Moderna seeks Health Canada nod for new double-protection COVID-19 booster – National |

Moderna has submitted an application to Health Canada for approval of its new COVID-19 vaccine, designed to protect against both the original strain and Omicron variant of the virus.

Patricia Gauthier, president and general manager for Moderna Canada, says the application for its combination shot, known as a bivalent vaccine, was submitted to the Canadian regulator Thursday.

If approved quickly, doses could be ready for Canadians as early as September, she said.

“Everybody wants a bivalent and want it for the early fall. This is why we are working very closely with the federal government to finalize the number of doses they want and when so that we can meet the needs of Canada.”

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Global News has requested confirmation from Health Canada that it has received this application, but has not yet received a response.

By combining both the ancestral SARS-CoV-2 strain first detected in Wuhan and the BA.1 subvariant of the Omicron variant, Moderna says its vaccine provides broader protection, including some immunity against the fast-spreading BA.4 and BA.5 subvariants of Omicron, which now make up 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, maybe not ahead of it, but at least current with it and really relevant with the new variants of concern that emerge,” Gauthier said.

Moderna’s preliminary study results show people given its combination shot experienced a higher boost in Omicron-fighting antibodies than if they just got 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 Health Canada-approved Moderna COVID-19 vaccine, only that it is updated with the new variant.

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Earlier on Thursday, Canada’s chief health officer, Dr. Theresa Tam, said Canada was still awaiting detailed data from vaccine manufacturers on new formulations of vaccines for approval, and that the timing and the availability of these new shots would be dependent on these steps being taken as quickly as possible.

She did speak of the importance of vaccines that offer better protection against emerging variants of concern.

“I do think that right now … looking at ways to broaden immune coverage and immune response would be a very important objective.”

The emergence and vaccine-resistant variants prompted the World Health Organization to call Wednesday for accelerated efforts and incentives to see a pan-coronavirus vaccine developed for use across the globe.

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U.S. FDA backs COVID-19 booster shots tailored to target Omicron BA.4, BA.5 subvariants

On Thursday, the U.S. Food and Drug Administration recommended COVID-19 vaccine manufacturers change the design of their booster shots beginning this fall to include components tailored to combat the currently dominant Omicron BA.4 and BA.5 subvariants of the coronavirus.

The FDA also has suggested it could authorize the new shots before studies testing them in humans are completed. Annual changes to flu vaccines do not require new trials.

Meanwhile, one of the key considerations for rollout of any new COVID-19 vaccine is supply. This is something Canadian health officials still don’t know anything about with any of the proposed new vaccines from various manufacturers, Tam said, which is why it’s unclear whether a fall rollout of any new vaccine could be possible.

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When the first COVID-19 shots were approved in late 2020, countries struggled with getting enough supplies of doses. In Canada, provinces and territories had to prioritize doses for the most vulnerable as they awaited larger stocks of the vaccines.

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Gauthier says Moderna was not equipped with a global supply chain for its products at that time, so it had to ramp up its operations to meet global demand.

The company has since evolved from those initial growing pains, she said.

“I think now we’re in a position where we do have very high capacity for manufacturing,” Gauthier said.

But with global demand for this new shot high, the company is working with the federal government to determine how many doses it would need, if it clears regulatory approval.

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Gauthier would not comment on the company’s contractual relationship with Canada, but did say it has formed a “strong collaboration” with the country.

“What I can say is that when the vaccine is approved, there are doses that would be coming to the country quickly. Then the question is: how many more do we need to bring after that to meet the needs of Canadians?”

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Pfizer and BioNTech are also testing several possible variant-adapted COVID-19 vaccines, including a bivalent candidate similar to Moderna’s.

— with files from The Associated Press and Reuters. 

© 2022 Global News, a division of Corus Entertainment Inc.

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