Pfizer COVID-19 vaccine candidate one step closer to approval

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    Doctor or lab technician holding vaccine of new coronavirus

    One of the vaccines in Canada’s COVID-19 arsenal is another step closer to approval, after Pfizer reported more results from its clinical trials Wednesday.
    The company said new test results show its coronavirus vaccine is 95 per cent effective, is safe and also protects older people most at risk of dying the last data needed to seek emergency use of limited shot supplies as the catastrophic outbreak worsens across the globe.
    Pfizer and its German partner BioNTech just last week estimated the vaccine was more than 90 per cent effective after 94 infections had been counted in a study that included 44,000 people. With the new announcement, the company now has accumulated 170 infections in the study and said only eight of them occurred in volunteers who got the actual vaccine rather than a dummy shot. One of those eight developed severe disease, the company said.
    “This is an extraordinarily strong protection,’’ Dr. Ugur Sahin, BioNTech’s CEO and co-founder, told The Associated Press.
    The companies have not yet released detailed data on its study, and results have not been analyzed by independent experts. Also still to be determined are important questions such as how long protection lasts and whether people might need boosters.
    Pfizer said it is preparing within days to formally ask U.S. regulators to allow emergency use of the vaccine.
    Pfizer applied to Health Canada for approval of the vaccine Oct. 9, and will submit the latest data to continue that process. Vaccines must be reviewed and authorized by the federal health department before they can be used in Canada. Health Canada is encouraging vaccine makers to submit for approval before their Phase 3 trials are done, so the approval process that normally takes up to a year can be finished faster.
    Pfizer is also undergoing similar “rolling submissions’’ for approval with regulators in Europe and the United Kingdom.
    AstraZeneca and Moderna have also submitted their vaccines for parallel review to Health Canada. All three are among the seven vaccine candidates Canada has contracts to buy on the understanding the doses will only be delivered if Health Canada green-lights the vaccine.
    Earlier this week Moderna, Inc. announced that its experimental vaccine appears to be 94.5 per cent effective after an interim analysis of its late-stage study.
    Similar results from two vaccines both made with a brand-new technology using a snippet of the genetic code of the coronavirus to train the body to recognize if the real virus comes along _ likely will add to experts’ reassurance about the novel approach.
    The companies didn’t disclose safety details but said no serious vaccine side effects have been reported, with the most common problem being fatigue after the second vaccine dose, affecting about 4% 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 would require an individual to get two doses of the vaccine, several weeks apart.
    Canada has contracts for four other vaccines but none of those companies have yet requested approval from Health
    Canada.
    The timeline for when the doses will actually come has always been murky. The federal government has been saying it is likely in the first quarter of 2021 but the specific timing depends on if and when they are approved.

    The Canadian Press