance of risks and benefits of all medicines and vaccines at the time of initial licensing and throughout their use in clinical practice. Where appropriate, the MHRA seeks advice from the independent Commission on Human Medicines (CHM). The voluntary reporting of suspected ADRs by healthcare professionals and patients via the Yellow Card Scheme enables the continued monitoring of the benefit/risk balance of vaccines and medicinal products following their market authorisation. In doing so, the MHRA ensures that these products are used safely and continue to meet appropriate standards of safety, quality, performance, and effectiveness. Patient safety has always been, and continues to be, the MHRA’s utmost priority, with

pharmacovigilance programmes like the Yellow Card Scheme supporting near real-time surveillance efforts.

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 DivisionFOI 22/018

28th January 2022

Dear,

Thank you for your email dated 30 December 2021 in which you made a complaint and Freedom of Information request regarding the MHRA’s continued endorsement of the various COVID-19 vaccinations. Under the Freedom of Information Act, you requested the following information:

1. The closest three medications causing similar numbers of adverse events to the COVID-19 vaccines authorised for use in the United Kingdom.

2. Whether the reportedly significantly lower number of vaccinated people identified in the United Kingdom by the Office for National Statistics (ONS) compared to other governmental data sources is being taken into account in the MHRA’s calculations for the benefit to risk ratio for each of the COVID-19 vaccines authorised for use in the United Kingdom.

As you have noted within your correspondence, the total number and the nature of the majority of Yellow Cards reports received so far is not unusual for a new vaccine for which members of the public and healthcare professionals are encouraged to report any suspected adverse reaction. It is the role of the MHRA to continually monitor safety during widespread use of a vaccine and as such we have in place a proactive strategy to do this. As part of this strategy we are working to increase awareness, actively promote and make reporting to the scheme more accessible for everyone. For example, invitations to be vaccinated and information leaflets provided at the time of vaccination signpost individuals to the Coronavirus Yellow Card reporting site. In addition, we have run social media campaigns informing healthcare professionals and members of the public that reporting to the Coronavirus Yellow Card reporting site will enable us to rapidly identify new and emerging side-effects.

We have also issued a Drug Safety Update, a press release, and the general public have also been

encouraged to report any suspected side-effects to the vaccine to the MHRA via a Yellow Card in

recent televised press briefings. In our collaborative work with healthcare professionals we may ask for reports of particular suspected events to be submitted. Lastly, since the launch of the national

immunisation campaign the Yellow Card Scheme has benefited from an increased spotlight and, as

such, we have seen an increase in reports received for non-COVID-19 related drugs and vaccines.

The reporting rate for spontaneous adverse drug reactions (ADRs) is variable and can depend on a multitude of factors. As you mentioned, some historical studies have estimated only 10% of ADRs are reported, however the actual rate is unknown and likely to be highly variable as it will be influenced by public awareness and seriousness of events as well as publicity around the use of vaccines. These estimates should not be used as indicators of the reporting rate for suspected reactions to COVID-19 vaccines through the Yellow Card Scheme, for which there is a higher than normal public awareness.

Regarding your request for examples of new vaccines or medicines that have generated similar levels of adverse reactions and deaths to warrant describing the COVID-19 vaccine figures as “not unusual”, I can confirm that this statement is based on information taken from previous vaccination campaigns.

Several vaccination campaigns such as those concerning human papillomavirus (HPV) and the swine flu pandemic were considered to estimate the likely ADR volumes at the start of the COVID-19 vaccination campaign. Although these earlier vaccination campaigns were used as models to estimate volumes of reports, there are key differences such as the much wider patient population who received the vaccine, greater awareness of how to report from patient leaflets given to vaccine recipients, and the influence on reporting from social media. Actual rates are dependent on the reactogenicity of the vaccine used, number of dosages, use of concurrent treatments (for instance to suppress fevers) and publicity around campaigns. These estimates were used as a baseline with the anticipation that volumes would increase depending on the nature of the campaign, such as authorisation of use in different patient populations. It is important to consider the increased work the MHRA has carried out to raise awareness around reporting suspected ADRs following COVID-19 vaccination to the Yellow Card Scheme, which has exceeded that of other vaccination campaigns.

The statement referenced in your correspondence is also based on our continual assessment of safety information from a range of sources and not only the absolute numbers of Yellow Card reports. As described in our surveillance strategy, the MHRA continually assesses data from the Yellow Card Scheme, clinical trials, and ongoing or new safety studies. Each Yellow Card report is assessed, together with additional sources of evidence, by a team of safety experts. Statistical techniques are applied to indicate if there are more events than would be expected, based on what is known about background rates of illness in the absence of vaccination, which aims to account for factors such as coincidental illness. Clinical characteristics are analysed to see if new patterns of illness are emerging that could indicate a new safety concern. We also monitor death rates over time and the information is thoroughly analysed for patterns or evidence which might suggest a causal link between the vaccination and the death.

Regarding your second request, I can inform you that the data published in the MHRA’s weekly summary of Yellow Card reporting pertaining to COVID-19 vaccines are based on data acquired from the governmental coronavirus data website. It is important to note that these data are supplemented by the ONS. Further information regarding the data can be accessed here. Whilst the MHRA uses numbers of vaccinated individuals to aid our benefit-risk assessment, several other data sources are also used as described above. The MHRA assesses the balance of risks and benefits of all medicines and vaccines at the time of initial licensing and throughout their use in clinical practice. Where appropriate, the MHRA seeks advice from the independent Commission on Human Medicines (CHM). The voluntary reporting of suspected ADRs by healthcare professionals and patients via the Yellow Card Scheme enables the continued monitoring of the benefit/risk balance of vaccines and medicinal products following their market authorisation. In doing so, the MHRA ensures that these products are used safely and continue to meet appropriate standards of safety, quality, performance, and effectiveness. Patient safety has always been, and continues to be, the MHRA’s utmost priority, with

pharmacovigilance programmes like the Yellow Card Scheme supporting near real-time surveillance efforts.

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