FOI release

Freedom of Information request on the yellow card scheme and the COVID-19 vaccinations (FOI 22/772)

Published 21 December 2023

FOI 22/772

5th July 2022

Dear

Thank you for your email dated 3rd June 2022 regarding coronavirus vaccines and the Yellow Card Scheme. This response addresses your question in regard to the following:

“Is the YCS purely voluntary and the only method for administering-professionals or recipient-patients to report a side effect/side effects? If so,

a)Were patients informed of the YCS before they were injected? If not, why not? If so, how e.g., information leaflet, follow-up letter, etc? This question is necessary in my mind because the MHRA authorise new clinical trials, so I am wondering if they keep patients informed of how they can report side effects anonymously, or better still, without anonymity.

b)What percentage of potential side effect from the vaccination is: 1) reported by administering professionals; 2) patients; 3) a combination of both AP and patient regarding the same patient’s side effects?

c)Do professionals such as General Practitioners, Pharmacy staff, vaccine center staff, etc have a mandatory duty to investigate and report suspected side effect/adverse effects of new medical/clinical trials or procedures?”

As you are aware, the MHRA continually monitors safety during widespread use of a vaccine. We have in place a proactive strategy to do this. 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. Part of our monitoring role includes reviewing reports of suspected side effects.

Any member of the public or health professional can submit suspected side effects through the voluntary Yellow Card scheme. The nature of Yellow Card reporting means that reported events are not always proven side effects. Some events may have happened anyway, regardless of vaccination. This is particularly the case when millions of people are vaccinated, and especially when vaccines are being given to the most elderly people and people who have underlying illness. We encourage all individuals to report any suspect side effects directly to the MHRA, however individuals can also report any suspected side effects to the pharmaceutical company of the product they were administered. Pharmaceutical companies then have a legal responsibility to report these to the MHRA.

Regarding your questions around awareness of the Yellow Card scheme, as part of our surveillance 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 total number and the nature of the majority of Yellow Cards received so far is not unusual for a new vaccine for which members of the public and healthcare professionals are actively encouraged to report any suspected adverse reaction. The reporting rate for spontaneous adverse drug reactions (ADRs) is variable and can depend on a multitude of factors. 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. 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.

I can confirm that for all UK spontaneous suspected reports received directly up to and including 30/06/2022 for COVID-19 vaccines, 75.55% of reports are from patients, 15.88% are from healthcare professionals (this includes various health professionals such as GPs and Hospital Doctors who may not necessary have administered the vaccine to the patient in question) and 9.57% are from non-healthcare professionals such as carers and parents. Where a healthcare professional and patient both report a Yellow Card with the same suspected side effects, these are merged into a single report on our database.

It is not within the remit of the MHRA to regulate healthcare professionals, their education nor their clinical practice. Reporting of side effects within clinical trials to regulatory agencies is mandatory and this data is used to help determine the suitability of the medicinal product for the market. Post marketing reporting of side effects is not mandatory but is strongly encouraged, particularly for new medicinal products.

Healthcare professionals should be taught about reporting of patient safety incidents, including the reporting of suspected side effects to the Yellow Card scheme, as part of their training and within their curriculum. Yellow Card reporting is considered part of a healthcare professionals’ responsibility and as such MHRA has worked with key partners so that reporting is reinforced through inclusion within their relevant codes of conduct or policy and supported by their relevant healthcare professional bodies. Additionally, to support education, the MHRA works with universities and has also developed e-learning modules, all of which are accredited for Continuing Professional Development (CPD) for healthcare professionals for the reporting of suspected side effects.

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