FOI release

Freedom of Information request on systems used to support the proactive vigilance of the COVID-19 vaccination programme (FOI 21/512)

Published 28 June 2021

© Crown copyright 2021

This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.

Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.

This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-24-may-2021/freedom-of-information-request-on-systems-used-to-support-the-proactive-vigilance-of-the-covid-19-vaccination-programme-foi-21512

25th May 2021 FOI 21/512

Dear

Thank you for your email.

Please find below answers to the question you have raised in blue below;

  1. Has the system been delivered? If so: Yes the system has been delivered
  2. Is the system in use? If so: The system is currently in use by the MHRA
  3. How have the system and its outputs been used? We have a range of resources and technology to support the proactive vigilance of the COVID-19 vaccination programme. The use of artificial intelligence (AI) is only one element of that. The AI tool reduces the amount of manual coding for each report by checking information in narrative fields is appropriately captured in structured data, thereby saving resource in processing cases and ensuring they are rapidly available for scientific analysis. The tool is not 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.
  4. What actions have been taken as a result of using the system? The MHRA publishes summary data received and our assessment of it on a weekly basis: Coronavirus (COVID-19) vaccine adverse reactions - GOV.UK (www.gov.uk)
  5. Are the data or outputs of the system publicly available? If so, how can the public obtain these? See above If the system is not yet in use:
  6. What was the originally agreed “go live” date of the MHRA AI system to be supplied by Genpact? NA
  7. What is the currently predicted “go live” date? NA
  8. What are the phases and expected dates of the roll out plan (e.g. alpha, testing, beta testing etc)? NA
  9. If the phases and expected dates of the roll out plan are not yet known, when and how will they be decided? When and how will they be published? NA
  10. Will the system data or outputs be made publicly available? NA
  11. What will the new system deliver over and above what any existing system already delivers? NA

If you have a query about the information provided, please reply to this email

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 you receive this response and addressed to: info@mhra.gov.uk

Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF

Yours sincerely

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU

Back to top