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Health Canada Approves Pill For COVID-19

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Pfizer Canada has received Health Canada approval for a use of a new COVID treatment in tablet form.

Paxlovid is intended for high-risk adults, 18 and older, who develop mild-to-moderate symptoms.

Dr. Supriya Sharma from Health Canada says a recent study on unvaccinated people who have COVID-19 symptoms showed Paxlovid to be very effective.

“The study showed that treatment with Paxlovid compared with no treatment, reduced the risk of hospitalization and death caused by COVID-19 by 89 percent when the medications were started within three days of the beginning of symptoms and 85 percent when started within five days,” states Dr. Sharma.

Dr. Sharma suggests studies show the pills are effective against the omicron variant.

“The recent data also included laboratory information confirming the effectiveness of the medication against the omicron variant. This submission included data from a clinical trial conducted in unvaccinated, non-hospitalized, high-risk adults, having COVID-19 symptoms.”

The pharmaceutical company says it will begin shipping it out as soon as possible.

Pfizer signed an agreement with the federal government for one million units this year.

Alexandra Hilkene is a spokesperson for the Minister of Health in Ontario and she issued the following statement:

“Ontario welcomes the news that Health Canada has approved Pfizer’s antiviral, Paxlovid.

We expect to receive approximately 10,000 courses of treatment from the federal government in January with details on timing of shipments to be confirmed.

Based on the limited supply we expect to receive from the federal government, we have worked with our hospital partners and are prepared for distribution of antivirals at 15 sites across the province as soon we receive them. Courses will initially be prioritized for adults with the highest risk of severe outcomes including immunocompromised patients and could help keep thousands of people out of our hospitals.

The arrival of these pills gives us increased confidence as we continue to review key indicators and data to determine when we can begin safely and gradually lifting public health measures, and we look forward to providing additional details in the near future.”

(With files from Randy Thoms)

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Recall Of Dole And President’s Choice Salads

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Dole Canada Company and President’s Choice is recalling some of its salad products due to a possible risk of contamination by Listeria monocytogenes.

The recalled products have been sold nationally.

The Canadian Food Inspection Agency says you should not consume the recalled products. They should be thrown out or returned to the store where they were purchased. If you think you became sick from consuming a recalled product, call your doctor.

Affected products

(Photo: Health Canada)

(Photo: Health Canada)

(Photo: Health Canada)

More information can be found on Health Canada’s website.

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Pfizer, Moderna Receive Full Health Canada Approval

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Both the Pfizer-BioNTech and Moderna COVID-19 vaccines have been granted full approval for anyone 12 years of age or older.

Pfizer was the first shot to be authorized in Canada on December 9, 2020, after clinical data showed it did in fact protect against COVID-19.

With this approval comes a renaming of both the vaccines, though they will still have the same formulation and be considered interchangeable by Health Canada.

Pfizer will now be referred to as Comirnaty and Moderna will be called Spikevax.

“Based on the longer-term follow-up data that we submitted, today’s decision by Health Canada affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,” said Fabien Paquette, Pfizer Canada’s Vaccine Lead. “While a significant number of eligible Canadians are fully vaccinated, there is still much work to be done as infection and hospitalization rates continue to rise across the country, primarily among unvaccinated populations.”

BioNTech has shipped more than 1.4-billion vaccines worldwide.

84.1 per cent of the Canadian population 12 and up have received at last one dose of Health Canada approved vaccine.

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Health Canada Warns Of “Very Rare” Pfizer Side Effect

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A warning of a very rare side effect of the Pfizer-BioNTech COVID-19 vaccine.

Health Canada says a small number of people in Canada and around the world have reported temporary weakness or paralysis on one side of the face after getting the vaccine.

The condition, called Bell’s Palsy, usually starts to improve in a few weeks and was already listed as a possible side effect of the Moderna vaccine.

Health Canada is looking into this issue in other COVID-19 vaccines, but says all authorized vaccines are still safe and protect against the virus.

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Age Threshold For AstraZeneca Vaccine Lowered

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As conditions in Canada worsen during the third wave, the National Advisory Committee on Immunization recommends the AstraZeneca vaccine for those who are 30-years-of-age and older.

After looking over the most recent international data, Health Canada says the benefits of this vaccine outweigh the potential risks.

NACI suggested provinces and territories adjust the age threshold for using the AstraZeneca vaccine based on their local epidemiology.

Canada’s chief medical health officers said Friday they support the move adding with earlier access to vaccination, they may be able to vaccinate people faster, protect the health care system, reduce severe illness and save lives.

The following is an excerpt from the Statement from the Council of Chief Medical Officers of Health issued on Friday:

“On April 12th, following a safety review, Health Canada concluded that there is a possible link between very rare blood clotting events accompanied by low platelets and the use of the AstraZeneca vaccine, having assessed the latest available international data. As a result, the AstraZeneca COVID-19 vaccine product monograph has been updated accordingly by Health Canada. Overall, Health Canada concluded that the benefits of this vaccine continue to outweigh the potential risks. This adverse event is being referred to as Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) and is estimated to occur in one in every 100,000 to one in every 250,000 people vaccinated with the AstraZeneca COVID-19 vaccine.

Based on international evidence on VITT, as well the risk of severe outcomes of COVID-19 in Canada, the National Advisory Committee on Immunization (NACI) has updated its recommendations on the use of the AstraZeneca vaccine. The recommendations have been updated based on an assessment of the risk of VITT, COVID-19 exposure risk and the benefits of the vaccine in preventing serious COVID-19 disease for various age groups. NACI has lowered the age threshold for the AstraZeneca vaccine and has provided jurisdictions with considerations that will help us determine how to achieve the greatest benefits from the use of this vaccine. There are no clear risk factors for VITT; it occurs across a range of ages. However, age is a key factor in the risk of serious complications of COVID-19.”

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UPDATED: AstraZeneca Vaccines Get Health Canada Approval

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Canada will soon have two more vaccines to combat the COVID-19 virus.

Health Canada has approved the AstraZeneca vaccine along with a related shot by the Serum Institue of India.

Dr. Supriya Sharma, a senior medical advisor with Health Canada, provided details about the vaccines during a briefing Friday morning.

Sharma said unlike the Pfizer/BioNTech and Moderna vaccines, which are m-R-N-A based, these new vaccines are viral-vector-based.

“Viral-vector vaccines use a harmless modified version of a different virus, the vector, to deliver instructions to our cells,” said Sharma. “The cells begin to make proteins from the virus that causes COVID-19, which then prompts the body to develop an immune response.”

Sharma said the virus used in these vaccines are adenoviruses, which have been used in vaccines for decades.

She said the adenoviruses can cause common cold-like symptoms but do not cause illness.

“These are two-dose vaccines with the second dose being given between four and 12 weeks after the first. Evidence suggests that efficacy increases with longer dosing intervals,” said Sharma.

Sharma said the vaccines are about 62 per cent effective in preventing symptomatic cases of COVID-19, much lower than the Pfizer/BioNTech and Moderna vaccines.

But she said there is “emerging, promising evidence” that is beginning to be reported from real-world use of the vaccine.

Sharma said two other vaccine submissions remain under review by Health Canada.

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Health Canada Awaiting More Data From AstraZeneca

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Health Canada says it is too soon to say when AstraZeneca’s COVID-19 vaccine could be approved for use in our country.

The federal health agency issued a statement Wednesday after the United Kingdom authorized the company’s vaccine for use.

Health Canada says it has been reviewing AstraZeneca’s vaccine since it was submitted on Oct. 1 and is expediting the review of COVID-19 vaccines.

“There is still information and data to be provided by AstraZeneca for review. Health Canada cannot provide a definite timeline for the completion of the review at this time,” the agency said.

Health Canada said it is working closely with international regulators, including those in the U.K., to share information and data on vaccines currently under review.

Federal health officials have approved two vaccines for use in Canada to date — one by Pfizer-BioNTech and the other by Moderna.

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Health Canada Approves Moderna COVID-19 Vaccine

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Health Canada has approved a second COVID-19 vaccine for use in the country.

The agency gave the green light for the Moderna COVID-19 vaccine on Wednesday.

It comes two weeks to the day after the federal health agency approved the Pfizer-BioNTech vaccine.

“Today’s authorization is a critical step in ensuring additional COVID-19 vaccines are available to all Canadians in all parts of the country,” the agency said in a statement.

“The different storage and handling requirements of the Moderna COVID-19 vaccine mean that it can be distributed to isolated and remote communities, including the territories.”

A high-level summary of evidence reviewed by Health Canada said Moderna’s vaccine efficacy was evaluated to be 94.1 per cent.

“There were no important safety issues identified and no life-threatening adverse events or deaths related to the vaccine,” the agency said in its overview.

Health Canada said the most frequently reported adverse reactions after any dose were pain at the injection site, fatigue, headache, myalgia and chills. Most were mild to moderate in severity and resolved within two to three days.

Adverse reactions were more common in younger adults as compared to older adults and most were reported following the second dose of the vaccine.

Last week, Ottawa announced it had reached an agreement with Moderna for up to 168,000 doses by the end of December. It is part of the guaranteed 40 million doses the government has secured from the company.

Prime Minister Justin Trudeau said the vaccine can be distributed 48 hours after it receives Health Canada approval.

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COVID Vaccine Recommendations For People With Serious Allergies

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Health Canada says people who are allergic to ingredients in the Pfizer-BioNTech COVID-19 vaccine should not receive it.

The warning comes after two people in the United Kingdom reported allergic reactions to the vaccine last week.

Officials say both had a history of severe allergic reactions and carried adrenaline auto-injectors. They were both treated and have recovered.

“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,” said Health Canada.

“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.”

The vaccine’s ingredients are as follows:

Medicinal ingredient:

  • mRNA

Non-medicinal ingredients:

  • ALC-315 = ((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

Health Canada says immunization clinics are equipped to manage “rare” incidents of serious allergic reactions.

If you have experienced a serious allergic reaction to another vaccine, drug or food, the agency said you should talk to your health professional before receiving the COVID vaccine.

Anyone who has experienced a serious allergic reaction to another vaccine, drug or food should talk to their health professional before receiving the COVID vaccine.

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Health Canada Approves COVID-19 Vaccine

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Canada reached a critical milestone in its fight against COVID-19 today.

Health Canada has approved the first COVID-19 vaccine.

They have determined that the Pfizer-BioNTech immunization meets the requirements for use in Canada.

Initial indications show this vaccine is for use in those aged 16 and old.

The companies are running further clinical trials on children, and a revision could be made in the future.

Health Canada advisor Supriya Sharma is assuring Canadians the Pfizer-BioNTech vaccine has been thoroughly tested for its safety.

“When we do an authorization it means we’ve looked at it and the benefits outweigh the potential risks, but it is still a drug…and there are potential risk even if they’re rare so that’s why it’s important we continue to monitor it,” stresses the health official.

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