08/04/2021
Monitoring the safety profile of CO-VID-19 vaccines
HSA has issued a Dear Healthcare Professional Letter (DHCPL) to highlight to healthcare professionals the requirements on the safety monitoring of CO-VID-19 vac-cine(s) that has been authorised for use in Singapore. As the CO-VID-19 vac-cination programme is progressively rolled out, healthcare professionals are advised to remind vac-cine recipients to monitor any ad-verse events (AEs) that may occur with CO-VID-19 vac-cine(s) and to report all suspected serious adverse events (SAEs) to HSA:
all fatal and life-threatening events should be reported within 24 hours (Note: Fatal events are reportable as Coroner’s cases under the Coroners Act)
all other SAEs and Adverse Events of Special Interest (AESIs) are to be reported as soon as possible and within 48 hours
Healthcare professionals are also required to notify the National Immunisation Registry as soon as possible, within 48 hours, of all persons who have been vaccinated with the CO-VID-19 vac-cine(s) through the respective IT systems. HSA will continue to monitor the safety profile of CO-VID-19 vac-cine(s) and communicate any relevant updates to healthcare professionals.
Please refer to the letter for details.
Healthcare professional, Industry member, Therapeutic Products
Published: 29 Dec 2020
https://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/monitoring-the-safety-profile-of-covid-19-vaccines
HSA's Regulatory Information and Consumer Advisories
https://www.hsa.gov.sg/covid-19-information-and-advisories
HSA has issued a Dear Healthcare Professional Letter (DHCPL) to highlight to healthcare professionals the requirements on the safety monitoring of COVID-19 vaccine(s) that has been authorised for use in Singapore. As the COVID-19 vaccination programme is progressively rolled out, healthcare profe...