Novavax vaccine authorized for use in Canada

mentalfloss

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Jun 28, 2010
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Another marvel of science.


Novavax vaccine authorized for use in Canada​

Health Canada has authorized the use of the Novavax COVID-19 vaccine for adults in Canada.

The two-dose Novavax Nuvaxovid vaccine showed 90 per cent effectiveness in protecting clinical trial participants from symptomatic COVID-19, and 100 per cent effectiveness in preventing severe disease, according to a press release from the agency.

 

spaminator

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Oct 26, 2009
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Canada approves Medicago's plant-based COVID-19 vaccine in adults
Author of the article:Canadian Press
Canadian Press
Publishing date:Feb 24, 2022 • 13 hours ago • 3 minute read • 17 Comments
View of vials on a production line at the factory of British multinational pharmaceutical company GlaxoSmithKline (GSK) in Saint-Amand-les-Eaux, northern France, on December 3, 2020, where the adjuvant for Covid-19 vaccines will be manufactured.
View of vials on a production line at the factory of British multinational pharmaceutical company GlaxoSmithKline (GSK) in Saint-Amand-les-Eaux, northern France, on December 3, 2020, where the adjuvant for Covid-19 vaccines will be manufactured. PHOTO BY FRANCOIS LO PRESTI /AFP via Getty Images
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Health Canada authorized a new COVID-19 vaccine Thursday that it touted as the first greenlit shot to be developed by a Canadian company and the first to be made with plant-based technology.

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Known as Covifenz, the vaccine was developed by Medicago, a biotechnology company based in Quebec City that uses a plant host to make virus-like particles which help the body’s immune system make antibodies.

Dr. Supriya Sharma, chief medical adviser at Health Canada, said the vaccine’s active ingredients consist of particles that “mimic the spike protein of the virus that causes COVID-19.”

That allows the body to recognize them and spark an immune response.

“The virus-like particles are grown in plants that are similar to tobacco plants, which can produce large amounts of the virus particles in a short period of time,” Sharma said Thursday in a virtual press briefing. “Once these particles are injected into the body, they trigger the immune system to produce antibodies against the virus.”

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Sharma added that the virus-like particles mimic the natural structure of the virus without containing any of its genetic material — “which makes the person’s immune system able to recognize the particles without causing infection.”

Sharma said that while other vaccines, including jabs that protect against HPV and hepatitis B, use virus-like particles, Medicago’s COVID-19 shot is the first to use plant-based technology.

Clinical trials suggested the vaccine — a two-dose series administered on a 21-day interval — was 71 per cent effective in protecting against COVID-19 infection one week after the second dose.

Sharma said the trials involved 30,000 participants and the vaccine was 100 per cent effective against severe disease in those studies.

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Medicago’s product is authorized for use in people aged 18 to 64, with Health Canada noting its effectiveness and safety in those under 18 and over 64 is still unknown.

Sharma said Medicago is “currently gathering data on older individuals,” adding that the company’s clinical trials had limited participants over age 65 because many of them were already vaccinated when the studies took place.

Clinical trials were conducted before the currently dominant Omicron variant of COVID-19 took hold, but Sharma said they did take place while other variants, including Alpha, Gamma, Lambda, Delta and Mu, were circulating.

She said, however, that preliminary laboratory data suggests Medicago’s jab does produce neutralizing antibodies against Omicron, adding that the company is “required to provide data regarding protection against current and emerging variants of concern as soon as it’s available” as a condition of its authorization.

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Medicago, along with British pharmaceutical company GlaxoSmithKline, submitted Phase 3 data to Health Canada in December.

Sharma said mild side effects that are typical of all vaccines were seen in the Medicago trials, with no difference in serious side effects reported between the vaccine and placebo groups.

Dr. Marc Berthiaume, director of the bureau of medical sciences for Health Canada, said the Medicago vaccine is expected to be available by mid-May, though he added “the calendar and number of doses is still under discussion.”

Medicago’s jab is the sixth COVID-19 vaccine authorized by Health Canada, following the mRNA shots from Pfizer-BioNTech and Moderna, the viral-vector vaccines from Oxford-AstraZeneca and Johnson & Johnson, and a protein-subunit jab from Novavax.

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Novavax’s product was authorized by Health Canada last week, and the National Advisory Committee on Immunization described it in their Feb. 17 guidance as a “new option” for people who were unable or unwilling to receive an mRNA vaccine.

Dr. Howard Njoo, Canada’s deputy chief public health officer, said Thursday that NACI’s preference has leaned towards the mRNA products in the past — “both from an effectiveness point of view but also because of the well-known safety profile.”

He said NACI is expected to provide guidance on the use of Medicago’s product within the next couple of weeks.

“It’s not for me to speculate what they will indicate,” Njoo said. “Certainly the data is there and they will analyze that.”

Health Canada’s online vaccination coverage tracker shows that more than 88 per cent of the eligible population had received at least one dose of a COVID-19 vaccine, with 84 per cent fully vaccinated as of Feb. 13.

Forty-four per cent of Canadians have also received a booster dose.

Sharma said the Medicago vaccine gives Canada “an additional option to fight the pandemic.”
 

spaminator

Hall of Fame Member
Oct 26, 2009
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Is it a day late and a dollar short ?
yeah, i know what you mean. it would have been great if they came out with these vaccines at beginning of the kung flu. better late then never i guess.
 

Tecumsehsbones

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Mar 18, 2013
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Washington DC
yeah, i know what you mean. it would have been great if they came out with these vaccines at beginning of the kung flu. better late then never i guess.
Yep. How DARE True Dope not have a vaccine for a previously-unknown disease just waiting on the shelf! Traitor! Murderer!
 

spaminator

Hall of Fame Member
Oct 26, 2009
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WHO may reject Canadian-made Medicago COVID-19 vaccine because of ties to big tobacco
Author of the article:Canadian Press
Canadian Press
Mia Rabson
Publishing date:Mar 17, 2022 • 11 hours ago • 3 minute read • 19 Comments
A vial of a plant-derived COVID-19 vaccine candidate, developed by Medicago, is shown in Quebec City on Monday, July 13, 2020 as part of the company's Phase 1 clinical trials in this handout photo.
A vial of a plant-derived COVID-19 vaccine candidate, developed by Medicago, is shown in Quebec City on Monday, July 13, 2020 as part of the company's Phase 1 clinical trials in this handout photo. SunMedia
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OTTAWA — Canada may not be able to donate millions of doses of the only COVID-19 vaccine made in the country because the World Health Organization is leaning against granting it an emergency-use licence.

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Medicago’s two-dose Covifenz vaccine was authorized by Health Canada in February for adults 18 to 64. In clinical trials it was more than 70 per cent effective at preventing COVID-19 infections and 100 per cent effective against severe illness, prior to the Omicron wave.

Medicago has also submitted an application to get their vaccine — the only one in the world that uses vaccine-like particles grown in a plant — approved by the World Health Organization.

However, tobacco company Philip Morris owns about one-fifth of Medicago, and the WHO indicated Wednesday that the application was unlikely to proceed for that reason.

Dr. Mariangela Simão, WHO’s assistant director general for drug access, vaccines and pharmaceuticals, said the WHO has strict policies about engaging with tobacco companies and arms manufacturers. As such, she said the review process for Medicago is on hold, and “it’s very likely that it won’t be accepted for the emergency-use licence.”

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Medicago President Takashi Nagao said in a written statement that the company has not had an “official communication” from the WHO but stressed the issue is not related at all to the vaccine’s safety or effectiveness.

A WHO emergency-use licence is required for a vaccine to be used by the COVAX vaccine-sharing alliance, the main mechanism for helping get vaccines to people in countries that can’t afford to buy them.

If the WHO rejects Medicago’s vaccine, Canada won’t be able to donate any of its doses to the alliance, which is desperate for doses to reach its goal of vaccinating 70 per cent of people in every country by July.

Canada has a contract for 20 million doses and an option for up to 56 million more, but Canada does not need them. More than 85 per cent of Canadians over the age of five are now fully vaccinated and going forward Canada is relying almost solely on the mRNA vaccines from Pfizer-BioNTech and Moderna.

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Canada had promised to donate any excess vaccines it purchased to COVAX.

Canada could try to sign bilateral donation deals to donate Medicago but those are more time-consuming and many countries that need vaccines the most still rely on WHO approval processes rather than conducting their own.

University of Ottawa law professor David Sweanor, who has made a career of going after tobacco companies in court, said it is “crazy” for the WHO to reject a perfectly good vaccine just to make a point about tobacco.

“We would rather have deaths by COVID in low- and middle-income countries, that would depend on approval by WHO, than a tobacco company ⦠even indirectly get any credit for having saved those lives,” he said.

“And why are we mad at the tobacco companies? Because they’ve caused people to get sick and die. So how are we going to get even? We’re going to cause people to get sick and die.”

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Currently only one in 10 people in the world’s poorest nations are fully vaccinated against COVID-19, and only one in seven have even one dose. In high-income countries, three in four people are fully vaccinated and half now have a third booster dose as well.

The WHO has authorized 10 vaccines now for an emergency-use licence, including Pfizer, Moderna, Oxford-AstraZeneca and Johnson & Johnson.

Health Minister Jean-Yves Duclos said Thursday he and Innovation Minister Francois-Philippe Champagne are following the process with the WHO very closely.

“Minister Champagne and I have contacted Medicago to make sure that its contact with WHO is done properly,” he said.

Canada invested $173 million in Medicago in 2020 to support development of the Covifenz vaccine and help Medicago expand its production facility in Quebec.

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Nagao confirmed Canada is currently Medicago’s first and only customer, but he said there are ongoing discussions with others. Medicago has not said if it applied for approval anywhere else yet.

“We cannot comment further on these discussions as they are confidential,” he said.

On Thursday, Health Canada approved the use of Moderna’s COVID-19 vaccine for children between the ages of six and 11 years old.

The vaccine known as Spikevax had already been approved for those ages 12 and up. The pediatric version for children six to 11 is two 50-microgram doses. The vaccine for ages 12 and up is two 100-microgram doses.