COVID-19 has changed the entire world. In Medlior’s latest blog post, we look at vaccine development and approval in Canada, answering questions about how the vaccines could be developed so quickly, and what contributed to Canada’s slow start in rolling them out.
Looking back, we can see that it took less than a year from the time the world learned about the disease that would come to be known as COVID-19 to the day Canadians had access to a vaccine to prevent it. How was this possible?
Develop a vaccine in a year?
The first factor for the expediency of the vaccine development was that not all of the science was new, so vaccine development was not starting from scratch. Labs worldwide had been refining nucleic acid – the NA in DNA and RNA – vaccine technology for years. The prior SARS and MERS outbreaks had prompted research into designing the right “target” for new vaccines.
Moderna and Pfizer/BioNTech are now household names, thanks to their mRNA vaccines. Although it was yet to become newsworthy, these companies had been researching the mRNA vaccine platform for years. Germany’s BioNTech had partnered with Pfizer in 2018 to make an mRNA flu vaccine. Moderna had similarly already been developing an mRNA vaccine against the Zika virus. As soon as the genetic sequence for SARS-CoV-2 was made available, both companies immediately switched gears, and transitioned the target virus to SARS-CoV-2.
The second big factor in expediency of vaccines was organizations, governments and other sources poured money into research efforts. This eliminated the usual commercial risk usually associated with prioritizing candidates for research. Unprecedented urgency and commitment from across the globe meant that by May 2020, more than 125 vaccine candidates were already in development.
The third big factor was that the system for approval was made more efficient.
The influx of funding meant that manufacturing processing could be developed in parallel to clinical studies. It also meant that certain aspect of clinical trials could be run parallel or in quick succession. Because of the increased funding, the financial risk of pursuing the wrong candidate was gone. The science became the only determining factor in what went ahead. Additionally, Health Canada issued an interim order for COVID-related medicines, which created a fast-tracked process that meant:
- Manufacturers could submit data as they became available; and
- Health Canada could review data as soon as it was received.
If the vaccines were ready, why couldn’t we get them right away?
Despite fast development and approval, Canada’s vaccine roll-out has been slower than that of countries to which it is commonly compared, such as the UK or the US.
A big reason for this is that Canada lacks domestic production. Government objectives over the past decade, such as achieving the lowest possible prices, have served to weaken Canada’s domestic pharmaceutical sector and resulted in increased reliance on imports and a more vulnerable pharmaceutical supply chain. Supply of the COVID-19 vaccines needed to be secured from elsewhere.
Deals with EU factories were initially prioritized over fear of an “American First” ban on vaccine exports from US facilities. These EU factories unfortunately struggled to meet supply commitments. Having never brought a drug to market before, Moderna dealt with production delays and, because it had received funding from Operation Warp Speed in the US, was required to supply a certain amount to the United States first.
The COVID-19 pandemic has raised awareness of the need for a strong domestic industry. The Canadian government has announced a $2.2 Billion investment in Canadian life sciences in an attempt to boost the industry into a global leader. Similarly, the federal government has started production on a new vaccine production plant. Once the plant is operational, a new COVID-19 vaccine, Novavax, will begin production.
This newly invigorated interest in having a strong domestic industry is, unfortunately, at odds with recent drug pricing reforms taking place in Canada. The Patented Medicine Prices Review Board (PMPRB) is set to impose further restrictions on the prices companies can charge for new medicines coming to market. This move is unlikely incentivize investment in country. “You can’t do both. You can’t take 70, 80, 90 percent off the bottom line of businesses and expect them to be really happy about investing in the country,” said Pamela Fralick, President of Innovative Medicines Canada. This is definitely an area to watch.
Is that hope we feel?
Wonderfully, a made-in-Alberta vaccine has progressed through the initial phases of development and will shortly be moving to in-human trials. This DNA-based vaccine has been developed by Entos Pharmaceuticals based out of Edmonton and has been produced through work at UofA’s Alberta Cell Therapy Manufacturing facility.
Read more on the effects of COVID-19 in the following Medlior blogs:
- Report on Virus-neutralizing Monoclonal Antibodies for the Treatment of SARS-CoV-2
- The Effects of COVID-19 on Cancer Screening
- COVID-19 and Opioid Overdose Deaths: Insights from Alberta’s Substance Use Surveillance Data
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