Corby Novavax trial 'guinea pig' stuck in UK as vaccine passport not yet valid

A volunteer for a Covid vaccination clinical trial based in Corby has voiced her fears that she has been left 'in limbo'.

Elspeth Robb, 58, of Corby, put herself forward for the Novavax Covid-19 vaccine trial carried out by GPs at Lakeside Healthcare in Cottingham Road.

More than 600 people had been recruited to trial the vaccine starting in October 2020, with half being given a placebo and half the real vaccine - NVX-CoV2373 - in two doses.

Despite volunteering to be jabbed against the deadly coronavirus months before the rest of the population she has now been left without a 'Covid passport' and is unable to travel abroad or prove her vaccine status, since the Novavax vaccine has yet to be authorised by regulatory agencies worldwide.

Ms Robb said: "Even though I received two doses of the vaccine, not the placebo, way back in October last year, I am currently unable to enjoy any of the double-vaccinated benefits other people in the UK are now getting. Our vaccine is not recognised for foreign travel, or suitability for work purposes, since it is yet to pass the MHRA tests there is also no proof of its effectiveness, which is deeply concerning.

"In short, the trial has been an unmitigated disaster, affecting the lives of hundreds of local people who were prepared to act as 'guinea pigs' in an effort to improve our battle against Covid."

Ms Robb was initially thrilled to learn that she was to take part in the trial as she had been shielding. She is the full-time, live-in carer to her 90-year-old father who has chronic COPD. She hoped the vaccine would prevent her and in turn her father from catching the virus.

She said: "I spoke to a doctor at Lakeside Research to voice my extreme concerns regarding the Novavax vaccine, and the lack of communication to all patients involved, only to be told that they are not permitted to make statements locally, and all communications must come from a central source.

"I was also informed that the 'party line' is that all recipients of the Novavax vaccine are advised by said 'centralised source' to get re-vaccinated with a UK registered alternative vaccine.

"This suggestion frankly horrified me. I asked what data was available in regards to the safety of such a measure, and I was told there is none. When I pushed the doctor further as to whether he would recommend me getting a second vaccine he finally admitted that this was a very bad idea, and personally as a medical professional he couldn't advise this route."

Results show the Novavax vaccine to be nearly 90 per cent effective in the trial among the 15,000-plus participants recruited from 35 research UK sites.

In January Dr Amardeep Heer, GP partner and director of research and innovation at Lakeside Healthcare, had said: “This is a great achievement and is directly due to the fantastic response we received from patient volunteers who came forward to take part in this trial at Lakeside Corby.

"Together, the hard work of the research delivery team and the enthusiasm of the trial volunteers have allowed us to reach this very important milestone.

“I would like to thank all of the patient volunteers who contacted us and gave up their valuable time to take part together with all of the Lakeside and clinical research network staff who have worked so tirelessly on this trial.”

The Novavax study has been the largest ever double blind, placebo-controlled trial to be undertaken in the UK. Half of the volunteers were given two intramuscular injections of the vaccine 21 days apart and half a saline solution.

The study enrolled more than 15,000 participants between 18 and 84 years of age, including 27 per cent over the age of 65.

Ms Robb said: "When I was asked by Lakeside surgery in an email to take part in this trial, I weighed up the pros and cons, as I'm sure all participants did. We are currently in complete limbo, with absolutely no communication as to whether or not this situation is likely to be resolved any time soon."

"I had booked a trip to Mykanos three weeks ago which I actually cancelled as my son contracted Covid and I didn't want to be out of the country when he was so ill. But I could well have been unable to travel. It's a very disruptive and prejudicial situation and one that is currently affecting thousands of trial participants.

"I'm feeling quite stressed out. Now travel is back I would like to go, but I can't. I lived abroad for 10 years in Sydney and 10 years in Asia. All of my cousins live abroad and I'm stuck here."

A spokesman for Novavax said: "With regard to proof of vaccination, we are supporting efforts to help participants with their return to post-pandemic life.

"The UK government and Novavax are of the position and are making the case that those who participate in clinical trials should be treated the same in terms of certification as someone who has received a deployed vaccine from a public health perspective, and we continue to advocate for this.

“We continue to work with the National Health Service, Vaccine Task Force and National Institute for Health Research so that those who received NVX-CoV2373 will soon have their vaccination dates entered into the NHS App.

"As noted in an open letter from Deputy Chief Medical Officer of the UK Department of Health and Social Care, the NHS App vaccine certificate was expected to show ‘green ticks’ for all UK trial participants, as if they have been fully vaccinated under the standard NHS program.

"This is now complete and all UK trial participants should have received a letter to this effect.

"The letter from Professor Van-Tam stated that while individual countries control their own policies, the UK government will ‘work hard to influence this situation internationally.’

"We are working with urgency to finish the work required for our regulatory filing with the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency and we expect to finalize our submission to the Medicines and Healthcare products Regulatory Agency (MHRA) in Q3 (July-August-September) 2021. This includes clinical data released earlier this year as well as manufacturing data. Completing this work is our number one priority."

Volunteers on the trial, who need PCR tests for travel, have been promised to have their expenses paid by Novavax.

The spokesman said: "For travel, different countries and institutions may have their own requirements with respect to Covid-19 vaccination and testing status and international travel.

"Novavax is now able to reimburse trial participants for two Covid PCR tests to help comply with travel requirements in some countries."

In response to participants in the trail receiving additional vaccination, the spokesman added: "No clinical studies of boosters or additional rounds of vaccinations have been completed and evaluated by regulatory agencies to date to establish safety and efficacy.

"As such, individuals will need to make decisions on this topic in consultation with their health care providers."

Additional information can be found on NIHR’s ‘Be Part of Research’ website available under Vaccine Passports/Certification and Travel.”

A spokesman for the National Institute for Health Research (NIHR) said: "We firstly want to express our tremendous gratitude for the contribution of the 40,000 people across the UK who have taken part in COVID-19 clinical vaccine studies. It is thanks to them and volunteers in other countries that we now have some protection against this virus.

"A number of different organisations have been working hard with NHS data authorities to ensure vaccine study participants can benefit from the Covid Pass in a similar way to those who have had a full course of an approved vaccine. Most are now able to use the Covid Pass, see their vaccine history and the ‘green tick’ allowing access to domestic events. UK participants also benefit from the same exemption from quarantine on return from amber list countries.

"We understand the frustration subsequent travel restrictions have caused for participants and their families, and are aware of Government negotiations to help resolve this. The entry requirements set by other countries are, however, outside the control of UK authorities.

"As the nation’s largest funder of health research, the National Institute for Health Research (NIHR) funds and supports the clinical trial process, but the approval process of study vaccines in the UK, including Novavax, is the remit of the Medicines and Healthcare products Regulatory Agency (MHRA).

"Novavax trial participants are not advised to get a full course of approved vaccine on top of their trial vaccine, as there is a lack of safety data and this is not thought to be clinically necessary at this time."

Some participants have started to see updates to their status on the NHS app already, and progress continues with data entry underway.

Through the Government’s Vaccine Taskforce, the UK has secured access to 60 million doses Novavax's NVX-CoV2373.

Approved vaccines include BioNTech/Pfizer with 40 million doses secured, Oxford/Astra Zeneca with 100 million doses secured, Moderna with 17 million doses secured and the one-jab Janssen vaccine with 30 million doses secured.