Pfizer COVID-19 vaccine candidate one step closer to approval

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 on Nov. 18.

The company said new test results show its coronavirus vaccine is 95% 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.

Ontario Health Minister Christine Elliott said in Queen’s Park Wednesday that Canada was supposed to get four million doses of Pfizer’s vaccine, and two million of Moderna’s in the first three months of next year. She said Ontario is to get 40 per cent of those doses.

Federal Health Minister Patty Hajdu refused to confirm that however, saying on Parliament Hill that Ottawa would work out distribution to the provinces to make sure every Canadian gets access.

“There are a number of steps to go through before we actually get to the point of distribution,” Hajdu said.

Canada is trying to be ready to roll out the vaccine as soon as it gets approved, including buying millions of syringes, needles, bandages and the like, and most recently signing two contracts to buy freezers to store the vaccine. Pfizer’s vaccine has to be stored at -70 C, while Moderna’s requires temperatures of at least -20 C. Procurement Minister Anita Anand said Canada is going to buy 26 freezers that can be as cold as -80 C and 100 that can be up to -20 C.

Pfizer and BioNTech said they expect to produce up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses in 2021.

U.S. officials have said they hope to have about 20 million vaccine doses each from Moderna and Pfizer available for distribution in late December. The first shots are expected to be offered to vulnerable groups like medical and nursing home workers, and people with serious health conditions.

Canada’s National Advisory Committee on Immunization recommended similar priorities be made for the first doses of vaccine here.

— with files from The Associated Press