HSA Authorises the Updated Spikevax Vaccine by Moderna Targeting Omicron Subvariants
The Health Sciences Authority (HSA) has on 13 October 2023 authorised the updated Spikevax vaccine by Moderna to be used in Singapore for the prevention of Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and above. This is the second updated COVID-19 vaccine to be authorised by HSA after the approval of Pfizer-BioNTech’s updated Comirnaty vaccine on 12 September.
2 The updated Spikevax vaccine works in the same way as the original vaccine. In line with international recommendations, the updated vaccine comprises a monovalent (single) component that corresponds to the Omicron XBB.1.5 variant. This ensures that the vaccine continues to be protective against current Omicron subvariants. There are no other changes to the quality, safety, and efficacy of the vaccine and the updated vaccine is expected to retain the favourable benefit-risk balance of the original Spikevax Monovalent Vaccine.
3 In reviewing the updated vaccine, HSA had considered the extensive data accrued from the previous versions of Spikevax Vaccine, as well as additional data which demonstrated that the updated vaccine could enhance the immune responses against the predominant circulating Omicron subvariants including XBB.1.5, EG.5 (Eris), as well as the emerging BA.2.86. Based on the totality of evidence, and with the support of the Medicines Advisory Committee and the Panel of Infectious Diseases Experts, HSA has assessed that the overall evidence supported authorisation of the updated Spikevax Vaccine.
4 As SARS-CoV-2 continues to evolve and new variants emerge, regular updating of approved COVID-19 vaccines would be necessary to ensure the continued effectiveness of the vaccines. Such changes include replacement of strain, antigen, or coding sequence according to international recommendations. This approach has been established for seasonal influenza vaccines which are updated every 6 months.
5 As with all other vaccines and medicines registered in Singapore, HSA will actively monitor and review evolving effectiveness and safety data to ensure that the benefits of the vaccine continue to outweigh the known risks.
HEALTH SCIENCES AUTHORITY
13 OCTOBER 2023
Download pdf version here 126 KB