COVID-19 – Accelerating Vaccine Development and Manufacturing
COVID-19 – Accelerating Vaccine Development and Manufacturing
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As the COVID-19 outbreak rapidly evolves, work to develop a vaccine and to test antivirals and other therapeutics continues in parallel.
On March 23, 2020, Canada’s Prime Minister Justin Trudeau announced that the Vaccine and Infectious Disease Organization – International Vaccine Centre (VIDO-InterVac), a research organization of the University of Saskatchewan, will receive $23.3 million to support development of a vaccine for COVID-19 and the organization's work on other infectious disease threats.
Technology Networks spoke with Dr Paul Hodgson, Associate Director of Business Development at VIDO-InterVac to learn more about their experience working with coronaviruses, the organization's manufacturing facilities, and the other antivirals and therapeutics they are currently testing in relation to COVID-19.
Laura Lansdowne (LL): Could you elaborate on VIDO-InterVac’s experience working with infectious diseases? Particularly touching on your track record working with, and making vaccines against, coronaviruses?
Paul Hodgson (PH): VIDO-InterVac has been researching infectious diseases of humans and animals, and developing vaccines to prevent these infections for the last 45 years. Our technologies have been in eight commercially available vaccines, with more vaccines in regulatory development. Historically, we developed the first bovine coronavirus combination vaccine, one of the first coronavirus vaccines for porcine epidemic diarrhea virus, were involved in the SARS Accelerated Vaccine Initiative (SAVI), and have ongoing research projects on MERS including developing a vaccine for camels to stop transmission to humans. The research and development on the new coronavirus (SARS-CoV-2) is well aligned with our scientific expertise.
LL: What key considerations should be made when developing a vaccine?
PH: There are several key considerations when making a vaccine including: selecting the antigen and the type of antigen (e.g. gene based, protein based); choosing an adjuvant (part of the vaccine formulation); determining the safety profile of the vaccine; determining how the vaccine will be administered and how well the vaccine protects against infection (vaccine efficacy). Additional considerations include ease and consistency of production which will be valuable to the regulators that approve the vaccine and the companies that will be manufacturing and marketing it.
LL: Could you tell us more about the pilot-scale manufacturing facility on campus to accelerate COVID-19 vaccine development in Canada and abroad? How will this influence clinical development efforts?
PH: The pilot-scale manufacturing facility will be located within VIDO-InterVac’s containment level 3 building. The containment level 3 production will be able to make vaccine antigens using both bacterial and mammalian systems (i.e. vaccines for both bacteria and viruses) under good manufacturing practices (GMP) standards. This standard is required for human vaccine production. Having access to GMP production will enable researchers to commercially advance their technologies. The facility will also tie into large vaccine manufacturers in Canada to help with process development and scale-up. It can also assist the government with emergency preparedness for infectious diseases.
LL: What does a “typical” vaccine manufacturing process look like? Have adjustments had to be to optimize the process in response to the current global need for a COVID-19 vaccine?
PH: The typical vaccine development process involves preclinical and clinical work. The preclinical process starts by defining and characterizing the vaccine candidate and work focuses on identifying the best antigen and adjuvant (the formulation) as well as determining the ideal route of administration. The antigen is usually produced on a small (or “bench”) scale in a microorganism. The choice of this microorganism is important for large scale manufacturing.
Once the antigen and the adjuvant are selected from the preclinical work, a process development facility scales up the production and purification processes under high quality requirements. The material prepared from engineering runs is characterized and used to establish product specifications and stability. A GMP production run is then conducted to prepare clinical grade material – this material will be assessed in animal safety studies and used in human clinical trials.
There are not many options for production optimization. Companies can scale up GMP production prior to receiving the results from animal studies, or they can bring multiple vaccine candidates forward at the same time and choose the ideal candidate based on the animal studies and other production criteria. This mitigates lag time, but also puts the company at a financial risk. In addition, recently companies have been working with the regulators to have their production systems approved as “platform” systems. This gives them some flexibility to seek approval from the regulators to initiate Phase 1 trials concurrently with supporting data from previous trials that used these systems.
Molly Campbell: In the press release you say "VIDO-InterVac is the first lab in the country to have a vaccine candidate in animal testing" – please can you expand on the preclinical data you have obtained thus far?
PH: At this point, we have developed in vitro culture systems and a ferret model of infection using a virus isolated from a clinical sample from Sunnybrook Health Sciences. We have manufactured a vaccine candidate at lab scale and formulated it with several adjuvants to see which one provides the best protection. The selection of antigen as well as the adjuvants being tested are based on historic expertise on coronaviruses. In several weeks we will have data to demonstrate if our vaccine formulations are protective. Based on previous data we have generated in SARS and MERS we are optimistic the vaccine will be effective.
LL: In relation to COVID-19, what other antivirals and therapeutics is VIDO-InterVac currently testing?
PH: We have been approached by multiple companies and academics who have technologies they want to test. This includes antiviral compounds, immune stimulators, and therapeutics. Some of these are novel compounds and some are medicines already used in humans for other diseases. The benefit of approved medicines is that they have the potential to be quickly repurposed to help in the fight against the morbidity and mortality of COVID-19.
Paul Hodgson was speaking with Laura Elizabeth Lansdowne and Molly Campbell, Science Writers for Technology Networks.