Exploring participant experiences with Novavax clinical trial regulations

Now that large percentages of the US and UK population have received their second Covid-19 vaccine, social media posts of the double-jabbed jet-setting are beginning to skyrocket.

These freedoms would not be possible if it weren’t for those who raised their hands to be part of the clinical trials that tested the safety and efficacy of the many vaccines now available.

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However, people who took part in the Novavax clinical trials of its Covid-19 vaccine NVX-CoV2373 are being left behind, with no proof that they have been inoculated against Covid-19.

These people, partners in the scientific breakthroughs that are helping to lead us out of the pandemic, are unable to travel alongside those double-jabbed in the national roll-outs of approved vaccines, and report being “invisible in the system.”

70-year-old Jo Wiggans was one of the 15,000 volunteers who took part in the UK Novavax trials in November and December of 2020. She was not warned about any travel implications at the time. Now she is blocked from being able to visit family in France, which currently has the UK on their amber list, meaning those not fully vaccinated can only visit for essential reasons. “My husband can go because he had the Pfizer vaccine,” Mrs Wiggans told the BBC.

“I thought I was doing a good thing, but it’s not on my record.”

“I’m invisible on the system and the result is that France won’t let me in, because I cannot provide evidence that I have been vaccinated.”

Mrs Wiggans said while she had no regrets about raising her hand to volunteer, she “never, ever expected to be in a disadvantaged position.”

“I really think this is unjust and massively unfair,” she added.

Another thwarting factor for ‘Novavax refugees’ is that numerous countries mandate quarantines for unvaccinated visitors, which often is not feasible for travellers on limited time.

Computer says ‘no’

Over the past few weeks, multiple news sites have published first-hand accounts of Novavax Covid-19 Phase III trial participants, all of whom said they did not know that being involved in the trials would put them at such a disadvantage.

Despite potentially being one of the most effective Covid-19 vaccines out there, demonstrating a 90% efficacy according to interim analysis of both its ongoing US and UK Phase III trials, Novavax is still trying to get its product across the finish line.

In May, Novavax said it would not be applying for authorisation until July at the earliest, citing supply and manufacturing issues.

In the UK, where 60 million doses have been pre-bought pending approval, the issue for the thousands of Novavax trial participants is that the NHS app does not recognise clinical trial participants as vaccinated. For these people, the app still states: “No Covid-19 records found,” and a green tick will not yet have appeared on their vaccine passport.

This is currently the only gateway to get out of the country.

“Unfortunately it seems there are a few more twists and turns on Novavax’s road to success,” UK Novavax trial participant Amy Carden wrote in The Telegraph. “Ultimately it may never cross the approvals finish line, which leaves 15,000 of us clinical trial guinea pigs in somewhat of a bureaucratic quandary.”

State bureaucracy putting participants at risk

Some patients, in a frenzy to have a recognised vaccine status, have chosen to be unblinded from the Phase III Novavax trials to know whether they received the vaccine or the placebo. This means that they have had to leave the trial before it is completed.

Despite finding out that they had indeed received the vaccine, some participants are now booking themselves in to get doses of one of the legally recognised jabs, both with and without the knowledge of their GPs.

Last month, when Novavax UK trial participant Francis Beckett told his doctor that he had two jabs of the firm’s vaccine in November 2020 and had now left the trial, he reported that the doctor had “seen Novavax refugees before” and signed him up for his first shot of the AstraZeneca jab.

“I’ve been lucky,” he wrote in The Guardian. “Other Novavax refugees are being refused a vaccine.”

But perhaps this refusal is for good reason. Scientists have not yet confirmed whether mixing vaccines is safe and studies like Com-Cov testing the mix and match theory are still currently ongoing.

Novavax trial participants have been facing similar issues across the pond, as the vaccine is still not approved in the US either.

“I decided to become a human guinea pig to be part of the solution,” wrote US Novavax trial participant Mark Dickinson in Salon. “Now, I feel like I’m being penalised, even though I put my life at risk for science.”

Dickinson, who like Beckett chose to be unblinded from the trial and discovered he had received the jab not placebo, reported that he had mulled over the idea of getting an approved Covid-19 inoculation on top in order to earn his Centers for Disease Control and Prevention (CDC) vaccine card. In the end he decided against it.

“Studies suggest mixing two different vaccines might actually enhance one’s defence against the coronavirus, but more research is needed,” he said. “I’m not ready to take such a gamble for a piece of paper.”

Novavax UK trial participant Daniel Hugill tweets about his experience and decision to be unblinded and jabbed with the Pfizer vaccine in this Twitter thread.

Novavax working with authorities

Luckily for Dickinson, the US situation is close to being resolved.

Novavax spoke out on June 30th to affirm that it “firmly believes that clinical trial participants should not be disadvantaged with respect to providing proof of vaccination.” It promised to help verify Covid-19 vaccine status for participants as the world reopens for cross-border travel.

Now that efficacy data from the PREVENT-19 Phase III trial is available and has been reviewed by the independent Data Safety Monitoring Board (DSMB), participants who received active vaccine have become eligible for a modified version of the vaccination cards provided by the CDC.

“This modified vaccination card states that the participant has been vaccinated through a clinical trial and the individual is to be considered fully vaccinated for public health purposes,” said the firm.

These modified cards are currently being “proactively distributed” to trial participants through Novavax’s contract research organisation ICON in coordination with the trial sites.

If the jab gets regulatory authorisation, participants may receive the standard CDC vaccination card if desired and the vaccine can also be recorded in the Immunization Information Systems (IIS).

In the UK, the wheels of bureaucracy appear to be moving a little slower.

“In the UK, we continue to work with the NHS, Vaccine Task Force and National Institute for Health Research (NIHR) so that those who received NVX-CoV2373 will soon have their vaccination dates entered into the NHS App,” said Novavax.

As noted in an open letter from UK Deputy Chief Medical Officer Jonathan Van-Tam, the NHS App vaccine certificate is expected to show a ‘green tick’ by the end of July for all UK trial participants, just as if they had been fully vaccinated under the standard NHS program.

Van-Tam also stated that while individual countries control their own policies, the UK government will “work hard to influence this situation internationally.”

On 8 July UK Secretary of State for Transport Grant Shapps said: “The success of our vaccine programme has been aided by those selflessly creating the great benefits for society and for the rest of the world by being part of the clinical trials, without which we would not have this vaccine programme. We committed to ensuring they are not disadvantaged as a result of being part of those trials, and I am delighted to announce that those on approved clinical trials in the UK will also not need to self-isolate, or take the day eight test after arrival from an amber list country.”

Not just Novavax

Thousands of volunteers in other trials have also been forced to put their summer holiday plans on hold. Without a green tick on their vaccine passport and a lack of clarity on when the issue will be sorted, booking a holiday could be a huge risk.

Up to 40,000 volunteers have been told by Van-Tam that the NHS system will not accept proof that they have taken part in a clinical trial for several more weeks. This has left many scared to risk booking a holiday, even if they have had two jabs of an approved vaccine in clinical trials.

One volunteer who took part in the trial of the Johnson & Johnson vaccine at Barts Hospital, London, told The Telegraph: “I was just trying to do the right thing in helping to trial a vaccine at a time when the drugs were experimental and I was putting my own health at risk for the good of others.

“But it feels like a kick in the teeth that the thanks that I get is not being able to go on holiday because the NHS computer says no. Surely it would not have been impossible in the six months since I had my second jab for someone to simply enter my details onto a separate IT system?”

Time for change

While the issue may be close to being resolved for Covid-19 vaccine trial participants – and for Novavax participants too, providing the vaccine is approved – it has highlighted an important hole in the system that could act as a huge deterrent for clinical trial participation in the future.

“The unprecedented Covid-19 pandemic led to extraordinary feats of science to respond to the virus and develop vaccines in record time, all of which would not have been possible without clinical trial participants,” Novavax said.

“The lifting of restrictions by different countries at different times throughout the pandemic presents challenges, and we empathise with those who are navigating the requirements while awaiting additional documentation. The vaccine development process is complex and we are working to complete regulatory filings for our vaccine as soon as possible. In the meantime, we continue to support efforts to provide proof of vaccination to our volunteers and will share additional updates as they become available.”