Health Canada says 9 adverse reactions after COVID-19 vaccinations are in line with clinical trials

Health Canada has received nine reports of adverse medicalreactionsfollowing coronavirus vaccinations in Canada but has seen no evidence of unexpected side effects, federal public health officials said today.

At a news briefing in Ottawa, Canada's Chief Public Health Officer Dr. Theresa Tam said the federal government has launched anewwebsite that will provide weekly reports on vaccine safety.

"As with any new undertaking, we all have questions. These weekly reports on COVID-19 vaccine safety aim to provide Canadians with regular access to credible information that will assist them in making informed and confident decisions on vaccination for themselves and their families," Tam said.

According to the website, nine people reported experiencing a total of65 symptoms eight of which were considered severe as of Jan. 1.All nine peoplereceived thePfizer-BioNTechvaccine.

Vaccinations began on Dec. 14 and, according to data collated by the COVID-19 Data Working group a volunteer group of academics and data analystsat least 234,000 doseshave administered so far, mostly to front-line healthcare workers and long-term care residents and employees.

Adverse events can range from soreness at the site of injection or a slight fever to more serious issues, such as severe allergic reactions.

Of those who reported serious symptoms, three sufferedsevere allergic reactions. One patient reported aheadache, one reportedfacial paralysis, one sufferedchills, another faintedand one reportedpain in extremities.

The most frequent non-serious adverse events reported so far have been swelling at the site of injection, nauseaand a sensation ofpins and needles,according to the data.

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

"The benefits of vaccines authorized in Canada continue to outweigh the risks," the site reads.

No unexpected side effects

Dr. Supriya Sharma is Health Canada's chief medical adviser andis overseeing the vaccine review process. She said there have beenno reports of unexpected sideeffects from patients vaccinated against COVID-19 to date.

"There haven't been any serious adverse events, or even the mild and moderate adverse events, that have been out of line or different than what we've seen in the clinical trials," Sharma said in an interview with The Canadian Press on Friday.

She said experts look to answertwo questionswhen reviewing data after vaccines are delivered. The first is whether anything has happened that was not observed during the clinical trials. The second is whether the sideeffectsdocumented are more severe, or greater in number, than what the trials saw.

The answer to both questions in Canada so far has been no, said Sharma.

"It seems that the clinical trials are pretty representative," she said.

Canada approved two vaccines against COVID-19 last month. One ismade through a partnership between U.S. pharmaceutical giant Pfizer and German biotechnology company BioNTech, while theother is producedby the U.S. firm Moderna.

In both the U.S. and Canada, vaccine recipients are supposed to hang around after the injection in case they experienceallergic reactions andneed immediate treatment.

Health Canada has advisedthatpeople with allergies to any of the ingredientsin the Pfizer-BioNTech and Moderna coronavirus vaccines should not receive themand should speak with a health professional about any serious allergies or other health conditions they may have before they receive a coronavirus vaccine.

The regulatorcontinues to review data from two other vaccine developers British pharmaceutical firmAstraZeneca and Janssen Inc., a subsidiary of Johnson & Johnson but is still awaiting more data from the companies. Sharma said she can't say when Health Canada would be ready to make a decision about either vaccine.

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