Health Canada Says 9 Side Effects After COVID-19 Vaccination Consistent With Clinical Trials


Health Canada has received nine reports of adverse medical reactions to coronavirus vaccinations in Canada, but has seen no evidence of any unexpected side effects, federal public health officials said today.
During a press briefing in Ottawa, Canada’s Chief Public Health Officer, Dr. Theresa Tam, said the federal government has launched a new website that will provide weekly vaccine safety reports.

“As with any new business, we all have questions. These weekly COVID-19 vaccine safety reports aim to provide Canadians with regular access to credible information that will help them make informed and confident immunization decisions for themselves and their families. ” Tam said.

According to the website, nine people said they experienced a total of 65 symptoms – eight of which were considered serious – as of January 1. All nine people received the Pfizer-BioNTech vaccine.

Vaccinations began on December 14 and, according to data assembled by the COVID-19 Data Task Force – a volunteer group of academics and data analysts – at least 234,000 doses have been administered so far, primarily to frontline and long-term health workers. residents and care workers.

Adverse events can range from pain at the injection site or a mild fever to more serious problems, such as severe allergic reactions.

Of those who reported severe symptoms, three suffered from severe allergic reactions. One patient reported a headache, one reported facial paralysis, one suffered from chills, another passed out and one reported pain in extremity.

The most common non-serious adverse events reported to date have been swelling at the injection site, nausea, and a tingling and needling sensation, according to the data.

The website notes that not all adverse events that people experience after receiving a vaccine are necessarily caused by the vaccine.

“The benefits of vaccines authorized in Canada continue to outweigh the risks,” the site says.

No unexpected side effects

Dr. Supriya Sharma is the Chief Medical Advisor for Health Canada and oversees the vaccine review process. She said there have been no reports of unexpected side effects from patients vaccinated against COVID-19 to date.

“There have been no serious adverse events, not even mild and moderate adverse events, that have been irrelevant or different from what we’ve seen in clinical trials,” Sharma said in an interview with La Canadian Press on Friday.

She said experts are looking to answer two questions when reviewing the data after vaccine delivery. The first is whether something happened that was not observed during clinical trials. The second is whether the documented side effects are more serious or more numerous than what the trials have seen.

So far, the answer to both questions in Canada has been no, Sharma said.

“It looks like the clinical trials are pretty representative,” she said.

A COVID-19 vaccination center at the Winnipeg Convention Center on January 1, 2021 (John Woods / The Canadian Press)

Canada approved two COVID-19 vaccines last month. One is made through a partnership between US pharmaceutical giant Pfizer and German biotechnology company BioNTech, while the other is produced by US company Moderna.

In the United States and Canada, vaccine recipients are expected to hang around after the injection in case they have allergic reactions and need immediate treatment.

Health Canada has indicated that people who are allergic to any of the ingredients in coronavirus vaccines Pfizer-BioNTech and Moderna should not receive them and should talk to a healthcare practitioner about any serious allergies or other health issues they may have before receiving a coronavirus vaccine.

The regulator continues to review data from two other vaccine developers – UK pharmaceutical company AstraZeneca and Janssen Inc., a subsidiary of Johnson & Johnson – but still awaits more data from companies. Sharma said she couldn’t say when Health Canada would be ready to make a decision on either vaccine.

The two companies are expected to complete Phase 3 clinical trials in the United States this month.


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