Janssen seeks approval from Health Canada for its COVID-19 vaccine

Ottawa announced a deal with Janssen on August 31 to secure up to 38 million doses of the vaccine, which requires only one dose to provide immunity instead of two.

The Janssen vaccine is a non-replicating viral vector vaccine, based on viral material that has been genetically modified so that it cannot replicate and cause disease.

Johnson & Johnson began Phase 3 clinical trials in September, with a massive study that would have tested the stroke on 60,000 volunteers in the United States, South Africa, Argentina, Brazil, Chile, Colombia, Mexico and Peru.

The trial was suspended in early October as the company investigated an “unexplained disease” among one of the study participants, but was restarted a few weeks later after the company reported it found no evidence that the vaccine caused the volunteer’s illness.

“Janssen is committed to bringing an affordable, non-profit COVID-19 vaccine to the public for use in an emergency pandemic,” the company said in a statement.

Health Canada is evaluating three other candidate vaccines as part of what it calls a “rolling review process” that allows companies to submit data from clinical trials even if those trials are still ongoing.

The regulator must approve a vaccine as safe and effective before it can be given to Canadians. Health Canada is currently evaluating vaccine candidates from US pharmaceutical giant Pfizer and its German partner BioNTech, US biotechnology company Moderna, and UK pharmaceutical company AstraZeneca.

Canadians eagerly await approval of the vaccine

The question of when a vaccine will be approved and distributed has become the subject of intense speculation and debate in Canada as other countries, such as the United States, the United Kingdom and Germany, have announced plans to begin distributing their vaccines in December.

Opposition politicians, some premieres and public health experts have criticized the liberal government for lagging behind other countries when it comes to approving vaccines and planning their distribution.

Despite the criticism, none of these countries have yet granted final approval for a vaccine.

WATCH | The prime minister is asked about Johnson & Johnson’s new vaccine candidate:

Prime Minister Justin Trudeau spoke to CBC’s Tom Parry on Tuesday. 2:10

The U.S. Food and Drug Administration has scheduled a meeting for December 10, during which independent public health experts will discuss whether to grant approval for emergency use of the Pfizer vaccine. Moderna’s vaccine will be considered at a similar meeting a week later.

The European Medicines Agency – the regulator for the EU – will meet on December 29 to consider data on the safety and efficacy of Pfizer’s vaccine and may meet as early as January 12 to consider Moderna’s product.

In a technical briefing with reporters last week, Health Canada’s chief medical advisor said Health Canada is well on its way to making a decision on similar deadlines to US and European regulators.

“Canadians can be sure that whatever Canada approves, in terms of vaccines, will only be done when it is completely safe,” Hajdu told reporters Tuesday.

The premiers want answers on the delivery of vaccines

According to research from Duke University’s Global Health Institute, the federal government has entered into agreements with seven companies for up to 429 million doses, the most per capita of any country in the world. By obtaining doses from a variety of vaccine manufacturers before they are approved, Ottawa says it is increasing the chances of having priority access to a successful vaccine even if some on the list fail clinical trials.

Officials said six million doses could arrive in the first three months of 2021, but gave few details on exactly when those doses will arrive or how they will be distributed.

Ontario Premier Doug Ford said Monday he was dissatisfied with the lack of information from the federal government and urged the prime minister to specify a delivery date for the province’s vaccine quota, adding that “time is running out.”

Ford said he would speak directly to Pfizer on Monday afternoon to ask for details, but he should be informed that the information must come from Ottawa.

Conservative leader Erin O’Toole said the government’s inability to specify a timeline for delivery showed a “lack of leadership”.

Prime Minister Justin Trudeau defended his government’s procurement plan, arguing that Canada has secured access to a wide variety of potential vaccines that provide the country with multiple options.

LISTEN | Trudeau talks to Matt Galloway on CBC Radio’s The Current:

“Everyone wants to know when it will end,” Trudeau told CBC Radio The current Tuesday. “What Canadians may know is that we have the plan to get through all of this, to get the vaccines here, to get the vaccines into people’s arms, and we’re going to do it with provinces that have a high degree of experience on this. . “

Trudeau said Health Canada is working with the same data as regulators in the United States, but Canada will make its own decision on when and whether to approve a vaccine.

“It is so important that these vaccines are safe for Canadians, and we have no intention of cutting any corners to make sure that when Health Canada stands up that this vaccine is safe to use and release to the general public. [that] people can know it’s going to be really safe, “Trudeau said.

Last week, the federal government appointed Maj. Gen. Dany Fortin, the current chief of staff of the Canadian Joint Operations Command and former commander of the NATO mission in Iraq, to ​​lead the national COVID-19 vaccine deployment effort. .