Vaccine trials for international vaccines could take place in New Zealand. This might help secure access to vaccines in global hot demand.
The Vaccine Alliance Aotearoa New Zealand – Ohu Kaupare Huaketo – is trying to make sure New Zealand has access to Covid-19 vaccines.
The seemingly unusual grouping between the University of Otago, Victoria University of Wellington and independent entity, the Malaghan Institute of Medical Research, has received $10 million in funding as part of the Government’s Covid-19 vaccine strategy.
Members of the alliance have been lobbying the Government since April for New Zealand to have its own vaccine programme. Before Covid-19, New Zealand had no coordinated funding approach to vaccine science. Pharmac and Medsafe are both part of New Zealand’s vaccine strategy taskforce, but Pharmac is traditionally focused on procurement and Medsafe on safety.
“It was clear to us we would need a vaccine,” said Vaccine Alliance Aotearoa New Zealand’s (VAANZ) science director, University of Otago’s associate professor James Ussher.
“We were concerned about the uncertainty on the horizon, given all the issues around Covid and supply chains breaking. We saw a need for New Zealand to be involved, rather than just sitting on the sidelines waiting for something to be delivered,” said Ussher.
The government strategy for vaccine access, which includes the alliance, was announced late August, against a backdrop of various countries doing deals to secure potential vaccines for their population. It’s estimated 40 percent of the vaccines able to be manufactured between now and December 2021 have already been pre-ordered before any of them have been approved for general use.
This ‘vaccine nationalism’ – or hoarding -means countries without huge budgets to splash around could find themselves at the back of the vaccine queue.
VAANZ is not a procurement group and it won’t be buying Covid-19 vaccines. It’s also not a public health group, and it won’t be part of a vaccine roll-out making a call on who’s eligible for a Covid-19 vaccine when the first shipments become available.
Its task, according to the Ministry of Business, Innovation and Employment’s website, is to lead “Covid-19 vaccine research in New Zealand, working with local and international scientists to support the development of potential vaccine candidates”.
What exactly does that mean on the ground?
Ussher said the alliance’s purpose is to get early and ongoing access to vaccines.
There are a few strands to the work VAANZ is doing.
One way is to take part in the development process of vaccines being developed globally. Vaccines passing VAANZ’s evaluation could be helped by running pre-clinical and clinical trials in New Zealand.
“We’ve got an excellent network of clinical trial units. We’ve got good processes in place and local experience in running clinical trials for safety and immunogenicity.”
This work could be done for pre-clinical trials, and phase one and two safety and immune response trials.
A platform is being set up for pre-clinical safety testing. Phase one and two trials usually involve recruiting suitable volunteers, administering the vaccine or placebo, monitoring participants for reactions to the vaccine like a sore arm, headache or fever and testing immune reaction to the vaccine through blood tests.
Ussher said VAANZ was still in planning mode and no clinical trials were being run at present. A portion of the $10m funding is expected to go towards future trials.
Asked if this would help New Zealand cut a deal with the vaccine creators, he said participation in clinical trials was something they’re looking at as a way to “help facilitate New Zealand’s early access”.
This could mean preferential access, or “whether something could potentially be manufactured under licence here”.
Manufacturing vaccines in New Zealand
There’s the capability to manufacture vaccines in New Zealand although it’s not being done for humans at the moment. Identifying what capacity already exists within the country is another area VAANZ has been involved in. This could be to manufacture vaccines developed in New Zealand, or to locally manufacture vaccines from overseas.
“There is expertise there that could be stood up to contribute to the global requirements for increased manufacturing for various vaccines,” said Ussher.
Different technology is required for different types of vaccines. Ussher said viral vector and protein subunit vaccines could be manufactured. Inactivated, RNA and DNA vaccines would likely require more investment and time to be able to manufacture locally.
Auckland company Biocell has received $3m in government funding to upgrade its facilities. This is over and above the $10m the alliance has received.
Biocell is currently working with a United States-based company Stabilitech, on a vaccine in pill form. South Pacific Sera in Timaru also has the potential capability to manufacture some types of vaccines.
DIY – New Zealand’s home grown vaccines
The final area of work is creating a homegrown vaccine. It’s unlikely anything we create from scratch ourselves will win the vaccine race, but it could be part of a second wave of vaccines.
This includes a recombinant spike protein vaccine being developed out of Dr Davide Comoletti’s lab at Victoria University of Wellington, an inactivated virus vaccine in progress in Professor Miguel Quiñones-Mateu’s lab at the University of Otago and a pan-coronavirus vaccine being explored by Avalia Immunotherapies with international collaborators.
Ussher said the development of the vaccines is funded from other sources, but some of the $10m in funding the alliance has received is being put toward setting up infrastructure for pre-clinical trials and running clinical trials for these.
Funds with KPI strings
The $10m of funding wasn’t handed out willy-nilly.
Dr Peter Crabtree, chair, Covid-19 Vaccine Strategy Task Force said credibility, expertise and connections were among the reasons VAANZ was funded. “The Malaghan Institute, University of Otago and Victoria University of Wellington are credible research organisations with a history of vaccine-related research and commercialisation. The lead team of researchers in the alliance are well-connected in New Zealand and internationally, with existing links to New Zealand manufacturers, and are committed to collaboration and to being flexible in a rapidly-changing environment.”
He said independent advice was sought that the platform VAANZ is proposing for pre-clinical testing and trials was a credible contribution to national and international vaccine research.
The funding comes with key performance indicators which include:
– establishing a national Covid-19 vaccine evaluation and development platform to screen, trial and progress the development of potential domestic and international Covid-19 vaccines;
– developing domestic vaccine candidates, which may be promising candidates for the later stage vaccines and potentially offer domestic access to vaccine IP;
– building domestic and global research collaborations to progress the development of local vaccine candidates and help secure New Zealand’s access to potential international vaccines;
– linking in with domestic manufacturing to determine whether successful candidates can be produced at a commercial scale in New Zealand and will help build New Zealand’s capability in vaccine development and production to ensure New Zealand is prepared for future pandemics.
Crabtree said the the funding was part of a strategy to make sure there were plenty of options.
“By investing in a range of approaches, the task force will build a portfolio to ensure that New Zealand has options, should some of the vaccine candidates not be successful.”
Other parts of the Government’s vaccine strategy include involvement in international schemes. In May, $15m was invested with Coalition for Epidemic Preparedness Innovations (CEPI) and $7m of assistance was given to global vaccine alliance GAVI.
In August it was announced further funds had been set aside, amounting to “hundreds of millions”.
One of the recipients is the Covax facility, a programme set up by CEPI. Its goal is to distribute two billion doses of vaccine in 2021. One billion doses for low to middle-income countries, to be supplied free or at low cost, and the rest for wealthier countries that will pay for their vaccines.
These funds could also be used to buy vaccines.
An exact figure wasn’t released as it could impact the ability to negotiate.
Research, Science and Innovation Minister Megan Woods said the $3m in funding given to Biocell would help the company produce up to 100 million doses of vaccine which would be shared with Pacific countries. Another $2m has been allocated to support manufacturing capability, it’s not clear if this has has been awarded yet.
The odd alliance
For the Government’s pandemic vaccine strategy to partly rely on a grouping of university and independent institute staff may seem a little odd.
VAANZ’s programme director is Professor Graham Le Gros, who is the director of the Malaghan Institute. He explained how this came to be. Partly it’s a result of people not willing to sit on the sidelines when they can contribute. These people saw a gap they could help with.
“It has to be acknowledged that it is hard for governments to maintain coordinated funding over the long term because pandemics do not occur that often and other acute health issues become a priority for government’s health spend.”
Enter a pandemic and there’s a vaccine science vacuum.
“The reason why our VAANZ is seemingly oddly scattered amongst such different organisations just reflects that there is no coordinated funding approach by the government towards vaccine science anymore. In recent years, New Zealand has always been in a position to wait and get the best product after it has been tested. We may not have the luxury this time.
“It has been left up to individuals – or the marketplace if you like – in recent years. The Malaghan Institute stands out in the particular case of Covid-19 because we are the immunology centre for New Zealand specialising in understanding how to make vaccines and what causes adverse reactions.”
The second wave of vaccines
Le Gros and Ussher both expect the pay-off of their work to come in a second wave of vaccines. The vaccines in phase 3 trials may not offer long-term immunity, or may not work as well for all ages. Le Gros said some of the vaccines being developed were unlikely to be able to be used repeatedly.
“They’re the first cab off the rank, which is fine, but that’s why we’ve got to build generation two or three vaccines, where you can get, say, 10 years of immunity, or you can give repeated immunisations.
“Everyone thinks we’re going to have one vaccine which solves it all. No.”