Safety Updates on COVID-19 Vaccines

Introduction

HSA actively monitors the safety of COVID-19 vaccines authorised in Singapore to ensure that the benefits of these vaccines continue to outweigh the risks and that they remain safe for use. This is done through adverse events (AEs) monitoring systems to detect any potential safety signals so that relevant measures can be taken expeditiously. 

*Pfizer-BioNTech/Comirnaty is registered as a therapeutic product by HSA on 10 December 2021. Moderna/Spikevax, Nuvaxovid, Sinovac-CoronaVac are authorised under the Pandemic Special Access Route. 

The following report provides an overview of suspected AEs that have been reported to HSA by healthcare professionals following the use of COVID-19 vaccines. The report also includes HSA's assessment of these reported AEs.

Since January 2023, HSA has been receiving significantly fewer COVID-19 vaccines AE reports and the safety profiles of the vaccines have been reviewed to be consistent, with no new safety signals. The safety of the COVID-19 vaccines is also now more established following extensive safety data accumulated from their wide global uptake during the pandemic. HSA will therefore cease publishing our regular safety update reports on COVID-19 vaccines. Nonetheless, as part of our post-market surveillance programme, HSA will continue to closely monitor the safety profile of all COVID-19 vaccines used in Singapore and will inform members of the public should there be any significant new safety concerns.

Key Updates (as of 30 June 2023)

Date of publish: 18 July 2023

i) mRNA COVID-19 Vaccines

• A total of 15,926,075 doses of the monovalent mRNA COVID-19 vaccines and 1,292,537 doses of the bivalent mRNA COVID-19 vaccines were administered.

• The reporting rates of AEs and serious AEs for the mRNA vaccines (monovalent and bivalent versions) remained rare at 0.10% (17,904 reports) and 0.007% (1,163 reports) respectively. The serious AE reporting rates for the first, second and third booster doses were at 0.004% (187 reports), 0.002% (25 reports) and 0.001% (2 reports) respectively, which were lower compared to the primary doses at 0.009% (954 reports).

• There were no new safety findings from the use of the mRNA vaccines in all age groups, including children, since the last update in February 2023 (Please refer to the previous HSA's COVID-19 Vaccine Safety Update [PDF, 164 KB] for details).

ii) Nuvaxovid, Sinovac-CoronoVac and Sinopharm COVID-19 Vaccine

• A total of 49,485 doses of the Nuvaxovid vaccine were administered. The serious AE reporting rate remained rare at 0.02% (9 reports).

• A total of 824,173 doses of the Sinovac-CoronoVac and Sinopharm vaccines were administered. The serious AE reporting rate remained rare at 0.005% (41 reports).

• As with the mRNA vaccines, there were no new safety findings for the protein-subunit and the inactivated vaccines since the last update published in February 2023 (Please refer to the previous HSA's COVID-19 Vaccine Safety Update [PDF, 164 KB] for details).

Based on HSA’s assessment of local and overseas data, the benefits of the vaccines continue to outweigh the known risks.

More details can be found in the latest report on HSA's safety assessment of COVID-19 vaccines.

Download the latest report on HSA's safety assessment of COVID-19 vaccines.

HSA Safety Update No.15 on COVID-19 Vaccines (30 December 2020 to 30 June 2023)

For more information on COVID-19 vaccination in Singapore, please refer to MOH website (https://www.moh.gov.sg/covid-19/vaccination).