Novavax’s COVID-19 vaccine has been approved for use in Canadians aged 18 and older by Health Canada.
The approval of the vaccine, known as Nuvaxovid, comes about 18 months after the federal government announced an agreement to produce batches of it in Montreal.
Health Canada recommends that the interval for the two-dose vaccine be at least 21 days based on evidence from clinical trials.
Chief Public Health Officer Dr Theresa Tam told a briefing on Thursday that the first delivery of Nuvaxovid is expected in March from India’s Serum Institute. Federal officials said they were unable to provide clarification on the size or timing of deliveries.
Data from trials involving around 45,000 people in several countries suggest the vaccine is more than 90% effective in preventing serious 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 indicates that Novavax will be “required to provide data regarding protection against current and emerging variants of concern, when they will be available”.
Novavax has conducted trials of its vaccine for use in adolescents when Delta was the dominant variant, but has not yet filed for approval for younger age groups.
Health Canada’s chief medical adviser, Dr Supriya Sharma, said the company had also submitted laboratory studies which, although “flawed” from clinical trials, show that neutralizing antibodies are formed by the vaccine. against variant infections of Omicron.
The National Advisory Committee on Immunization advises that the Novavax vaccine can be used for a primary series or a third dose for “people who were unable, due to contraindications, or who do not wish to receive a vaccine to mRNA COVID19”.
The most common potential side effects of the vaccine would be consistent with what has been documented with the four COVID-19 vaccines previously approved in Canada: pain at the injection site, chills, fatigue, muscle and joint pain, nausea and headache . .
Plagued 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 this to continue through 2022 and 2023,” John Trizzino, chief commercial officer and chief business officer of Novavax, said in an interview with CBC News in mid-2021.
“And so, we think it’s important that we have enough production capacity in Canada to accommodate that.”
In October 2021, the NRC said in a statement that “work with Novavax is proceeding as planned.”
Sharma said Thursday that the facility has not yet reached the state where a site inspection is required, which would be a prelude to producing doses there.
WATCH More information on Novavax’s production agreement in Canada:
Federal officials have said that up to 24 million vaccine doses a year could be produced at the Montreal facility.
In the United States, Novavax was one of the companies on which the Donald Trump administration had bet early to produce vaccines, up to a federal contract awarded in July 2020 and estimated between 1.6 and 1.75 billion dollars. dollars.
But the Maryland-based company has encountered issues with mass-manufacturing its doses and meeting regulatory requests.
At the end of 2021, it obtained authorization for use in Indonesia and intensified its regulatory submissions, including in Canada, Australia, the European Union, the Philippines and the United Kingdom. Australia, for its part, 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 trouble fulfilling orders where they were approved.
The company has yet to deliver a vaccine on its biggest 1.1 billion dose contract to COVAX — a global vaccine distribution program for the poorest countries — which would make Novavax its third-largest supplier, according to the company. business data and analytics company GlobalData Plc.
Canada has pledged both money and vaccine doses in an effort to get much of the world vaccinated.
However, it was not immediately clear whether Novavax doses would eventually feature prominently in those contributions, given Canada’s progress in its national inoculation campaign. According to CBC tracking, 84.1% of the eligible population over the age of five is considered fully vaccinated while 46.6% received a booster dose.
Protein subunit vaccine
Novavax’s product is the first protein subunit vaccine against COVID-19 to be approved in Canada. Protein subunit vaccines use nanoparticles of a lab-grown spike protein that mimics the natural spike protein on the surface of the new coronavirus and helps the virus bind to cells and cause infection. When the particles are injected into the body with an adjuvant – a compound that enhances the immune response – the body learns to recognize and fight off the virus.
Protein subunit vaccines do not 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 saponin.
Health Canada had said in a recent tweet that decisions were expected in the “coming weeks” for COVID-19 vaccines from Novavax and Medicago, herbal injections made in Canada.