Moderna has filed an application with Health Canada for approval of its new COVID-19 vaccine, designed to protect both the original strain and the Omicron variant of the virus.
Patricia Gauthier, president and CEO of Modern Canada, says the application for its combined vaccine, known as the bivalent vaccine, was filed Thursday with the Canadian regulator.
If approved quickly, the doses could be ready for Canadians as early as September, he said.
“Everyone wants a bivalent and flies it for early fall. That’s why we’re working very closely with the federal government to finalize the number of doses they want and when so we can meet Canada’s needs.”
Read more: Moderna aims to release Omicron COVID-19 vaccine in autumn
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Global News has requested confirmation from Health Canada that it has received this request, but has not yet received a response.
By combining both the ancestral strain SARS-CoV-2 first detected in Wuhan and the BA.1 subvariant of the Omicron variant, Moderna says its vaccine provides broader protection, including some immunity against BA variants.4 and BA.5 of rapid spread. of Omicron, which now account for at least half of all coronavirus cases in the United States.
“With the new variants of concern that are emerging, we need to use our mRNA platform to help us stay afloat, perhaps not ahead, but at least updated and really relevant to the new variants of concern that are emerging.” , said Gauthier. .
The results of Moderna’s preliminary study show that people with their combined vaccine experienced an increase in Omicron-fighting antibodies than if they had just received a fourth dose of the original vaccine.
“So this is a really significant protection,” Gauthier said.
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The company also says its bivalent vaccine has the same safety profile as its original Modern COVID-19 vaccine approved by Health Canada, only it is updated with the new variant.
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Earlier Thursday, Canada’s director of health, Dr. Theresa Tam, said Canada was still waiting for detailed data from vaccine manufacturers on new vaccine formulations for approval, and that the timing and availability of these new vaccines would depend on the performance of these steps. taken as soon as possible.
He spoke about the importance of vaccines that offer better protection against emerging variants of concern.
“I think right now … looking for ways to expand immune coverage and the immune response would be a very important goal.”
The emergence and resistant variants of vaccines prompted the World Health Organization on Wednesday to call for accelerated efforts and incentives to see a pan-coronavirus vaccine developed for use worldwide.
Read more: US FDA supports COVID-19 booster injections adapted to Omicron BA.4, BA.5 subvariants
On Thursday, the U.S. Food and Drug Administration recommended that manufacturers of COVID-19 vaccines change the design of their booster injections starting this fall to include components adapted to combat Omicron BA subvariants. 4 and BA.5 currently dominant of the coronavirus.
The FDA has also suggested that it could authorize new injections before studies providing them in humans are completed. Annual changes to influenza vaccines do not require further testing.
Meanwhile, one of the key considerations for the deployment of any new vaccine against COVID-19 is supply. This is something that Canadian health officials still know nothing about with any of the new vaccines proposed by several manufacturers, Tam said, and so it is unclear whether a new vaccine could be released in the fall.
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When the first COVID-19 injections were approved in late 2020, countries struggled to get enough dose supplies. In Canada, provinces and territories had to prioritize doses for the most vulnerable while waiting for larger vaccine stocks.
Read more: Canadians urged to receive COVID-19 booster vaccinations before possible fall
Gauthier says Moderna was not equipped with a global supply chain for its products at the time, so it had to increase its operations to meet global demand.
The company has evolved from those initial growth pains, he said.
“I think we are now in a position where we have a very high manufacturing capacity,” Gauthier said.
But with global demand for this new high injection, the company is working with the federal government to determine how many doses it would need, if it approves regulatory approval.
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Gauthier did not comment on the company’s contractual relationship with Canada, but did say it has formed a “strong partnership” with the country.
“What I can say is that when the vaccine is approved, there are doses that would get to the country quickly. So the question is, how many more do we have to bring after that to meet the needs of Canadians?
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Pfizer and BioNTech are also testing several possible vaccines against COVID-19 adapted to variants, including a bivalent candidate similar to that of Moderna.
– with archives of The Associated Press and Reuters.
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