New Zealand has been chosen to be part of a late-stage trial for a new European Covid-19 vaccine.
The VLA2001 vaccine, created by French biotech company Valneva, has already been trialled on approximately 4000 volunteers in Europe.
The company is now looking for 300 adults across New Zealand.
The participants must be older than 56 and not have previously had Covid-19 or received a Covid-19 vaccine.
Director of Southern Clinical Trials Christchurch Dr. Simon Carson is the lead coordinating investigator for the New Zealand trial. He said New Zealand’s low case numbers and slower vaccine rollout is a large part of the reason for the trials being conducted here.
“The trial began in the UK but it requires people who a) haven’t had Covid them self and b) haven’t had a Covid vaccine and with the rapid rollout and with the state of Covid in the UK, they were basically running out of people, and pretty much the only place in the world to come to was New Zealand.”
The New Zealand clinical trial is being managed by PharmaSols and will take place at eight Pacific Research Network sites across the country.
Carson said the VLA2001 vaccine is different from the Pfizer vaccine, in that it is a traditionally developed vaccine compared to some of the newer mRNA vaccines.
“It’s thought that rather than just creating antibodies for the spike proteins, like the Pfizer one does, this may create a slightly larger range of antibodies and may give you more protection against other strains.”
The vaccine is two doses, taken four weeks apart.
Participants will keep electronic diaries of any symptoms and undertake blood tests to monitor their antibodies.
He said the risks involved in participating in the trial are outlined in a patient information sheet.
“No vaccine is entirely safe, there is a range of side effects including local side effects such as a slightly sore arm, swelling and there are more generalised side effects such as raised temperature, feeling a bit off-colour for a few hours or slightly more.
“The side effects are looked at constantly through the trial and accessed by a safety committee and they appear to be no more than any other vaccine.”
The company has been advertising the trial on several channels and Carson said it has received a good response so far.
“It’s coinciding with the national rollout of the Pfizer vaccine so quite a few people have already had the Pfizer vaccine and people have contacted us saying ‘Oh I would’ve come on this if I’d known about this slightly earlier’, but with the timelines we’ve been given it is what it is.”
He said he is excited to be a part of the global effort in fighting the virus.
“We continue to need new types of Covid vaccines, just the make sure population groups can access safe and effective vaccines. we’re doing this not just for New Zealand but it’s really a global endeavour if you like.”
Vaccine Alliance Aotearoa New Zealand clinical evaluation director Dr Frances Priddy said she is supportive of the trial, and of increasing New Zealand’s involvement in new Covid-19 vaccine studies.
“New Zealand needs to continue to contribute to the global effort to develop Covid-19 vaccines. This study gives New Zealanders an opportunity to be involved at a personal level. The participation of older adults is critical to help evaluate new vaccines for this population.”
Valneva chief medical officer Juan Carlos Jaramillo added, “The fight against Covid-19 continues and it’s extremely important that we continue to gather as much data as possible in all age groups across the population.
“Everyone should have access to technology best suited to protect them against this virus. We have also been working on variants of concern as part of our continued efforts to stay ahead of the virus causing Covid-19 especially since we believe that our inactivated, whole-virus platform will be adaptable across variants.
“Hence we are extremely pleased to be able to invest in this very important additional clinical trial”.
New Zealand is the only country outside of Europe where the VLA2001 vaccine is being trialled.
The UK government has already ordered 100 million doses of the vaccine. Production began at a factory in Scotland in January.
If all goes well the vaccine will be approved by regulators overseas and could be available in the UK by the end of the year.