September 21st will go down as one of my favourite days as a CEO. This was the day that Clover Biopharmaceuticals released fantastic results for their COVID-19 vaccine, for which Linear played a key role as Linear was the sole site for Clover’s phase I study, which opened up the pathway for their successful phase II/III trial.
To think that our amazing team, alongside those selfless volunteers who put their hand up to take part, made a key contribution to something that will impact so many is a huge thrill. Directly, it has the potential to impact hundreds of millions of people, and indirectly, it will make a major contribution to the global fight against the pandemic.
While well-known names, like Pfizer and AstraZeneca, used multiple sites for their respective phase I studies, the team at Linear was able to conduct the entirety of Clover’s phase I study independently and in record time, accelerating this critical program. Phase I studies are essential as they establish the safety and immunological parameters for vaccine trials to progress to the next stage.
To give a sense of what it takes to run the first stage of a major vaccine study, here are just some of the basic statistics for the study:
- 48,614 website visits
- 8,000 applications to participate
- 6,500 calls by Linear’s recruitment team
- 1,499 bookings for screening
- 804 COVID nasal swabs
- 357 people screened
- 150 people dosed with the vaccine
- 65,000 samples processed
To achieve this feat, almost 50% of the entire team, or well over 100 staff were directly involved in some shape or form on this pivotal project. This included Linear’s Associate Medical Director, Dr Lara Hatchuel, as Principal Investigator and leading infectious disease expert, Professor Peter Richmond, as an independent medical monitor. Importantly, the project is continuing to collect vital data to help us understand the long-term immune profile of this vaccine.
What does this all mean?
Most importantly, the final results were very impressive, with a 79% efficacy against Delta reported (across 30,000 volunteers spanning multiple continents), including 100% efficacy against severe COVID-19 or hospitalisation with any variant. The safety profile (measured by the number of adverse events) was fantastic and more favourable than current vaccines. The vaccine can be easily distributed, only requiring normal refrigeration, as opposed to many vaccines that require complex distribution systems.
According to the official news release, Clover will be seeking Emergency Use Listing from the World Health Organisation, and upon receipt plans to supply 414 million doses to the COVAX facility, administered by global vaccine alliance (Gavi), which includes members such as UNICEF, Coalition of Epidemic Preparedness and the World Bank. Some of the key countries likely to benefit from this will be many of Australia’s key neighbours in the Asia-Pacific region.
So, what about Australia? While Australia has committed to the COVAX facility, at this stage, it is unlikely that Clover will find its way here, given the current stocks of Pfizer, AstraZeneca and Moderna already available. Despite this, Australia’s financial commitment to the COVAX facility will support the efforts to distribute vaccines, such as Clover’s, to less-fortunate countries. This is vitally important in helping stop the spread of COVID and the development of new variants and will ultimately help Australians.
From Linear’s perspective, this demonstrates the outsized impact the life science sector here in Perth can have on local and global health. Furthermore, Linear has gone on to deliver a range of COVID-19 trials for five global biopharmaceutical companies with additional, next-generation vaccine and therapeutic trials slated to begin in the next six-to-twelve months. It also underscores the need for government and private investment in this sector as it is only getting bigger. This example not only demonstrates the potential return on investment to this state, through increased jobs and state economic activity, but it also demonstrates how it helps us to tackle global healthcare problems that save lives, resulting in even greater economic and community development at a global level as well.
