Scottish Covid vaccine trialists ‘treated like second-class citizens’
Novavax volunteers fear start of vaccine passports next month could put them at further disadvantage
Scottish vaccine volunteers are being treated like “second-class citizens” while waiting for the Novavax jab to be approved, an MSP has said, as they continue a months-long fight to have their vaccines recognised on the standard NHS Scotland database.
The trialists are worried that the introduction of vaccine passports in Scotland next month could put them at a further disadvantage as they cannot access the standard electronic version, instead possessing only a piece of paper.
Some have been abused online by anti-vaxxers while others have felt forced to lie to obtain an approved dose, despite having no information about side-effects of vaccine mixing.
Their plight was highlighted on Sunday when the Observer reported that England’s deputy chief medical officer, Prof Jonathan Van-Tam, had asked ministers to withhold all UK clinical trial data from the EU if European countries continued to deny entry to Novavax and Valneva trial volunteers.
About 1,000 Scots signed up for the Novavax trial, which began in the autumn of 2020, a significant cohort of the 15,000 across the UK, and the initial results were considered extremely promising. But the Guardian has also seen a notification sent to trial participants in the north of England this week of a further delay in regulatory approval of at least two months, meaning they will not be offered booster vaccines.
The email from the medical lead of the local trial said: “Novavax is unable to provide guidance on the safety of receiving either 2 doses of an authorised vaccine or a booster of an authorised vaccine after having previously received 2 doses of the Novavax vaccine.”
The Scottish Liberal Democrat leader, Alex Cole-Hamilton, urged the Scottish government to get to grips with the irregularities. “It’s concerning that those who volunteered to trial new vaccines that could keep all of us safe are being treated as second-class citizens,” he said.
While Scottish government ministers have repeatedly reassured the volunteers that clinical trial participants have the same status as someone vaccinated through the NHS programme, volunteers question how equal that really is when they are not included on the NHS Inform database, cannot get a QR code on their phone and have only a paper record of their status.
One Aberdeen participant said: “We have to self-isolate as though we haven’t been vaccinated, our details are not on the NHS Inform website, we can’t download a QR code – and when vaccine passports come into force next month all we have is a paper letter, which is not equal to an app on your phone.”
She added: “I didn’t take part in this trial to fight against my own government. People don’t understand what it takes to be in a trial, and if we’d known we would never have signed up for it.”
When asked about the situation after her Covid statement last Tuesday, the first minister, Nicola Sturgeon, reiterated that “nobody who took part in a trial will be disadvantaged”.
She said: “All clinical trial participants have already received a letter from their principal investigator, which can be used for proof of their trial status. This provided an interim measure to enable people to gain access to domestic venues where certification is required.
“Recently we have also issued participants with a record of vaccination which contains a 1D barcode and security features consistent with all records of vaccination.”
Vaccine passports will be required in Scotland in a host of settings. These include nightclubs, seated indoor venues with more than 500 people in attendance, and unseated events with more than 10,000.
Scottish vaccine volunteers point out that most venue and travel staff will be trained to deal with QR codes, not paper certificates. Although the UK Department of Health and Social Care insists it is working with devolved administrations to ensure a consistent approach, these participants are angry at what they claim is the Scottish government’s refusal to register their details online, as happens automatically for anyone with an approved vaccine.
Michaela, another volunteer from Aberdeen, said trial officials told her the only way to secure the certification she needed to visit her family in the EU was to formally withdraw from the trial and attend a drop-in centre. Initially she was turned away when the vaccinator realised she had already had a trial dose.
“Eventually I decided there was no other way but to lie,” she said. “I felt let down and like I had to run my own experiment, because I don’t know if there are side-effects of mixing vaccines.”
Another volunteer from Glasgow, who works in healthcare, also felt she had no choice but to lie in order to get an approved vaccine. After her child caught Covid, she described the “kick in the teeth” of being told she was considered unvaccinated for the purposes of self-isolation – just as the rules were changed to allow close contacts to return to work if fully vaccinated.
She said: “In what world is that not disadvantaging trial participants? I couldn’t go to work, leaving my team understaffed and affecting patient care.”
Novavax told the Guardian that it anticipated “final filings” to the MHRA to happen in the next couple of months, and that “in addition to working day and night to complete the submission process, we are doing all we can to advocate on the behalf of clinical trail participants”.
The trialists are worried that the introduction of vaccine passports in Scotland next month could put them at a further disadvantage as they cannot access the standard electronic version, instead possessing only a piece of paper.
Some have been abused online by anti-vaxxers while others have felt forced to lie to obtain an approved dose, despite having no information about side-effects of vaccine mixing.
Their plight was highlighted on Sunday when the Observer reported that England’s deputy chief medical officer, Prof Jonathan Van-Tam, had asked ministers to withhold all UK clinical trial data from the EU if European countries continued to deny entry to Novavax and Valneva trial volunteers.
About 1,000 Scots signed up for the Novavax trial, which began in the autumn of 2020, a significant cohort of the 15,000 across the UK, and the initial results were considered extremely promising. But the Guardian has also seen a notification sent to trial participants in the north of England this week of a further delay in regulatory approval of at least two months, meaning they will not be offered booster vaccines.
The email from the medical lead of the local trial said: “Novavax is unable to provide guidance on the safety of receiving either 2 doses of an authorised vaccine or a booster of an authorised vaccine after having previously received 2 doses of the Novavax vaccine.”
The Scottish Liberal Democrat leader, Alex Cole-Hamilton, urged the Scottish government to get to grips with the irregularities. “It’s concerning that those who volunteered to trial new vaccines that could keep all of us safe are being treated as second-class citizens,” he said.
While Scottish government ministers have repeatedly reassured the volunteers that clinical trial participants have the same status as someone vaccinated through the NHS programme, volunteers question how equal that really is when they are not included on the NHS Inform database, cannot get a QR code on their phone and have only a paper record of their status.
One Aberdeen participant said: “We have to self-isolate as though we haven’t been vaccinated, our details are not on the NHS Inform website, we can’t download a QR code – and when vaccine passports come into force next month all we have is a paper letter, which is not equal to an app on your phone.”
She added: “I didn’t take part in this trial to fight against my own government. People don’t understand what it takes to be in a trial, and if we’d known we would never have signed up for it.”
When asked about the situation after her Covid statement last Tuesday, the first minister, Nicola Sturgeon, reiterated that “nobody who took part in a trial will be disadvantaged”.
She said: “All clinical trial participants have already received a letter from their principal investigator, which can be used for proof of their trial status. This provided an interim measure to enable people to gain access to domestic venues where certification is required.
“Recently we have also issued participants with a record of vaccination which contains a 1D barcode and security features consistent with all records of vaccination.”
Vaccine passports will be required in Scotland in a host of settings. These include nightclubs, seated indoor venues with more than 500 people in attendance, and unseated events with more than 10,000.
Scottish vaccine volunteers point out that most venue and travel staff will be trained to deal with QR codes, not paper certificates. Although the UK Department of Health and Social Care insists it is working with devolved administrations to ensure a consistent approach, these participants are angry at what they claim is the Scottish government’s refusal to register their details online, as happens automatically for anyone with an approved vaccine.
Michaela, another volunteer from Aberdeen, said trial officials told her the only way to secure the certification she needed to visit her family in the EU was to formally withdraw from the trial and attend a drop-in centre. Initially she was turned away when the vaccinator realised she had already had a trial dose.
“Eventually I decided there was no other way but to lie,” she said. “I felt let down and like I had to run my own experiment, because I don’t know if there are side-effects of mixing vaccines.”
Another volunteer from Glasgow, who works in healthcare, also felt she had no choice but to lie in order to get an approved vaccine. After her child caught Covid, she described the “kick in the teeth” of being told she was considered unvaccinated for the purposes of self-isolation – just as the rules were changed to allow close contacts to return to work if fully vaccinated.
She said: “In what world is that not disadvantaging trial participants? I couldn’t go to work, leaving my team understaffed and affecting patient care.”
Novavax told the Guardian that it anticipated “final filings” to the MHRA to happen in the next couple of months, and that “in addition to working day and night to complete the submission process, we are doing all we can to advocate on the behalf of clinical trail participants”.
