NCT04834869

COVID-19 Vaccines Safety Tracking (CoVaST)

COVID-19 Vaccines Safety Tracking: Global Consortium Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30,000 (estimated)
• Sponsor: Masaryk University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This project aims to monitor the side effects of COVID-19 vaccines worldwide actively. The primary objectives of the project include a) to estimate the prevalence of each local and systemic side effect of each COVID-19 vaccine among healthcare workers (HCW), old adults over +65 (OA), and schoolteachers (ST); b) to evaluate the potential demographic and medical risk factors for side effects frequency and intensity; c) to evaluate the long-term consequences of COVID-19 vaccines. The secondary objectives include a) to evaluate the relative safety of COVID-19 vaccines compared to each other; b) to evaluate the impact of palliative drugs used by the recently vaccinated individuals on their short-term side effects resolution.

Detailed description

Introduction: COVID-19 vaccines are the foremost asset to overcome the ongoing pandemic; therefore, mass vaccination has become a high priority for the world's governments. While vaccination strategies need to be accelerated to minimise daily fatalities and relieve the pandemic's economic burdens, vaccine hesitancy (VH) remains a serious challenge for these efforts. VH refers to "delay in acceptance or refusal of vaccines despite availability of vaccine services",; and it is an emerging public health challenge nourished by misinformation related to vaccines effectiveness and safety. Aversion to vaccines' potential side effects is the most frequent cause of VH among population groups. Therefore, a recent systematic review revealed that raising public awareness of vaccines' effectiveness and side effects is vital for improving vaccine uptake. Public health systems globally experience a novel and unique challenge due to the variety of vaccines manufacturers and the high levels of public awareness about those manufacturers and their marketing strategies. This unprecedented situation is predicted to create what we can refer to as "vaccine selectivity, " increasing the pressure on our weakened health systems and economies and increasing vaccine hesitancy levels. Independent (non-sponsored) studies with rigorous methods can perfectly lead the pharmacovigilance efforts of COVID-19 vaccines globally. Given their independent nature and transparent design, these studies can play a key role in suppressing vaccine hesitancy levels by enhancing public confidence in vaccines. Design This project comprises two phases; a) a cross-sectional survey for the short-term side effects of COVID-19 vaccines; b) a prospective cohort study for the long-term safety of COVID-19 vaccines. Phase A: A validated self-administered questionnaire will be developed and delivered online to the target population groups (HCW, OA \& ST). The questionnaire will be inquiring about the short-term side effects that emerged within 30 days following the vaccine shot (either the first or the second dose). The side effects will be classified as local or systemic, and their onset, duration, and intensity will be self-assessed and self-reported by the respondents. This phase is proposed to take place until December 31st, 2021. Phase B: A validated self-administered questionnaire will be developed and delivered online to the volunteers who participated in Phase A and expressed their interest to report their long-term side effects. In this phase, the vaccine effectiveness and side effects will be evaluated after booster doses. Phase B will take place for five consecutive years starting from 2022.

Conditions

• Adverse Reaction to Vaccine
• COVID19 Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	BNT162b2	Receiving either the first dose only or both doses of BNT162b2 vaccine (Pfizer-BioNTech COVID-19 Vaccine)
BIOLOGICAL	mRNA-1273	Receiving either the first dose only or both doses of mRNA-1273 vaccine (Moderna COVID-19 Vaccine)
BIOLOGICAL	AZD1222	Receiving either the first dose only or both doses of AZD1222 vaccine (AstraZeneca-Oxford University COVID-19 Vaccine)
BIOLOGICAL	CoronaVac	Receiving either the first dose only or both doses of CoronaVac (Sinovac COVID-19 Vaccine)
BIOLOGICAL	Sinopharm	Receiving either the first dose only or both doses of Sinopharm Vero Cell COVID-19 Vaccine
BIOLOGICAL	Gam-COVID-Vac	Receiving either the first dose only or both doses of Gam-COVID-Vac (Sputnik V)
BIOLOGICAL	JNJ-78436735	Receiving JNJ-78436735 (Janssen COVID-19 Vaccine)
BIOLOGICAL	CVnCoV	Receiving either the first dose only or both doses of CVnCoV (CureVac COVID-19 vaccine)
BIOLOGICAL	NVX-CoV2373	Receiving either the first dose only or both doses of NVX-CoV2373 (Novavax COVID-19 vaccine)
BIOLOGICAL	BBV152	Receiving either the first dose only or both doses of BBV152 (Covaxin COVID-19 vaccine)

Timeline

• Start date: 2021-04-01
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2021-04-08
• Last updated: 2022-04-06

Locations

14 sites across 14 countries: United States, Canada, Croatia, Czechia, Estonia, Ethiopia, Germany, Ghana, Mexico, Poland, Portugal, Russia, Serbia, Slovenia

Regulatory

• FDA-regulated drug study