Pfizer's COVID vaccine could be approved by Health Canada in January

Grant Boone
November 19, 2020

The two-dose vaccine, jointly developed with German firm BioNTech SE, met "all of the study's primary efficacy endpoints", the companies said in their press release, noting that an analysis indicated the vaccine was 95 percent effective in preventing the disease caused by the novel coronavirus.

Pfizer and BioNTech said they will now submit a request "within days" for emergency use authorization with the Food and Drug Administration, while sharing their data with regulators in Europe and elsewhere.

"If all goes well I could imagine that we gain approval (from US FDA) in the second half of December and start deliveries before Christmas, but really only if all goes positively", he told Reuters TV.

Pfizer and BioNTech have announced their large Phase 3 COVID-19 vaccine trial is complete. It added that no serious safety concerns had been reported and that 10 severe cases of COVID-19 were observed during the trial, with nine occurring in the placebo group, and one in the vaccinated group.

During question period at Queen's Park on Wednesday, Elliott said that her government is expecting to receive 1.6 million doses of the Pfizer vaccine and 800,000 doses of the Moderna vaccine in January, February and March of 2021. "Today is a special day", Bucci said.

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Pfizer said its two-dose vaccine, BNT162b2, was well-tolerated and that side effects were mostly mild to moderate, and cleared up quickly. This is a big deal because other vaccines have been known to be less effective among older people, who are most at risk from getting seriously ill from Covid-19.

The better-than-expected results from the two vaccines, both developed with new messenger RNA (mRNA) technology, have raised hopes for an end to a pandemic that has killed more than 1.3 million people and wreaked havoc upon economies and daily life.

Not only has it shown, like Moderna's jab, to be 95% effective but it works very well in the over-65s too. It also has agreements with the European Union, Germany and Japan where distribution could begin next year. The vaccine must be stored at minus 94 degrees Fahrenheit, colder than any other vaccine in development.

Pfizer is also developing temperature-controlled containers to ship its vaccine at minus-70 degrees Celsius. It can, however, be kept in a normal fridge for up to five days, or up to 15 days in a thermal shipping box. Any side effects resolved themselves "shortly after vaccination", and among older adults these tended to be "fewer and milder", the statement said.

Andrew Hill is a researcher at the University of Liverpool's department of pharmacology.

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