Covid-19 Vaccine Health Canada, FDA closely watching for any adverse reactions of Pfizer vaccine
Canada/IBNS: Health Canada and US Food and Drug Administration (FDA) are being cautious for any unexpected side effects of COVID-19 vaccines after a health worker in Alaska (US), with no history of allergies, had a severe anaphylactic reaction to the vaccine, and after Britain reported two similar cases last week, media reports said.
Vaccine recipients have been advised by the U.S. Centers for Disease Control and Prevention (CDC) to stay around for 15-30 minutes, so they can be treated immediately if they have a reaction.
"Balancing any potential risks with the benefits the vaccine provides in the pandemic is an ongoing process," CDC's Dr. Jay Butler cautioned Wednesday, CBC News reported.
No major safety risks Pfizer-BioNTech COVID-19 vaccine and Moderna vaccine were uncovered by the US Food and Drug Administration (FDA)'s huge studies, said FDA and added no serious side effects were found in the tens of thousands enrolled in studies of the vaccine.
"Health Canada has reviewed the available evidence and has concluded that the current Product Monograph and available public health guidance are appropriate, and is not recommending any changes to the product's use at this time...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 department said in an advisory to the general public and health professionals.
The most common symptoms of the side effects reported are sore arm, fever and some flu-like symptoms, fatigue, aches, chills, headache which last about a day, and more common after the second dose and in younger people, said the health authorities.
Health Canada advised earlier this week that people with allergies to any of the ingredients in the Pfizer-BioNTech COVID 19 vaccine should not receive it and should speak with their health professional about any serious allergies or other health conditions they may have before they receive this vaccine.
In Canada, those who experience a potential side effect following immunization are asked to report it to their health-care professional who can also help manage any side effects.
Health-care professionals who have a patient that experiences a potential side effect following immunization, are required by Health Canada to complete the Adverse Events Following Immunization (AEFI) form appropriate for their province or territory and send it to their local health unit.
Health Canada participates with international regulators to share information about coronavirus vaccines as they are rolled out around the world.
(Reporting by Asha Bajaj)
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