Moderna seeks approval for a newCOVID-19 vaccinedesigned to protect against both the original strain and theOmicronvariant. I submitted my application to Health Canada. Of the virus.
Patricia Gauthier, President and General Manager of Moderna Canada, said an application for a combination shot known as a bivalent vaccine was submitted to Canadian regulatory authorities on Thursday.
She said that if approved promptly, it could be available to Canadians as early as September.
"Everyone wants a divalent vaccine and wants it in early fall. It needs to work closely with the federal government to meet Canada's needs. This is the reason for the final decision on the number and timing of doses. "
Read more:Moderna aims for fall release of COVID-19 Omicron vaccine
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Global News requires the Canadian Department of Health to confirm receipt of this application. I did, but I haven't received a reply yet.
By combining both the first ancestral SARS-CoV-2 strain detected in Wuhan with the BA.1 subvariant of the Omicron variant, Moderna responded to the rapidly spreading BA of the vaccine. It states that it provides a wide range of defenses, including immunity. Omicron 4 and BA.5 subvariants currently account for at least half of all coronavirus cases in the United States.
"Because of the emergence of new concerns, we may not be ahead of the game using the mRNA platform, but at least it is up-to-date and actually related to the new concerns. Must be. It will emerge, "Gautier said.
According to Moderna's preliminary findings, people given combination shots had a higher boost in antibodies to fight Omicron than if they had been given a fourth dose of the original vaccine.
"So this is a really important protection," Gautier said.
The company also has the same safety profile for its bivalent vaccine as the original Health Canada-approved ModernaCOVID-19vaccine, but only updated with a new variant.
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Earlier Thursday, Canada's Chief Health Officer Dr. Teresatam said Canada was about a new formulation from a vaccine maker. He said he was still waiting for detailed data. Vaccines for approval, and the timing and availability of these new shots, depend on these steps being performed as quickly as possible.
She talked about the importance of vaccines that provide better protection against new mutant strains of concern.
"I think it is now a very important goal to consider ways to expand the immune range and immune response."
With the emergence and vaccine-resistant variants The World Health Organization called on Wednesday to accelerate efforts and incentives to identify the pancoronavirus vaccine developed for use worldwide.
Read more: US FDA supports COVID-19 booster shots targeting Omicron BA.4 and BA.5 subvariants
On Thursday, the U.S. Food and Drug Administration announced that the COVID-19 vaccine maker changed the design of booster shots from this fall, and the coronavirus's current predominant Omicron BA.4 and BA. Recommended to include components tuned to fight .5 subvariants. The
FDA also suggested that new shots could be approved before the study to test them in humans was completed. Annual changes to the flu vaccine do not require new trials.
On the other hand, one of the important considerations for the deployment of the new COVID-19 vaccine is supply. This is something that Canadian health officials still don't know about new vaccines proposed by various manufacturers, Tam said. Therefore, it is unclear if a new vaccine can be fall-rolled out.
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When the first COVID-19 shot is approved in late 2020, countries will get a sufficient dose I had a hard time. In Canada, states and territories were waiting for large stocks of vaccines, so doses for the most vulnerable people had to be prioritized.
Read more: Canadians urged to take COVID-19 booster shots before potential fall waves
Gauthier says Moderna At the time, the company's products weren't equipped with a global supply chain, so they needed to expand their business to meet global demand.
Since then, she said the company has evolved from those first growing pains.
"I think we are in a position to have a very high manufacturing capacity right now," Gautier said.
However, due to the high global demand for this new shot, the company is working with the federal government to determine the dose required if regulatory approval is obtained.
Read more: COVID-19 boosters recommended this fall ahead of future pandemic waves, NACI
Gautier says he will do so, but he does not comment on the company's contractual relationship with Canada, but states that it has formed a "strong partnership" with Canada.
"What I can say is that there are doses that come to the country as soon as the vaccine is approved. The next problem is how many people then have to meet the needs of Canadians. Is it necessary to go? "
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Pfizer and BioNTech have bivalent candidates similar to Moderna. We are also testing several possible variants of the COVID-19 vaccine, including.
—The Associated Press and Reuters files are used.
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