6-week sprint got Canada's nod for AstraZeneca Covid-19 vaccine

Problems at AstraZeneca Plc’s European production site in January kicked off a six-week push to get a version of its Covid-19 vaccine made at an Indian facility approved by Canada’s drug regulator, acco­rding to the Canadian pharmaceutical company that filed the application.

Last week, when Health Canada approved Astra­Zen­eca’s Covid-19 vaccine, it also cleared a version of the shot made by the Serum Institute of India (SII). SII filed the application with a Can­adian partner, Verity Pharmaceuticals.

Some 500,000 doses made by SII, the world’s largest vaccine producer, are set to arrive in Canada on Wednesday, a surprise boost for Canada’s lagging vaccination drive.

Health Canada’s relatively fast approval was underpinned by SII and Verity’s four years of working to bring a cancer treatment to Canada. “It’s been a lightning six weeks,” said Verity’s Chief Executive How­ard Glase in an interview. “The health regulators have really outdone each other ... They’ve really put in 24- hour days.”

After Friday’s approval, Canada said it agreed to buy 2 million vaccine doses from Verity and Serum by mid-May, enough to vaccinate as much as 2.7 per cent of its population. Only about 3.6 per cent of Canadians have received at least one vaccine dose in Can­ada, according to volunteer-run data project Covid-19 Tracker Canada. With no local Covid-19 vaccine production, Canada trails many developed nations in inoculations as the world works toward vaccinating enough people to halt the pandemic that has claimed more than 2.5 million lives globally.

The SII shipment comes weeks after Prime Minister Narendra Modi assured Cana­dian counterpart Justin Trud­eau that India would do its best to supply Canada with vaccines, a sign of improving diplomatic relations that soured after Trud­eau expressed concern over India’s farmer protests late last year.

Health Canada and Verity’s staff put in long hours to get the approval done, working thr­ough the night to get the document describing the vaccine’s properties and intended uses, known as a product monograph, translated, proofed and approved in the early hours of Friday morning, said Glase. Health Canada confirmed that staff worked through the night.