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Canadian COVID-19 Vaccine Registry for Pregnant & Lactating Individuals (COVERED): An Evaluation of Safety, Effectiveness & Acceptability
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Canadian COVID-19 Vaccine Registry for Pregnant & Lactating Individuals (COVERED): An Evaluation of Safety, Effectiveness & Acceptability

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Datasets -
Variables -
Start Year
2021
End Year
2023
Supplementary Information
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Investigators Contacts
  • Dr. Deborah Money
    FRCSC (University of British Columbia)
  • Dr. Chelsea Elwood
    University of British Columbia
  • Dr. Arianne Albert
    Women’s Health Research Institute
  • Dr. Elisabeth McClymont
    University of British Columbia
  • Dr. Eda Karacabeyli
    University of British Columbia
  • Dr. Julie Bettinger
    Vaccine Evaluation Center, BC Children’s Hospital Research Institution
  • Dr. Lori Brotto
    University of british columbia
  • Dr. Manish Sadarangani
    BC Children's Hospital, University of British Columbia
  • Dr. Tatiana Sotindjo
    University of British Columbia
  • Dr. Agatha Jassem
    University of British Columbia
  • Dr. Inna Sekirov
    University of British Columbia
  • Dr. Mel Krajden
    University of British Columbia
  • Dr. Paul Levett
    University of British Columbia
  • Dr. Muhammed Morshed
    University of British Columbia & British Columbia Centre for Disease Control
  • Dr. Deborah Money
    FRCSC (University of British Columbia)

Design

Study design
Cohort
Follow Up
* After baseline, pregnant and lactating Individuals participating in the COVERED main study are followed every two months. * Pregnant and lactating Individuals participating in the Immune Sub-Study are followed at delivery, 4 to 6 weeks after delivery and before and after COVID-19 vaccine doses. * Infants participating in the COVERED main study are followed 6 and 12 months after birth. * Infants participating in the Immune Sub-Study are followed at delivery and 4 to 6 weeks after delivery.
Supplementary Information
Data collected from individuals who do not receive COVID-19 vaccines will act as an internal comparison group. Self-identified gender will be capture through our online demographics questionnaire to examine differences by gender.

Recruitment

Recruitment Target
  • Individuals

Number of Participants

Number of Participants
7,340
Number of Participants with Biological Samples
101
Supplementary Information
Pregnant and lactating individuals : 59 participants with biological samples. Infants: 42 participants with biological samples.

Access

Availability of data and biosamples

Possible Access to Data
Possible Access to Biosamples
Other

Availability of access information

On the study website : https://covered.med.ubc.ca

Yes
No
Not applicable
Don't know

Timeline

Populations

Selection Criteria
Sex
Women
Minimum age
19
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status
Other Criteria
Inclusion : * Pregnancy will or has concluded after March 1, 2020 Inclusion criteria Immune Sub-Study ; * Able to communicate in english * Scheduled to or have been vaccinated with a COVID-19 vaccination * Registered to deliver at BC Women’s Hospital * Living in British Columbia

Recruitment

Sources of recruitment
  • General population
General Population
  • Volunteer enrolment
  • Selected sample
Supplementary Information
Participants were recuited through the study website, social media and traditional media campaign and through dissemination of recruitment materials by health care providers. Immune Sub-Study participants were recruited through the baseline survey in the COVERED vaccine registry when eligible.

Number of Participants

Number of Participants
7,340
Number of Participants with Biological Samples
59
Supplementary Information about selection criteria
59 participants from the main study are recruited to participate in the Immune Sub-Study.
Data Collection Events
# Name Description Start End
0 COVERED - Pregnant and lactating individuals - Baseline survey Pregnancy status, vaccination status, demographics information, health history, COVID-19 history and pregnancy history are assessed through survey. 2021-07 2023-12
1 COVERED - Pregnant and lactating individuals - Additional surveys Information on COVID-19 outcomes, vaccine opinion and health events are assessed through the following additional survey modules: * The vaccine attitudes module collects information on feelings, ... 2021-07 2023-12
2 COVERED - Pregnant and lactating individuals - Immune sub-study - Delivery Blood samples are collected for Immune Sub-Study participants only. 2021-07 2023-12
3 COVERED - Pregnant and lactating individuals - Immune sub-study - 4 to 6 weeks after delivery Blood samples are collected for Immune Sub-Study participants only. Breast milk sample is also collected for immune substudy participants only. 2021-07 2023-12
4 COVERED - Pregnant and lactating individuals - Immune sub-study - Doses visits Blood samples are collected for immune sub-study participants before and after each COVID 19 vaccination doses. 2021-07 2023-12
5 COVERED - Pregnant and lactating individuals - 2 month follow-up survey Changes in vaccination status, COVID-19 status, pregnancy outcomes (gestational hypertension, gestational diabetes, placental abruption, preterm birth, NICU admission, congenital anomalies, ... 2021-09 2023-12
6 COVERED - Pregnant and lactating individuals - 4 month follow-up survey Changes in vaccination status, COVID-19 status, pregnancy outcomes (gestational hypertension, gestational diabetes, placental abruption, preterm birth, NICU admission, congenital anomalies, ... 2021-11 2023-12
7 COVERED - Pregnant and lactating individuals - 6 month follow-up survey Changes in vaccination status, COVID-19 status, pregnancy outcomes (gestational hypertension, gestational diabetes, placental abruption, preterm birth, NICU admission, congenital anomalies, ... 2022-01 2023-12
8 COVERED - Pregnant and lactating individuals - 8 month follow-up survey Changes in vaccination status, COVID-19 status, pregnancy outcomes (gestational hypertension, gestational diabetes, placental abruption, preterm birth, NICU admission, congenital anomalies, ... 2022-03 2023-12
9 COVERED - Pregnant and lactating individuals - 10 month follow-up survey Changes in vaccination status, COVID-19 status, pregnancy outcomes (gestational hypertension, gestational diabetes, placental abruption, preterm birth, NICU admission, congenital anomalies, ... 2022-05 2023-12
10 COVERED - Pregnant and lactating individuals - 12 month follow-up survey Changes in vaccination status, COVID-19 status, pregnancy outcomes (gestational hypertension, gestational diabetes, placental abruption, preterm birth, NICU admission, congenital anomalies, ... 2022-07 2023-12
11 COVERED - Pregnant and lactating individuals - 14 month follow-up survey Changes in vaccination status, COVID-19 status, pregnancy outcomes (gestational hypertension, gestational diabetes, placental abruption, preterm birth, NICU admission, congenital anomalies, ... 2022-09 2023-12
Selection Criteria
Minimum age
0
Maximum age
1
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status

Recruitment

Sources of recruitment
  • Specific population
Specific Population
  • Other specific population : Children of participating mothers.

Number of Participants

Number of Participants
42
Number of Participants with Biological Samples
42
Supplementary Information about selection criteria
42 samples from the infant of the pregnant women enrolled in the Immune Sub-Study are collected.
Data Collection Events
# Name Description Start End
0 COVERED - Infants - Immune sub-study - Delivery Blood samples are collected. 2021-07 2023-12
1 COVERED - Infants - Immune sub-study - 4 to 6 weeks post delivery Blood samples are collected. 2021-07 2023-12
2 COVERED - Infants - 6 months after delivery Infant postnatally information including infant SARS-CoV-2 infection, hospitalization, growth parameters, and neurodevelopment (hyper vigilance) are assessed through questionnaire. 2021-07 2023-12
3 COVERED - Infants - 12 months after delivery Infant postnatally information including infant SARS-CoV-2 infection, hospitalization, growth parameters, and neurodevelopment (hyper vigilance) are assessed through questionnaire. 2021-07 2023-12

Classifications

Socio-demographic and economic characteristics
Lifestyle and behaviours
Birth, pregnancy and reproductive health history
Perception of health, quality of life, development and functional limitations
Diseases
Symptoms and signs
Medication and supplements
Non-pharmacological interventions
Health and community care services utilization
Death
Physical measures and assessments
Laboratory measures
Cognition, personality and psychological measures and assessments
Life events, life plans, beliefs and values
Preschool, school and work life
Social environment and relationships
Physical environment
Administrative information
Perception of health
Quality of life
Life course development
Functional limitations
Other perception of health, quality of life and functional limitation-related information

Socio-demographic and economic characteristics

Age/birthdate
Sex/gender
Family and household structure
Education
Residence
Birthplace
Ethnicity, race and religion
Labour force and retirement

Lifestyle and behaviours

Tobacco
Alcohol
Drugs
Nutrition
Breastfeeding

Birth, pregnancy and reproductive health history

Pregnancy, delivery and birth
Fertility and sexual health

Perception of health, quality of life, development and functional limitations

Life course development
Functional limitations

Diseases

Certain infectious and parasitic diseases (A00-B99)
Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism (D50-D89)
Endocrine, nutritional and metabolic diseases (E00-E90)
Mental and behavioural disorders (F00-F99)
Diseases of the nervous system (G00-G99)
Diseases of the circulatory system (I00-I99)
Diseases of the respiratory system (J00-J99)
Diseases of the digestive system (K00-K93)
Diseases of the genitourinary system (N00-N99)
Pregnancy, childbirth and the puerperium (O00-O9A)
Congenital malformations, deformations and chromosomal abnormalities (Q00-Q99)
Diseases without precise specification or falling into multiple categories

Symptoms and signs

Symptoms and signs involving the circulatory and respiratory systems (R00-R09)
Symptoms and signs involving the digestive system and abdomen (R10-R19)
Symptoms and signs involving nervous and musculoskeletal systems (R25-R29)
Symptoms and signs involving cognition, perception, emotional state and behaviour (R40-R46)
General symptoms and signs (R50-R69)
Symptoms related to multiple categories

Medication and supplements

Medication and supplement intake

Non-pharmacological interventions

Radiological interventions
Educational and health promotion interventions
Laboratory diagnosis interventions
Other and unspecified non-pharmacological interventions

Health and community care services utilization

Visits to health professionals
Hospitalizations

Physical measures and assessments

Anthropometry

Laboratory measures

Virology

Life events, life plans, beliefs and values

Beliefs and values

Administrative information

Identifiers
Date and time-related information
Questionnaire and interview-related information
Other administrative information

Life course development

Ages and Stages Questionnaire