COVID-19 vaccine updates: Revised vaccine Product Monographs and accelerated dosing intervals for youth
July 2, 2021
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To: Health Care Providers
FOR IMMEDIATE ATTENTION
This Advisory Alert provides information on Health Canada’s latest updates to the AstraZeneca and COVISHIELD Product Monographs highlighting the rare capillary leak syndrome and updated Pfizer-BioNTech and Moderna Product Monographs to describe very rare reports of myocarditis and pericarditis. It also provides information on Ontario’s accelerated dosing interval for youth.
Health Canada updates AstraZeneca and COVISHIELD Product Monographs as well as Pfizer-BioNTech and Moderna Product Monographs
AstraZeneca and COVISHIELD
On June 29, 2021, Health Canada updated the AstraZeneca and COVISHIELD Product Monographs and issued a Health Product Risk Communication. These updates highlight that capillary leak syndrome has been observed very rarely following vaccination with the AstraZeneca COVID-19 vaccine, and provide further guidance for healthcare professionals and vaccine recipients. In addition, information about thrombosis and thrombocytopenia (rare adverse reactions to the vaccine) has been updated on the label, recommending to healthcare professionals that individuals with thrombocytopenia following vaccination with the AstraZeneca COVID-19 vaccine should be investigated for signs of thrombosis, and similarly individuals who present with thrombosis should be investigated for thrombocytopenia. Health Canada continues to work closely with the manufacturer and international regulators to review data as it becomes available on these rare events. Updated documents are available at https://covid-vaccine.canada.ca/. The Ministry of Health documents are being updated and will be posted shortly.
Pfizer-BioNTech and Moderna
On June 30, 2021, Health Canada updated the Pfizer-BioNTech and Moderna Product Monographs to describe very rare reports of myocarditis and pericarditis following vaccination. Cases of myocarditis and/or pericarditis following immunization with COVID-19 vaccines have been reported in a small number of people in Canada and internationally. These reports are very rare and investigations into the association between myocarditis/pericarditis and mRNA vaccines continue. Updated documents are available at https://covid-vaccine.canada.ca/ The Ministry of Health documents are being updated and will be posted shortly.
COVID-19 vaccines continue to be recommended. The benefits of COVID-19 vaccines continue to outweigh their potential risks, as scientific evidence shows that they reduce deaths and hospitalizations due to COVID-19. The Government of Canada encourages people to get vaccinated and to complete their vaccine series as soon as they are eligible.
This issue was identified in our June 18 Advisory Alert as well as the June 21 Public Service Announcement.
Health care providers are encouraged to continue discussions with patients about the benefits and risks of the COVID-19 vaccines. Informed consent is required for all vaccinations. Individuals eligible to receive a COVID-19 vaccine who have questions, are encouraged to speak with their health care provider and/or immunizer prior to receiving an mRNA vaccine.
Any adverse event occurring after a vaccination (which may or may not be related to the vaccine itself) are reported to public health to ensure ongoing review of any potential safety signals.
Reporting adverse events following immunization
All cases of any adverse event following immunization, including myocarditis or pericarditis, should be reported to Public Health Sudbury & Districts:
- Call Public Health at 705.522.9200, ext. 458 (toll-free 1.866.522.9200) during business hours or after-hours at 705.688.4366.
- Complete the Adverse Events Following Immunization (AEFI) Report Form available from Public Health Ontario. Fax the completed form to Public Health Sudbury & Districts’ confidential fax line at 705.677.9618 or email us at AEFI@phsd.ca.
Accelerated dosing intervals youth (Pfizer vaccine)
On July 2, the Government of Ontario announced that effective Monday, July 5, the provincial booking system will allow youth between the ages of 12 to 17 to book second dose appointments at a minimum interval of 28 days.
Note that the provincial online booking system is set at a 28-day interval. Those attending a walk-in clinic for their second dose may do so at an interval of 21 days or greater after receiving their first dose of the Pfizer vaccine. This is aligned with the Product Monograph for Pfizer. Individuals 12 to17 years old must book into a clinic offering Pfizer.
Information on obtaining vaccine
Online booking through the province
Book online using the provincial booking centre.
Call 705.674.2299 (toll-free: 1.800.708.2505), between 8 a.m. and 8 p.m., seven days a week.
Currently only Pfizer-BioNTech vaccine is authorized for youth aged 12 to 17. Youth of this age can only attend walk-in clinics offering Pfizer vaccine. First and second doses are offered at Public Health walk-in clinics.
Present to a Public Health led walk-in clinic if you are 12+ and have received a first dose of vaccine more than 21 days ago (Pfizer-BioNTech). Those 18 and older may present to any mRNA clinic for their second dose if they have received their first dose more than 21 days ago (Pfizer) or 28 days ago (Moderna).
With the delta variant circulating in Ontario, it is even more important to be fully immunized with two doses of COVID-19 vaccine as quickly as possible. All who are eligible should book an appointment for their first and second doses as soon as possible or attend a walk-in clinic near you.
For additional information on the COVID-19 vaccines, as well as for specific answers to your frequently asked questions visit our FAQ web page or call Public Health Sudbury & Districts at 705.522.9200 (toll-free 1.866.522.9200).
Original Signed By
Dr. Penny Sutcliffe
Medical Officer of Health and Chief Executive Officer
NOTE: All Advisory Alerts are found on our website.
This item was last modified on July 2, 2021