FOI release

Freedom of Information request for ADR Data and yellow card reporting, investigation procedures and COVID19 Vaccine ADR Data (FOI 21-167)

Published 24 March 2021

Thank you for your FOI request dated 9th February 2021, whereby you requested information regarding vaccines, adverse effects and Yellow Card reporting. Please find below the responses from the MHRA to each of your questions.

The MHRA continuously monitors the safety of medicines and 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. Any emerging evidence relating to possible risks associated with vaccines and medicines, is carefully reviewed and, if appropriate, regulatory action would be taken if any serious risks were confirmed.

1.How are vaccine adverse effects reported and investigated? How do you know if there is a link between the vaccine and the adverse effect?

A Yellow Card report can be made online and via the Yellow Card app. Usually, adverse effects can also be reported via post, and there is a specially designed form for the public which can be found on the Yellow Card website, however, during the pandemic all suspected side effects are requested to be reported electronically due to MHRA staff working remotely. Anyone who cannot report a suspected side effect electronically to the Yellow Card scheme, can call 0800 731 6789 for free, Monday to Friday during business hours. Certain healthcare professional GP and hospital computer systems also allow for healthcare professionals to report a Yellow Card to the MHRA directly.

Specifically for COVID-19 vaccines, suspected adverse effects to COVID-19 vaccines can be reported via the dedicated Coronavirus Yellow Card reporting site or through the Yellow Card app. Additionally, Yellow Card Vaccine Monitor is a targeted active monitoring programme which runs in parallel to these systems. Our COVID-19 surveillance strategy details our approach to vigilance of COVID-19 vaccines, including how Yellow Card reports are investigated, as well as other sources of safety information that are used. The MHRA will consult the Commission on Human Medicines (CHM) and its Expert Groups regarding any new risks identified and, if deemed necessary, regulatory action would be taken to minimise risk and support safe use of the vaccine.

2.Who is trained about where to report adverse effects and how to promote schemes like yellow card to patients? For example, can you name different groups of health professionals such as GPs, nurses, healthcare assistants and describe the type and frequency of training they receive. Have they received any additional training on reporting adverse effects for Covid vaccines and if so what additional training?

Healthcare professionals should be taught about reporting of patient safety incidents, as part of their training and within their curriculum. The reporting of suspected side effects is considered part of a healthcare professionals’ responsibility and as such reporting is also reinforced through relevant codes of conduct or policy and supported by their relevant healthcare professional bodies. It is not within the remit of the MHRA to regulate healthcare professionals, their education nor their clinical practice.

However, please be assured that we continue to work to increase awareness of the scheme and encourage reporting through our Yellow Card Strategy. This includes ADR campaigns that target specific reporter groups including patients, engaging with professional health professional bodies, development of Pharmacovigilance learning modules, and through working with other organisations to develop training information for health professionals. The strategy also has a strong focus in facilitating reporting and making reporting more time efficient for healthcare professionals by integrating Yellow Card reporting into clinical IT systems.

The MHRA also commissions five regional Yellow Card Centres (YCCs) to support the education and promotion of Yellow Card reporting in their region, including reporting for Covid-19 treatments and vaccines. They are involved in various programmes which improve ADR reporting rates, including the establishment of nominated hospital pharmacists or pharmacy technicians as ‘Yellow Card Champions’. YCCs also work with devolved administrations and local healthcare professional bodies as well as local patient organisations to increase awareness and education about the importance of Yellow Card reporting for patient safety.

Following the development of the dedicated Coronavirus Yellow Card reporting site a letter was sent to all healthcare professionals in the UK through the NHS Central Alerting System to inform them. Information on Yellow Card reporting to COVID-19 vaccines has been included in NHS training materials, as well as the materials available to individuals both before and after vaccination. Both vaccine recipients and healthcare professionals are strongly encouraged to report any suspicion of a side effect to the MHRA.

3.Is it part of the routine procedure when a patient has an illness shortly after a vaccine that they would be advised to report it? How does the health professional determine if it’s an adverse effect from a vaccine or just an illness occurring coincidentally?

To report an adverse effect the healthcare professional or member of public must only have a suspicion of an association of the adverse effect and the medicine or vaccine.

The MHRA has worked with its partners to include information about the Yellow Card scheme and encouraging the reporting of suspected side effects to a Covid-19 vaccine such as in the Public Health England booklet leaflet given to every vaccine; https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/961301/ PHE_11843_Covid-19_vaccination_Easy_Read_guide.pdf

Within the product information for every medicine, including Covid-19 vaccines that is given to patients, there is a section on possible side effects and reporting of side effects to the Yellow Card scheme and what to do if you are concerned about a side effect or an adverse event.

MHRA’s reporting guidelines encourage the reporting of any and all suspected side effects to new medicinal products, including Covid-19 vaccines. Healthcare professionals are encouraged to always discuss potential side effects with any medicine or vaccine prior to administration as well as what to do if one experiences a side effect, and informing the patient about the Yellow Card scheme.

4.How does any investigation into an illness someone has had shortly after a vaccine, determine whether there is a link between the vaccine and the illness? How are results fed back to pharmaceutical company and government and what actions are taken as a result of adverse effects.

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. Regulatory action can include communication with marketing authorisation holders with a view to implementing risk minimisation measures such as updates to the product information (to add or improve clinical guidance or warnings regarding ADRs), direct communications or the provision of educational materials to healthcare professionals, and changes to the indications or contraindications of the medicine.

If a pharmaceutical company holds a license for a medicinal product or as is the case with COVID-19 vaccines under regulation 174, all reports received for that particular medicine or vaccine will also be sent to the company. Currently we are holding fortnightly meetings with Pfizer and AstraZeneca with regards to COVID-19 vaccines.

Since the start of the vaccine campaigns we have been working in close collaboration across the healthcare system and regularly liaise with other government bodies and devolved administrations, as well international colleagues.

5.What will you do with the data on adverse reactions reported to the yellow card scheme.

All data from the Yellow Card scheme is kept on our database and used to assess potential side effects as described above. For medicines, the data is also provided to the public in the form of interactive Drug Analysis Prints (iDAPs) available on the Yellow Card website. Covid vaccine data is provided on a weekly report on our website; https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions.

6.Have any of the approved UK vaccines been tested on people who have already had Covid or tested to see what happens to people who have the vaccine and then go on to contract Covid? What were the safety and efficacy results?

Please find below links to the public assessment reports which contain this information. Please note that they contain details on serostatus for the detail on people who had previously had Covid, these would have been seropositive at baseline.

AZ: <https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca Pfizer: https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19>

7.How many people have suffered an adverse reaction (please list by level of severity of reaction) to each of the rolled out vaccines so far both trial participants and general public who have received vaccine since roll out. Data on the number of suspected side effects reported to the MHRA can be found in a weekly report here; https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions.

8.How many people have been hospitalised with Covid in the UK who have received the vaccine. (List by those who have received just one shot and those with two). Of those that have received a vaccine and subsequently been hospitalised with Covid, how many reported an adverse effect from the vaccine and what level of severity?

The MHRA are the medicines regulator and therefore do not hold data on hospitalisations due to Covid.

9.Has anyone died after receiving the vaccine since roll out and how has any link to the vaccine been investigated? How many have died from Covid after having the vaccine?

Data on the number of side effects reported to the MHRA can be found in a weekly report here including those associated with a fatal outcome; https://www.gov.uk/government/publications/coronavirus-covid-19- vaccine-adverse-reactions.

10.Is there a contract been issued or being planned to be issued e.g. out for tender, to a Software company to design a reporting system for patients to report adverse effects due to anticipated high levels that may be reported? Why won’t the yellow card scheme suffice?

As per the above, the Yellow Card scheme is being used to collect reports of side effects to COVID-19 vaccines. With any major new vaccination campaign, we always develop a proactive vigilance strategy, and COVID vaccines are no exception. We have a range of resources and technology to support the proactive vigilance of any COVID-19 vaccination programme. The MHRA is using artificial intelligence (AI) software to reduce the amount of manual coding for each report, thereby saving resource in processing cases and ensuring they are rapidly available for scientific analysis. The tool is not being used for assessment of data, but to help ensure that all the information from the reporter is well structured to support analysis and subject to robust quality assessment.

This specific AI tool is for the surveillance of COVID-19 vaccines due to the size and scale of the vaccination campaign, rather than because of concerns about the safety profile. We published the award notice for the AI contract on Tenders Electronic Daily as is required under the rules of the Public Contracts Regulation 2015, this is publicly visible worldwide.

11.Is the yellow card scheme routinely promoted when people a) get the vaccine and b) report an incident post vaccine e.g. when they suspect an adverse effect?

See response to question 1 and 3 above in which this is covered. In addition, the MHRA are proactively encouraging reports through a targeted communications campaign, aimed at those that are having the vaccines and aligned with DHSC communications strategy.

The MHRA have worked closely with the government vaccination programme to ensure that individuals receiving vaccines are aware of the Yellow Card scheme. Public health authorities in each of the four devolved nations have produced supporting materials for individuals to understand more about their vaccine, including how to report to the Yellow Card scheme.

12.Are NHS volunteers trained in yellow card scheme and when do they promote it?

Please see response to question 2.

13.Do you gather feedback from patients on the quality of care provided when they report adverse effects and how seriously they feel health professionals take their reports? Please describe how you do this and please send any results from this research.

The MHRA values the reports from patients and encourages patient reporting. Patients are the single largest reporter group to the Yellow Card scheme and their reporting is invaluable to our work.

The MHRA has no jurisdiction over clinical practice. If patients are unhappy with their care, the General Medical Council (GMC) is the organisation which regulates doctors and clinical practice in the UK. The GMC (www.gmc-uk.org) provides advice on how to raise concerns about the care received from healthcare professionals.

14.How do people claim compensation if they have had an adverse effect particularly if resulting in disability or death? Do people get legal assistance and what level of independence is there in people assessing claims, given that it is the government who has to pay rather than the pharmaceutical company?

The MHRA are the medicines regulator and do not hold data on compensation claims. the MHRA and the Yellow Card scheme has no relationship to the Vaccine Damage Payment Scheme. More information on the Vaccine Damage Payment Scheme and relevant contacts can be found here https://www.gov.uk/vaccine-damage-payment.

15.Why doesn’t the pharmaceutical company hold any liability for any adverse effects or injury? What are their concerns about the risk of lawsuits and why has the government granted them indemnity from prosecution? Please send any risk assessments NHS have done around vaccines and adverse effects. E.g. risk level of adverse effects in population, financial risk level.”

The MHRA are the medicines regulator and therefore do not hold information on this, we would therefore suggest you contact the Department of Health and Social Care (DHSC) as they were responsible for this work.

I hope the information provided is helpful. The MHRA encourages the use of Yellow Card data however wishes to ensure that the data is studied and applied appropriately, and that any conclusions/interpretations take into account the above information. For this reason, if you wish to use this information for a publication, we request that you engage with the MHRA prior to publication and provide a copy of the report.

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