Correspondence

Open letter from Deputy Chief Medical Officer to UK residents who have volunteered to take part in COVID-19 vaccine studies

Published 11 June 2021

From:

Professor Jonathan Van-Tam
Deputy Chief Medical Officer
Department of Health and Social Care
39 Victoria Street
London
SW1H 0EU

Dear Volunteer,

Clinical trials of COVID-19 vaccinations are critical for responding to COVID-19. They are a global public health good. Those who are taking part in them are creating great benefit for our society and indeed the rest of the world.

The Department of Health and Social Care makes a firm commitment to all volunteers in formally approved COVID-19 vaccine trials in the UK that you will not be disadvantaged in terms of any future domestic vaccine certification, if introduced, compared to anyone else who has had their vaccines under the standard NHS programme.

This applies to all volunteers irrespective of whether you have had a vaccine that is licenced or unlicensed, whether you have had a placebo (dummy) vaccine or not, and if you are taking part in a ‘mix and match’ study such as ComCov or CovBoost. The combination does not matter and neither does the order in which vaccines are given.

This assurance applies to trials which have recently started, those planned for the future, and those which are still in follow-up (for example, the Novavax trial in which 15,000 UK residents generously participated).

You will be covered by any potential UK domestic vaccine certification from the moment you enter a trial until you leave. At the end, if you have had a vaccine that is not going to be licenced or a placebo (dummy), you will remain certified during a grace period to allow you to have the NHS standard vaccines if these are recommended by the doctor in charge of the trial. The government has assured me it intends to take all the action available to ensure that this is the case and that you will never be disadvantaged.

The government will ensure that information on those in clinical vaccine trials is linked to any potential mechanisms to demonstrate your vaccine status to ensure that anyone on a vaccine clinical trial can prove they are in a clinical trial and therefore should be treated as fully vaccinated. Operationally, it will take a few weeks for the NHS to complete the programming work, but it will happen before the end of July.

Participants in well-regulated clinical trials should also not be disadvantaged as global travel resumes. We believe the added risk of allowing the relatively small number of clinical trial participants to travel (in the UK approximately 40,000 people, the vast majority of whom have been vaccinated) is strongly outweighed by the benefit of ensuring that recruitment and retention into clinical trials can continue.

The UK government position is that a vaccine should not be a requirement for travel at this time. This is aligned to the current World Health Organization (WHO) approach to international travel. Clearly, individual countries control their own policies and exemptions, but the government will work hard to influence this situation internationally. Discussions are ongoing with other countries, including through groups such as the G7, the EU Commission and the WHO to shape the approach taken around the world to sharing health status for travel, including vaccination status. Indeed, the G7 Group of nations has now committed to this approach.

From the G7 Health Ministers’ Meeting, June 2021: communique:

We should work to ensure that processes and national certification policies do not disadvantage certain groups of people, while retaining effective controls on the potential transmission of variants of concern and variants of interest. This includes working to ensure that participants in vaccine clinical trials are not disadvantaged.

As a global public health good, the UK government will make the case internationally that anyone on a COVID-19 vaccine trial should be treated the same in terms of certification as someone who has received a deployed vaccine.

Until the NHS can make the technical fix in the next few weeks so that your NHS App vaccine certificate will show a ‘green tick’ as if you have been fully vaccinated under the standard NHS programme, it will be possible to obtain this proof for domestic purposes. The chief investigator for each UK trial, or the local principal investigator for your trial site, will send you a letter confirming your participation in the specific vaccine study and confirming that you have the same ‘protected’ status as someone who has received the approved vaccines. These letters are in preparation now and you should receive yours shortly.

Please note that the NHS App is used in England alone. However, if you are a participant in a vaccine trial in England, Wales, Northern Ireland or Scotland, you will receive a letter confirming your vaccine status.

All Chief Medical Officers agree this approach and will be looking to embed these arrangements across the 4 nations, where and when appropriate.

I know there has been anxiety about this issue among volunteers and that is perfectly understandable. I hope this letter will provide the reassurance that you require.

Yours sincerely,

Professor Jonathan Van-Tam
MBE, BMedSci, BM BS, DM, FFPH, FRCPath, FRSB, FRSPH, Hon FFPM, FMedSci
Deputy Chief Medical Officer, Department of Health and Social Care