COVID-19 Vaccines Safety Tracking (CoVaST)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BNT162b2, mRNA-1273, AZD1222, CoronaVac.
- Who it may be relevant to
- Registry conditions: Adverse Reaction to Vaccine, COVID19 Vaccine. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada, Croatia, Czechia, Estonia +9
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
COVID-19 Vaccines Safety Tracking: Global Consortium Study
Overview
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.
Interventions
- 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)
Primary outcome measures
- Local Side Effects [Time frame: 0-30 days after the COVID-19 vaccine shot]
- Systemic Side Effects [Time frame: 0-30 days after the COVID-19 vaccine shot]
Secondary outcome measures (1)
- Unrecognized Side Effects [Time frame: 0-30 days after the COVID-19 vaccine shot]
Eligibility criteria
Inclusion criteria
- HCW, OA and ST who received COVID-19 vaccine.
- Participating subjects should be at least 18-year-old and able to give their informed consent independently.
Exclusion criteria
- Non HCW, OA and ST who received the COVID-19.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 1 center
- American College of Physicians — Philadelphia
Canada · 1 center
- McMaster University — Hamilton
Croatia · 1 center
- University of Split — Split
Czechia · 1 center
- Masaryk University — Brno
Estonia · 1 center
- University of Tartu — Tartu
Ethiopia · 1 center
- Jimma University — Jimma
Germany · 1 center
- Justus-Liebig University Giessen — Giessen
Ghana · 1 center
- University of Ghana — Accra
Mexico · 1 center
- Sinaloa's Pediatric Hospital — Culiacán
Poland · 1 center
- Medical University of Silesia — Katowice
Portugal · 1 center
- Nursing School of Coimbra — Coimbra
Russia · 1 center
- Irkutsk Scientific Center of Siberian Branch of Russian Academy of Sciences — Irkutsk
Serbia · 1 center
- University of Belgrade — Belgrade
Slovenia · 1 center
- University of Ljubljana — Ljubljana
Publications
- Riad A, Pokorna A, Attia S, Klugarova J, Koscik M, Klugar M. Prevalence of COVID-19 Vaccine Side Effects among Healthcare Workers in the Czech Republic. J Clin Med. 2021 Apr 1;10(7):1428. doi: 10.3390/jcm10071428. PMID 33916020
- Riad A, Schunemann H, Attia S, Pericic TP, Zuljevic MF, Jurisson M, Kalda R, Lang K, Morankar S, Yesuf EA, Mekhemar M, Danso-Appiah A, Sofi-Mahmudi A, Perez-Gaxiola G, Dziedzic A, Apostolo J, Cardoso D, Marc J, Moreno-Casbas M, Wiysonge CS, Qaseem A, Gryschek A, Tadic I, Hussain S, Khan MA, Klugarova J, Pokorna A, Koscik M, Klugar M. COVID-19 Vaccines Safety Tracking (CoVaST): Protocol of a Multi- PMID 34360156
Identifiers
NCT: NCT04834869 · CoVaST