Approval for COVID vaccine expected soon

FIRST ONE COULD BE OKED WITHIN TWO WEEKS

The first COVID-19 vaccine could be approved for use in Canada within two weeks, Health Canada’s chief medical adviser said Thursday.

The department’s medicine review team is currently reviewing three COVID-19 vaccines — one from Pfizer and BioNtech, a second from Moderna and a third from AstraZeneca.

Dr. Supriya Sharma said at a briefing to reporters in Ottawa Thursday that the Pfizer review is the most advanced of the three. Health Canada is working alongside similar review teams in the United States and

Europe, and Sharma.

“We’re basically looking at the same data packages. We have very similar authorization pathways that are available for public health emergencies,” she said.

“The way that the reviews are progressing is that we’re expecting to make a final decision on the vaccines around the same time as the (U.S. Food and Drug Administration) and the European Medicines Agency.”

Sharma was less definitive about when Canadians will start getting vaccinated. She said it is possible the first doses could arrive before the end of December, but seemed to think it more realistic for them to start shipping here in January.

The United States is to get more than six million doses from Pfizer in mid-December, and expects to begin vaccinating people within 48 hours of approval being given.

Canada is set to receive four million doses from Pfizer in the first three months of 2021.

A Pfizer spokeswoman told The Canadian Press Thursday there is no date yet for shipments to Canada, adding the timing will depend on when it gets approved.

“We are working with urgency in collaboration with stakeholders, including Health Canada and public health decision makers, to bring our vaccine candidate to Canada in a timely manner,” Christina Antoniou said.

Pfizer reported preliminary results from its clinical trials earlier this month, claiming their genetics-based vaccine is 94.5 per cent effective, and has been shown to be effective in preventing disease in older adults as well.

Seniors are considered to be at highest risk of serious illness and death from COVID-19. Pfizer has not publicly released the data on its trials yet but said out of 170 people in the study who contracted COVID-19, only eight were in people who got the actual vaccine instead of a placebo. One of those eight people developed severe disease.

There were more than 43,000 people enrolled in the study.

Sharma said Health Canada typically assigns seven to 12 people to review a new vaccine for approval, and that those people will go through hundreds of thousands of pages of data. It’s normally a process that takes more than 2,000 hours.

Sharma said they are dedicating even more people to the process for COVID-19, but said safety is a top priority when it comes to deciding if the vaccine can be used in Canada.

“We will only authorize a vaccine if its benefits outweigh its risks,” said Sharma.

Canada has a purchase deal to buy at least 20 million doses of Pfizer’s vaccine, with the first four million of those on track to arrive before the end of March.

Canada has advanced purchase agreements with seven vaccine manufacturers, and the assistant deputy minister at Public Services and Procurement Canada said Thursday five of those agreements are now final, including the one with Pfizer.

None of the vaccines have completed clinical trials yet and Health Canada would still need to approve all of them once they do.

Conservative health critic Michelle Rempel was irate Thursday that the government isn’t fully ready to lay out a vaccine strategy.

She said if more people die in Canada because we don’t properly roll out the vaccine, it would be on the conscience of Health Minister Patty Hajdu.

“I ask again, I beg the minister: when is she going to tell Canadians when they are going to produce a vaccine and give it to Canadians?” Rempel said in question period.

Hajdu said Ottawa is working “day and night” to protect Canadians.

“The vaccines, indeed, are a light at the end of the tunnel, and we are working across government to make sure that we have access to the vaccines so we can deploy them,” she said.