Canada committed to partnership with Novavax despite report of production problems with COVID-19 vaccine

Canada committed to partnership with Novavax despite report of production problems with COVID-19 vaccine
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OTTAWA — The federal government is “very carefully” following reports in the U.S. about production problems facing vaccine manufacturer Novavax, which is supposed to eventually produce millions of made-in-Canada vaccine doses at a new public facility in Montreal.

Innovation Minister Francois-Philippe Champagne said although the company has not yet received Health Canada approval to distribute or manufacture its COVID-19 vaccine here, he is “confident” that it soon will.

“Novavax, in terms of the technology and the science, is solid,” said Champagne in an interview with the Star.

However, Champagne said that if Health Canada decides that the company doesn’t qualify for certification, the advantage of having a publicly owned facility is that it can switch gears if needed.

“We have a good partnership with Novavax, but we could partner down the road with someone else to make sure that we make best use of that facility,” Champagne said.

The government has spent $170 million through the National Research Council to build new vaccine production capacity at its Royalmount site in Montreal.

Work on the facility that is expected to produce two million vaccine doses a month was completed in June. The plant is geared to producing viral vector vaccines, and could not be used to produce mRNA vaccines, such as the COVID-19 vaccines developed by Pfizer and Moderna.

Work to build a separate facility that would produce vaccines using the same kinds of technology for clinical trial purposes is ongoing and expected to be completed next summer.

Novavax is currently transferring its vaccine technology to Canada through the NRC, and working with Health Canada’s regulators to certify the facility, said Champagne.

He said the certification process “will look at all the issues to make sure what’s coming out of that facility in terms of manufacturing would be the highest standard in order for that to be approved for production.”

In addition to Canada one day manufacturing the Novavax COVID-19 vaccine here, Ottawa has an advance purchase agreement with Novavax for 52 million doses and an option to purchase an additional 24 million doses.

The company submitted its application for a rolling review of its data by Health Canada in January.

In a report published Tuesday night, U.S.-based Politico said Novavax’s production issues are deeper than the company indicated in quarterly financial statements, hampering global plans to widely distribute its vaccine as COVID-19 variants drive outbreaks around the world.

Citing unnamed sources, Politico said the company has struggled to reach American requirements of a 90-per-cent purity level for its vaccine batches, achieving only around 70 per cent.

Novavax didn’t respond directly to the Star’s queries on Wednesday, but released a statement Wednesday that defended its vaccine and said it plans to hit its production goals.

“In response to a recent news article citing anonymous sources, Novavax confirms our confidence in our ability to deliver our high-quality vaccine. Further, we underscore our ongoing commitment to the stringent standards of production and manufacturing for our ... COVID-19 vaccine candidate.”

It pointed to growing capacity in its global supply chain using production sites in India, the Czech Republic, South Korea, Japan and “additional manufacturing arrangements around the world” without mentioning Canada.

But Novavax said it expects to complete its rolling regulatory submissions “within the next couple of weeks” in Canada, the United Kingdom, Europe, Australia and New Zealand, and will file for authorization in the U.S. before the end of the year.

It has already filed for emergency use approval by the World Health Organization, saying that will allow the company to deliver its promised 1.1 billion doses to the global vaccine sharing facility COVAX.

Health Canada refused to confirm any timeline for its review or approval of the Novavax COVID-19 vaccine.

Spokesperson Anne Genier said in a written statement that the company’s submission to have its vaccine approved here is still under review.

Genier referred any questions about its future production plans in Canada to the NRC, which declined to respond to the Star’s questions or to grant an interview with its president, Iain Stewart, who has returned to the NRC after a stint as the head of the Public Health Agency of Canada.



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