Health Canada has approved the use of the country’s first variant of a targeted COVID-19 booster shot, marking what health officials are calling a “landmark” in Canada’s response to the pandemic. On Thursday, the federal health regulator announced it had given the go-ahead to Moderna’s bivalent Covid-19 vaccine targeting Omicron, for ages 18 and older. The “Spikevax Bivalent” booster is a modified version of Moderna’s original mRNA vaccine and targets both the original strain of COVID-19 and the Omicron variant. “It’s essentially two vaccines in one,” said Canada’s chief medical adviser, Dr. Supriya Sharma. “This booster is also meant to extend the protection’s durability. This will help us deal with the next wave.” The mutated and highly contagious version of the new coronavirus and its sub-variants have been circulating in Canada since November 2021, currently accounting for the majority of new cases. Health Canada said, according to a study comparing people immunized with the bivalent vaccine and those who received the original dose of Moderna’s mRNA, the findings showed that the updated vaccine “provides a better immune response to Omicron BA.1.” Moderna submitted its bivalent enhancer to Health Canada for regulatory approval on June 30. “After a thorough and independent scientific review of the evidence, Health Canada has determined that the bivalent booster Moderna Spikevax is safe and effective,” the health agency said. “It was also found to produce a good immune response against the Omicron BA.4 and BA.5 subvariants.” This news came ahead of an afternoon announcement by Health Minister Jean-Yves Duclos on “the importance of vaccination against COVID-19 as we approach autumn”. Duclos said the initial 780,000 doses of Moderna’s bivalent vaccine will begin arriving in Canada on Friday, with more than 10 million more to come by the end of September. “Since vaccine protection wanes over time, it’s important to stay informed,” said Deputy Director of Public Health Dr. Howard Njoo. “If it has been six months since your last dose or six months since you were infected with COVID-19, get another booster dose.” Asked what he would say to Canadians who may feel overwhelmed by the evolving vaccine options, Njoo said people should know there is nothing wrong with the original COVID-19 vaccines offered, either as a primary vaccine series or as booster doses .
WHO SHOULD GET THIS SHOOT?
According to authorization information published by Health Canada, the recommended dosing regimen is an interval of “at least four months after an initial series and/or previous booster dose.” The National Advisory Committee on Immunization (NACI) issued guidance on Thursday, stating that adults 18 and older who are recommended to receive a fall booster should be offered a shot of the bivalent vaccine. This has been described by NACI as a “strong” recommendation. However, NACI said those eligible for a booster this fall and at higher risk “should not delay scheduled vaccination in anticipation of a bivalent Omicron-containing COVID-19 vaccine,” as the original mRNA vaccines will still provide timely protection . While the booster vaccine was submitted by Moderna for approval for ages 12 and older, Health Canada decided to limit its license to use in adults. Still, NACI said Thursday that adolescents aged 12 to 17 with “moderately to severely immunosuppressed conditions and/or who have biological or social risk factors that place them at high risk of serious outcomes” could be offered a dose of the bivalent souvenir “off label.” This has been described by NACI as a “discretionary” recommendation NACI said that while there are no data on the efficacy, immunogenicity or safety of this booster in people under the age of 18, its benefit may “overweigh any potential risks that are currently unknown.” Given as an intramuscular injection — as with other COVID-19 vaccines — the 50-microgram dose can cause common side effects such as pain, swelling or redness at the injection site, as well as fatigue, muscle aches and stiffness, fever and chills. The federal health agency warns against getting this vaccine if you’ve had an allergic reaction to a previous dose of Moderna’s vaccine for COVID-19.
PFIZER BIVALENT UNDER REVIEW
Moderna’s bivalent vaccine will be the first such vaccine available in Canada. Pfizer-BioNTech has also submitted its bivalent enhancer for regulatory evaluation. That submission went to Canada’s federal health regulator on July 25, and approval may be imminent. Sharma said Health Canada has also reached out to both pharmaceutical companies to request submissions for vaccines specifically targeting Omicron’s BA.4 and BA.5 subvariants, “to make sure we have as many options as possible “, as the virus continues to change. Those submissions are expected to be received within the next few weeks, Sharma said. Moderna’s bivalent approval on Thursday comes on the heels of the US Food and Drug Administration granting emergency use licenses on Wednesday to both Moderna and Pfizer’s bivalent vaccines for use as single booster doses at least two months after the initial or booster vaccination. The UK approved the Moderna bivalent vaccine on 15 August. As with previous COVID-19 vaccine approvals, Health Canada has placed terms and conditions on the authorization, requiring the pharmaceutical giant to continue to provide safety and efficacy information.
BUY 12 MILLION LOTS
The federal government has already bought 12 million doses of the vaccine, striking a deal with Moderna to replace part of its planned supply of the original mRNA vaccine with the newer version, with delivery expected before the end of the year. As has been the case throughout the pandemic, provincial health authorities will be responsible for determining the distribution of this vaccine and who will be prioritized to receive it. “Canada is well positioned to deliver a strong bilateral aid campaign and shipments will begin to arrive in the coming days and months,” Njoo said. “Check your provincial, district or local health authority’s website for information on when the vaccine will be available in your area.” “The exact timing of booster doses and the appropriate populations for booster doses will depend on a number of factors, including local epidemiological contexts that are constantly evolving and may differ between provinces and territories,” Health Canada said in a summary of its regulatory decision. . . With pandemic restrictions largely lifted in all provinces and Canadians expected to spend more and more time indoors, doctors and epidemiologists are warning of an increase in COVID-19 cases this fall and winter .
title: “Bivalent Vaccine In Canada Omicron Booster Approved Klmat” ShowToc: true date: “2022-12-05” author: “Delphine Tam”
Health Canada has approved the use of the country’s first variant of a targeted COVID-19 booster shot, marking what health officials are calling a “landmark” in Canada’s response to the pandemic. On Thursday, the federal health regulator announced it had given the go-ahead to Moderna’s bivalent Covid-19 vaccine targeting Omicron, for ages 18 and older. The “Spikevax Bivalent” booster is a modified version of Moderna’s original mRNA vaccine and targets both the original strain of COVID-19 and the Omicron variant. “It’s essentially two vaccines in one,” said Canada’s chief medical adviser, Dr. Supriya Sharma. “This booster is also meant to extend the protection’s durability. This will help us deal with the next wave.” The mutated and highly contagious version of the new coronavirus and its sub-variants have been circulating in Canada since November 2021, currently accounting for the majority of new cases. Health Canada said, according to a study comparing people immunized with the bivalent vaccine and those who received the original dose of Moderna’s mRNA, the findings showed that the updated vaccine “provides a better immune response to Omicron BA.1.” Moderna submitted its bivalent enhancer to Health Canada for regulatory approval on June 30. “After a thorough and independent scientific review of the evidence, Health Canada has determined that the bivalent booster Moderna Spikevax is safe and effective,” the health agency said. “It was also found to produce a good immune response against the Omicron BA.4 and BA.5 subvariants.” This news came ahead of an afternoon announcement by Health Minister Jean-Yves Duclos on “the importance of vaccination against COVID-19 as we approach autumn”. Duclos said the initial 780,000 doses of Moderna’s bivalent vaccine will begin arriving in Canada on Friday, with more than 10 million more to come by the end of September. “Since vaccine protection wanes over time, it’s important to stay informed,” said Deputy Director of Public Health Dr. Howard Njoo. “If it has been six months since your last dose or six months since you were infected with COVID-19, get another booster dose.” Asked what he would say to Canadians who may feel overwhelmed by the evolving vaccine options, Njoo said people should know there is nothing wrong with the original COVID-19 vaccines offered, either as a primary vaccine series or as booster doses .
WHO SHOULD GET THIS SHOOT?
According to authorization information published by Health Canada, the recommended dosing regimen is an interval of “at least four months after an initial series and/or previous booster dose.” The National Advisory Committee on Immunization (NACI) issued guidance on Thursday, stating that adults 18 and older who are recommended to receive a fall booster should be offered a shot of the bivalent vaccine. This has been described by NACI as a “strong” recommendation. However, NACI said those eligible for a booster this fall and at higher risk “should not delay scheduled vaccination in anticipation of a bivalent Omicron-containing COVID-19 vaccine,” as the original mRNA vaccines will still provide timely protection . While the booster vaccine was submitted by Moderna for approval for ages 12 and older, Health Canada decided to limit its license to use in adults. Still, NACI said Thursday that adolescents aged 12 to 17 with “moderately to severely immunosuppressed conditions and/or who have biological or social risk factors that place them at high risk of serious outcomes” could be offered a dose of the bivalent souvenir “off label.” This has been described by NACI as a “discretionary” recommendation NACI said that while there are no data on the efficacy, immunogenicity or safety of this booster in people under the age of 18, its benefit may “overweigh any potential risks that are currently unknown.” Given as an intramuscular injection — as with other COVID-19 vaccines — the 50-microgram dose can cause common side effects such as pain, swelling or redness at the injection site, as well as fatigue, muscle aches and stiffness, fever and chills. The federal health agency warns against getting this vaccine if you’ve had an allergic reaction to a previous dose of Moderna’s vaccine for COVID-19.
PFIZER BIVALENT UNDER REVIEW
Moderna’s bivalent vaccine will be the first such vaccine available in Canada. Pfizer-BioNTech has also submitted its bivalent enhancer for regulatory evaluation. That submission went to Canada’s federal health regulator on July 25, and approval may be imminent. Sharma said Health Canada has also reached out to both pharmaceutical companies to request submissions for vaccines specifically targeting Omicron’s BA.4 and BA.5 subvariants, “to make sure we have as many options as possible “, as the virus continues to change. Those submissions are expected to be received within the next few weeks, Sharma said. Moderna’s bivalent approval on Thursday comes on the heels of the US Food and Drug Administration granting emergency use licenses on Wednesday to both Moderna and Pfizer’s bivalent vaccines for use as single booster doses at least two months after the initial or booster vaccination. The UK approved the Moderna bivalent vaccine on 15 August. As with previous COVID-19 vaccine approvals, Health Canada has placed terms and conditions on the authorization, requiring the pharmaceutical giant to continue to provide safety and efficacy information.
BUY 12 MILLION LOTS
The federal government has already bought 12 million doses of the vaccine, striking a deal with Moderna to replace part of its planned supply of the original mRNA vaccine with the newer version, with delivery expected before the end of the year. As has been the case throughout the pandemic, provincial health authorities will be responsible for determining the distribution of this vaccine and who will be prioritized to receive it. “Canada is well positioned to deliver a strong bilateral aid campaign and shipments will begin to arrive in the coming days and months,” Njoo said. “Check your provincial, district or local health authority’s website for information on when the vaccine will be available in your area.” “The exact timing of booster doses and the appropriate populations for booster doses will depend on a number of factors, including local epidemiological contexts that are constantly evolving and may differ between provinces and territories,” Health Canada said in a summary of its regulatory decision. . . With pandemic restrictions largely lifted in all provinces and Canadians expected to spend more and more time indoors, doctors and epidemiologists are warning of an increase in COVID-19 cases this fall and winter .
title: “Bivalent Vaccine In Canada Omicron Booster Approved Klmat” ShowToc: true date: “2022-11-18” author: “Niki Lamb”
Health Canada has approved the use of the country’s first variant of a targeted COVID-19 booster shot, marking what health officials are calling a “landmark” in Canada’s response to the pandemic. On Thursday, the federal health regulator announced it had given the go-ahead to Moderna’s bivalent Covid-19 vaccine targeting Omicron, for ages 18 and older. The “Spikevax Bivalent” booster is a modified version of Moderna’s original mRNA vaccine and targets both the original strain of COVID-19 and the Omicron variant. “It’s essentially two vaccines in one,” said Canada’s chief medical adviser, Dr. Supriya Sharma. “This booster is also meant to extend the protection’s durability. This will help us deal with the next wave.” The mutated and highly contagious version of the new coronavirus and its sub-variants have been circulating in Canada since November 2021, currently accounting for the majority of new cases. Health Canada said, according to a study comparing people immunized with the bivalent vaccine and those who received the original dose of Moderna’s mRNA, the findings showed that the updated vaccine “provides a better immune response to Omicron BA.1.” Moderna submitted its bivalent enhancer to Health Canada for regulatory approval on June 30. “After a thorough and independent scientific review of the evidence, Health Canada has determined that the bivalent booster Moderna Spikevax is safe and effective,” the health agency said. “It was also found to produce a good immune response against the Omicron BA.4 and BA.5 subvariants.” This news came ahead of an afternoon announcement by Health Minister Jean-Yves Duclos on “the importance of vaccination against COVID-19 as we approach autumn”. Duclos said the initial 780,000 doses of Moderna’s bivalent vaccine will begin arriving in Canada on Friday, with more than 10 million more to come by the end of September. “Since vaccine protection wanes over time, it’s important to stay informed,” said Deputy Director of Public Health Dr. Howard Njoo. “If it has been six months since your last dose or six months since you were infected with COVID-19, get another booster dose.” Asked what he would say to Canadians who may feel overwhelmed by the evolving vaccine options, Njoo said people should know there is nothing wrong with the original COVID-19 vaccines offered, either as a primary vaccine series or as booster doses .
WHO SHOULD GET THIS SHOOT?
According to authorization information published by Health Canada, the recommended dosing regimen is an interval of “at least four months after an initial series and/or previous booster dose.” The National Advisory Committee on Immunization (NACI) issued guidance on Thursday, stating that adults 18 and older who are recommended to receive a fall booster should be offered a shot of the bivalent vaccine. This has been described by NACI as a “strong” recommendation. However, NACI said those eligible for a booster this fall and at higher risk “should not delay scheduled vaccination in anticipation of a bivalent Omicron-containing COVID-19 vaccine,” as the original mRNA vaccines will still provide timely protection . While the booster vaccine was submitted by Moderna for approval for ages 12 and older, Health Canada decided to limit its license to use in adults. Still, NACI said Thursday that adolescents aged 12 to 17 with “moderately to severely immunosuppressed conditions and/or who have biological or social risk factors that place them at high risk of serious outcomes” could be offered a dose of the bivalent souvenir “off label.” This has been described by NACI as a “discretionary” recommendation NACI said that while there are no data on the efficacy, immunogenicity or safety of this booster in people under the age of 18, its benefit may “overweigh any potential risks that are currently unknown.” Given as an intramuscular injection — as with other COVID-19 vaccines — the 50-microgram dose can cause common side effects such as pain, swelling or redness at the injection site, as well as fatigue, muscle aches and stiffness, fever and chills. The federal health agency warns against getting this vaccine if you’ve had an allergic reaction to a previous dose of Moderna’s vaccine for COVID-19.
PFIZER BIVALENT UNDER REVIEW
Moderna’s bivalent vaccine will be the first such vaccine available in Canada. Pfizer-BioNTech has also submitted its bivalent enhancer for regulatory evaluation. That submission went to Canada’s federal health regulator on July 25, and approval may be imminent. Sharma said Health Canada has also reached out to both pharmaceutical companies to request submissions for vaccines specifically targeting Omicron’s BA.4 and BA.5 subvariants, “to make sure we have as many options as possible “, as the virus continues to change. Those submissions are expected to be received within the next few weeks, Sharma said. Moderna’s bivalent approval on Thursday comes on the heels of the US Food and Drug Administration granting emergency use licenses on Wednesday to both Moderna and Pfizer’s bivalent vaccines for use as single booster doses at least two months after the initial or booster vaccination. The UK approved the Moderna bivalent vaccine on 15 August. As with previous COVID-19 vaccine approvals, Health Canada has placed terms and conditions on the authorization, requiring the pharmaceutical giant to continue to provide safety and efficacy information.
BUY 12 MILLION LOTS
The federal government has already bought 12 million doses of the vaccine, striking a deal with Moderna to replace part of its planned supply of the original mRNA vaccine with the newer version, with delivery expected before the end of the year. As has been the case throughout the pandemic, provincial health authorities will be responsible for determining the distribution of this vaccine and who will be prioritized to receive it. “Canada is well positioned to deliver a strong bilateral aid campaign and shipments will begin to arrive in the coming days and months,” Njoo said. “Check your provincial, district or local health authority’s website for information on when the vaccine will be available in your area.” “The exact timing of booster doses and the appropriate populations for booster doses will depend on a number of factors, including local epidemiological contexts that are constantly evolving and may differ between provinces and territories,” Health Canada said in a summary of its regulatory decision. . . With pandemic restrictions largely lifted in all provinces and Canadians expected to spend more and more time indoors, doctors and epidemiologists are warning of an increase in COVID-19 cases this fall and winter .
title: “Bivalent Vaccine In Canada Omicron Booster Approved Klmat” ShowToc: true date: “2022-10-30” author: “Clarence Villagomez”
Health Canada has approved the use of the country’s first variant of a targeted COVID-19 booster shot, marking what health officials are calling a “landmark” in Canada’s response to the pandemic. On Thursday, the federal health regulator announced it had given the go-ahead to Moderna’s bivalent Covid-19 vaccine targeting Omicron, for ages 18 and older. The “Spikevax Bivalent” booster is a modified version of Moderna’s original mRNA vaccine and targets both the original strain of COVID-19 and the Omicron variant. “It’s essentially two vaccines in one,” said Canada’s chief medical adviser, Dr. Supriya Sharma. “This booster is also meant to extend the protection’s durability. This will help us deal with the next wave.” The mutated and highly contagious version of the new coronavirus and its sub-variants have been circulating in Canada since November 2021, currently accounting for the majority of new cases. Health Canada said, according to a study comparing people immunized with the bivalent vaccine and those who received the original dose of Moderna’s mRNA, the findings showed that the updated vaccine “provides a better immune response to Omicron BA.1.” Moderna submitted its bivalent enhancer to Health Canada for regulatory approval on June 30. “After a thorough and independent scientific review of the evidence, Health Canada has determined that the bivalent booster Moderna Spikevax is safe and effective,” the health agency said. “It was also found to produce a good immune response against the Omicron BA.4 and BA.5 subvariants.” This news came ahead of an afternoon announcement by Health Minister Jean-Yves Duclos on “the importance of vaccination against COVID-19 as we approach autumn”. Duclos said the initial 780,000 doses of Moderna’s bivalent vaccine will begin arriving in Canada on Friday, with more than 10 million more to come by the end of September. “Since vaccine protection wanes over time, it’s important to stay informed,” said Deputy Director of Public Health Dr. Howard Njoo. “If it has been six months since your last dose or six months since you were infected with COVID-19, get another booster dose.” Asked what he would say to Canadians who may feel overwhelmed by the evolving vaccine options, Njoo said people should know there is nothing wrong with the original COVID-19 vaccines offered, either as a primary vaccine series or as booster doses .
WHO SHOULD GET THIS SHOOT?
According to authorization information published by Health Canada, the recommended dosing regimen is an interval of “at least four months after an initial series and/or previous booster dose.” The National Advisory Committee on Immunization (NACI) issued guidance on Thursday, stating that adults 18 and older who are recommended to receive a fall booster should be offered a shot of the bivalent vaccine. This has been described by NACI as a “strong” recommendation. However, NACI said those eligible for a booster this fall and at higher risk “should not delay scheduled vaccination in anticipation of a bivalent Omicron-containing COVID-19 vaccine,” as the original mRNA vaccines will still provide timely protection . While the booster vaccine was submitted by Moderna for approval for ages 12 and older, Health Canada decided to limit its license to use in adults. Still, NACI said Thursday that adolescents aged 12 to 17 with “moderately to severely immunosuppressed conditions and/or who have biological or social risk factors that place them at high risk of serious outcomes” could be offered a dose of the bivalent souvenir “off label.” This has been described by NACI as a “discretionary” recommendation NACI said that while there are no data on the efficacy, immunogenicity or safety of this booster in people under the age of 18, its benefit may “overweigh any potential risks that are currently unknown.” Given as an intramuscular injection — as with other COVID-19 vaccines — the 50-microgram dose can cause common side effects such as pain, swelling or redness at the injection site, as well as fatigue, muscle aches and stiffness, fever and chills. The federal health agency warns against getting this vaccine if you’ve had an allergic reaction to a previous dose of Moderna’s vaccine for COVID-19.
PFIZER BIVALENT UNDER REVIEW
Moderna’s bivalent vaccine will be the first such vaccine available in Canada. Pfizer-BioNTech has also submitted its bivalent enhancer for regulatory evaluation. That submission went to Canada’s federal health regulator on July 25, and approval may be imminent. Sharma said Health Canada has also reached out to both pharmaceutical companies to request submissions for vaccines specifically targeting Omicron’s BA.4 and BA.5 subvariants, “to make sure we have as many options as possible “, as the virus continues to change. Those submissions are expected to be received within the next few weeks, Sharma said. Moderna’s bivalent approval on Thursday comes on the heels of the US Food and Drug Administration granting emergency use licenses on Wednesday to both Moderna and Pfizer’s bivalent vaccines for use as single booster doses at least two months after the initial or booster vaccination. The UK approved the Moderna bivalent vaccine on 15 August. As with previous COVID-19 vaccine approvals, Health Canada has placed terms and conditions on the authorization, requiring the pharmaceutical giant to continue to provide safety and efficacy information.
BUY 12 MILLION LOTS
The federal government has already bought 12 million doses of the vaccine, striking a deal with Moderna to replace part of its planned supply of the original mRNA vaccine with the newer version, with delivery expected before the end of the year. As has been the case throughout the pandemic, provincial health authorities will be responsible for determining the distribution of this vaccine and who will be prioritized to receive it. “Canada is well positioned to deliver a strong bilateral aid campaign and shipments will begin to arrive in the coming days and months,” Njoo said. “Check your provincial, district or local health authority’s website for information on when the vaccine will be available in your area.” “The exact timing of booster doses and the appropriate populations for booster doses will depend on a number of factors, including local epidemiological contexts that are constantly evolving and may differ between provinces and territories,” Health Canada said in a summary of its regulatory decision. . . With pandemic restrictions largely lifted in all provinces and Canadians expected to spend more and more time indoors, doctors and epidemiologists are warning of an increase in COVID-19 cases this fall and winter .
