Cohort Event Monitoring of safety of COVID-19 vaccines in special populations (pregnant and lactating women, children and adolescents, immunocompromised, people with history of allergy, people with prior SARS-CoV-2 infection) (Covid-Vaccine-Monitor CVM)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study

Non-interventional study

• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary data collection
• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Prospective study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  100000096568

  combinations
• Medical condition to be studied:
  Pregnancy

  COVID-19

Population studied

• Short description of the study population:
  The study population comprised of pregnant and lactating women, children and adolescents, immunocompromised, people with history of allergy and people with prior SARS-CoV-2 infection who received COVID-19 vaccines for period of February 2021 to August 2022.
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adult and elderly population (>18 years)

  Adults (18 to < 65 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Elderly (≥ 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  60000

Study design details

• Study design:
  Prospective cohort study in special populations (pregnant and lactating women, children and adolescents, immunocompromised, people with history of allergy and people with prior SARS-CoV-2 infection).
• Main study objective:
  To generate and compare incidence rates of patient-reported adverse reactions of different COVID-19 vaccines across the participating countries in pregnant and lactating women, children and adolescents, immunocompromised, people with history of allergy and people with prior SARS-CoV-2 infection.
• Data analysis plan:
  Risk estimation: for each special cohort, a dedicated cumulative structured overview of numbers and incidence of all adverse reactions per vaccine will be provided, overall, and also stratified by vaccine brand, country, gender, and age group. For each adverse reaction, cumulative incidence with its 95% confidence interval (CI) will be reported by COVID-19 vaccine brand and dose.

Documents

Results tables

EUPAS42504-105818

EUPAS42504-106484

Study publications

Ahmadizar F, Luxi N, Raethke M, Schmikli S, Riefolo F, Saraswati PW, Bucsa C, O…

Luxi, N, Raethke, M, Ruijs, L, Schmikli, S, Riefolo, F, Trifiro, G, & Sturkenbo…

Luxi Nicoletta, Riefolo Fabio, Raethke Monika, van Hunsel Florence, Sturkenboom…

Francesco Ciccimarra et al. (2024). Safety Monitoring of COVID-19 Vaccines in P…