On October 13, 2023, the Health Sciences Authority (HSA) officially granted authorization for the revised Spikevax vaccine, developed by Moderna, to be employed in Singapore for the prevention of Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older.
This marks the second approved updated COVID-19 vaccine by HSA, following the approval of Pfizer-BioNTech’s revised Comirnaty vaccine on September 12.
Link to the approval of Pfizer-BioNTech’s revised Comirnaty vaccine: https://www.pomconnect.com/news/hsa-authorises-the-updated-comirnaty-vaccine-by-pfizer-targeting-omicron-subvariants/
The updated Spikevax vaccine functions in the same manner as the original version. In accordance with international guidelines, the updated vaccine contains a single component designed to target the Omicron XBB.1.5 variant. This design ensures that the vaccine remains effective against the current Omicron subvariants. There have been no alterations to the vaccine’s quality, safety, or efficacy, and it is expected to maintain the favorable balance between benefits and risks, similar to the original Spikevax Monovalent Vaccine.
In the assessment of the updated vaccine, HSA considered a substantial body of data obtained from previous iterations of the Spikevax Vaccine, as well as supplementary data demonstrating the vaccine’s ability to enhance immune responses against prevailing Omicron subvariants, including XBB.1.5, EG.5 (Eris), and the emerging BA.2.86. Based on a comprehensive evaluation of this evidence, and with the endorsement of the Medicines Advisory Committee and the Panel of Infectious Diseases Experts, HSA concluded that the evidence as a whole supported the authorization of the updated Spikevax Vaccine.
Given the ongoing evolution of SARS-CoV-2 and the emergence of new variants, it is imperative to regularly update approved COVID-19 vaccines to ensure their ongoing effectiveness. Such updates may include modifications to the viral strain, antigen, or genetic coding sequence in accordance with international recommendations. This approach aligns with the established practice for seasonal influenza vaccines, which are regularly updated every six months.
As with all other vaccines and medications registered in Singapore, HSA will actively monitor and assess evolving data on the vaccine’s effectiveness and safety to ensure that the benefits of the vaccine continue to outweigh the known risks.
COVID-19: Coronavirus Disease 2019
Link to the official press release: https://www.hsa.gov.sg/announcements/press-release/updated-spikevax-vaccine
HSA’s official press release (PDF): https://www.hsa.gov.sg/docs/default-source/default-document-library/hsa-pr_hsa-authorises-updated-spikevax-vaccine-by-moderna_final.pdf
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