Six-Week Sprint Got AstraZeneca Vaccine Approved in Canada

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TORONTO (Reuters) – 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% of its population. Only about 3.6% 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 Indian 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.

ALL-NIGHTER

In January, AstraZeneca warned European customers it would fall short of its first-quarter vaccine supply commitments because of production issues.

It was after this that the British drugmaker called on Serum to make doses for Canada, and AstraZeneca and Canadian government officials approached Verity, Glase said.

Verity had been working with SII on a product called BCG, a tuberculosis vaccine that can also treat some bladder cancers. Canadian patients had endured years of shortages, so Verity applied to import a supply made by SII. That application was approved with conditions in December 2020, regulatory records show.

As part of that process, Verity brought Health Canada inspectors to SII more than a year ago, Glase said. That meant it did not have to visit again to approve the vaccine manufacturing site.

Separately, Britain’s drug regulator inspected SII’s manufacturing operations last month. The UK and Canadian regulators have a mutual recognition agreement that makes their manufacturing site approvals equivalent.

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.

SII, whose CEO recently publicly assured Canada it would soon receive vaccine supplies, did not immediately respond to a request for comment on when it secured export permit approvals from the government to ship to Canada.

So far, Canada has received about 2.4 million doses of the vaccines from Pfizer Inc/BioNTech SE and Moderna Inc. The government has said shipments should increase sharply in the second quarter.

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