Fever was common after the first dose (3.7% of 16-55 year olds, 1.4% of >55 year olds) but was very common after the second dose (15.8% of 16-55 year olds, 10.9% of >55 year olds). Canada’s National Advisory Committee on Immunization (NACI) recommends suspending the use of the Oxford-AstraZeneca COVID-19 vaccine for anyone under the age of 55 as a precautionary measure, pending further investigation. There's enough to worry about during a pregnancy, even without a pandemic. (Discretionary NACI Recommendation). We strongly recommend that women talk with their doctor to discuss all … The NACI also recommended the continued use of the AstraZeneca vaccine among people over the age of 55 with informed consent, due to the lower risk of … NACI has not specifically reviewed evidence for the SII vaccine, but Health Canada has deemed SII and AstraZeneca vaccines to be comparable. Wingert A, Pillay J, Gates M, Guitard S, Rahman S, Beck A, Vandermeer B, Hartling L. Risk factors for severe outcomes of COVID-19: a rapid review. NACI continues to recommend a complete two-dose COVID-19 vaccine series with the same vaccine product and will continue to monitor the evidence and update recommendations as needed. For details on the development and application of NACI's EEFA Framework and evidence-informed tools (including the Ethics Integrated Filters, Equity Matrix, Feasibility Matrix, and Acceptability Matrix), please see A framework for the systematic consideration of ethics, equity, feasibility, and acceptability in vaccine program recommendations. NACI recommends that COVID-19 vaccine should not be offered to individuals who are pregnant until after completion of pregnancy, until further evidence is available (Strong Recommendation). In a survey of Canadians conducted between December 16 and 22, 2020, Intention to get vaccinated when it becomes available and recommended is similar for a safe vaccine vs. an effective vaccine (65% vs 63% agreed, n=2,125), For those who will wait to get the vaccine once it is available: 80% will wait to ensure the safety of the vaccine, 64% will wait to ensure the effectiveness of the vaccine (n=691), In a survey of health care providers conducted on Dec 4-13, 2020. Refer to Adverse Events Following Immunization (AEFI) in the CIG, Part 2 — Vaccine Safety for additional information on definitions, reporting, investigating and managing, and causality assessments for AEFIs. Evidence from the ongoing Phase 2/3 trial were published recently, after NACI's review of the evidenceFootnote 10. Updated national, provincial and territorial-level data on COVID-19 cases and deaths in Canada over time is available from the PHAC webpage on Coronavirus disease (COVID-19): Outbreak update. 2020;396:479-88 doi:S0140-6736(20)31605-6. Binding and neutralizing antibodies were both induced by one dose of vaccine and boosted by the second dose of vaccine. To access the most recent updates to specific elements, please refer to the links below. After Dose 2, severe systemic events had frequencies of <2% with the exception of fatigue (3.8%) and headache (2.0%). A recently published article contains additional evidence on humoral responsesFootnote 6. What level of COVID-19 vaccination coverage is required to achieve various public health milestones, including: coverage to reduce the burden on the health care system to a manageable degree, achieve herd immunity to protect non-vaccinated individuals, and remove PHM controls. Happening right now in Cleveland is research to confirm early findings that women who are vaccinated against the coronavirus during pregnancy pass along protection to their babies. Liaison representatives: LM Bucci (Canadian Public Health Association), E Castillo (Society of Obstetricians and Gynaecologists of Canada), A Cohn (Centers for Disease Control and Prevention, United States), L Dupuis (Canadian Nurses Association), J Emili (College of Family Physicians of Canada), D Fell (Canadian Association for Immunization Research and Evaluation), M Lavoie (Council of Chief Medical Officers of Health), D Moore (Canadian Paediatric Society), M Naus (Canadian Immunization Committee), and A Pham-Huy (Association of Medical Microbiology and Infectious Disease Canada). If so, what is the minimum interval required for vaccine administration following receipt of convalescent plasma or monoclonal antibodies? Updated information on COVID-19 vaccines in pregnancy. No other solicited uncommon, rare, or very rare adverse events were reported among vaccinated participants in the clinical trials at this time. There were no clinically meaningful differences in AEs by category observed by age, sex, or race/ethnicity. Serologic testing is not needed before or after immunization with COVID-19 vaccine. No serious safety concerns related to the vaccines have been identified to date in clinical trials; however, studies are ongoing. Efficacy of a two-dose series was consistent across age groups. Equity: Efforts should be made to increase access to immunization services to reduce health inequities without further stigmatization or discrimination, and to engage systematically marginalized and racialized populations in immunization program planning. Liaison representatives: Dr. LM Bucci (Canadian Public Health Association), Dr. E Castillo (Society of Obstetricians and Gynaecologists of Canada), Dr. A Cohn (Centers for Disease Control and Prevention, United States), Ms. L Dupuis (Canadian Nurses Association), Dr. J Emili (College of Family Physicians of Canada), Dr. D Fell (Canadian Association for Immunization Research and Evaluation), Dr. M Lavoie (Council of Chief Medical Officers of Health), Dr. D Moore (Canadian Paediatric Society), Dr. M Naus (Canadian Immunization Committee), and Dr. A Pham-Huy (Association of Medical Microbiology and Infectious Disease Canada). Systemic reactions are more frequent after the second vaccine dose and in younger adults. Jurisdictions should ensure close and rapid monitoring of safety, effectiveness, and coverage of the vaccines in different key populations, as well as effective and efficient immunization of populations in hardly reached, remote and isolated communities. Efforts should be made to increase access to immunization services to reduce health inequities without further stigmatization or discrimination, and to engage systemically marginalized populations and racialized populations in immunization program planning. Can COVID-19 vaccines be given in individuals who have received convalescent plasma or anti-SARS-CoV-2 spike protein monoclonal antibodies? A pregnant woman receives a vaccine for the coronavirus disease (COVID-19) at Skippack Pharmacy in Schwenksville, Pennsylvania, on Feb 11, 2021. Related recommendations were approved on March 13, 2021. There have been no theoretical concerns about these vaccines in breastfeeding individuals or their breastfed infants. Due to the availability of only short-term clinical trial data, the duration of COVID-19 vaccine efficacy, and vaccine effectiveness, are currently unknown. Grade 3 reactions were reported by 2.9% and 15.7% of vaccine recipients after Dose 1 and Dose 2, respectivelyFootnote 13. Redness and swelling are common or very common after administration. PHAC Participants: N Abraham, P Doyon-Plourde, K Farrah, V Ferrante, N Forbes, SJ Ismail, A Killikelly, A Nam, M Patel, A Sinilaite, E Tice, MC Tunis, MW Yeung, K Young, and L Zhao. This applies to both the AstraZeneca COVID-19 vaccine and … COVID-19 disease and associated vaccines are novel; therefore, research is warranted in many areas. There is currently no evidence on the benefit from administration of oral analgesics for the prevention of immunization injection pain or systemic reactions. A total of 6 deaths were reported among study participants (2 in the vaccine group and 4 in the control group). However, if challenging from a feasibility perspective, jurisdictions may elect to disregard prior PCR-confirmed SARS-CoV-2 infection status and vaccinate everyone in a given target group. After the first puncture, the vial can be re-refrigerated, but the cumulative storage time at room temperature must not exceed 6 hours, and the total cumulative storage time must not exceed 48 hours. What is the epidemiological profile of COVID-19 (e.g., communicable period, all risk groups)? Refer to Vaccine Administration Practices in the CIG, Part 1 — Key Immunization Information for additional information. NACI will continue to monitor the evidence and update recommendations as needed. After first opening, chemical and physical in-use stability has been demonstrated from the time of vial puncture to administration for no more than 6 hours at room temperature (up to +30ºC) or 48 hours in a refrigerator (+2ºC to +8ºC). Ottawa: PHAC; 2020 Nov 20. mRNA COVID-19 vaccines are authorized in individuals 16 years of age and older (Pfizer-BioNTech COVID-19 vaccine) and in individuals 18 years of age and older (Moderna COVID-19 vaccine). The median duration of follow-up was 105 days post-Dose 1 and 62 days post-Dose 2. Therefore, the balance of benefits and risks must be made on a case-by-case basis. NACI recommends that as additional COVID-19 vaccine supplies become available with sufficient supply to vaccinate the above populations, authorized COVID-19 vaccine(s) should be offered to individuals without contraindications in the following populations: The risk of infection with SARS-CoV-2 is high in congregate settings where physical distancing and other infection prevention and control measures are challenging and individuals may not be able to exercise sufficient personal actions to adequately protect themselves from infection. Populations that receive a lower efficacy COVID-19 vaccine will have protection against COVID-19 disease earlier than if they had waited for mRNA vaccines to be available. “That was the only time I felt like maybe it wasn’t the right move,” Eicher says. However, neutralization is not the only anti-vector immune response that could impact vaccine-induced immunity. There is currently no evidence to guide the time interval between the completion of the COVID-19 vaccine series and conception. Component in contrast media, oral and parenteral medications. After months of shifting advice, Ontario has become the first Canadian province to prioritize pregnant women in a COVID-19 vaccine rollout plan, without … Although there have been relatively few cases and outbreaks in these communities to date in Canada, the number of cases in these communities is increasingFootnote 8. There were no clear imbalances by System Organ Class (SOC). Vaccine providers are asked to report AEFIs through local public health departments and to follow AEFI reporting requirements that are specific to their province or territory. Vials may also be stored at -25°C to -15°C for up to 2 weeks. Common adverse events are defined as those that occur in 1% to less than 10% of vaccine recipients; very common adverse events occur in 10% or more of vaccine recipients. Lancet. However, studies are ongoing. The third section presents considerations for sequencing and prioritization, which will be based on evolving evidence. Research priorities for COVID-19 vaccines to support public health decisions [internet]. In the updated dataset as of December 7, 2020, there were 1,375 study participants ≥65 years of age (699 in the vaccine group and 676 in the control group). Current data from clinical trials are insufficient to determine the efficacy of the AstraZeneca vaccine in individuals ≥65 years of age. A complete vaccine series with a currently authorized COVID-19 vaccine should be offered to: A complete vaccine series with a currently authorized COVID-19 vaccine may be offered to: For some specific populations who were either excluded from, or were represented by small numbers of participants in clinical trials, NACI recommends that a complete vaccine series with a currently authorized COVID-19 vaccine may be offered, if a risk assessment deems that the benefits of vaccination outweigh the potential risks for the individual (e.g., where the risk of severe outcomes of COVID-19 and/or risk of exposure to SARS-CoV-2 is high) or for the fetus/infant (in the case of pregnancy/breastfeeding) and if informed consent includes discussion about the insufficient evidence in these populations: These recommendations may change as more evidence on safety and/or efficacy/effectiveness in these populations becomes available. The National Advisory Committee on Immunization (NACI) recommends that the AstraZeneca COVID-19 not be used for people under the age of 55 in Canada, following concerns around blood clots associated with low levels of platelets, vaccine-induced prothrombotic immune thrombocytopenia (VIPIT).. The public health benefits of offering the AstraZeneca vaccine earlier only to individuals 55 to 64 years were less certain given the shorter expected wait times of this population for mRNA vaccines. In individuals with bleeding disorders, the condition should be managed prior to immunization to minimize the risk of bleeding. Institut national de Santé Publique du Québec, 18 décembre 2020 (in French only). Study C4591001 is the pivotal Phase 1/2/3 trial for the Pfizer-BioNTech COVID-19 vaccine. The rationale for the intervals included in this table has been included. The coronavirus (Covid-19) vaccines available in the UK have been shown to be effective and safe. Refer to Part 2 - Vaccine Safety in the CIG for definitions of AEFIs and additional general information. Localized axillary swelling and tenderness was solicited and occurred in less than 5% of placebo recipients after any dose, and 10.2% and 14.2% of vaccine recipients after Dose 1 and 2, respectively. Vaccine. (WTNH) — Some good news for expecting mothers who want to get the COVID-19 vaccine. The recommendation on the use of the AstraZeneca COVID-19 vaccine has been updated to include use in those 65 years of age and older. What strategies can improve acceptability of a COVID-19 vaccine in these groups? Immunization during pregnancy will be further discussed by NACI in its forthcoming recommendations on the use of COVID-19 vaccine(s). Safe and effective COVID-19 vaccines could help achieve this goal. Epidemiological summary of COVID-19 cases in Canada [Internet]. 49.2% to 67.1% when Dose 2 was provided after at ≥6 weeks). More than a quarter of vaccine recipients experienced headache, and/or fatigue after any dose. Designations of essential services in the context of the COVID-19 pandemic vary across jurisdictions within Canada. The storage requirements for this vaccine could increase access to the vaccine for some populations. There is currently insufficient evidence on the duration of protection and on the efficacy of these vaccines in preventing death, hospitalization, asymptomatic infection and reducing transmission of SARS-CoV-2, although studies are ongoing. A phase 3, randomized, stratified, observer-blind, placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine in adults aged 18 years and older. How does vaccination impact individual-level variation in transmission (e.g., superspreaders)? The majority of systemic reactions after either dose occurred within the first 1 to 2 days post-vaccination and had a median duration of 1 to 2 days. Therefore, the balance of benefits and risks must be made on a case-by-case basis. Vaccine. An authorized COVID-19 vaccine should not be offered routinely to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after previous administration of a COVID-19 vaccine using a similar platform (mRNA or viral vector). NACI developed the following recommendations based on the evidence and extensive stakeholder consultations synthesized and presented in the NACI Preliminary guidance on key populations for early COVID-19 immunization, the most recent information available at the time of deliberation on vaccine supply, and preliminary information suggesting comparable efficacy and safety of the Moderna and Pfizer/BioNTech COVID-19 vaccines. 2. AEFI: adverse event following immunization, MenACWY: Quadrivalent meningococcal vaccine. A lipid nanoparticle formulation delivers the mRNA into the recipient's cells. However, due to restrictive storage and handling requirements, there is a risk of dose wastage if excess doses remain after complete immunization in a particular setting. The estimated vaccine efficacy against confirmed COVID-19 from 7 days after Dose 2 was greater than 91% (between 91.7% and 100.0%) in all subgroups stratified by "at risk" status (e.g., presence of a 1 or more comorbidities). The Phase 2/3 trial was based in the United Kingdom, (UK) while the Phase 3 trial was based in Brazil. No Grade 4 local reactions were reported. There were changes from a single to a two-dose vaccine regimen, the use of both a low dose/standard dose (LD/SD) (in COV002 only, due to dosing error) and standard dose/standard dose (SD/SD) vaccine regimen, and the recruitment of progressively older study participants (56-69 and then ≥70 years of age) after the initial focus on adults 18-55 years of age. Efforts should be made to improve knowledge about the benefits of vaccines in general and of COVID-19 vaccine(s) specifically once available, address misinformation about immunization, and communicate transparently about COVID-19 vaccine allocation decisions. As of a data cut-off date of November 4, 2020 the primary analysis population (study participants who received either the LD/SD or SD/SD regimens) for the primary outcome included 11,636 participants seronegative at baseline (5,807 in the vaccine group, 5,829 in the control group). The AstraZeneca vaccine can be stored between +2ºC to +8ºC and protected from light in the original packaging. The basis for this minimum interval is that the per-protocol design for the Pfizer-BioNTech COVID-19 vaccine clinical trial was 19-23 days, An alternate interval of 28 days may be more feasible to implement. A discretionary recommendation may/may not be offered for some populations/individuals in some circumstances. There have been no drug interactions studies performed to date. NACI recommends that a complete vaccine series with a COVID-19 vaccine may be offered to pregnant individuals in the authorized age group if a risk assessment deems that the benefits outweigh the potential risks for the individual and the fetus, and if informed consent includes discussion about the absence of evidence on the use of COVID-19 vaccines in this population. A preliminary analysis of limited data in an ongoing trial suggests the Moderna COVID-19 vaccine may be efficacious in preventing asymptomatic infection, however data is still being collected and the final analysis is not complete. The Phase 3 portion of the trial involved 30,413 study participants randomized (1:1) to receive either the vaccine (2 doses of 100 mcg) or placebo. At the present time, there are insufficient data to estimate the efficacy of the viral vector vaccine against severe COVID-19 disease. CORTEZ, Colo. (KDVR) – A mother who received a two-dose COVID-19 vaccine while pregnant gave birth to a baby who tested positive for antibodies … It remains unclear if immune responses to the ChAd vector will impact the efficacy or effectiveness of this vaccine. At all time points and age groups, immune responses were higher than placebo. The relatively higher incidence of cases post-vaccination could negatively affect the public's acceptability of COVID-19 vaccines and vaccines in general. Three SAEs in vaccinated individuals were considered by the study sponsor to be related to the trial intervention: two cases of facial swelling and one case of nausea and vomiting with headaches and fever. Enhance social and socioeconomic data collected and made available to understand and address health inequities related to COVID-19, Systematic examination of the Canadian burden and epidemiology of COVID-19 outbreaks by setting and severity, identifying high-risk activities, settings and populations, Evaluation of the success of public health interventions to minimize or prevent COVID-19 outbreak events, especially in vulnerable or high-risk communities, Enhance laboratory surveillance in order to provide early warning of increasing or decreasing activity by age, sex, and presence of symptoms, and help interpret case data based on changes to testing algorithms, Conduct genomic surveillance to identify international and inter-provincial transmission and new strains/variants with differing severity, transmissibility, or vaccine comparability, Explore other SARS-CoV-2 detection kits at point of care with immediate results, Reliably monitor coverage rates for each authorized COVID-19 vaccine in different key populations, ensuring data on series completion, Ensure existing mechanisms for the evaluation of adverse events are positioned to generate data for each authorized COVID-19 vaccine, Hyams et al., Assessing the Effectiveness of BNT162b2 and ChAdOx1nCoV-19 COVID-19 Vaccination in Prevention of Hospitalisations in Elderly and Frail Adults: A Single Centre Test Negative Case-Control Study. Intermediate time points were not reported. NACI recommends that a complete series with a COVID-19 vaccine may be offered to individuals in the authorized age group without contraindications to the vaccine who have had previously PCR-confirmed SARS-CoV-2 infection. [Unpublished], COVID-19 Snapshot Monitoring (COSMO Canada). Refer to Anaphylaxis and other Acute Reactions Following Vaccination in the CIG, Part 2 — Vaccine Safety for information on the management of anaphylaxis post-vaccination. However, in the context of limited supply, receipt of any vaccine may be more acceptable than waiting for additional doses of a higher efficacy vaccine to some individuals. Participants who inadvertently received the vaccine (n=6) or placebo (n=7) while pregnant are being followed. 2021;397:99-111 doi:S0140-6736(20)32661-1. About 1 in 5 study participants in the UK clinical trial (18.9%) received the SD/SD regimen with a >12-week interval between vaccine doses, and in the Brazil trial it was less than 1 in 50 study participants (1.8%). Vaccine efficacy against COVID-19 associated hospitalizations was assessed at multiple time points (Table 11). Among participants who were followed <2 weeks to <14 weeks after Dose 2, there were a total of 12 participants with SAEs of appendicitis; 8 of which were in the vaccine group. Unless otherwise noted, all data presented in this summary is based on the SD/SD vaccine regimen and as of a data cut-off date of December 7, 2020. Conflicting results have been shown for other age groups in recently published data. … Available at: https://www.canada.ca/en/public-health/services/immunization/national-advisory-committee-on-immunization-naci/guidance-prioritization-key-populations-covid-19-vaccination.html. Pfizer and BioNTech conclude phase 3 study of covid-19 vaccine candidate, meeting all primary efficacy endpoints [press release]; 18 Nov 2020 [cited: 2020 Nov 24]. Furthermore, many residents in these settings have inequitable access to health care. The cause of death among vaccine recipients included malignant neoplasm and fungal pneumonia, with neither considered to be related to the study intervention by the investigators. Administration of these products close together may result in decreased effectiveness of a COVID-19 vaccine and/or anti-SARS-CoV-2 monoclonal antibodies because the monoclonal antibodies have high affinity for the spike protein expressed by the vaccines, which could prevent the production of antibodies stimulated by the vaccine. Is it safe for pregnant women to have a COVID-19 vaccine? Remote or isolated communities, for example, may not have ready access to sufficient health care infrastructure. 2010;28:A58-63. The characterization of these cells indicates a Th-1 biased cellular immune response. During storage, vials should be protected from light. Finally, the underlying principles guiding decision-making are presented. Oral analgesics or antipyretics may be considered for the management of adverse events (e.g., pain or fever, respectively), if they occur after vaccination.