Author: Dr Chih Wei Teng
The world waits in bated breath for a COVID-19 vaccine as numerous countries remain locked down in varying degrees. At the time of writing, most regions in the State of Victoria, Australia are in the Stage 4 lockdown where people are only able to leave their homes for food and other essential items, caregiving and receiving medical treatment, exercise and permitted work. In recent days, there appears to be some silver lining in the clouds as new COVID-19 cases seemed to have plateaued, but when discussions arise about a new normal occurring, there is bound to be a mention about vaccines.
A couple of weeks ago, there were a series of newspaper articles pointing to the lack of Australian manufacturing capabilities for producing vaccines. The general impression given was that even if Australia develops an effective vaccine, it is likely that manufacturing needs to occur overseas. The exception being the vaccine from the University of Queensland where a deal has been signed with CSL Behring. An interview with the CEO of Ausbiotech revealed confidence that CSL Behring can supply enough vaccines for the Australian population but has doubts about its potential to manufacture sufficient quantities if Australia chooses to attempt capturing global demand.
A similar story is seen in the regenerative medicine sector. There are 14 facilities in Australia with Good Manufacturing Practices (GMP) laboratories supporting cell and gene therapies. While there might be a reason to claim that some of the facilities are capable of supplying cell and gene therapy at quantities needed to treat the Australian population, those facilities will no doubt struggle in an attempt to provide to the global market.
Internationally, we have seen attempts in constructing large scale cell and gene therapy manufacturing facilities such as the USD1.1 billion project at the King of Prussia in Pennsylvania, US. Should Australia follow in the same footsteps, i.e. take a leap of faith and invest in developing a major manufacturing facility at a scale that is comparable to the ambitions of Australia? A prudent response may be one that argues for caution as opposed to ‘if we build it, they will come’. Loosely explained, GMP manufacturing is what happens as a result of ‘funnelling pipeline’ that has brought together ideas, entrepreneurship, financial capital, partnerships and years of blood, sweat and tears. To ensure that manufacturing capacity is utilised, there must be a rational approach to build up existing efforts to enrich that pipeline with local innovation, supplemented with international activities. Having local innovation without manufacturing is a lost opportunity and having manufacturing without utilisation is an idle resource.
Witnessing multiple calls by peak body organisations for a regenerative medicine roadmap is inspiring CCRM Australia to delve deeper into the challenges for Australia and to consider a way forward. Working with stakeholders and partners, CCRM Australia has been imagining a possible ecosystem for Australia; one that elevates the translation side of the process while working with our GMP facility partners to increase utilisation and footprint. The opportunity to take a thoughtful review is timely amid COVID-19 as State and Federal Governments are managing the pandemic while looking to develop a post-pandemic roadmap for economic recovery.
Back on the COVID-19 front, there have been some good signs on the horizon. The Australian Government has just issued a request for information to Australian and Australia-based companies in an attempt to audit their current capabilities in commercial manufacturing, fill and finish, packing and cold supply chain management. It is a positive step in the right direction in understanding the capabilities and capacities available onshore to enable local manufacture and distribution of a COVID-19 vaccine to Australians.
However, I recall making a casual observation to a colleague during the early phase of the pandemic that despite the bleak short to medium term future, we should be proud of how Australian researchers and biotechs have come together to develop a vaccine that is ready for trials in a matter of months. To date, there are over 160 COVID-19 vaccines undergoing research and development globally. That said, my observation also carried the hint that the COVID-19 situation is an outlier. It’s a black swan event. While Australia is taking the right steps to establish some form of self-sufficiency in the production of COVID-19 medicines, significant steps to build major capabilities should not be a reactive but a rational one.
If we lack the ecosystem that supports translation, commercialisation and manufacture, Australia will always need to be negotiating with international biopharmaceuticals with a hefty financial commitment to secure guaranteed supply. CCRM Australia hopes to continue and lead a broader conversation around developing a national roadmap and manufacturing capabilities to support the translation of novel therapies as a cornerstone of a vibrant Australian regenerative medicine sector.
This blog is one of many covering the topic opportunities and challenges arising from COVID-19 as part of Signal’s fifth annual blog carnival. Please click here to read what other bloggers think about this.
Koehn (2020). Australian COVID researchers warn vaccines will have to be made overseas. Sydney Herald Sun
Koehn (2020). Australia left in the dark as manufacturers race to make Oxford COVID-19 vaccine. Sydney Herald Sun
Ewing (2020). Manufacturing is the missing link in vaccine supply chain. Financial Review
Ziffer (2020). No coronavirus vaccine exists yet, but Australia is getting ready to make it. ABC News