COVID-19 Vaccines Safety Tracking (CoVaST)
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Pfizer-BioNTech COVID-19 Vaccine Recently vaccinated individuals by Pfizer-BioNTech COVID-19 Vaccine (Comirnaty) |
Biological: BNT162b2
Receiving either the first dose only or both doses of BNT162b2 vaccine (Pfizer-BioNTech COVID-19 Vaccine)
|
| Moderna COVID-19 Vaccine Recently vaccinated individuals by Moderna COVID-19 Vaccine |
Biological: mRNA-1273
Receiving either the first dose only or both doses of mRNA-1273 vaccine (Moderna COVID-19 Vaccine)
|
| AstraZeneca-Oxford University COVID-19 Vaccine Recently vaccinated individuals by AstraZeneca-Oxford University COVID-19 Vaccine (Vaxzevria) |
Biological: AZD1222
Receiving either the first dose only or both doses of AZD1222 vaccine (AstraZeneca-Oxford University COVID-19 Vaccine)
|
| CoronaVac Recently vaccinated individuals by CoronaVac (Sinovac COVID-19 Vaccine) |
Biological: CoronaVac
Receiving either the first dose only or both doses of CoronaVac (Sinovac COVID-19 Vaccine)
|
| Sinopharm Recently vaccinated individuals by Vero Cells (Sinopharm COVID-19 Vaccine) |
Biological: Sinopharm
Receiving either the first dose only or both doses of Sinopharm Vero Cell COVID-19 Vaccine
|
| Sputnik V Recently vaccinated individuals by Sputnik V COVID-19 Vaccine |
Biological: Gam-COVID-Vac
Receiving either the first dose only or both doses of Gam-COVID-Vac (Sputnik V)
|
| Janssen Recently vaccinated individuals by Janssen COVID-19 Vaccine |
Biological: JNJ-78436735
Receiving JNJ-78436735 (Janssen COVID-19 Vaccine)
|
| CureVac Recently vaccinated individuals by CureVac COVID-19 Vaccine |
Biological: CVnCoV
Receiving either the first dose only or both doses of CVnCoV (CureVac COVID-19 vaccine)
|
| Novavax Recently vaccinated individuals by Novavax COVID-19 Vaccine |
Biological: NVX-CoV2373
Receiving either the first dose only or both doses of NVX-CoV2373 (Novavax COVID-19 vaccine)
|
| Covaxin Recently vaccinated individuals by Covaxin COVID-19 Vaccine |
Biological: BBV152
Receiving either the first dose only or both doses of BBV152 (Covaxin COVID-19 vaccine)
|
| CanSino Recently vaccinated individuals by CanSino COVID-19 Vaccine |
Outcome Measures
Primary Outcome Measures
- Local Side Effects [0-30 days after the COVID-19 vaccine shot]
Dichotomous outcome for the emergence of local side effects (e.g. injection site pain, injection site swelling, and injection site redness)
- Systemic Side Effects [0-30 days after the COVID-19 vaccine shot]
Dichotomous outcome for the emergence of systemic side effects (e.g. fever, chills, headache, fatigue, nausea, diarrhea, etc)
Secondary Outcome Measures
- Unrecognized Side Effects [0-30 days after the COVID-19 vaccine shot]
Dichotomous outcome for the emergence of oral and dermatologic side effects (e.g. oral paresthesia, oral ulcers, dysgeusia, skin rash, acne, urticaria, etc)
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | American College of Physicians | Philadelphia | Pennsylvania | United States | 19106 |
| 2 | McMaster University | Hamilton | Ontario | Canada | |
| 3 | University of Split | Split | Croatia | ||
| 4 | Masaryk University | Brno | Czechia | ||
| 5 | University of Tartu | Tartu | Estonia | ||
| 6 | Jimma University | Jimma | Ethiopia | ||
| 7 | Justus-Liebig University Giessen | Giessen | Germany | ||
| 8 | University of Ghana | Accra | Ghana | ||
| 9 | Sinaloa's Pediatric Hospital | Culiacán | Mexico | ||
| 10 | Medical University of Silesia | Katowice | Poland | ||
| 11 | Nursing School of Coimbra | Coimbra | Portugal | ||
| 12 | Irkutsk Scientific Center of Siberian Branch of Russian Academy of Sciences | Irkutsk | Russian Federation | 664033 | |
| 13 | University of Belgrade | Belgrade | Serbia | 11221 | |
| 14 | University of Ljubljana | Ljubljana | Slovenia |
Sponsors and Collaborators
- Masaryk University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- CoVaST