HSA approves Moderna’s Spikevax for Omicron sub-variants

SINGAPORE: On Friday, Oct 13, HSA approves Moderna’s Spikevax. The Health Sciences Authority (HSA) has granted authorisation for using Moderna’s updated Spikevax vaccine in Singapore.

This vaccine is intended to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged six months and above. Notably, this marks the second updated COVID-19 vaccine to receive approval from HSA, following the endorsement of Pfizer-BioNTech’s updated Comirnaty vaccine on Sept 12.

The updated Spikevax vaccine functions in the same manner as the original version. In alignment with international recommendations, this updated vaccine comprises a monovalent (single) component designed to target the Omicron XBB.1.5 variant.

This targeted approach ensures the vaccine remains effective against the various Omicron subvariants currently circulating. No alterations have been made to the vaccine’s quality, safety, or efficacy. As a result, the updated vaccine is expected to maintain the favourable benefit-risk balance of the original Spikevax Monovalent Vaccine.

While assessing this updated vaccine, HSA considered extensive data accumulated from previous iterations of the Spikevax Vaccine. Additionally, they reviewed supplementary data demonstrating the vaccine’s capacity to bolster immune responses against the most prevalent Omicron subvariants, including XBB.1.5, EG.5 (Eris), and the emerging BA.2.86.

After thoroughly examining the evidence, with the support of the Medicines Advisory Committee and the Panel of Infectious Diseases Experts, HSA concluded that the overall data justified the authorisation of the updated Spikevax Vaccine.

In the context of an ever-evolving SARS-CoV-2 landscape with new variants continuously emerging, it becomes imperative to update approved COVID-19 vaccines regularly. Such updates may involve replacing strains and antigens or coding sequences according to international guidelines. This practice is consistent with the approach taken for seasonal influenza vaccines, which are refreshed every six months to ensure continued effectiveness.

As with all vaccines and medicines registered in Singapore, HSA is committed to actively monitoring and assessing evolving vaccine effectiveness and safety data. This ongoing vigilance is essential to ensure the vaccine’s benefits always outweigh any known risks.