FOI release

Freedom of Information request on the MHRA figure for the estimated under-reporting factor (URF) for reports of vaccine adverse reactions made to the Yellow Card Scheme, specifically for SARS-CoV-2 vaccines - all brands( FOI 22/032)

Published 31 May 2022

FOI 22/032

31st January 2022

Dear,

Thank you for your request for information under the Freedom of Information Act dated 9 January 2022. Your request asked for the following:

“I wish to know:

• The MHRA figure for the estimated under-reporting factor (URF) for reports of vaccine adverse reactions made to the Yellow Card Scheme.

• Specifically, I want this information for SARS-CoV-2 vaccines - all brands.

• If possible, could this information be disaggregated to show the figure for:

1. GP administered vaccines.

2. Hospital administered vaccines.

3. Vaccines administered by other vaccination centres. (Not GP or Hospitals.)”

It is important to note that the reporting rate for spontaneous adverse drug reactions (ADRs) is variable and can depend on a multitude of factors. The actual rate of reporting 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. Based on this, it is not possible for the estimated rate of under-reporting to be calculated for any medicines, including the COVID-19 vaccines, nor would it be possible to disaggregate this information as per your request. Please be assured we evaluate all aspects of the data including potential variability in levels of reporting for Yellow Card data as part of our ongoing monitoring procedures.

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 – more details of which you can find here. 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.

I would like to offer reassurance that we fully evaluate all 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. Additionally, 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. The MHRA hold weekly meetings in which reports are assessed by a group of scientific and medical assessors to determine if risk-minimisation measures need to be implemented. We are also working in collaboration with partners in the health system to rapidly assess all available safety data in real time and communicate any emerging issues, as necessary. Any emerging evidence relating to possible risks associated with medicines and vaccines, is carefully reviewed and, if appropriate, regulatory action would be taken if any serious risks are confirmed.

The MHRA continuously monitors the safety of vaccines through a variety of pharmacovigilance processes including the Yellow Card scheme. As part of our signal detection processes all adverse reaction reports received by the Yellow Card scheme are individually assessed and cumulative information reviewed at regular intervals.

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 22/032

31st January 2022

Dear,

Thank you for your request for information under the Freedom of Information Act dated 9 January 2022. Your request asked for the following:

“I wish to know:

• The MHRA figure for the estimated under-reporting factor (URF) for reports of vaccine adverse reactions made to the Yellow Card Scheme.

• Specifically, I want this information for SARS-CoV-2 vaccines - all brands.

• If possible, could this information be disaggregated to show the figure for:

1. GP administered vaccines.

2. Hospital administered vaccines.

3. Vaccines administered by other vaccination centres. (Not GP or Hospitals.)”

It is important to note that the reporting rate for spontaneous adverse drug reactions (ADRs) is variable and can depend on a multitude of factors. The actual rate of reporting 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. Based on this, it is not possible for the estimated rate of under-reporting to be calculated for any medicines, including the COVID-19 vaccines, nor would it be possible to disaggregate this information as per your request. Please be assured we evaluate all aspects of the data including potential variability in levels of reporting for Yellow Card data as part of our ongoing monitoring procedures.

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 – more details of which you can find here. 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.

I would like to offer reassurance that we fully evaluate all 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. Additionally, 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. The MHRA hold weekly meetings in which reports are assessed by a group of scientific and medical assessors to determine if risk-minimisation measures need to be implemented. We are also working in collaboration with partners in the health system to rapidly assess all available safety data in real time and communicate any emerging issues, as necessary. Any emerging evidence relating to possible risks associated with medicines and vaccines, is carefully reviewed and, if appropriate, regulatory action would be taken if any serious risks are confirmed.

The MHRA continuously monitors the safety of vaccines through a variety of pharmacovigilance processes including the Yellow Card scheme. As part of our signal detection processes all adverse reaction reports received by the Yellow Card scheme are individually assessed and cumulative information reviewed at regular intervals.

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