Novavax files for COVID-19 vaccine approval in Canada

Novavax announced Monday in a news release that it had completed a rolling submission to Health Canada for authorization of its two-dose COVID-19 vaccine, a long-awaited development for the Maryland company, which has struggled to bring its doses for use in the global inoculation campaign.

Shares of Novavax rose about 11 per cent before the opening bell after the company also said it had filed an application for emergency use for the vaccine to Canada as well as the European Medicines Agency.

“Novavax continues to deliver regulatory filings that we expect will bring the first protein-based COVID-19 vaccine based on Phase 3 data to the world,” Stanley C. Erck, Novavax’s president and chief executive officer, said in a statement.

Meanwhile, Novavax got its first approval anywhere in the world on Monday, when the company and partner Serum received emergency-use authorization for their COVID-19 vaccine in Indonesia.

For Indonesia, the vaccine will be manufactured by the world’s largest vaccine manufacturer, Serum Institute, and sold under the Indian company’s brand name, Covovax.

Novavax said initial shipments into Indonesia are expected to begin imminently. The country is slated to receive 20 million doses of the protein-based vaccine this year, according to the government.

According to tracking from Johns Hopkins University, just over 27 per cent of Indonesians have been fully vaccinated against COVID-19.

Agreement to produce doses in Montreal

Novavax has so far applied for emergency-use authorization in various countries, including the United Kingdom, Australia, India and the Philippines.

The company, along with Japanese partner Takeda Pharmaceutical Co., said on Friday it was preparing to seek regulatory approval for a rollout in Japan early next year.

Novavax and Serum Institute have committed to together provide more than 1.1 billion doses to the COVAX facility, co-led by the World Health Organization. The supply of the vaccine will start this year after securing an emergency use listing from the WHO and continue into 2022.

Novavax has delayed filing for U.S. approval to the end of this year, and Politico has reported that the company has faced production and quality problems. The Trump administration placed a big bet on the Maryland company early in the pandemic, Politico reported.

Erck told Yahoo! News last week that the company will be filing for approval to the U.S. Food and Drug Administration this quarter.

It’s not clear how Novavax’s shot would be utilized in Canada, where 84 per cent of those ages 12 and over have been fully vaccinated against COVID-19. As it did with several other companies, the federal government struck a deal with Novavax early in the pandemic, with Canada agreeing early this year to purchase 52 million doses.

It was announced that Novavax would produce its own COVID-19 vaccine at the National Research Council (NRC) site in Montreal, and in mid-October the NRC said in a statement that “the work with Novavax is proceeding as planned.”

The Novavax shot was shown to be more than 90 per cent effective, including against a variety of concerning variants of the coronavirus in a large, late-stage U.S.-based clinical trial, with no reports of rare blood clot or heart inflammation issues. That trial largely took place, however, before the delta variant took hold to become the variant of over 90 per cent of cases in North America.

Novavax said in August that in a trial ongoing in the U.S. and Australia that booster shots of its vaccine were providing strong protection against the delta variant.

How the protein vaccine works

Novavax’s product is a protein subunit vaccine, meaning it uses nanoparticles of a lab-grown spike protein that mimics the natural spike protein on the surface of the novel coronavirus and which helps the virus bind to cells and cause infection. When the particles are injected into the body with an adjuvant — a compound that enhances immune response — the body learns to recognize and fight off the virus.

Protein subunit vaccines don’t elicit as strong an immune response as whole virus vaccines, so they often include an adjuvant. Novavax uses a proprietary adjuvant called Matrix-M, which is based on a type of compound found in many plants called a saponin.

The company says it boosts the body’s immune response and generates a bigger immune response with a lower dose.

The tried-and-true method of making a custom copy of a virus spike protein has been used to develop vaccines against HPV, hepatitis B and influenza.

CBC