FOI release

Freedom of Information request on yellow card reports relating to the COVID-19 vaccinations (FOI 22/358)

Published 31 May 2022

FOI 22/358

14th February 2022

Dear,

Thank you for your email dated 18 January 2022 where you requested the following information under the Freedom of Information (FOI) act:

• How many million doses of vaccines have been given out (a) for all non-COVID-19 vaccines and (b) for COVID-19 vaccines?

• What does the MHRA regard as the underreporting rate for the Yellow Card Scheme? What evidence of underreporting (or overreporting) is the MHRA relying on?

• How many deaths among children, from vaccines, do you consider acceptable? For the COVID-19 vaccines do you have a stopping condition?

In response to your first question, whilst the MHRA considers vaccination uptake as part of our ongoing safety analysis, the MHRA does not hold the data on how many millions of doses of COVID-19 and non-COVID-19 vaccines have been administered. Therefore, we are unable to provide you with this information. We suggest you contact the UK Health Security Agency for this information.

When considering spontaneous Adverse Drug Reaction (ADR) data, it’s important to be aware of the following points:

• The fact that symptoms or events occur after use of a medicine or vaccine, and are reported via the Yellow Card Scheme, does not in itself mean that they are proven to have been caused by the medicine or 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 and therefore cannot be used to determine the incidence of a reaction. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular drug or vaccine and may be stimulated by promotion and publicity about a drug or vaccine. Reporting tends to be highest for newly introduced products during the first one to two years on the market and then falls over time.

As you are aware, 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 televised press briefings. In our collaborative work with healthcare professionals we may ask for reports of particular suspected events to be submitted. Since the launch of the national immunisation campaign the Yellow Card scheme has benefited from an increased spotlight and, as such, we have also 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. 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. 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.

In response to your last question, regarding how many deaths among children is acceptable, I would like to assure you that the MHRA takes all reports of fatal events in patients who have received a COVID-19 vaccine very seriously. Every report with a fatal outcome is fully evaluated and kept under continual review. There is no defined threshold at which a medicine or a vaccine would be removed from use as many different factors have to be taken into account. The MHRA assesses the benefit risk balance of all medicines and vaccines at the time of initial licensing and throughout their use in clinical practice and different patient populations. The safety of all COVID-19 vaccines is actively monitored by the MHRA on a continual basis including information from the Yellow Card scheme, epidemiological studies and information from international regulators. Should a safety issue be identified, all of this information, together with independent expert advice, would be evaluated to ensure that the benefit-risk balance remains positive in all populations. Therefore, due to these reasons I would like to repeat that there is no predefined threshold or “stopping condition” in order to take action as this information is continually under review. Where the benefit-risk balance is positive in the approved indication the medicine will retain its market approval.

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: [email protected]. Please remember to quote the reference number above in any future communications.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division