COVID-19 Novavax vaccination trials: FOI release

Information requested

1. Why was a database set up with no ability to add those in trials, despite the fact it was known there were Scottish peoples in trials?

2. Since the FM has publicly stated you were working effortlessly to resolve this since July 2nd can you please Inform me of what your team have done to do so?

3. NHS England also had an original data issue, resolved it in 6 weeks and on top of letters added 14000 people to the same website as those from other trials and thr NHS.

4. Why do you refuse to register Novavax as Generic something NHS England did, as they were grateful.

5. When will you give a date to resolve this? You've had since May for NHS Inform, now add in the app.

Response

Please find our responses to your queries below. For each query enumerated we have provided an answer where we hold it, or further information on where to direct your request in order to assist you to obtain the information you are seeking.

1 – 2. The standard NHS routes for storing information on the National Clinical Data Stores (NCDS) database cannot accommodate all the technical details associated with participation in a clinical trial. There is therefore a separate system for storing clinical trial data where a vaccine is not yet approved or participants are still on a blinded study.

Work is ongoing to find a robust solution to storing all the technical details associated with participation in a clinical trial within the NHS data store.

In the meantime, clinical trial participants can continue to use their paper copies of their vaccine certification. Further information can be found in the NHS Inform guidance – Information for coronavirus (COVID-19) vaccination clinical trial participants.

These certificates are fully equivalent to the certificates provided through the digital route for use domestically, and in the common travel area (CTA). They enable easier access to venues and will also permit smoother inbound entry to the UK.

3 – 4. The Scottish Government cannot comment on the work of other administrations.

Work is ongoing to find a robust solution to storing all the technical details associated with participation in a clinical trial within the NHS data store. In the meantime, clinical trial participants can continue to use their paper copies of their vaccine certification. Further information can be found in the NHS Inform guidance – Information for coronavirus (COVID-19) vaccination clinical trial participants.

These certificates are fully equivalent to the certificates provided through the digital route for use domestically, and in the common travel area (CTA). They enable easier access to venues and will also permit smoother inbound entry to the UK.

5. Work is ongoing to find a robust solution to storing all the technical details associated with participation in a clinical trial within the NHS data store.

If Novavax is approved by the Medicines and Healthcare products Regulatory Agency (MHRA) then we will work to include this information on the National Clinical Data Store (NCDS) as soon as possible.

Accordingly, you may wish to direct further details of your enquiry to the MHRA’s published FOI route: Medicines and Healthcare products Regulatory Agency, Customer Services, 10 South Colonnade, Canary Wharf, London, E14 4PU, who may be able to help you. Alternatively, you may reach the MHRA by email at: info@mhra.gov.uk.

In the meantime, clinical trial participants can continue to use their paper copies of their vaccine certification. Further information can be found in the NHS Inform guidance – Information for coronavirus (COVID-19) vaccination clinical trial participants.

About FOI

The Scottish Government is committed to publishing all information released in response to Freedom of Information requests. View all FOI responses at http://www.gov.scot/foi-responses.