AstraZeneca Archives - Muskoka411

Astra Zeneca Canada To Produce 100,000 Doses Of COVID-19 Therapy

Muskoka411 Staff — Sun, 27 Feb 2022 15:29:48 +0000

AstraZeneca Canada has signed an agreement with the Government of Canada for the supply of 100,000 doses of Evusheld (tixagevimab co-packaged with cilgavimab), its long-acting antibody (LAAB) combination for the prevention (pre-exposure prophylaxis) of COVID-19 in those patient populations who require additional protection.

Doses will be delivered in 2022, should Evusheld (the proposed trade name for AZD7442), receive regulatory approval from Health Canada.

In November 2021, AstraZeneca Canada announced it had initiated a rolling review New Drug Submission with Health Canada for the authorization of Evusheld. If granted, Evusheld would be the first LAAB combination to receive Health Canada authorization for COVID-19 prevention.

“Thousands of Canadians remain at serious risk for COVID-19 because they are unable to mount an adequate response to a vaccine due to an underlying health condition or medication they take that compromises their immune system,” said Kiersten Combs, President of AstraZeneca Canada. “We are proud to play a leading role in fighting the COVID-19 pandemic and, with Evusheld, we now have an easily-administered, long-lasting option, which we hope will soon be available to offer protection to immune-compromised populations against COVID-19 in Canada.”

Approximately 2% of the global population is considered at increased risk of an inadequate response to a COVID-19 vaccine.^1,2 Additionally, more than 40% of those hospitalized with breakthrough COVID-19 infections after vaccination are immune-compromised.^3,4 This includes people with blood cancers or other cancers being treated with chemotherapy, and those taking medications after an organ transplant or who are taking immunosuppressive drugs for conditions, including multiple sclerosis and rheumatoid arthritis.^5-9 Emerging evidence indicates that protecting vulnerable populations from getting COVID-19 could help prevent viral evolution that is an important factor in the emergence of variants.¹⁰

In August 2021, AstraZeneca announced high-level results of the primary analysis from the PROVENT pre-exposure prophylaxis trial, which showed Evusheld reduced the risk of developing symptomatic COVID-19 by 77% (95% confidence interval (CI): 46, 90), compared to placebo. Importantly, the trial population included people with co-morbidities and who may need additional protection from SARS-CoV-2 infection. Greater than 75% of participants in PROVENT presented with co-morbidities associated with an increased risk of severe disease or a reduced immune response to vaccination. Further data of the ongoing PROVENT trial announced in November 2021 demonstrated the long-term benefits with an 83% reduction in the risk of developing symptomatic COVID-19 compared to placebo at a median of 6 months follow-up.

Multiple independent pseudovirus and authentic ‘live’ virus studies show that Evusheld retains neutralizing activity against the Omicron variant and all other tested variants of concern to date.

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Ontario Accelerates Second Doses Of AstraZeneca COVID-19 Vaccine

Muskoka411 Staff — Sun, 13 Jun 2021 01:49:48 +0000

The Ontario government, in consultation with the Chief Medical Officer of Health and other health experts, including the Ontario Science Advisory Table, is further accelerating the second dose interval for individuals who received their first dose of an AstraZeneca COVID-19 vaccine to eight weeks, with informed consent, from 12 weeks.

With informed consent, individuals can choose between a second dose of AstraZeneca or an mRNA vaccine, at an eight to 12-week interval, recognizing that while waiting 12 weeks helps to ultimately provide more protection, some may choose to receive their second dose sooner to have the increased protection provided by a second dose earlier. All of these options provide protection against COVID-19, including the Delta variant, and have been deemed safe.

This decision is based on emerging clinical evidence about the administration of two doses of different vaccines, as supported by the National Advisory Committee on Immunization (NACI). Evidence from multiple studies indicates that mixing of COVID-19 vaccines (receiving an mRNA vaccine after an AstraZeneca vaccine) at dosing intervals between eight and 12 weeks is safe and demonstrates a beneficial immune response. There is evidence that a longer interval between two doses of the AstraZeneca vaccine (such as a 12-week interval) provides higher protection.

Beginning Monday, June 14, 2021 at 8:00 a.m., individuals who received their first dose of the AstraZeneca vaccine will be eligible to book their second dose appointment at an interval of eight weeks or more with informed consent.

Individuals who wish to receive an mRNA vaccine for their second dose can book an appointment through the provincial booking system, through public health units that use their own booking system, or a participating pharmacy. For individuals who wish to receive second dose of the AstraZeneca vaccine, individuals can contact the pharmacy or primary care provider where they received their first dose.

All Ontarians are encouraged to get vaccinated as soon as they can, and to receive their second dose as soon as they are eligible and within the recommended interval to ensure maximum protection against COVID-19.

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1st And 2nd Doses Of Different COVID-19 Vaccines Can Be Safely Combined

Muskoka411 Staff — Thu, 03 Jun 2021 14:41:35 +0000

The Ontario government, in consultation with the Chief Medical Officer of Health and other health experts, is providing updated guidance for individuals who received the first dose of the AstraZeneca vaccine and who have not yet received their second dose, to allow for the mixing of COVID-19 vaccines if desired. This decision is in alignment with updated guidance from the National Advisory Committee on Immunization (NACI) recommendation.

“Nothing is more important than the health of Ontarians, and for the best protection against COVID-19 it is vital that everyone who received the AstraZeneca vaccine for their first dose receives a second dose of a COVID-19 vaccine,” said Dr. David Williams, Chief Medical Officer of Health. “We are providing individuals who have received only their first dose of the AstraZeneca vaccine with two recommended options based on the available data and evidence and will continue to work with Health Canada to monitor the quality and efficacy of all COVID-19 vaccines being used in Ontario.”

Effective June 4, 2021 and in alignment with NACI’s recommendation, Ontarians who have received their first dose of the AstraZeneca COVID-19 vaccine can choose to either receive a second dose of the AstraZeneca vaccine, or an mRNA (Pfizer or Moderna) vaccine for their second dose. Both second-dose options available to individuals who received their first dose of the AstraZeneca vaccine are safe and provide strong protection against COVID-19 and will count as a completed series. These second dose options will be provided at the recommended 12-week interval.

Beginning June 4, 2021, individuals who received their first dose of the AstraZeneca vaccine 12 weeks ago and who would like their second dose of the AstraZeneca vaccine, can contact the pharmacy or primary care provider where they received their first dose to book an appointment. Individuals who received their first dose of the AstraZeneca vaccine and are opting to receive an mRNA vaccine have the option to schedule their second dose appointment at a participating pharmacy where the Pfizer or Moderna vaccines are administered. Primary care settings and pharmacies may also be reaching out to eligible Ontarians.

In addition, expected the week of June 7, 2021, individuals who received their first dose of the AstraZeneca vaccine and who choose to receive an mRNA vaccine for their second dose can register for a “second dose only” at a 12-week interval through the provincial booking system. Eligible individuals will also be able to schedule their second dose appointment directly through public health units that use their own booking system.

Combining similar vaccines from different manufacturers in a series is not a new concept. Different vaccine products have been safely and effectively used to complete vaccine series for influenza, hepatitis A, and others. Individuals are encouraged to speak with a health care professional for help understanding the options available to them so that they can make an informed decision on their vaccination.

NACI’s guidance also advises that the Pfizer and Moderna COVID-19 vaccines can be safely interchanged for first and second doses if the original mRNA vaccine is not readily available. Ontarians who received a first dose of an mRNA vaccine should be offered the same mRNA vaccine for their second dose. If the same mRNA vaccine is not readily available, another mRNA vaccine can be offered instead to complete the vaccine series.

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Health Canada Extends Expiry Date Of AstraZeneca Vaccine By A Month

Muskoka411 Staff — Sun, 30 May 2021 04:11:03 +0000

Health Canada has approved an extension to the expiry dates of two lots (MT0055 and MT0056) of the AstraZeneca COVID-19 vaccine by 30 days, from May 31, 2021, to July 1, 2021. The approval to extend the shelf life was supported by scientific evidence.

Health Canada had previously approved a shelf life of six months for AstraZeneca’s COVID-19 vaccine. On May 27, 2021, Health Canada received a submission from AstraZeneca that included product stability and mathematical modelling data that demonstrated that the quality, safety and efficacy of the two lots would be maintained for an extra month, for a total of up to seven months.

This change will ensure that provinces and territories are able to use up their existing inventory and provide Canadians access to much needed doses of the vaccine.

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Ontario Confirms Second Case Of Rare AstraZeneca Linked Blood Clotting

Muskoka411 Staff — Sat, 24 Apr 2021 16:02:11 +0000

Yesterday, Dr. David Williams, Ontario’s Chief Medical Officer of Health, issued the following statement on the province’s first confirmed case of vaccine-induced immune thrombotic thrombocytopenia (VITT) in a patient after receiving the AstraZeneca/COVISHIELD vaccine:

Hamilton Public Health said A man in his 60’s is receiving care in hospital after he developed rare blood clotting, known as vaccine-induced immune thrombotic thrombocytopenia, following his first dose of the AstraZeneca vaccine.

On Friday, Dr. Williams said aother Ontario man in his 60s is also recovering at home after suffering the same issue.

“We have confirmed the first case of the rare blood clotting condition known as vaccine-induced immune thrombotic thrombocytopenia (VITT) in Ontario. The patient is a male in his 60s who had received his first dose of the AstraZeneca/COVISHIELD vaccine. The patient has received treatment and is recovering at home. Additional details will not be publicly released to protect the patient’s privacy.

The health and safety of Ontarians remains our top priority. While these serious reactions remain extremely rare, we have a robust process in place to monitor for any adverse events and have taken steps to ensure that these events are identified and treated as quickly as possible.

All COVID-19 vaccines available in the province have been determined to be safe and effective by Health Canada, and have been shown to prevent serious illness, hospitalization and death.

This case marks the 5th case of VITT out of more than 1.1 million doses of the AstraZeneca/COVISHIELD vaccine that have been administered in Canada to date. We will continue to actively monitor the evolving situation and safety of all COVID-19 vaccines with our partners across the country.

Ontario will continue to offer the AstraZeneca vaccine to individuals aged 40 years and over at the time of vaccination or any time in 2021. This approach is helping to maximize the number of people protected as quickly as possible to prevent further transmission and the much higher risks that come from COVID-19 infection.

The Health Canada approved vaccines are the best way to protect your health and those around you. Ontarians are encouraged to get vaccinated as soon as they are eligible and monitor their health after receiving their vaccination.”

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