{"id":50405,"date":"2021-06-07T17:41:25","date_gmt":"2021-06-07T16:41:25","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmj\/?p=50405"},"modified":"2021-06-11T09:00:57","modified_gmt":"2021-06-11T08:00:57","slug":"left-in-limbo-barriers-to-covid-passports-for-trial-participants-will-deter-people-from-taking-part-in-research","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmj\/2021\/06\/07\/left-in-limbo-barriers-to-covid-passports-for-trial-participants-will-deter-people-from-taking-part-in-research\/","title":{"rendered":"Left in limbo\u2014barriers to covid \u201cpassports\u201d for trial participants will deter people from taking part in research"},"content":{"rendered":"

It\u2019s a situation that risks putting people off future vaccine trials and it needs to be fixed urgently, says Henry Scowcroft<\/p>\n

<\/p>\n

Late last year, partly out of self-interest, and partly altruistically, I decided to enrol in a covid-19 vaccine trial.<\/span><\/p>\n

What I didn\u2019t realise back then, with the second covid-19 wave just about to break, was that the decision would ultimately land me in a bureaucratic and administrative black hole, unable to officially prove my vaccination status, and with no certainty as to when I will be able to do so.\u00a0<\/span><\/p>\n

The study I enrolled on<\/span>\u2014<\/span>a randomised, placebo-controlled phase III trial<\/span>\u2014<\/span>was testing Johnson & Johnson\u2019s then still experimental \u201cone-shot\u201d vaccine, in a two dose regimen. [1] I knew enough of the science to realise it was a good bet: J&J\u2019s vaccine relies on the same “spike” antigen as Pfizer\u2019s, Moderna\u2019s, and AstraZeneca\u2019s vaccines, and is built on a similar adenovirus-based platform to the latter. In my eyes, taking part meant a 50:50 chance of a potentially effective vaccine.\u00a0<\/span><\/p>\n

By early 2021, I\u2019d had two shots of something or other in my arm, the first of which gave me a 12 hour bout of fever, headache, and myalgia. By this point, the UK\u2019s vaccine rollout was in full swing, the UK was in the middle of a second covid-19 wave, and J&J\u2019s vaccine had been approved for use across much of the world in a one dose regimen. [2-5]\u00a0 However, thanks in part to Brexit, and the fact that the decisions of the European Medicines Agency no longer apply to the UK, the vaccine was still not licensed for use here.\u00a0<\/span><\/p>\n

Then, in April, the problems started. For ethical reasons, the trial team decided to unblind all participants. Those in the placebo arm would be offered a single dose of J&J\u2019s vaccine. I eagerly booked an appointment, and headed to the trial centre.<\/span><\/p>\n

At my “unblinding” appointment, overhearing another participant talking to a nurse, I discovered an issue<\/span>\u2014<\/span>there is no guarantee that our vaccine status, post-trial, will count towards \u201cofficial\u201d NHS passports. And we are advised not to take up any “official” NHS vaccine, due to concerns about how vaccines might interact, and concerns emerging about rare blood clots.\u00a0<\/span><\/p>\n

On further probing, it transpired that these were common questions from participants, as we realised we were now vaccinated\u2026 but not \u201c<\/span>NHS <\/span><\/i>vaccinated.\u201d\u00a0<\/span><\/p>\n

I was then “unblinded” and, as I\u2019d hoped and suspected, I\u2019d had the vaccine. I was handed a printed, signed letter in a blank envelope. I was now fully covid-protected, but with just a sheet of A4 to prove it. A strangely analogue ending to a global story of high-tech medical triumph.<\/span><\/p>\n

Since then, the UK government has rolled out vaccine passports via the NHS App. [6] I\u2019ve downloaded the app, and hiding among 138 test results, 97 consultations and events, 17 prescriptions going back to 2005, and an immunisation record that goes back to November 1977, is an entry under the \u201cDocuments\u201d tab.<\/span><\/p>\n

It\u2019s a grainy, scanned 26-page TIFF version of a letter, entitled \u201cPatient in research study, added 4 May 2021.\u201d Buried within it is a tiny, unobtrusive line of text on page 19: \u201cStudy arm: ACTIVE.\u201d\u00a0<\/span><\/p>\n

Elsewhere in the NHS App, under an entirely different tab: my official covid-19 vaccination status, which says, boldly: \u201cWe could not find your vaccination details.\u201d Similarly, under \u201cShare your COVID-19 Status\u201d it says, \u201cno vaccination records found.\u201d\u00a0<\/span><\/p>\n

I am reminded of an old Eddie Izzard comedy sketch. [7] \u201c\u2018Cannot access printer\u2019? But it\u2019s here!\u201d<\/span><\/p>\n

I correspond with my local GP practice, whose practice manager assures me she\u2019s now manually updated the relevant field on their system. I wait five days<\/span>\u2014<\/span>nothing. I call the NHS covid hotline on 119, and a friendly man tells me he\u2019s raised a ticket, and has \u201cnever heard of\u201d the J&J vaccine,” which does not give me confidence the issue will be resolved. As of time of writing, the app still cannot find my vaccination details. The NHS has “closed” my ticket. I am in limbo.\u00a0<\/span><\/p>\n

To try and understand why, I\u2019ve done as much digging as I am able, but still cannot get to the bottom of it. As with so many frustrations in healthcare, the root cause is likely multifactorial. After a considerable delay compared to other countries, the UK\u2019s regulator, the Medicines and Healthcare Regulatory Agency (MHRA), has now approved J&J\u2019s vaccine, but the Joint Committee on Vaccination and Immunisation has yet to rule on its usage, meaning the vaccine is perhaps still not “official” enough for inclusion. [8] There are other possibilities beyond this. Trial participants have repeatedly flagged this issue, which suggests a failure of patient\/public involvement in the trial\u2019s design. Surely this issue should have been spotted earlier, and relevant information prepared? And then there\u2019s the gap in IT infrastructure<\/span>\u2014<\/span>between NHS research data, primary care records, and the NHS App<\/span>\u2014<\/span>meaning I have had to try to chivvy along various bits of the system to get my records updated.<\/span><\/p>\n

These are broad issues. Some of my friends have also enrolled in clinical trials, and have ended up in the placebo arm. They report the opposite issue<\/span>\u2014<\/span>confirming their \u201cplacebo\u201d status to allow for an official vaccine is similarly frustrating.\u00a0<\/span><\/p>\n

Most worrying of all, another tells me: \u201cI\u2019m embarrassed to admit that I turned down a vaccine trial about a month ago. My job requires that I have to be at various events (if they happen), events which will most likely require a vaccine passport. I looked into it and it\u2019s fiercely apparent that won\u2019t be possible if you\u2019re on a trial.\u201d<\/span><\/p>\n

This is a depressing picture, and one now recognised, if not dealt with, at the highest level. [9] Those of us who have enrolled on trials, to advance science as well as to advance our own immunity, find ourselves hobbled by our altruism. As a lifelong advocate for medical research, to read that people are being put off participation is deeply worrying. And, most frustratingly, you can see on the distant horizon how the system <\/span>could <\/span><\/i>work\u2014slick, frictionless, real time access to one\u2019s up to date healthcare records, and ability to use them to participate fully in society.\u00a0<\/span><\/p>\n

Wouldn\u2019t that be nice.\u00a0<\/span><\/p>\n

Henry Scowcroft<\/strong>, BMJ patient editor.<\/span><\/i><\/p>\n

References<\/strong>:<\/span><\/p>\n

    \n
  1. A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults (ENSEMBLE 2). <\/span>https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04614948<\/span><\/a>\u00a0<\/span><\/li>\n
  2. Press Release: FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine. U.S. Food and Drug Administration, February 2021 <\/span>https:\/\/www.fda.gov\/emergency-preparedness-and-response\/coronavirus-disease-2019-covid-19\/janssen-covid-19-vaccine<\/span><\/a><\/li>\n
  3. Press Release: EMA recommends COVID-19 Vaccine Janssen for authorisation in the EU. European Medicines Agency, March 2021 <\/span>https:\/\/www.ema.europa.eu\/en\/news\/ema-recommends-covid-19-vaccine-janssen-authorisation-eu<\/span><\/a>\u00a0<\/span><\/li>\n
  4. Press Release: WHO adds Janssen vaccine to list of safe and effective emergency tools against COVID-19. World Health Organisation, March 2021 <\/span>https:\/\/www.who.int\/news\/item\/12-03-2021-who-adds-janssen-vaccine-to-list-of-safe-and-effective-emergency-tools-against-covid-19<\/span><\/a>\u00a0<\/span><\/li>\n
  5. Sadoff, J et al. Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19. NEJM. April 21, 2021. DOI: 10.1056\/NEJMoa2101544<\/span><\/li>\n
  6. Guidance: Demonstrating your COVID-19 vaccination status when travelling abroad. Gov.uk, accessed 21<\/span>st<\/span> May 2021 <\/span>https:\/\/www.gov.uk\/guidance\/demonstrating-your-covid-19-vaccination-status-when-travelling-abroad<\/span><\/a>\u00a0<\/span><\/li>\n
  7. Eddie Izzard \u2013 Control, P, Print. Glorious, 1997\u00a0 <\/span>https:\/\/www.youtube.com\/watch?v=-5pyEkBuIb8<\/span><\/a>\u00a0<\/span><\/li>\n
  8. Roxby, P. Janssen single-dose Covid vaccine approved by UK. BBC, 28th May 2021 <\/span>https:\/\/www.bbc.co.uk\/news\/health-57283837<\/span><\/a>\u00a0<\/span><\/li>\n
  9. Press release. New G7 clinical trials charter to bolster global health defences. Department of Health and Social Care, 4th June 2021 <\/span>https:\/\/www.gov.uk\/government\/news\/new-g7-clinical-trials-charter-to-bolster-global-health-defences<\/span><\/a>\u00a0<\/span><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    It\u2019s a situation that risks putting people off future vaccine trials and it needs to be fixed urgently, says Henry Scowcroft […]<\/p>\n

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