Wednesday, February 3, 2021

Canada To Make Shots

From the CBC:

“Canada inks deal to produce millions of COVID-19 shots domestically”



Prime Minister Justin Trudeau announced today a plan to produce millions of COVID-19 shots at a plant in Montreal starting later this year, securing a domestic supply of vaccines as the global market contends with delivery delays and protectionist measures. The National Research Council-owned Royalmount facility will churn out tens of millions of doses of the product developed by Maryland-based Novavax, Trudeau said. That company submitted its vaccine to Health Canada for regulatory approval last Friday. "This is a major step forward to get vaccines made in Canada, for Canadians.... We need as much domestic capacity for vaccine production as possible," Trudeau said. "We won't rest until every Canadian who wants a vaccine has received one." The agreement will help jump start Canada's largely dormant domestic vaccine manufacturing industry but it will do little to meet the short-term demand for COVID-19 vaccines. The Novavax product has to be approved by Health Canada regulators, the NRC has to finish building the plant itself and the facility has to be certified to make the vaccines; all of which is expected to take months to complete.

The first Canadian-made Novavax vials won't be produced until the end of the year, the government said, well after the prime minister has promised every Canadian would be inoculated against COVID-19. Novavax has said its protein-based COVID-19 vaccine product produced an efficacy rate of 89.3 per cent in late stage clinical trials, with strong protection against the strain of the virus first reported in the U.K., which has shown to be more resistant to other vaccine candidates. Canada agreed to purchase shots from Novavax — a biotechnology company that has been at the forefront of developing new vaccines against influenza — last August. The government has since upped that purchase agreement with a commitment to buy at least 52 million doses of the two-dose product. Last summer, Trudeau announced more than $125 million to upgrade the NRC facility to produce vaccines domestically and avoid the global scramble for shots. At the time, Trudeau said the factory could produce hundreds of thousands of shots starting in November. But the project ran into problems when it was determined the facility didn't meet exacting good manufacturing practices (GMP) required for such a site. The plant was slated to produce shots co-developed with CanSino, a Chinese-based firm, but that ill-fated partnership was shelved after the Chinese government blocked shipments before clinical trials could begin. The work on upgrading the NRC facility has continued and it's now expected to be ready to produce COVID-19 shots sometime this year, the prime minister said, with a production capacity of approximately 4,000 litres per month, which is equivalent to approximately two million doses of a vaccine. When complete, the facility will be able to make viral vector, protein subunit, virus-like particle based vaccine doses, but not mRNA shots like those developed by Pfizer-BioNTech and Moderna. The Novavax product is of the protein subunit variety.

While construction of the site is expected to finish in July, the NRC facility then has to secure GMP approvals from Health Canada. Trudeau said once the plant secures certification, production will start "quickly after that" suggesting the facility could be operational as soon as this summer. But Innovation Minister François-Philippe Champagne later clarified that the earliest possible production start date is likely "at the end of the year," after most Canadians have been vaccinated against COVID-19 with foreign-sourced shots. Champagne said building this sort of facility from the ground up on such a constrained timeline was akin to the 1960s-era U.S. mission to put a man on the moon. "This is like the Apollo project," Champagne said in an interview with CBC's Power & Politics. "Normally, it would take two to three years to do this, to get a production facility up and running. We've been pushing them, working with them, and we're developing this pillar of resiliency." Trudeau said this NRC investment is principally designed to revitalize Canada's domestic pharmaceutical sector and to help the country guard against future variants or other deadly viruses. "Whether it's for further waves of this virus, or it's for future viruses, Canada has made a commitment to ensure that we have both the scientific and the production capacity to meet the needs of Canadians regardless of what the future is," he said.

'Why did the Liberal government wait so long?' Beyond the Novavax production agreement, Trudeau said the government is helping to finance the development of vaccines produced by Vancouver-based Precision NanoSystems. The $25.1 million investment will help the company construct a biomanufacturing centre to produce vaccines and therapeutics for the prevention and treatment of infectious diseases, rare diseases and cancer. But the company's planned self-amplifying ribonucleic acid (RNA) COVID-19 vaccine will not be ready this year, in fact, according to a government backgrounder, Precision NanoSystems's shot won't be produced in Canada until sometime in March 2023. The University of Saskatchewan's Vaccine and Infectious Disease Organization (VIDO) is also working to stand up domestic manufacturing capacity of a COVID-19 vaccine, but that facility won't be completed until the end of 2021 at the earliest.

"This is a good step forward, but it is very late' While this new production capacity will help the country combat possible future variants of COVID-19, or other infectious diseases, the agreements will do little to reduce the insatiable demand for vaccines in the present. Canada passed on the domestic manufacturing rights to the AstraZeneca product. But other allies, like Australia and Japan, are set to produce that shot at their own facilities starting this spring. Melbourne-based CSL will produce 2 million doses of the AstraZeneca each month starting in late March. JCR Pharmaceuticals will produce some 90 million doses this year for the Japanese market. Conservative Leader Erin O'Toole welcomed the Novavax partnership but said such an agreement should have been signed much earlier so that Canada wasn't entirely dependent on foreign sources for these life-saving products. He said Trudeau has shown "slow and inactive leadership" over the last 10 months of this pandemic. "Why did the Liberal government wait so long to act? When will domestically produced vaccines be available to Canadians – and how will Canadians get vaccines now?" O'Toole said. "Today's announcement changes absolutely nothing in the short term. We need to do better." NDP Leader Jagmeet Singh has also been pushing the federal government to invest in vaccine production through the creation of some sort of Crown corporation. "This is a good step forward but it is very late. This is something that should have been secured a long time ago, it would have addressed a lot of the insecurity people are feeling about not getting the vaccine and seeing delays in the rollout because of production delays," Singh said. Champagne batted away any suggestion that Canada could have acted sooner to secure a domestic supply of shots, saying vaccine manufacturing has atrophied to such a point that there simply isn't a facility available to produce something like the AstraZeneca shot right now. The U.K. also had very little domestic capacity but the British government spent $175 million last July to rebuild a facility in Essex, England to produce some of those shots at home. "We didn't have the same scale in terms of manufacturing capability as the U.K., that's why they are where they are today," Champagne said. "We didn't start from the same base."

Canada receives assurances about Moderna, Pfizer supply The funding announcements come at a time that Canada's inoculation campaign is facing a series of disruptions. The two primary suppliers, Pfizer and Moderna, have been beset with manufacturing issues that have resulted in lower shipments to Canada. The European Union has also introduced new export controls that could result in some shipments being delayed or cancelled altogether because Canada's current supply of shots comes from plants in Europe. Canada was not one of the dozens of countries that received an exemption from the "export transparency mechanism." The protectionist push threatens to derail deliveries in the short term, although International Trade Minister Mary Ng has said she has received verbal assurances from European leaders that Canada's supply will not be affected. Asked why his government didn't secure a written commitment from the EU that Canada's shipments would be untouched by the export crackdown, Trudeau said, in diplomacy, "an awful lot of firm commitments are made in conversations." "It's not like a small claims court where you can show a document. The conversations I had with the president of the European Commission were enough to reassure me that Canada's contracts will be respected and that our supply of vaccines not be interfered with," he said. Indeed, Public Services and Procurement Minister Anita Anand said Tuesday "all systems are a go" for the shipments that will arrive this week — some 79,000 doses from Pfizer and another 180,400 from Moderna.

^ I guess this is good since Canada has been well-behind the Covid fight. Canadian scientists couldn’t make a vaccine themselves so the next best thing is for them to start making the vaccines from other countries. ^

https://www.cbc.ca/news/politics/vaccines-canada-production-trudeau-1.5897343

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