SARS-CoV-2 VACCINATION for COVID-19 DISEASE SAFETY STUDY (VAC4COVID STUDY)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44381
• EU PAS number:
  EUPAS44124
• Study ID:
  44381
• Official title and acronym:
  SARS-CoV-2 VACCINATION for COVID-19 DISEASE SAFETY STUDY (VAC4COVID STUDY)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  VAC4COVID is an online study created by MEMO (Medicines Monitoring Unit) Research at the University of Dundee to track all authorised vaccines used to prevent COVID-19 infection. All licensed/authorised vaccines have already been tested extensively for effectiveness and safety in large clinical trials. As with every new medicine, governments and researchers need to keep monitoring how COVID-19 vaccines are working once they are being used in the wider population. This is standard practice and an important part of how medicines and vaccines are regulated. This study will track vaccines to check they are working well. It will be big enough to detect any rare unexpected vaccine side effects. Participation in this study is voluntary and it will not interfere with participants’ usual health care. The aim of the study is to monitor the effectiveness and safety of COVID-19 vaccines by gathering information from a large number of participants about their health before and after they are vaccinated. Participants are prompted by email at monthly intervals to state whether they have had any changes in their health and wellbeing. They are also asked if any reported events required emergency care or resulted in hospitalisation. For the four weeks following vaccination, they are asked to provide these updates on their health on a weekly basis, then return to monthly follow-ups for at least 11 months. Participants are asked to provide consent to allow follow-up and investigation of any adverse events they may experience following vaccination against COVID-19.
• Study status:
  Ongoing

Research institutions and networks

Institutions

University of Dundee

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 16/12/2020

Actual: 16/12/2020

Study start date

Planned: 28/01/2021

Actual: 02/02/2021

Date of final study report

Planned: 31/12/2025

Sources of funding

Other

More details on funding

University of Dundee

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

ISRCTN -ISRCTN95881792 https://doi.org/10.1186/ISRCTN95881792