Legality of vaccine administration

Summary

The requester questioned the legality of COVID-19 vaccine administration in the Isle of Man after the State of Emergency ended in June 2020. The Cabinet Office clarified that vaccine authorizations are managed by the UK's MHRA and are independent of the local state of emergency, confirming the vaccines are legal.

Key Facts

• The Medical and Health Care products Regulatory Agency (MHRA) authorizes drugs and vaccines for the UK and Crown Dependencies.
• Vaccine approval was not part of the Isle of Man Emergency Response to COVID-19.
• The ending of the Isle of Man State of Emergency on 26 June 2020 had no impact on vaccine authorizations.
• All COVID-19 vaccine authorizations occurred subsequent to June 2020.
• Temporary authorizations are separate from legislation and remain in place.

Data Disclosed

• 26 June 2020
• 26 August 2021
• 10 September 2021
• 1967161
• section 20

Exemptions Cited

• Section 20 of the Freedom of Information Act 2015 (information already reasonably accessible)

Original Request

COVID-19 vaccines have been given Emergency Use Authorisation (EUA) for use during a public health emergency. The Isle of Man State of Emergency ended on 26 June 2020. How then are these Covid-19 vaccines still being administered legally? (Cabinet Office staff have advised that any FOI not relating to the Cabinet Office would be forwarded to the relevant department.)

Data Tables (1)

Full Response Text

Government Office Douglas Isle of Man IM1 3PN Telephone: (+44) 01624 686244 Website: www.gov.im/co

Our ref: 1967161 10 September 2021

Dear ###

We write further to your request which was received on 26 August 2021 and which states:

"COVID-19 vaccines have been given Emergency Use Authorisation (EUA) for use during a public health emergency. The Isle of Man State of Emergency ended on 26 June 2020. How then are these Covid-19 vaccines still being administered legally? (Cabinet Office staff have advised that any FOI not relating to the Cabinet Office would be forwarded to the relevant department.)"

Our response to your request is as follows:

The Medical and Health Care products Regulatory Agency (MHRA) is the body that authorises drugs, including vaccines, for use in the UK and Crown Dependencies.
Details of the authorisations granted by the MHRA for each of the COVID vaccines is publicly available on the gov.uk website. Approval for use of these vaccines was not part of the Isle of Man Emergency Response to COVID-19 and therefore the ending of the state of emergency had no impact on their authorisations (all of which occurred subsequent to June 2020) or, indeed, on the authorisations for any other drugs. The temporary authorisations are completely separate from any legislation – and the MHRA authorisations remain in place. Vaccines are not being administered illegally. While our aim is to provide information whenever possible, under section 20 of the Act, we are not required to provide information in response to a request if it is already reasonably accessible to you, whether free of charge or on payment of a fee. Information on the MHRA and MHRA authorisation of vaccines is available online at the following links:

https://www.gov.uk/government/organisations/medicines-and-healthcare-products- regulatory-agency/about https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech- vaccine-for-covid-19/conditions-of-authorisation-for-pfizerbiontech-covid-19- vaccine#general Please quote the reference number 1967161 in any future communications.

Your right to request a review

If you are unhappy with this response to your freedom of information request, you may ask us to carry out an internal review of the response, by completing a complaint form and submitting it electronically or by delivery/post.

An electronic version of our complaint form can be found by going to our website at https://services.gov.im/freedom-of-information/Review . If you would like a paper version of our complaint form to be sent to you by post, please contact me and I will be happy to arrange for this. Your review request should explain why you are dissatisfied with this response, and should be made as soon as practicable. We will respond as soon as the review has been concluded. If you are not satisfied with the result of the review, you then have the right to appeal to the Information Commissioner for a decision on; 1. Whether we have responded to your request for information in accordance with Part 2 of the Freedom of Information Act 2015; or 2. Whether we are justified in refusing to give you the information requested.
In response to an application for review, the Information Commissioner may, at any time, attempt to resolve a matter by negotiation, conciliation, mediation or another form of alternative dispute resolution and will have regard to any outcome of this in making any subsequent decision. More detailed information on your right to a review can be found on the Information Commissioner’s website at www.inforights.im. Should you have any queries concerning this letter, please do not hesitate to contact me. Further information about freedom of information requests can be found at www.gov.im/foi. I will now close your request as of this date.

Yours sincerely