Novavax’s COVID-19 vaccine approved for Canadians 18 and over
Novavax’s COVID-19 vaccine has been approved for use in Canadians age 18 and older by Health Canada.
The approval of the vaccine, known as Nuvaxovid, comes about 18 months after the federal government announced a deal to produce batches of it in Montreal.
Health Canada is recommending the interval for the two-dose vaccine to be at least 21 days based on evidence from clinical trials.
It’s not immediately clear how much of the vaccine will be supplied to Canada, which is well into its booster-dose campaign. The agency was holding a technical briefing early Thursday afternoon.
Trial data suggests the vaccine is more than 90 per cent effective in preventing severe illness and death.
The trials conducted by Novavax as part of its regulatory filing took place when the Alpha variant of the coronavirus was predominant, and Health Canada says Novavax will be “required to provide data regarding protection against current and emerging variants of concern, when available.”
Novavax has conducted trials of its vaccine for use in teens when Delta was the dominant variant.
The most common potential side effects of the vaccine are said to be in line with what has been documented with the four previously approved COVID-19 vaccines in Canada: soreness at the injection spot, chills, fatigue, muscle and joint aches, nausea and headaches.
Beset by delays
As it did with several other companies, the federal government struck a deal with Novavax early in the pandemic, with Canada agreeing to purchase 52 million doses.
Subsequently, it was announced that Novavax would produce its own COVID-19 vaccine at the National Research Council (NRC) site in Montreal.
“We expect that there’s going to be a circulation of this continuing through 2022 and 2023,” John Trizzino, the chief commercial officer and business officer for Novavax, said in an interview with CBC News in mid-2021.
“And so therefore, we think it’s important that we have enough production capacity in Canada to satisfy that.”
In October 2021, the NRC said in a statement that “the work with Novavax is proceeding as planned.”
WATCH More on the deal to produce Novavax in Canada:
Federal officials have said up to 24 million doses of vaccine per year could be produced at the Montreal facility.
In the U.S., Novavax was one of the companies the Donald Trump administration placed an early bet on to produce vaccines, to the tune of a federal contract awarded in July 2020 that has been estimated at being worth $1.6-1.75 billion.
But the Maryland-based company encountered issues with respect to mass manufacturing its doses and fulfilling regulatory requests.
In late 2021, it gained an approval for use in Indonesia and ramped up its regulatory submissions, including to Canada, Australia, the European Union, the Philippines and the United Kingdom. Australia, for one, began administering its first doses of the Novavax COVID-19 vaccine last week.
But even as recently as last week, it was reported that Novavax was having issues fulfilling orders where it has been approved.
The company has yet to deliver vaccine on its largest contract for 1.1 billion doses to COVAX — a global vaccine distribution program for poorer countries – which would make Novavax its third largest supplier, according to business data and analytics firm GlobalData Plc.
Protein subunit vaccine
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.
Health Canada had said in a recent tweet that decisions were expected in the “coming weeks” for the COVID-19 vaccines from both Novavax and Medicago, the Canadian-made, plant-based shots.