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Healthcare Provider Q&A

This Q&A document includes general information about COVID-19 vaccines and questions and answers specific to the vaccines currently in use in BC.
COVID-19 vaccine information is evolving, and as such, this Q&A will be updated as new information becomes available. Refer to the BC Immunization Manual Part 4 - Biological Products, COVID-19 vaccines for complete information on the COVID-19 vaccines prior to administration.

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COVID-19 disease

Information on COVID-19 epidemiology is continually evolving. For the most up-to-date data on COVID-19 cases, go to:
 
The COVID-19 pandemic has caused significant morbidity and mortality, as well as social and economic disruption in Canada and worldwide. Since their introductions, COVID-19 vaccines have shown to be very effective at preventing severe disease, including hospitalization and death due to COVID-19. COVID-19 vaccination protects not only the person being vaccinated, but also people around them, including those who are unable to get the vaccine. The more people in a community who are immunized and protected from COVID-19, the harder it is for COVID-19 to spread.
 
 
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Vaccine development and safety 

Factors that allowed COVID-19 vaccines to progress quickly include advances in vaccine development technology, government funding and purchase commitments, international collaboration among health professionals, researchers, industry and governments to develop the vaccines, rapid recruitment of participants for clinical trials, and streamlined vaccine approval processes by the regulatory body at Health Canada. Canada’s rigorous vaccine approval process has remained in place to assess COVID-19 vaccines. 

As for all vaccines and treatments that are authorized in Canada, Health Canada reviews the evidence and scientific data and decides whether to authorize the COVID-19 vaccine and will only do so when the evidence shows that the vaccine:
  • is safe, effective and of good quality and
  • demonstrates that the benefits outweigh the known and potential risks
Health Canada also has processes in place to share information with other countries’ regulatory bodies including the US Food and Drug Administration and the European Medicines Agency. 

Once a vaccine is approved, vaccine safety and effectiveness are continuously monitored to detect rare serious or unexpected side effects.
 
The Biologic and Radiopharmaceutical Drugs Directorate (BRDD), which is part of Health Canada, supervises all aspects of vaccine production and quality control throughout the vaccine’s lifecycle. When a manufacturer develops enough scientific and clinical evidence of a vaccine’s safety, efficacy, and quality, they file a complete package of information that is submitted to BRDD for market authorization. A submission contains data from scientific studies, including laboratory and clinical studies, and information about the manufacturing process, including the manufacturing facility and manufacturing method. BRDD thoroughly reviews the submission to determine whether the benefits of a vaccine outweigh any potential risks. BRDD also reviews procedures for the manufacturer’s safety monitoring and any plans to minimize any identified risks. In addition, BRDD may visit the manufacturing site to evaluate the manufacturing process’ quality and make sure the manufacturer can carry out the necessary quality controls for the vaccine. 

The expedited review performed for COVID-19 vaccines has been possible because of a number of administrative changes to the process. These have included allowance of submission of data when available rather than the sponsor needing to wait until the entire data package is complete prior to submission. As well, for approval of these vaccines in Canada and many countries, there has been allowance for a shorter period of follow-up of people enrolled into the phase 3 clinical trials, whereas for non-pandemic vaccines, that follow-up period is typically upwards of one year. As a result, the clinical trials will continue to accrue cases and safety information for up to two years following immunization. Results from these studies will be reported in the future and will provide additional information about issues such as duration of protection from the vaccine(s).

 
For an effective conversation about COVID-19 vaccines, we can start from a place of compassion and understanding. Patients consistently rank healthcare providers as their most trusted source for vaccine information. Be transparent about the latest vaccine(s) information, reassure that we have a robust vaccine safety system in Canada, and emphasize vaccines’ role to protect recipients and the people around them. Your willingness to listen to the patients’ concerns will play a significant role in building trust in you and your recommendation. If a patient has concerns or questions, this doesn’t necessarily mean they won’t accept a COVID-19 vaccine. Sometimes patients simply want your answers to their questions. Once you’ve answered their questions, let them know that you are open to continuing the conversation. Encourage your patients to schedule another appointment or go to the BCCDC or ImmunizeBC websites for more information about COVID-19 vaccination. Continue the conversation about COVID-19 vaccination during future visits.

‎Canada has a system of local, provincial, and national surveillance to carefully monitor adverse events following immunization and detect any vaccine safety concerns. Once a vaccine is approved, its safety is continuously being monitored as long as it is used. In most provinces and territories, including BC, health care providers are legally obliged to report all serious and unexpected adverse events following immunization to the medical health officer. Every serious or concerning event is reported to the BC Centre for Disease Control (BCCDC). These reports are reviewed at BCCDC and also sent to the Public Health Agency of Canada system called the Canadian Adverse Events Following Immunization System (CAEFISS), as are reports from all provinces and territories. Additional monitoring for adverse events is being done through a system called CANVAS (Canadian National Vaccine Safety Network) through which recipients of the vaccine can enroll to self-report adverse events following receipt of the vaccine, with serious events being reported on to the regional health authority.


Vaccine safety is also monitored at the international level. The World Health Organization’s International Drug Monitoring Program collects reports from over 75 countries and uses these global data to monitor for any vaccine safety concerns. In addition, all vaccine manufacturers must report serious adverse events of which they become aware, in Canada or internationally, to Health Canada. For COVID-19 vaccines, manufacturers are expected to implement enhanced monitoring activities.

In B.C., reports on adverse events following COVID-19 immunization are available on BCCDC's COVID-19 Vaccine Safety page. 

The national reports on adverse events following COVID-19 immunization are available on Health Canada’s Reported Side Effects Following COVID-19 Vaccination in Canada page.

More information about the Canadian vaccine safety surveillance system is contained in the Canadian Immunization Guide, Part 2 – Vaccine Safety, Vaccine safety and pharmacovigilance
 

‎Vaccine providers should refer to the BC Immunization Manual, Part 5 – Adverse Events Following Immunization for criteria on reporting adverse events following immunization (AEFI), and report AEFIs to the regional health authority. Information on reporting can be found on the BCCDC’s Surveillance Forms page under Adverse Events Following Immunization. There is a short version of the AEFI form available for Health Care Providers. Those providers who work in Public Health still need to use the long form.


For more information and details on how to report an AEFI in BC go to the BCCDC Reporting Adverse Events Following Immunization: For BC Community Vaccine Providers.

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General questions

Beginning in the Fall of 2023, NACI recommends a dose of the XBB.1.5-containing formulation of COVID-19 vaccine for individuals 6 months of age and older. This new formulation of the vaccine is expected to offer better protection against newer variants compared to previous COVID-19 vaccines, similar to the annual updates seen with the influenza vaccine.1 Additional doses of a COVID-19 vaccine are particularly important for older adults and those with underlying conditions due to risk of severe outcomes. The risk of hospital admission or severe illness from COVID-19 increases with age.

Recombinant XBB sub-lineages continue to circulate in Canada and globally. From sequencing data up to the week of August 6, 2023, XBB.1.9.2 is the most prevalent lineage in Canada, and is expected to become the dominant lineage group in the following weeks. EG.5 is a sub-lineage of XBB.1.9.2.2  Its prevalence has been steadily increasing in Canada, and is the most prevalent lineage group globally as of the week of July 30. 

Individuals vaccinated with the updated XBB.1.5-containing COVID-19 vaccine are expected to benefit from a better immune response against currently circulating strains, compared to earlier formulations. Preliminary clinical data demonstrated that a booster dose of a monovalent XBB.1.5-containing COVID-19 vaccine generated similar immune responses against XBB* sub-lineages XBB.1.5, XBB.1.16 and XBB.2.3.2.3

For the latest recommendations for COVID-19 Vaccines in BC, go to COVID-19 Vaccine Eligibility.‎

Protection conferred by SARS-CoV-2 infection alone varies due to factors such as the degree of illness severity, age, and whether other comorbidities are present. Prior to the prevalence of the Omicron variant, protection due to vaccination was shown to be more durable than immunity from infection. In B.C., research demonstrated that prior to Omicron, two doses of COVID-19 vaccine provided strong protection against infection and hospitalizations and that this protection was maintained for at least four months. Vaccine effectiveness against severe outcomes due to Omicron remains high, however the longevity of protection against Omicron is still unknown and will continue to be monitored.


Real world evidence suggests moderate to high vaccine effectiveness at preventing severe illness, such as hospitalization and death, which is sustained out to at least 6 months in most populations aged 12 years and older, including in older and frail populations. There is some decline in overall effectiveness noted in older adults (such as those 80 years of age and over) and residents in long term care homes over time, although protection against severe outcomes appears to be more durable than protection against infection.4 See information below regarding hybrid immunity.

 
It is estimated that half of all Canadians have contracted COVID-19 as Canada faced a 7th COVID-19 wave driven by BA.4 and BA.5 variants.5,6

In the current epidemiological context of the COVID-19 pandemic, individuals who have developed immunity against COVID-19 have done so through one of the following circumstances:
  • Infection-induced immunity which describes the immune protection in an unvaccinated individual after one or more SARS-CoV-2 infections
  • Vaccine-induced immunity which is the immunity achieved by an individual who has not been infected with SARS-CoV-2 but has a primary series of any COVID-19 vaccine or has received a booster vaccination
  • Hybrid immunity is defined as the immune protection in an individual who has had one or more doses of a COVID-19 vaccine and experienced at least one SARS-CoV-2 infection before or after receiving COVID-19 vaccine7 
Evidence demonstrates that hybrid immunity may provide superior protection against COVID-19 compared to vaccination or previous infection alone.8 In a vaccinated individual, infection acts as a “dose” to increase neutralizing antibodies and may induce broader antibodies that respond better to variants. Evidence is emerging that vaccinated individuals who had been infected also demonstrate increased T cell proliferation and broadened T cell responses9 as well as increased neutralizing antibodies, compared to those without a history of infection.10 It is also noted that the level of B cell response significantly increases when individuals who have received two or three doses of COVID-19 vaccine also had a prior Omicron infection, compared to those who received two or three doses of COVID-19 vaccine but had not been infected with the Omicron strain.11 Hybrid immunity may provide better protection against reinfection with variants of concern (including Omicron).10 Available evidence suggests protection from infection is variant dependent. For instance, infection with Omicron BA.1 most efficiently neutralizes subsequent BA.1 infections, followed by BA.2, BA.2.13 and BA.2.12.1, while the protection for subsequent infection with BA.4 and/or BA.5 sublineages would be less effective. However, those who were infected with the Omicron strain and were also vaccinated had higher neutralizing antibody responses against Omicron sublineages compared to those who had history of infection with the Omicron strain and were unvaccinated.11 It should be noted, however, that infection-induced responses vary much more widely than vaccine-induced, thus reliance on infection-induced immunity alone is risky. Vaccination is still the safest and most reliable way to induce protection against severe COVID-19.8

Immunity induced by vaccination or infection wanes against COVID-19 to varying degrees. Humoral immunity, which relies on antibodies, wanes most quickly, while cellular immunity is better preserved, regardless of how immunity was acquired. Additionally, T cells are less susceptible to immune evasion by variants, likely due to a wider range of epitopes available for T cell recognition. T cell defences, which mobilize cytotoxic capabilities and help to optimize production of antibodies from B cells, are potential explanations for protection against severe disease from COVID-19. In individuals with hybrid immunity, T cell responses were the highest.

The latest Canadian data on hybrid immunity has identified that adolescents and young adults have the highest proportion of hybrid immunity. In Canada, a greater proportion of older adults have protection from vaccination only and have not been infected as compared to younger ages, while a large proportion of children have been infected but not vaccinated.12

A recent systematic review found that the effectiveness of hybrid immunity against hospital admission or severe disease was 97.4% at 12 months with primary series and 95.3% at 6 months with first booster after the most recent infection or vaccination.13 This hybrid immunity appears to plateau after 2 doses and does not improve with more (assessed as 3 to 5) doses of vaccine.  Hybrid immunity has been observed among those infected in the pre-Omicron and Omicron era; in the period of circulation of the BA.4/5 variants, protection against hospitalization upon reinfection is >90% among individuals with hybrid immunity who have received at least two doses of vaccine.14 

NACI recommends if readily available (i.e., easily available at the time of vaccination without delay or vaccine wastage), the same COVID-19 mRNA vaccine product should be offered for the subsequent dose in a vaccine series started with a COVID-19 mRNA vaccine. However, when the same COVID-19 mRNA product is not readily available, or is unknown, another COVID-19 mRNA vaccine product recommended for use in that age group can be considered interchangeable and should be offered to complete the vaccine series. Such a series should be considered as valid, without need to restart the series with a new product.4

Yes. COVID-19 vaccines may be given concomitantly (i.e., same day), or at any time before or after non-COVID-19 vaccines (including live and non-live vaccines). If more than one vaccine is administered at a single visit, they should be administered at different injection sites using separate injection equipment. Preferably this is in different limbs, however if the same limb must be used, the injection sites should be separated by at least 2.5 cm (1 inch).4

Co-administration of COVID-19 vaccines with other vaccines is in accordance with NACI recommendations, general best practices for immunization, and is supported by the US Center for Disease Control and Prevention and the World Health Organization.
Data from recent studies also support the co-administration of COVID-19 and influenza vaccines.  These studies have found co-administration to be safe and the immune response towards all influenza strains and the SARS-CoV-2 spike protein with co-administration is generally non-inferior to that seen when either vaccine is administered alone.15-21 There are also data to support the co-administration of COVID-19 vaccine and pneumococcal polysaccharide 23 vaccine.9 The overall rate of solicited local and systemic adverse events was similar between subjects who received COVID-19 and influenza vaccine and those who received the COVID-19 vaccine alone. The adverse events reported were mostly mild-to-moderate and self-limiting.21 

Co-administration has several potential benefits, including improved patient convenience and compliance, simplified immunization schedules, fewer missed opportunities to vaccinate, reduced costs, and logistical advantages.21 Co-administration reduces barriers to the provision of routine childhood immunizations and seasonal influenza immunization.4 ‎

‎No. COVID-19 vaccines do not cause infertility and there is no scientific reason to believe that they will. Recent studies have shown that COVID-19 vaccines do not impact fertility.22, 23


The Society of Obstetricians and Gynaecologists of Canada (SOGC) addresses this online rumor in their recent statement stressing, “there is absolutely no evidence, and no theoretic reason to suspect that the COVID-19 vaccine could impair male or female fertility” and added, that “the widespread social media concern stems from misinformation about the similarities between syncytin-1 (used for placental implantation) and the SARS-CoV-2 spike protein. While the two proteins have several similar amino acids, they remain vastly different. The antibodies produced against the SARS-CoV-2 spike protein would not have cross-reactivity with syncitin-1.”24

The minimum age for COVID-19 immunization is 6 months (not 24 weeks). For premature infants, chronological age based on actual birth date should be used as opposed to corrected age.25

‎COVID-19 vaccination among pregnant people remains a priority.26

Pregnancy is a higher risk period for complications from COVID-19 infection. Pregnant people are more likely to be hospitalized and admitted to intensive care compared to their non-pregnant age-matched peers.4, 26 Infants born to mothers infected with COVID-19 are also at higher risk of severe outcomes, including stillbirth, admission to the neonatal intensive care unit, and death.26, 27

Pregnant people with complete or boosted vaccine doses had reduced risk for severe symptoms, complications, and death. 


Although, the primary indication for administration of COVID-19 vaccination is for maternal protection, IgG antibodies from the pregnant person are transferred to the fetus. This provides passive immunity to the newborn, which may reduce the risk of infection for the infant during their first several months of life. SARS-CoV-2 vaccination during pregnancy has not been shown to increase the risk of miscarriage, congenital anomalies, preterm delivery or other adverse perinatal outcomes.28, 29

While the safety and efficacy of the COVID-19 vaccines were not studied in people who were pregnant or breastfeeding in the clinical trials for these vaccines, evidence during the post-marketing period has accumulated. Outcomes in participants who became pregnant during the clinical trials and fetal outcomes are reported through registries, and real-world evidence (mostly with mRNA vaccination) in now available. Both NACI and the Society of Obstetricians and Gynaecologists of Canada (SOGC) have pre-existing general recommendations that inactivated viral vaccines can be safely given in pregnancy. The SOGC recommends that pregnant people, those contemplating pregnancy, and those who are breastfeeding who are at high risk of infection and/or morbidity from COVID-19 should be offered the vaccine.30  

‎NACI continues to recommend that COVID-19 vaccines should be offered to people who have previously been infected with SARS-CoV-2.  There are no known safety risks with receiving a COVID-19 vaccine after a recent SARS-CoV-2 infection.31 COVID-19 vaccine can be offered to individuals at any time following recovery from SARS-CoV-2 infection. 


Although not required, people who recently had SARS-CoV-2 infection (i.e., tested positive for COVID-19 by PCR or rapid antigen test) may consider delaying COVID-19 vaccination by 3-6 months from symptom onset or, for asymptomatic cases, from the time of the positive test. The longer interval between infection and vaccination may result in a better immune response and longer-lasting protection against Omicron and its variants, and the likelihood of reinfection during this period of time is small. This suggested interval between SARS-CoV-2 infection and COVID-19 vaccination is intended to serve as a guide and is based on the available evidence on the safety, effectiveness and timing of vaccination following infection, immunological principles, and expert opinion.32 However, an individual's biological and social risk factors for exposure (e.g., local epidemiology, circulation of VOCs, living settings) and risk of severe disease should be taken into account when deciding whether to delay vaccination up to 3-6 months after infection.32, 33

‎Currently all COVID-19 vaccines approved for use in Canada are inactivated vaccines (not live vaccines) and antivirals have no effect on the response to inactivated vaccines. Therefore, clients receiving COVID-19 antiviral treatment can safely receive the COVID-19 vaccine. However, if the client is still experiencing symptoms of the viral illness for which the medication was prescribed, it might be best to delay the immunization so that the cause of any additional or worsening symptoms can easily be determined. 


For additional information, see the BC Immunization Manual, Appendix C: Contraindications and Precautions for Immunization.

‎There is a theoretical risk that mRNA vaccines could temporarily affect cell-mediated immunity, resulting in false-negative TST or IGRA test results. However, there is no direct evidence for this interaction. Therefore, in the absence of data and acknowledging the importance of both timely tuberculosis testing and immunization, vaccination with COVID-19 vaccines may take place at any time before, after or at the same visit as the TST or IGRA test. Repeat TST or IGRA (at least 4 weeks post-COVID-19 immunization) of individuals with negative TST or IGRA results for whom there is high suspicion of latent tuberculosis infection may be considered in order to avoid missing persons with TB infection.4

‎If administration of a COVID-19 vaccine dose is delayed beyond the recommended interval, the dose should be provided as soon as possible, and the series does not need to be restarted. In general, regardless of the time between doses, interruption of a vaccine series does not require restarting the series as delays between doses do not result in a reduction in final antibody concentrations for most other vaccines requiring more than one dose for a series. Maximum protection may not be attained until the complete vaccine series has been administered.

‎Prophylactic oral analgesics or antipyretics (e.g., acetaminophen or non-steroidal anti-inflammatory drugs such as ibuprofen) should not be routinely used before or at the time of vaccination. There is currently no evidence of benefit from administration of oral analgesics for the prevention of immunization injection pain or systemic reactions.4  While these medications may be considered for the management of adverse events (e.g., pain or fever, respectively), it is not known whether these may blunt the antibody response to vaccine. This phenomenon has been observed in some studies of other vaccines in children, although its clinical significance is unknown.34-36 If an individual has taken one of these medications prior to immunization for any reason, they should be immunized as planned.  

‎Lymphadenopathy (reactive adenopathy related to the immune response generated by the vaccine) in the regional nodes draining the deltoid area can occur. Such enlarged nodes may be viewed in imaging studies such as mammograms, and may be interpreted as abnormal and indicative of potential pathology. 


The BC Cancer Agency recommends that scheduled screening mammograms should not be cancelled or delayed because of COVID-19 immunization. Those undertaking imaging within 6 weeks following vaccination should be asked for information about the site of vaccination so that this information can be recorded and considered in the interpretation of the radiograph.37

For those being vaccinated in the context of suspect or known breast malignancy, the vaccine should be given in the contralateral arm for both doses.  
It is normal for parents/guardians to have questions about what is best for their children. Healthcare providers continue to be a trusted source for immunization information and as parents/guardians consider the possible risk and benefits of vaccinating their children, healthcare providers can be there to address their questions.

While the majority of children with COVID-19 have mild or asymptomatic disease, some children get severe disease and require hospitalization. Following infection with the SARS-CoV-2 virus children are also at risk of developing multisystem inflammatory syndrome in children (MIS-C) and may also develop a post-COVID condition also known as long-COVID or post-acute COVID. Unfortunately, we cannot predict which children could have severe outcomes associated with COVID-19 infection. 

Vaccination will provide their child with an additional layer of protection from COVID-19. Vaccinating their child may also help them to feel more comfortable when they are in group settings such as childcare and other activities.

For more information:

‎There have been increasing reports that some clients are requesting injection with aspiration. These requests are likely due to two recent studies in mice that seem to establish the possible link between small chances of vaccine leakage into the bloodstream and either rare instances of myocarditis or thrombosis with thrombocytopenia syndrome (TTS).38, 39 


As indicated in the BC Immunization Manual, Appendix B: Administration of Biological Products, aspiration prior to injection of a vaccine is no longer recommended as there are no large blood vessels at the recommended immunization sites and aspiration can increase pain resulting from the combined effects of a longer needle-dwelling time in the tissues and shearing action (wiggling) of the needle.40, 41 Aspiration was originally recommended for theoretical safety reasons, however the veins and arteries within reach of a needle in the anatomic areas recommended for vaccination are too small to allow an intravenous push of vaccine without blowing out the vessel.41

While there is no evidence to support the need for aspiration, there is no prohibition on aspiration when administering a vaccine. Therefore, to avoid barriers and missed opportunities for COVID-19 immunization, this procedure could be done to accommodate case-by-case requests. However, clients should be informed of the possibility of increased pain and discomfort at the injection site. Providing the rationale for not aspirating with injection may assist the client in making an informed choice on the procedure which may include the following information: 
  • There is no scientific evidence to support the need for aspiration 
  • There are no published reports of adverse effects associated with not aspirating 
  • The deltoid site used for intramuscular injection is not in close proximity to large blood vessels, therefore the possibility of inadvertently hitting a blood vessel is rare
  • For aspiration to be effective, it must be sustained for at least 5-10 seconds 
  • Injection with aspiration is more painful, likely because aspiration, when performed correctly for 5-10 seconds, results in longer contact time between the needle and the tissue and movement of the needle within the tissue during aspiration is expected
  • Bleeding at the injection site is common, and does not indicate incorrect injection technique or injection into a blood vessel
Oral analgesics or antipyretics may be considered post-vaccination for the management of symptoms attributed to the vaccine (e.g., pain, fever, headache, myalgia) if these cannot be readily tolerated using non-pharmaceutical strategies. 
Needle aspiration is performed by pulling back on the plunger (applying negative pressure) of the syringe after inserting the needle into the client and prior to injecting the vaccine and includes the following steps:
  • After the needle pierces the skin, use the thumb and forefinger of the non-dominant hand to hold the syringe barrel
  • Move the dominant hand to the end of the plunger 
  • Avoid moving the syringe 
  • Aspirate by holding the barrel of the syringe steady with you non dominant hand and by pulling back on the plunger with your dominant hand42
Effective aspiration may require 5 to 10 seconds prior to injection; if blood appears in the barrel of the syringe during this time, do not inject the vaccine and withdraw the needle, and properly discard the syringe.43


Source: BCcampus OpenEd
1. National Advisory Committee on Immunization (NACI). Summary supplemental statement: Addendum to the guidance on the use of COVID-19 vaccines in the fall 2023. Available from: https://www.canada.ca/en/public-health/services/publications/vaccines-immunization/national-advisory-committee-immunization-summary-supplemental-statement-september-12-2023-addendum-guidance-use-covid-19-vaccines-fall.html.

2. Public Health Agency of Canada. COVID-19 epidemiology update: Testing and variants. Data cut-off 2023 Aug 20 [Internet]. 2023 [cited 2023 Aug 30]. Available from: https://health-infobase.canada.ca/covid-19/testing-variants.html.

3. Moderna Inc. Moderna COVID-19 Variant Vaccines [slides presented at Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting June 15, 2023] [Internet]. Food and Drug Administration (FDA); 2023 Jun 15 [cited 2023 Jul 17].  Available from: https://www.fda.gov/media/169539/download.

4. Public Health Agency of Canada. Canadian Immunization Guide [Internet]. Evergreen ed. Part 4 - Immunization Agents: COVID-19 Vaccines. 2023. Available from: https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/page-26-covid-19-vaccine.html#a8.2.

5. Canadian Blood Services. COVID-19 Seroprevlance Report: Report #22. 2022.

6. Government of Canada. COVID-19 epidemiology update. Jul 22, 2022. Available from: https://health-infobase.canada.ca/covid-19/archive/2022-07-22/.

7. Public Health Agency of Canada. Vaccine Confidence InfoBulletin. September 2022. Available from: https://canvax.ca/sites/default/files/PHAC%20Vaccine%20Confidence%20InfoBulletin_Volume%202%20Issue%209%20-%20September%202022.pdf.

8. World Health Organization. Interim statement on hybrid immunity and increasing population seroprevalence rates. Jun 1 2022. Available from: https://www.who.int/news/item/01-06-2022-interim-statement-on-hybrid-immunity-and-increasing-population-seroprevalence-rates.

9. Moore SC, Kronsteiner B, Longet S, Adele S, Deeks AS et al. Evolution of long-term hybrid immunity in healthcare workers after different COVID-19 vaccination regimens: a longitudinal observational cohort study. medRxiv. 2022:1-49.

10. Stamatatos L, Czarostki J, Wan Y-H, Homad LJ, Rubin V et al. mRNA vaccination boosts cross-variant neutralizing antibodies elicited by SARS-CoV-2 infection. Science. 2021;372(6549):1413-8.

11. Emerging Science Group of the Public Health Agency of Canada. Is there protective immunity after an Omicron infection? Canada Communicable Disease Report (CCDR). 48(November/December 2022).  Available from: https://www.canada.ca/en/public-health/services/reports-publications/canada-communicable-disease-report-ccdr/monthly-issue/2022-48/issue-11-12-november-december-2022/protective-immunity-after-omicron-infection.html.

12. Public Health Agency of Canada. National Advisory Committee on Immunization (NACI) Statement: Guidance on an additional COVID-19 booster dose in the spring of 2023 for individuals at high risk of severe illness due to COVID-19. 2023 Mar 3. Available from: https://www.canada.ca/content/dam/phac-aspc/documents/services/publications/vaccines-immunization/national-advisory-committee-immunization-guidance-additional-covid-19-booster-dose-spring-2023-individuals-high-risk-severe-illness-due-covid-19/statement.pdf.

13. Bobrovitz N, Ware H, Ma X, Li Z, Hosseini R, Cao C, et al. Protective effectiveness of previous SARS-CoV-2 infection and hybrid immunity against the omicron variant and severe disease: a systematic review and meta-regression. The Lancet Infectious Diseases. 2023.

14. Institut National de Santé Publique du Quebec. Administration of COVID-19 booster doses: Recommendations for winter and spring 2023.  Available from: https://www.inspq.qc.ca/en/publications/3284-covid-19-booster-doses-winter-spring-2023.

15. Chen H, Huang Z, Chang S, Hu M, Lu Q, Zhang Y, Wang H, Xiao Y, Ge Y, Zou Y, Cui F. Immunogenicity and safety of an inactivated SARS-CoV-2 vaccine (Sinopharm BBIBP-CorV) coadministered with quadrivalent split-virion inactivated influenza vaccine and 23-valent pneumococcal polysaccharide vaccine in China: A multicentre, non-inferiority, open-label, randomised, controlled, phase 4 trial. Vaccine. 2022;40(36):5322-32.

16. Izikson R, Brune D, Bolduc JS, Bourron P, Fournier M, Moore TM, Pandey A, Perez L, Sater N, Shrestha A, Wague S. Safety and immunogenicity of a high-dose quadrivalent influenza vaccine administered concomitantly with a third dose of the mRNA-1273 SARS-CoV-2 vaccine in adults aged≥ 65 years: a phase 2, randomised, open-label study. The Lancet Respiratory Medicine. 2022;10(4):392-402.

17. Lazarus R, Baos S, Cappel-Porter H, Carson-Stevens A, Clout M, Culliford L, Emmett SR, Garstang J, Gbadamoshi L, Hallis B, Harris RA. Safety and immunogenicity of concomitant administration of COVID-19 vaccines (ChAdOx1 or BNT162b2) with seasonal influenza vaccines in adults in the UK (ComFluCOV): a multicentre, randomised, controlled, phase 4 trial. The Lancet. 2021;398(10318):2277-87.

18. Toback S, Galiza E, Cosgrove C, Galloway J, Goodman AL, Swift PA, Rajaram S, Graves-Jones A, Edelman J, Burns F, Minassian AM. Safety, immunogenicity, and efficacy of a COVID-19 vaccine (NVX-CoV2373) co-administered with seasonal influenza vaccines: an exploratory substudy of a randomised, observer-blinded, placebo-controlled, phase 3 trial. The Lancet Respiratory Medicine 2022;10(2):167-79.

19. Janssen C, Mosnier A, Gavazzi G, Combadière B, Crepey P, Gaillat J, Launay O, Botelho-Nevers E. Coadministration of seasonal influenza and COVID-19 vaccines: A systematic review of clinical studies. . Human Vaccines & Immunotherapeutics. 2022;2131166.

20. Shenyu W, Xiaoqian D, Bo C, Xuan D, Zeng W, Hangjie Z, Qianhui Z, Zhenzhen L, Chuanfu Y, Juan Y, Gang Z. Immunogenicity and safety of a SARS-CoV-2 inactivated vaccine (CoronaVac) co-administered with an inactivated quadrivalent influenza vaccine: A randomized, open-label, controlled study in healthy adults aged 18 to 59 years in China. Vaccine. 2022;40(36):5356-65.

21. Domnich A, Orsi A, Trombetta CS, Guarona G, Panatto D, Icardi G. COVID-19 and Seasonal Influenza Vaccination: Cross-Protection, Co-Administration, Combination Vaccines, and Hesitancy. Pharmaceuticals. 2022;15(3):322.

22. Bentov Y, Beharier O, Moav-Zafrir A, et al. Ovarian follicular function is not altered by sars-cov-2 infection or bnt162b2 mrna covid-19 vaccination. Hum Reprod. 2021;36(18):2506-13.

23. Wang M, Yang Q, Ren X, et al. Investigating the impact of asymptomatic or mild sarscov-2 infection on female fertility and in vitro fertilization outcomes: A retrospective cohort study. EClinicalMedicine. 2021;38:101013.

24. Society of Obstetricians and Gynecologists of Canada. Statement on COVID-19 vaccination and fertility. 2021. Available from: https://sogc.org/common/Uploaded%20files/Latest%20News/EN_SOGCStatement_COVID-19Vaccination-Fertility.pdf 

25. BC Centre for Disease Control. BC Communicable Disease Control Manual, Chapter 2: Immunization, Part 1 - Immunization Schedules, pg 3. 2020. Available from: http://www.bccdc.ca/resource-gallery/Documents/Guidelines%20and%20Forms/Guidelines%20and%20Manuals/Epid/CD%20Manual/Chapter%202%20-%20Imms/Part_1_Schedules.pdf.

26. Villar J, Conti CP, Gunier RB, Ariff S, Craik R, Cavoretto PI, Rauch S, Gandino S, Nieto R, Winsey A, Menis C, et al. Pregnancy outcomes and vaccine effectiveness during the period of omicron as the variant of concern, INTERCOVID-2022: a multinational, observational study. Lancet. Feb 2023;401:447-57.

27. Allotey J, Fernandez S, Bonet M, Stallings E, Yap M, Kew T, et al. Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus disease 2019 in pregnancy: living systematic review and meta-analysis. bmj. 2020;370.

28. Prabhu M, Riley L. Coronavirus disease 2019 (COVID-19) vaccination in pregnancy. Obstetrics & Gynecology. Mar 2023;141(3):473-82.

29. Shimabukuro TT, Kim SY, Myers TR, Moro PL, Oduyebo T, Panagiotakopoulos L, Marquez PL, Olson CK, Liu R, Chang KT, Ellington SR, Burkel VK, Smoots AN, Green CJ, Licata C, Zhang BC, Alimchandani M, Mba-Jonas A, Martin SW, Gee JM, Meaney-Delman DM. CDC v-safe COVID-19 Pregnancy Registry Team. Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons. N Engl J Med. 2021;384:2273-82.

30. Castillo E and Poliquin V. Immunization in pregnancy. J Obstet Gynaecol Can [Internet]. 2018;40(4):478-89.

31. National Advisory Committee on Immunization (NACI). Guidance on the use of COVID-19 vaccines in the fall of 2023 July 2023. Available from: https://www.canada.ca/en/public-health/services/publications/vaccines-immunization/national-advisory-committee-immunization-guidance-use-covid-19-vaccines-fall-2023.html.

32. National Advisory Committee on Immunization (NACI). Updated guidance on COVID-19 vaccination timing for individuals previously infected with SARS-CoV-2. February 2022. Available from: https://www.canada.ca/en/public-health/services/immunization/national-advisory-committee-on-immunization-naci/rapid-response-guidance-covid-19-vaccination-timing-individuals-previously-infected-sars-cov-2.html.

33. Immunization Action Coalition. Ask the Experts: COVID-19. 12 September 2023. Available from: https://www.immunize.org/askexperts/experts_cov.asp.

34. Saleh E, Moody MA, Walter EB. Effect of antipyretic analgesics on immune responses to vaccination. Hum Vaccin Immunother [Internet]. 2016.;12(9):2391-402.

35. Chau-Giendinning H, Baber B, Neher JO, Safranek S. Do prophylactic antipyretics reduce vaccination-associcated symptoms in children? J Fam Pract [Internet]. 2021;69(3):E21-2.

36. Das RR, Panigrahi I, Naik SS. The effect of prophylactic antipyretic administration on post-vaccination adverse reactions and antibody response in children: a systematic review. PLoS One [Internet]. 2021;69(3):e106629.

37. BC Cancer. COVID-19 and Cancer Screening. Does the COVID-19 vaccine affect my screening mammogram? 2021. Available from: http://www.bccancer.bc.ca/screening/health-professionals/covid-19-and-cancer-screening.

38. Li C., Chen Y., Zhao, Y., et al. Intravenous injection of COVID-19 mRNA vaccine can induce acute myopericarditis in mouse model. Clin Infect Dis. 2021;ciab707.

39. Nicolai L, Leunig A, Pekayvaz K, et al. Thrombocytopenia and splenic platelet directed immune responses after intravenous ChAdOx1 nCov-19 administration. bioRxiv [Preprint]. 2021.

40. Public Health Agency of Canada. Canadian Immunization Guide [Internet]. Evergreen ed. Part 1 - Key Immunization Information: Vaccine Administration Practices. 2017. Available from:

41. CDC. Epidemiology and Prevention of Vaccine-Preventable Diseases. The Pink Book Course TextBook 14th edition. Chapter 6: Vaccine Administration. Available from: https://www.cdc.gov/vaccines/pubs/pinkbook/vac-admin.html.

42. Clinical Skills [Internet]. Maryland Heights (MO): Elsevier Inc. Skills: Medication Administration: Intramuscular Injection 2021. Available from: https://point-of-care.elsevierperformancemanager.com/skills/376/quick-sheet?skillId=GN_21_5.

43. Moshe Ipp, Anna Taddio, Jonathan Sam, Morton Goldbach, and Patricia C Parkin. Vaccine‐related pain: randomised controlled trial of two injection techniques. 2007.


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COVID-19 mRNA vaccines

Both the Pfizer-BioNTech Comirnaty® and Moderna Spikevax®
COVID-19 vaccines are mRNA vaccines.  Messenger RNA (mRNA) is the ‘blueprint’ that cells use to synthesize proteins required for our physiology. The COVID-19 mRNA vaccines use mRNA contained inside a lipid nanoparticle (LNP) that contains the synthetic nucleotide sequences that codes for the SARS-CoV-2 spike protein. After injection, the LNP is taken up by immune system cells, and once inside a cell, the mRNA provides the instructions that allow the cell to manufacture the spike protein. Once manufactured, the spike protein exits the cell, and becomes anchored onto the cell's surface. The immune system is activated to recognize the spike protein as foreign and initiates an immune response. The mRNA is then cleared by the cell’s natural mRNA degradation process. The estimated half-life for mRNA after injection is about 8-10 hours before degradation by native RNases (enzymes that break up the mRNA) in the body; the expressed spike protein persists in the body for several days and during this time continues to stimulate the immune response. mRNA vaccines are not live vaccines and cannot cause infection in the host. The delivered mRNA does not replicate, and does not enter the cell nucleus or interact with or alter the recipient’s DNA.1- 3     

Several mRNA vaccines are under development for other infections including cytomegalovirus, human metapneumovirus, parainfluenza virus type 3, Zika and influenza viruses.  

Manufacturing of mRNA vaccines has been under development for a decade. The process is cell-free (does not use human or other animal cells) and does not use vectors (like other viruses) or animal products, preservatives or adjuvants. 
History of anaphylactic reaction to any component of the vaccine is generally considered a contraindication. Anaphylaxis has been reported to be very rare following mRNA vaccination. However, based on recent studies demonstrating that individuals who experienced anaphylaxis following their first dose of mRNA vaccine, were able to receive their second dose of mRNA vaccine with either mild or no side effects, re-vaccination may be offered with the same vaccine or the same platform if a risk assessment deems that the benefits outweigh the potential risks for the individual, informed consent is provided, and the following criteria are met:4
  • consultation with an allergist or another appropriate physician before receiving future doses of a COVID-19 mRNA vaccine
  • a controlled setting where the vaccine can be administered with expertise and equipment to manage anaphylaxis
  • an observation period of at least 30 minutes after vaccination (the normal observation period for people who have not experienced a severe immediate allergic reaction after vaccination is 15 minutes).
For those with a previous history of allergy to an mRNA vaccine where consultation with an allergist or other appropriate physician precludes further vaccination with an mRNA vaccine, vaccination with Novavax Nuvaxovid should be offered if the individual is in the authorized age group and does not have contraindications to the vaccine. They should also be observed for an extended period of at least 30 minutes after re-vaccination.4


 

Both Pfizer and Moderna COVID-19 mRNA vaccines contain polyethylene glycol (PEG) which can be found in various products such as: bowel preparation products for colonoscopy, laxatives, cough syrup, cosmetics, contact lens care solutions, skin care products and as an additive in some food and drinks. No cases of anaphylaxis to PEG in foods and drinks have been reported.‎

 
‎Tromethamine (Tris or trometamol) is used as a buffer in vaccines and medications, including those for use in children, to improve stability and prevent pH fluctuations in the solution. Tromethamine is widely used in several medications for topical, enteral or parenteral administration. It is also used in cosmetics as an emulsifier.5 No safety concerns have been identified with tromethamine. While tromethamine has been identified as a potential allergen, a review of existing evidence did not identify any cases of allergic reactions to tromethamine in children.6

Tromethamine has been identified as a potentially allergenic excipient and is present in the Pfizer-BioNTech and Moderna COVID-19 vaccines. However, there is increasing evidence that this is not the culprit excipient and/or the reactions are not IgE-mediated. This remains under investigation.7
 
In situations of suspected hypersensitivity or non-anaphylactic allergy to COVID-19 vaccine components, the vaccine should be administered in a controlled setting with expertise and equipment to manage anaphylaxis, with an extended period of observation post-vaccination of at least 30 minutes.

 
The mRNA vaccines do not contain a preservative to prevent microbial contamination following first vial puncture or dilution and therefore they must be used within the specified time periods indicated within the respective product pages in the BC Immunization Manual, Part 4 – Biological Products, COVID-19 Vaccines

For more information with regard to receiving and handling the Pfizer-BioNTech and Moderna vaccines, refer to the BC Immunization Manual, Appendix E: Management of Biologicals, Guidance for Receiving and Handling the Pfizer-BioNTech COVID-19 mRNA Vaccine (including dry ice procedures) and Guidance for Receiving and Handling the Moderna COVID-19 mRNA Vaccine.  Additional information, including standard operating procedures can be found on the COVID-19 Immunize BC Operations Centre: Standard Operating Procedures page.

 
1. Public Health Agency of Canada. Recommendations on the use of COVID-19 vaccines. 2021 [Jan 12 2021]. Available from: https://www.canada.ca/en/public-health/services/immunization/national-advisory-committee-on-immunization-naci/recommendations-use-covid-19-vaccines.html.

2. U.S. Food & Drug Administration [Internet]. Silver Spring (MD): U.S. Food & Drug Administration. 2020 meeting materials, vaccines and related biological products advisory committee December 10, 2020 meeting announcement. 2020 Available from: https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-december-10-2020-meeting-announcement.

3. U.S. Food & Drug Administration [Internet]. Silver Spring (MD): U.S. Food & Drug Administration. 2020 meeting materials, vaccines and related biological products advisory committee December 17, 2020 meeting announcement. 2020. Available from: https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-december-17-2020-meeting-announcement.

4. Public Health Agency of Canada. Canadian Immunization Guide [Internet]. Evergreen ed. Part 4 - Immunization Agents: COVID-19 Vaccines. 2023. Available from: https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/page-26-covid-19-vaccine.html#a8.2.

5. Canadian Society of Allery and Clinical Immunology. COVID-19 Vaccine Testing & Administration Guidance for Allergists/Immunologists from the CSACI. 2021. Available from: https://csaci.ca/wp-content/uploads/2021/11/2021-11-15-REVISED-UPDATE-COVID-19-Vaccine-Testing-Administration-Guidance_LBL.pdf 

6. Public Health Agency of Canada. Statement from the Council of Chief Medical Officers of Health (CCMOH): COVID-19 Vaccination in Children 5-11 years of age 2021. Available from: https://www.canada.ca/en/public-health/news/2021/11/statement-from-the-council-of-chief-medical-officers-of-health-ccmoh-covid-19-vaccination-in-children-5-11-years-of-age.html.

7. Nilsson L, Csuth Á, Storsaeter J, Garvey LH, Jenmalm MC. Vaccine allergy: evidence to consider for COVID-19 vaccines. 2021;214:401,9.

 

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COVID-19 protein subunit vaccine (Novavax)

The Novavax COVID-19 vaccine is a recombinant protein subunit vaccine. While this type of vaccine technology has been used for other vaccines such as the hepatitis B vaccine, this is the first COVID-19 vaccine authorized in Canada which uses this technology. 

Protein subunit vaccines are created by inserting a small piece of the virus’s genetic code into another cell (Novavax uses the Spodoptera frugiperda insect cell line) which instructs the cell to start building the SARS-CoV-2 spike protein. The virus spike protein is then extracted from the cell, purified and used as the active ingredient in the vaccine to stimulate an immune response. The Novavax COVID-19 vaccine includes a new type of adjuvant, Matrix-M, which helps the vaccine produce a better immune response.

COVID-19 mRNA vaccines are preferred due to the demonstrated high efficacy and effectiveness with longer term safety data. Novavax COVID-19 vaccine may be offered to individuals for whom COVID-19 mRNA vaccines are contraindicated or have been refused.
Novavax COVID-19 vaccine is contraindicated for individuals with a history of anaphylactic reaction to a previous dose of the vaccine or to any component of the vaccine. These individuals should be offered an mRNA COVID-19 vaccine and observed for at least 30 minutes after immunization. 

The Novavax COVID-19 vaccine contains polysorbate 80 which is considered a potential allergen. Polysorbate 80 can be found in various products such as cosmetics and medical preparations including vitamin oils, tablets, and anticancer agents. 

For a complete list of components in the vaccine see the Novavax Nuvaxovid™ Product Monograph.
 
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Individuals who are immunocompromised

To date, people with moderately to severely compromised immune systems have been observed to generally have lower antibody responses and lower vaccine effectiveness compared to 
immunocompetent individuals, although this varies depending on the underlying condition or immunosuppressive agents. 

Although the evidence is limited, observational studies show a reduction in vaccine effectiveness against SARS-CoV-2 infection and disease in immunocompromised adults when compared to the general population. A pooled analysis of three large population-based cohort studies estimated vaccine effectiveness against any SARS-CoV-2 infection after the second dose in immunocompromised persons to be 79% (95% confidence interval (CI): 69-91%), compared to vaccine effectiveness after the second dose in the general population of 90% (95% CI: 86-95%).1-3

The impact of immunocompromise on seroconversion after vaccination varies according to specific conditions and/or immunosuppressive therapy. The Moderna COVID-19 XBB.1.5 mRNA vaccine is the preferred product for individuals who are moderately to severely immunosuppressed due to a potentially greater immune response induced by this vaccine in these populations.4-7
 

‎HSCT generally involves the ablation of the bone marrow followed by re-implantation of the person’s own stem cells (autologous HSCT) or stem cells from a donor (allogeneic HSCT). HSCT recipients should be viewed as "never immunized" and require re-immunization after transplant because the ablation of hematopoietic cells in the bone marrow pre-transplant eliminates most or all immune memory.8   


COVID-19 re-immunization of HSCT recipients should occur with a three dose series of a COVID-19 XBB.1.5 mRNA vaccine.9 As a result of the prolonged period of immune suppression following transplantation, revaccination with inactivated vaccine is typically recommended 6-12 months post-transplant, however for certain vaccines such as influenza and COVID-19 vaccines, revaccination can occur as early as 3 months post-transplant.  The HSCT specialist will determine the appropriate time to commence immunizations and will provide written guidance to the client for sharing with the immunizing health care provider.

Similarly, CAR-T cell therapy recipients should be considered as “never immunized” as this therapy targets lymphocytes. COVID-19 re-immunization of CAR-T cell therapy recipients should occur with a three dose series of COVID-19 XBB.1.5 mRNA vaccine.  

For more information see:
1. Barda N, Dagan N, Balicer RD. BNT162b2 mRNA Covid-19 Vaccine in a nationwide mass vaccination setting. Reply. N Engl J Med. 2021 May 20;384(20):1970. 


2. Chodick G, Tene L, Rotem RS, Patalon T, Gazit S, Ben-Tov A, et al. The effectiveness of the TWO-DOSE BNT162b2 vaccine: analysis of real-world data. Clin Infect Dis. 2021 May 17:ciab438. 


3. Whitaker HJ, Tsang RSM, Byford R, Andrews NJ, Sherlock J, Pillai PS, et al. Pfizer-BioNTech and Oxford AstraZeneca COVID-19 vaccine effectiveness and immune response among individuals in clinical risk groups. Preprint posted on khub. 2021 Jul 9. https://khub.net/documents/135939561/430986542/RCGP+VE+riskgroups+paper.pdf/a6b54cd9-419d-9b63-e2bf-5dc796f5a91f.


4. Moor M, Suter-Riniker F, Horn MP, et al. Humoral and cellular responses to mRNA vaccines against SARS-CoV-2 in patients with a history of CD20 B-cell depleting therapy (RituxiVac): an investigator-initiated, single-centre, open-label study. The Lancet Rheumatology. 2021;3(11):E789-E97.

5. Sormani MP, Inglese M, Schiavetti I., et al. Effect of SARS-CoV-2 mRNA vaccination in MS patients treated with disease modifying therapies. EBioMedicine. 2021;72(103581).

6. Stumpf J, Siepmann T, Linder T., et al. Humoral and cellular immunity to SARS-CoV-2 vaccination in renal transplant versus dialysis patients: A prospective, multicenter observational study using mRNA-1273 or BNT162b2 mRNA vaccine. The Lancet Regional Health. 2021;9(100178).

7. Boyarsky B, Werbel W, Avery RK, et al. Antibody Response to 2-Dose SARS-CoV-2 mRNA Vaccine Series in Solid Organ Transplant Recipients. JAMA. 2021;325(21):2204-6.

8. Public Health Agency of Canada. Canadian Immunization Guide. Part 3 - Vaccination of Special Populations: Immunization of immunocompromised persons. 2022. Available from: https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-3-vaccination-specific-populations/page-8-immunization-immunocompromised-persons.html.

9. National Advisory Committee on Immunization (NACI). Updated guidance on COVID-19 vaccine booster doses in Canada. 2022 [Cited 2023 Feb 1]. Available from: https://www.canada.ca/content/dam/phac-aspc/documents/services/immunization/national-advisory-committee-on-immunization-naci/guidance-covid-19-vaccine-booster-doses.pdf.

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Adverse Events Following Immunization

Very rare cases of severe immediate allergic reactions (e.g., anaphylaxis) have been reported following vaccination with mRNA COVID-19 vaccines. Most of the reported cases have occurred within 30 minutes of vaccination. Individuals tend to recover quickly with appropriate treatment and there have been no fatalities nor long-term morbidity observed with any of these severe immediate allergic reactions in Canada.

Studies have shown that individuals with a severe immediate allergic reaction after a previous dose of mRNA vaccine can be re-vaccinated with the same vaccine or another mRNA COVID-19 vaccine following an appropriate medical assessment and provided certain criteria are met – see the PRECAUTIONS section within the respective product pages within the BC Immunization Manual Part 4: Biological Products, COVID-19 Vaccines. In these studies, re-vaccination was safe and well tolerated with predominantly no, or mild, reactions after re-vaccination when provided in a controlled environment. Available evidence also suggests that most of the reported severe immediate allergic reactions following mRNA COVID-19 vaccines are likely not immunoglobulin E (IgE)-mediated and therefore have a low risk of recurrence following future vaccine doses.1

Reports of reactions to COVID-19 vaccines have increased concerns about their safety for individuals with allergies. The Canadian Society of Allergy and Clinical Immunology (CSACI) guidelines stress that there is a low risk for allergic reactions to vaccines, and non-allergic reactions to vaccines are more common than allergic reactions. In addition, non-allergic reactions to vaccines also include anxiety-related adverse events that can mimic allergic reactions.2 It is important to note that other, less serious reactions may mimic allergic reactions such as vasovagal syncope which are not contraindications to further vaccination.3

Additional information regarding allergies and COVID-19 vaccine for the public can be found in the CSACI’s COVID-19 Vaccines FAQ resource.

For more information review the contraindications and precautions sections in the COVID-19 vaccine product pages of the BC Immunization Manual Part 4: Biological Products, COVID-19 Vaccines.

To learn more about anaphylaxis refer to the BC Immunization Manual Part 5: Adverse Events Following Immunization.

 
It is important to first determine whether the reaction was an anaphylactic reaction. If an individual experienced a serious adverse event following immunization (AEFI), an AEFI report may be available in the provincial immunization data system. The AEFI report will contain details about the AEFI as well as the Medical Health Officer (MHO) recommendation on further immunization. 

Although anaphylaxis occurs rarely after vaccination, it is potentially life threatening and requires immediate treatment. It is characterized by sudden onset, rapid progression of signs and symptoms and is set apart from simple allergic reactions by the simultaneous involvement of several organ systems. Anaphylaxis that has been proven to be causally associated with vaccines is estimated at a frequency of 1.3 episodes per 1,000,000 doses of vaccines administered.4 

For individuals with a history of anaphylactic reaction to a previous dose of a COVID19 mRNA vaccine, re-vaccination (i.e., administration of a subsequent dose in the series when indicated) may be offered with an mRNA vaccine if a risk assessment deems that the benefits outweigh the potential risks for the individual and if informed consent is provided. Prior to re-vaccination, consultation with an allergist or another appropriate physician (e.g., Medical Health Officer) is advised. If re-vaccinated, vaccine administration should be done in a controlled setting with expertise and equipment to manage anaphylaxis, with an extended period of observation of at least 30 minutes after revaccination.

History of anaphylactic reaction to a previous dose of Novavax COVID-19 vaccine or to any component of the vaccine is considered a contraindication to receipt of this vaccine. These individuals should be offered a COVID-19 mRNA vaccine and observed for at least 30 minutes after immunization.

The checklist below can be used as a tool to assist health care providers to determine how to proceed when an individual reports an allergic reaction following a COVID-19 vaccine.
  • Was the event considered a severe allergic reaction or physician-diagnosed anaphylaxis?
  • Is there a history of anaphylactic reaction to any component of COVID-19 vaccine? 
  • Was the event reported to public health as an AEFI?
  • If reported to public health, is an MHO recommendation available? 
  • Did the MHO recommendation indicate that a COVID-19 vaccine from a different vaccine platform be provided? 
 

Phase 2/3 of clinical trial data evaluated the frequency of adverse events in children aged 5-11 years for the pediatric Pfizer-BioNTech vaccine (10 mcg) and children 6-11 years for the Moderna vaccine (50 mcg). Local reactions including pain, redness and swelling were very common, appearing 1-2 days after any dose and typically resolved within 1-3 days. Systemic events were mild or moderate in severity and included fatigue, headache, muscle pain, chills, fever and joint pain. Onset of systemic events was within 1-4 days after vaccine receipt with a median duration of 1 day. ‎

‎Myocarditis is an inflammation of the heart muscle; if it is accompanied by pericarditis, an inflammation of the thin tissue surrounding the heart (the pericardium), it is referred to as myopericarditis. Symptoms can include shortness of breath, chest pain, or the feeling of a rapid or abnormal heart rhythm. Symptoms can be accompanied by abnormal tests (e.g., electrocardiogram, serum troponins, echocardiogram). These are inflammatory disorders of the outer lining of the heart and heart muscle, and occur for a variety of reasons including in association with viral infections. 


As such, myocarditis can occur as a complication of COVID-19 infection. In Israel, COVID-19 infection has been estimated to cause myocarditis at a rate of 11 events per 100,000 persons among individuals aged 16 years and older. A retrospective study from the US found myocarditis (or pericarditis or myopericarditis) rates after primary COVID-19 infection to be as high as 45 cases per 100,000 patients in young males aged 12-17 years.

mRNA COVID-19 Vaccines: 

Myocarditis following mRNA COVID-19 vaccination tends to have a similar epidemiologic profile to classic myocarditis (unrelated to COVID-19), as it occurs more commonly in adolescents and young adult males. Classic myocarditis is less common in younger children.5

Cases of myocarditis/pericarditis following COVID-19 mRNA vaccination occur most commonly in adolescents and young adults (12 to 29 years of age) however, the risk is considered rare. It is important to note, as well, that teens and adults are at higher risk of developing myocarditis/pericarditis following COVID-19 infection compared to COVID-19 mRNA vaccination; as such, the risk of experiencing myocarditis is greater in an unvaccinated person than a vaccinated person.6  

When cases of myocarditis and/or pericarditis following vaccination with COVID-19 mRNA vaccines were first detected, NACI recommended Pfizer BioNTech Comirnaty as the preferred product over Moderna Spikevax for the primary series in individuals 12-29 years due to the higher risk of myocarditis and/or pericarditis observed following the Moderna Spikevax 100 mcg original monovalent vaccine primary series (especially after the second dose). However this product preference is no longer being recommended. Compared to the original monovalent primary series, the risk of myocarditis and/or pericarditis is now expected to be lower due to the use of a 1-dose schedule in most individuals and potentially due to a lower dosage of the available Moderna Spikevax vaccine (50 mcg in the XBB.1.5 formulation compared to 100 mcg in the original monovalent formulation).7

Myocarditis/pericarditis usually occurs within a week of vaccination and is more common:
  • After the second dose
  • In males than females
  • After receipt of the Moderna vaccine than the Pfizer-BioNTech vaccine.
In both Canada and the US, no deaths attributed to COVID-19 mRNA vaccine-related myocarditis have been identified in adolescents or young adults. 

Available data indicate that most individuals affected have responded well to conservative therapy and have recovered 
quickly.3 

Protein Subunit Vaccine:

Pericarditis and myocarditis in association with Novavax COVID-19 vaccine have been reported internationally and in Canada per Public Health Agency of Canada. A longer interval of 8 weeks between doses in the primary series may reduce the likelihood of pericarditis and myocarditis. Most cases recover fully. The exact cause of these events is not known but is thought to be related to the immune response to the spike protein which is also important in immunity against COVID-19 virus.

Current Recommendation:

Additional doses of a COVID-19 vaccine should be deferred in those who experienced a physician-diagnosed myocarditis or pericarditis event following a previous dose of a COVID-19 vaccine. However, those with a history compatible with pericarditis who had no cardiac workup or had normal investigations may proceed to further vaccination once symptoms have resolved and 90 days have passed since receipt of the dose associated with the event.8 For those with confirmed myocarditis (with or without pericarditis), an individual risk/benefit discussion between the patient and their healthcare provider should occur so that the patient (with their parent/guardian as applicable) can make an informed decision about proceeding with a subsequent dose. If another dose is offered, the Pfizer-BioNTech COVID19 vaccine should be offered because of the lower rate of myocarditis/pericarditis compared to the Moderna vaccine. 

Deferral is not required for those with a prior history of myocarditis or pericarditis that is unrelated to COVID-19 vaccines and are no longer being followed by a medical professional for heart issues.

Informed consent should emphasize the unknown risk of recurrence of myocarditis and/or pericarditis for these individuals and the importance of seeking immediate medical assessment and care should these symptoms develop. 

In BC, we have ensured that health care providers are aware of this observation and the possibility of it being causally linked to the vaccine, and how to diagnose and report this event when it occurs after a COVID-19 vaccine. 


COVID-19 vaccine would only be contraindicated if the component to which the individual is allergic is also present in the influenza vaccine. Influenza vaccine and COVID-19 vaccine ingredients vary depending on the specific product. Refer to the respective product monographs for each vaccine or go to the BC Immunization Manual, Part 4 – Biological Products, COVID-19 and influenza vaccine pages for ingredient lists. 

With the exceptions of FluLaval® Tetra and Fluad®, which both contain polysorbate 80, none of the other influenza vaccines contain the potential allergens that are in the mRNA vaccines (polyethylene glycol [PEG]) or protein subunit vaccine (polysorbate 80). In addition, the COVID-19 vaccines do not contain any of the potential allergens found in the influenza vaccines (e.g., ovalbumin/egg protein, thimerosal, gelatin, antibiotics). These vaccines may have some other components in common but these are not known to be allergens, i.e., sucrose and various salts.‎

‎Yes. With GBS, typically the biological basis would have been an immune mediated reaction to the antigens in the vaccine. As these antigens are not shared across influenza and COVID-19 vaccines, GBS following receipt of an influenza vaccine is not a contraindication to receiving a COVID-19 vaccine.

Any health professional who is aware of an adverse event following immunization must report the event to the medical health officer as per the Public Health Act. Information on AEFI reporting can be found on the BCCDC COVID-19 Vaccination Health Care Provider Toolkit on the Adverse Events Following Immunization (AEFIs) page. More information about reporting anaphylaxis and other allergic reactions can be found in the BC Immunization Manual Part 5 - Adverse Events Following Immunization. In addition, the Report of Adverse Event Following Immunization is a shortened two page form available for non-public health professionals reporting AEFI.

 
1. Public Health Agency of Canada. Canadian Immunization Guide [Internet]. Evergreen ed. Part 4 - Immunization Agents: COVID-19 Vaccines. 2023. Available from: https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/page-26-covid-19-vaccine.

2. Vander Leek, T.K., Chan, E.S., Connors, L. et al. COVID-19 vaccine testing & administration guidance for allergists/immunologists from the Canadian Society of Allergy and Clinical Immunology (CSACI). Allergy Asthma Clin Immunol. 2021;17(29).

3. Public Health Agency of Canada. Recommendations on the use of COVID-19 vaccines. 2021 [Jan 12 2021]. Available from: https://www.canada.ca/en/public-health/services/immunization/national-advisory-committee-on-immunization-naci/recommendations-use-covid-19-vaccines.html.

4. Public Health Agency of Canada. Canadian Immunization Guide [Internet]. Evergreen ed. Part 2 - Vaccine Safety: Anaphylaxis and other acute reactions following vaccination. 2020. Available from: https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-2-vaccine-safety/page-4-early-vaccine-reactions-including-anaphylaxis.

5. National Advisory Committee on Immunization (NACI). Recommendation on the use of the Pfizer-BioNTech COVID-19 vaccine (10 mcg) in children 5-11 years of age. November 2021 Available from: https://www.canada.ca/en/public-health/services/immunization/national-advisory-committee-on-immunization-naci/recommendations-use-covid-19-vaccines/pfizer-biontech-10-mcg-children-5-11-years-age.html.

6. Children’s Hospital of Philadelphia. Feature Article: 3 Considerations for COVID-19 Vaccination of 5-11 year old Children. November 2021. Available from: https://www.chop.edu/news/feature-article-3-considerations-covid-19-vaccination-5-11-year-old-children.

7. National Advisory Committee on Immunization (NACI). Updated guidance on the use of COVID-19 vaccines in individuals who have not previously been vaccinated against COVID-19. 2023 Oct 27 Available from: https://www.canada.ca/content/dam/phac-aspc/documents/services/publications/vaccines-immunization/national-advisory-committee-immunization-updated-guidance-covid-19-vaccines-individuals-not-previously-vaccinated/naci-statement-2023-10-27.pdf.

8. National Advisory Committee on Immunization (NACI). Summary of NACI advice on vaccination with COVID-19 vaccines following myocarditis (with or without pericarditis). 2022 Jan 14. Available from:  https://www.canada.ca/en/public-health/services/immunization/national-advisory-committee-on-immunization-naci/summary-advice-vaccination-covid-19-vaccines-following-myocarditis-with-without-pericarditis.html.



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