Health Canada has approved U.S. pharmaceutical company Pfizer’s COVID-19 vaccine in the next step towards a nationwide immunization program.
Pfizer’s submission was received by Health Canada on October 9. After an independent review, the government agency says that the vaccine by Pfizer-BioNTech met their requirements.
“Canadians can have confidence in our rigorous review process, and that the vaccine was authorized only after a thorough assessment of the evidence demonstrated that it met Health Canada’s strict standards for safety, efficacy, and quality,” said Dr. Supriya Sharma, Health Canada Chief Medical Advisor, at a press conference on Wednesday.
Documentation on the approval decision, including information on possible side effects, has been made available to the public on the Government of Canada website.
Health Canada says that side effects from the Pfizer vaccine are mild and comparable to other vaccines, including pain at the site of injection, body chills, feeling tired and feeling feverish.
The government says they will also be publishing the detailed scientific summary and full clinical trial data package in weeks to come.
The vaccine’s initial approval is for use in people 16 or older. Further clinical trials are being run by Pfizer-BioNTech on children of all age groups, and the approval could be revised in the future to include children if the data supports it.
The initial indication of the vaccine is for use in people 16 years of age or older. Pfizer-BioNTech are running further clinical trials on children of all age groups and the indication could be revised in the future to include children if the data from these studies support it.
Three other vaccines, including one by U.S. pharmaceutical company Moderna, are being reviewed.
“We can say that Moderna is currently the most advanced of the candidates,” said Dr. Marc Berthiaume, Director, Bureau of Medical Sciences, on Wednesday. He added that a specific date for approval has not been determined.
“We expect an approval shortly.”
When asked if the authorization was conducted differently due to the emergency nature of the pandemic, Dr. Sharma said the approval still represents a full review, but was conducted under an “interim order pathway.”
She says that this distinction allows the review to begin on a rolling basis, taking information as it becomes available while ordinary reviews wait until all information is on hand before even beginning.
It also allows some flexibility around putting terms and conditions on licenses and other information.
“Those interim order pathways are similar to emergency use authorization in that they were put in place in response to the public health emergency,” said Dr. Sharma.
“But we want to make sure that we reassure Canadians that that review is basically the same review as we would with any vaccine. It has looked at all of the information.”
4,000 British Columbians are expected to be vaccinated next week in the first round of inoculation.
