Verity Pharma and India's SII apply to distribute AstraZeneca vaccine in Canada

TORONTO/NEW DELHI: Verity Pharmaceuticals and Serum Institute of India (SII) have applied to distribute SII's licensed version of AstraZeneca's COVID-19 vaccine in Canada, potentially easing shortages as European manufacturing sites struggle to meet global demand.

AstraZeneca Canada had filed a rolling application for its vaccine with Health Canada in October, but online records show Canada's Verity Pharmaceuticals and SII on Jan. 23 filed a separate application to sell the vaccine developed by AstraZeneca and Oxford University researchers.

SII, the world's biggest vaccine maker, has capacity to produce roughly 2.4 million doses per day at its campus in Pune, western India.

"Verity Pharmaceuticals is providing important support to Serum Institute of India related to its regulatory registration, importation and distribution of the vaccine in Canada, pending Health Canada approval," AstraZeneca Canada and Verity said in a joint statement.

A source close to the matter said discussions are ongoing between SII and Verity but it is too early to provide details on delivery timelines or volumes that SII could ship to Canada.

SII did not immediately respond to a request for comment.

The Indian company's chief executive, Adar Poonawalla, told Reuters last week that SII was happy to support AstraZeneca to meet any supply needs, but he emphasised that its primary focus was India and other poorer nations in Asia and Africa.

SII has already stepped in to help AstraZeneca to fulfil some orders in South Africa, Brazil, Saudi Arabia and other nations.

Canada, with a population of about 38 million, has ordered more vaccine doses per capita than any other country and was among the first to approve the Pfizer-BioNtech and Moderna vaccines, though deliveries have been sluggish.

Pharmaceutical manufacturing is a major industry in India, and several COVID-19 vaccines are being produced in the country at scale. Canada, by contrast, is entirely dependent on imports from European manufacturing sites, and both Pfizer and Moderna have cut planned deliveries in recent weeks.

Last week the European Union rolled out a new export control regime for vaccines, including a mechanism that could block certain exports. Canadian officials say they have been assured that shipments to Canada should not be affected, but Canada is not officially exempt from the regime.

Poonawalla last week told Reuters that SII had no plans to divert supplies to Europe.

SII, which had a stockpile of about 60 million doses of the vaccine last month, is adding a third production line by March. That would allow it to produce more than 3 million doses a day of COVISHIELD, the brand name under which it markets the AstraZeneca shot.

Beyond supplying India's vaccination drive, however, SII has also committed to supply tens of millions of doses to the GAVI/WHO-backed COVAX initiative to help to accelerate vaccinations in poorer nations.