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Health Canada warns people with allergies to Pfizer COVID-19 vaccine ingredients to not get it

The Pfizer-BioNTech COVID-19 vaccine at a vaccination centre in Cardiff, Wales, Tuesday Dec. 8, 2020. The United Kingdom, one of the countries hardest hit by the coronavirus, is beginning its vaccination campaign, a key step toward eventually ending the pandemic. (Ben Birchall/Pool via AP)

TORONTO -- Health Canada is warning individuals with allergies to any of the ingredients in Pfizer-BioNTech COVID-19 vaccine to not receive the shot.

In a notice Saturday, the health agency said they were issuing the recommendation following news that two vaccinated individuals in the U.K. experienced severe allergic reactions to it.

The anaphylactoid reactions to the Pfizer-BioNTech vaccine occurred on Dec. 8 – the first day the U.K.’s vaccine program – and affected individuals who had a history of severe allergic reactions and carried adrenaline auto-injectors.

Both of them have since recovered after treatment, according to the notice.

However, in light of their adverse reactions, Health Canada said they had followed up on the reports.

“As vaccine roll-out begins in Canada, Canadians may be wondering about the risks of allergic reactions,” the agency said. “In Canada, all vaccines carry a warning about the risk of serious allergic reactions, including anaphylaxis, and immunization clinics are equipped to manage these rare events.”

That’s why they cautioned individuals with allergies to any of the ingredients in the Pfizer-BioNTech vaccine to avoid receiving the shot.

Health Canada also listed the ingredients in the vaccine, which are as follows:

Medicinal ingredient:
  • mRNA
Non-medicinal ingredients:
  • ALC-0315 = ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate
  • ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide
  • 1,2-Distearoyl-sn-glycero-3-phosphocholine
  • cholesterol
  • dibasic sodium phosphate dihydrate
  • monobasic potassium phosphate
  • potassium chloride
  • sodium chloride
  • sucrose water for injection

In addition to those with known allergies to the above ingredients, Health Canada also urged individuals who have experienced a serious allergic reaction to another vaccine, drug, or food to speak with their health-care professional before they receive the vaccine.

The health agency said they have reviewed the available evidence related to the allergic reactions and have concluded the available public health guidance is appropriate and they’re “not recommending any changes to the product’s use at this time.”

“Health Canada will continue to monitor this situation closely,” the notice said. “If any new safety issues are confirmed, Health Canada will take appropriate action, which could include communicating any new risks to Canadians and health-care providers or changing the recommended use of the product.”

The government agency also stressed they have identified “no major safety concerns” for the Pfizer-BioNTech vaccine and its benefits outweigh the risks.

“The side effects observed during clinical trials of Pfizer-BioNTech’s COVID-19 vaccine are similar to those experienced with other vaccines, including pain at the site of injection, body chills, feeling tired and feeling feverish,” Health Canada said.

“These side effects will resolve on their own and do not pose a risk to health.”

Next week, 30,000 doses of the Pfizer-BioNTech vaccine are expected to be delivered across Canada so that prioritized groups can begin receiving the shot. Following that, there will be continuous deliveries of up to 249,000 doses of the vaccine that should arrive by the end of December.

Canada is expected to receive up to four million initial doses of the Pfizer-BioNTech vaccine – and another two million doses of the Moderna vaccine (pending regulatory approval) – by the end of March.

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