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U.S.-based Moderna Inc. said that interim results from a Phase 3 study of its mRNA-1273 vaccine show that the vaccine is 94.5 per cent effective with no significant safety concerns.

Moderna

A second coronavirus vaccine developed to thwart COVID-19 has shown to be effective at preventing the disease, further evidence the global effort to combat the pandemic may have reached a key turning point.

On Monday, U.S.-based Moderna Inc. said interim results from a large-scale Phase 3 study demonstrate its candidate vaccine is 94.5-per-cent effective with no significant safety concerns. Last week, similarly promising news was announced about another COVID-19 vaccine, produced jointly by the pharmaceutical companies Pfizer Inc. and BioNTech.

Both vaccines are among those Canada has arranged to purchase pending regulatory approval. In the case of the Moderna vaccine, the agreement consists of 56 million doses. For Pfizer, it’s 20 million.

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Production and delivery of the vaccines are still likely to be months away, but the back-to-back announcements have been widely seen as paving the way for distribution early next year.

Tal Zaks, Moderna’s chief medical officer, told The Globe and Mail that Moderna was now likely just days away from seeking emergency-use authorization for the vaccine from the U.S. Food and Drug Administration, a step that is contingent not only on the vaccine’s efficacy, but on its assessed safety two months into the Phase 3 trial. Previously, the regulator said a COVID-19 vaccine seeking approval should be at least 50-per-cent effective.

“I think that we have a basis now for anticipating global regulatory approval,” Dr. Zaks said.

Ottawa’s vaccine shopping list

Since August, the federal government has allocated more than $1-billion to purchase at least 358 million vaccine doses from seven companies or partnerships. Of those, one (Medicago) is based in Canada and the rest are based in the United States or Europe.

Vaccine type:

mRNA

Protein

Adenovirus vector

Virus-like particle

Pfizer/BioNTech 

20 million doses

Dosage:

Status: Interim Phase 3 results show greater

than 90% efficacy - approval pending

Moderna 

56

Dosage:

Status: Interim Phase 3 results show greater

than 90% efficacy - approval pending

NovaVax 

76

Dosage:

Status: Phase 3 in progress

Janssen/Johnson & Johnson

38

Dosage:

Status: Phase 3 in progress

AstraZeneca/Oxford U.

20

Dosage:

Status: Phase 3 in progress

Medicago/GSK

76

Dosage:

Status: Phase 2 / 3 trial launched Nov. 12

in U.S. and Canada

Sanofi/GSK

72

Dosage:

Status: Phase 3 anticipated to begin in

late 2020 or early 2021

MURAT YÜKSELIR AND IVAN SEMENIUK /

THE GLOBE AND MAIL

Ottawa’s vaccine shopping list

Since August, the federal government has allocated more than $1-billion to purchase at least 358 million vaccine doses from seven companies or partnerships. Of those, one (Medicago) is based in Canada and the rest are based in the United States or Europe.

Vaccine type:

mRNA

Protein

Adenovirus vector

Virus-like particle

Pfizer/BioNTech 

20 million doses

Dosage:

Status: Interim Phase 3 results show greater than 90%

efficacy - approval pending

Moderna 

56

Dosage:

Status: Interim Phase 3 results show greater than 90%

efficacy - approval pending

NovaVax 

76

Dosage:

Status: Phase 3 in progress

Janssen/Johnson & Johnson

38

Dosage:

Status: Phase 3 in progress

AstraZeneca/Oxford U.

20

Dosage:

Status: Phase 3 in progress

Medicago/GSK

76

Dosage:

Status: Phase 2 / 3 trial launched Nov. 12

in U.S. and Canada

Sanofi/GSK

72

Dosage:

Status: Phase 3 anticipated to begin in

late 2020 or early 2021

MURAT YÜKSELIR AND IVAN SEMENIUK / THE GLOBE AND MAIL

Ottawa’s vaccine shopping list

Since August, the federal government has allocated more than $1-billion to purchase at least 358 million vaccine doses from seven companies or partnerships. Of those, one (Medicago) is based in Canada and the rest are based in the United States or Europe.

Vaccine type:

mRNA

Protein

Adenovirus vector

Virus-like particle

Pfizer/BioNTech 

Dosage:

Status: Interim Phase 3

results show greater than

90% efficacy - approval

pending

20 million doses

Moderna 

Dosage:

Status: Interim Phase 3

results show greater than

90% efficacy - approval

pending

56

NovaVax 

Dosage:

76

Status: Phase 3 in progress

Janssen/Johnson & Johnson

Dosage:

38

Status: Phase 3 in progress

AstraZeneca/Oxford U.

Dosage:

20

Status: Phase 3 in progress

Medicago/GSK

Dosage:

Status: Phase 2 / 3 trial

launched Nov. 12 in U.S.

and Canada

76

Sanofi/GSK

Dosage:

Status: Phase 3 anticipated to

begin in late 2020 or early 2021

72

MURAT YÜKSELIR AND IVAN SEMENIUK / THE GLOBE AND MAIL

In Ottawa, federal Health Minister Patty Hajdu told reporters that the favourable results coming from both companies on vaccines that Canada has options to buy is good news, “but it is also early news.”

She added: “There are a number of steps that have to be completed with any vaccine to make sure that it is, in fact, safe for Canadians. And that’s the work that’s happening now.”

The Moderna trial, which is being conducted in the United States, involves 30,000 participants over the age of 18. Of the 95 cases of COVID-19 that arose two weeks after the second dose of the vaccine was administered, only five were found to have occurred among people who received the vaccine, with the remaining 90 coming from individuals who received a placebo in the trial. None of those who received the vaccine experienced a severe case of COVID-19.

While the numbers are small, the results so far appear to be consistent across the range of the subjects in the trial, including those of diverse racial and ethnic backgrounds and over age 65.

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Dr. Zaks, who only learned the results on Sunday, said he greeted the news with a combination of “elation and relief.”

In a second announcement that could prove consequential for distribution, Moderna said its vaccine can be stored for up to six months in an ordinary freezer at -20C, or for 30 days with normal refrigeration. That vaccine has also proved to remain stable at room temperature for up to 12 hours.

These data stand in contrast to Pfizer’s vaccine, which must be stored in medical freezers at -70C and can only last for five days at refrigerator temperatures once thawed.

Moderna has committed to producing 20 million doses of its vaccine in the U.S. by the end of this year. The first 100 million doses are already earmarked for the U.S. government. Globally, the company expects to have between 500 million and one billion doses produced by the end of 2021.

Canada’s share of the vaccine will be generated as part of the company’s European production. While it is not yet known how soon the country’s order will be filled, Canada was one of the earlier buyers of the vaccine and is home to the company’s first international subsidiary.

Like the Pfizer-BioNtech vaccine, Moderna’s candidate is based on a relatively untested approach. Instead of injecting subjects with an inactivated virus, or viral proteins to trigger an immune response, the vaccine consists of messenger RNA, a genetic code that the body’s cells can take up and use to automatically begin making viral proteins themselves.

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In addition to speeding up the production process, Dr. Zaks said that he believes the approach generates an immune response that is closer to what would be experienced through a live infection with COVID-19, without any risk of the disease to those who receive the vaccine.

The fact that the first two vaccines to show encouraging results from Phase 3 trials both use the RNA approach suggests the technology may be on the way to revolutionizing vaccine development across the board.

“It’s very exciting that a new platform has this amount of efficacy, because it suggests this technology could be used to build vaccine programs for new pathogens and for disease with vaccines that aren’t providing the protection we’d really like,” said Joanne Langley, an infectious disease researcher at Dalhousie University who co-chairs Canada’s vaccine task force.

With reports from Reuters, Associated Press

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