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Photo: The Canadian Press
FILE – In this photo from November 9, 2020, pedestrians pass in front of Pfizer’s world headquarters in New York. Pfizer announced on Wednesday, November 18, 2020, additional findings in its ongoing coronavirus vaccine study suggesting shots are 95% effective one month after the first dose. (AP Photo / Bebeto Matthews, File)
One of the vaccines in Canada’s COVID-19 arsenal is another step towards approval, after Pfizer reported more results from its clinical trials Wednesday.
The company said new test results show its coronavirus vaccine is 95% effective, safe, and protects even the elderly most at risk of death – the latest data needed to look for emergency use of limited stocks of pellets as the catastrophic epidemic worsens around the world.
Pfizer and its German partner BioNTech just last week estimated the vaccine was more than 90% effective after 94 infections were counted in a study that included 44,000 people. With the new announcement, the company has now amassed 170 infections in the study and said only eight of them occurred in volunteers who received the actual vaccine rather than a sham injection. One of those eight developed a serious illness, the company said.
“This is extraordinarily strong protection,” Dr. Ugur Sahin, CEO and co-founder of BioNTech, told The Associated Press.
The companies have not yet released detailed data on his study and the results have not been analyzed by independent experts. Still to be determined are important issues such as the duration of protection and whether people might need boosters.
Pfizer said it is preparing in a few days to formally ask US regulators to allow emergency use of the vaccine.
Pfizer asked Health Canada for approval of the vaccine on October 9 and will present the latest data to continue that process. Vaccines must be reviewed and licensed by the Federal Health Department before they can be used in Canada. Health Canada is encouraging vaccine manufacturers to submit approval before their Phase 3 studies are completed, so that the approval process that normally takes up to a year can be completed faster.
Pfizer is also undergoing similar “ongoing requests” for approval with regulators in Europe and the UK.
AstraZeneca and Moderna also presented their vaccines for parallel review to Health Canada. All three are among the seven vaccine candidates Canada has contracts to purchase, provided that doses will only be delivered if Health Canada gives the green light to the vaccine.
Earlier this week Moderna, Inc. announced that its experimental vaccine appears to be 94.5 percent effective after an interim analysis of its late-stage study.
Similar results from two vaccines both made with brand new technology – using a snippet of the coronavirus genetic code to train the body to recognize if the real virus arrives – will likely add to expert reassurance about the new approach.
The companies did not disclose safety details, but said that no serious side effects of the vaccine were reported, with the most common problem being fatigue after the second dose of the vaccine, affecting approximately 4 percent of participants.
Canada has contracts to get 20 million doses from Pfizer, Moderna and AstraZeneca, with options to get up to 56 million more from Pfizer and 36 million more from Moderna. All three require an individual to receive two doses of the vaccine, several weeks apart.
Canada has contracts for four other vaccines, but none of these companies have yet to apply for approval from Health Canada.
The timing for when doses actually arrive has always been obscure. The federal government has said it’s likely in the first quarter of 2021, but the specific timing depends on whether and when they’ll be approved.
Ontario Health Minister Christine Elliott told Queen’s Park Wednesday that Canada was due to receive four million doses of Pfizer vaccine and two million Moderna in the first three months of next year. He said Ontario will receive 40% of those doses.
Federal Health Minister Patty Hajdu declined to confirm this, however, telling Parliament Hill that Ottawa would process the distribution to the provinces to make sure every Canadian had access.
“There are a number of steps to take before actually getting to the distribution point,” said Hajdu.
Canada is trying to get ready to launch the vaccine as soon as it is approved, including the purchase of millions of syringes, needles, bandages and the like, and most recently the signing of two contracts to purchase freezers to store the vaccine. Pfizer’s vaccine should be stored at -70 ° C, while Moderna’s requires temperatures of at least -20 ° C. Procurement Minister Anita Anand said Canada will purchase 26 freezers that can be cold down to -80 ° C. and 100 which can be down to -20 C.
Pfizer and BioNTech said they plan to produce up to 50 million doses of the vaccine globally in 2020 and up to 1.3 billion doses in 2021.
US officials said they hope to have about 20 million doses of the vaccine each from Moderna and Pfizer available for distribution in late December. The first shots should be offered to vulnerable groups such as health and care workers and people with serious health conditions.
The Canadian National Advisory Committee on Immunization has recommended that similar priorities be established for the first doses of the vaccine here.
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