FOI release

Freedom of Information request on adverse reactions following the COVID-19 vaccinations (FOI 21/963)

Published 25 February 2022

20th September 2021

FOI 21/963

Dear

Thank you for your email dated 20th August 2021, where you asked for the following information under the FOI act:

• Please can you provide me a list of vaccines in order of Yellow Card adverse reaction data from least to most.

• Please could you provide a list of vaccines that have been denied or removed from market authorisation in order of Yellow Card adverse reaction data from least to most.

• Please can you provide me a list of vaccines that have been given full market authorisation in the UK that have MORE adverse side effects registered against them than ALL the COVID-19 vaccines.

In regard to your first question, it would be helpful if you could provide us with a list of the specific vaccines that you were interested in knowing the Yellow Card Adverse Drug Reaction (ADR) data for. Having a more focussed search will allow us to provide you with Vaccine Analysis Prints (VAPs) which detail the type of reactions experienced, as well as the number of times a reaction has been reported to us in association with the specific vaccine use. It is important to note that to provide all ADR data for all vaccines would exceed the appropriate time limit set out under Section 12 of the Freedom of Information Act (FOIA), therefore we are unable to provide all vaccine data in response to this question at this time.

In reference to your second question, Section 12 of the FOIA has also been applied. To provide a list of vaccines that have been denied or removed from market authorisation according to their Yellow Card Adverse Drug Reaction (ADR) data would exceed the appropriate time limit set out within this exemption. Please also note that the list of refused marketing authorisation applications for vaccines is exempt from release under Section 41 and Section 43 of the FOI Act.

Section 41 is an absolute exemption and no consideration of the public interest is required, except to state that we consider its disclosure to constitute an actionable breach of confidence.

Section 43 is a qualified exemption and a consideration of the public interest should be made. We have considered the public interest and cannot see any public interest argument that outweighs the commercial harm in releasing information on refused marketing authorisation applications, which can be used by competitors for their commercial advantage. Examples of public interest arguments would be a major public health risk or a major procedural failure or irregularity.

Finally, regarding your last question, it should be noted that a comparison of ADR’s is not feasible between vaccines that have been given full market authorisation in the UK and the COVID-19 vaccinations. There are a range of factors that can lead to variable reporting of one vaccine over another, for instance, socio-demographic factors of vaccine recipients or whether or not they have been encouraged by information, or a healthcare professional, to make a report. Large volumes of COVID-19 vaccines have also been administered due to the ongoing pandemic and emergency National rollout of the COVID-19 vaccines when compared to other routine vaccinations within the same time period. In addition to this, it should be noted that the reporting of suspected ADRs is on a voluntary basis by healthcare professionals and patients alike, however reporting is encouraged within the codes of practice of all healthcare professionals by their associations and regulators. We have in place a Yellow Card strategy that works to increase awareness, actively promote and make reporting to the scheme more accessible for everyone. Information leaflets provided at the time of vaccination or invitations to be vaccinated 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 the MHRA 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 on recent televised press briefings. These activities have sought to actively increase reporting rate during the ongoing pandemic as are key to accommodating our daily pharmacovigilance activities during the ongoing pandemic. Because of this, no robust inferences can be drawn from such comparisons. Please be assured that all reports are kept under continual review in order to identify possible new risks.

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