The federal regulator has found the evidence shows the vaccine is both safe and effective against the virus that causes COVID-19.
It is the fourth vaccine to be approved in Canada and the first and only one Canada has purchased that requires just a single dose.
Canada has pre-purchased 10 million doses, with options to buy another 28 million.
Joelle Paquette, the director general for vaccines at Public Services and Procurement Canada, says the 10 million doses are to arrive by September.
However, it’s not expected that any will flow to Canada until at least April.
“At the moment, we are still in discussion with Johnson and Johnson to determine where their doses will be coming from and the delivery schedule,” Paquette said Thursday.
Delivery schedules are not confirmed publicly until Health Canada’s regulatory review team gives a vaccine its seal of approval.
Johnson and Johnson announced promising results from its Phase 3 clinical trials at the end of January, suggesting its vaccine reduced severe COVID-19 disease by 85 per cent, and prevented 100 per cent of COVID-related hospitalization or death.
The vaccine had a 72 per cent efficacy in preventing COVID-19 infections after 28 days in the company’s U.S. trials. The efficacy dropped to 66 per cent when averaging in results from other global trials, including a South African study that factored in more transmissible variants of the COVID-19 virus.
A U.S.-based Food and Drug Administration (FDA) report last month said the vaccine was 64 per cent effective in preventing infection in South Africa about a month after the vaccines were administered.
Pfizer and Moderna showed 95 per cent efficacy in their respective trials, but those were both tested against previous dominant strains of the virus and didn’t account for the variants that have popped up since.
Pfizer, Moderna and AstraZeneca also had zero hospitalizations and deaths in their trials.
The FDA report said the Johnson and Johnson vaccine was similarly effective across age, race and people with comorbidities. The agency added that effectiveness appeared to be lower (42.3 per cent after one month) in people over 60 with comorbidities such as diabetes or heart disease.
The FDA document said no specific safety concerns were identified in participants regardless of age, race and comorbidities.
The FDA added the most common reported side effects were headache and fatigue, followed by muscle aches, nausea and fever.
Watch: Federal health officials discuss Johnson and Johnson’s COVID-19 vaccine. Story continues below.
The potential ease of distribution offered by a one-and-done shot, and its ability to be stored in a regular fridge are among its biggest strengths.
Vaccines from Pfizer, Moderna and AstraZeneca all require two doses.
Johnson and Johnson’s vaccine can be stored in a regular fridge for up to three months, the company says.
Pfizer’s vaccine initially required ultra-cold storage temperatures between -60 C and -80 C, though Health Canada said this week it could be stored in a regular freezer for up to 14 days.
Moderna’s vaccine can also be stored at regular freezer temperatures.
Unlike the mRNA technology used in Pfizer and Moderna’s products, Johnson and Johnson is a non-replicating viral vector vaccine similar to AstraZeneca’s.
That means it uses a different harmless virus as a vector, which can’t copy itself, to give our cells the instructions they need to make the coronavirus’s spike protein.
The immune system recognizes the protein and makes antibodies, which then allow us to fend off attack from the same virus if exposed in the future.
Deliveries slow to the U.S.
The United States became the first jurisdiction to approve Johnson and Johnson’s vaccine — which is officially produced by a subsidiary, Janssen Pharmaceuticals — on Feb. 26.
Production problems slowed initial deliveries in the United States. The Americans were to get 10 million doses as soon as the vaccine was approved but there were only four million doses shipped out March 1.
The U.S. expects to get another 16 million doses by the end of March and 100 million total by the end of June.
The European Medicines Agency, which Canada works with on all its COVID-19 vaccine reviews so far, is to make a decision on the vaccine in mid-March.
With files from Melissa Couto Zuber
This report by The Canadian Press was first published March 5, 2021.
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