HSA grants interim authorisation for first bivalent COVID-19 booster vaccine for those aged 18 and above

The interim authorisation was granted under Singapore’s Pandemic Special Access Route (PSAR).

Amanda Tan

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Published: 14 September 2022, 6:49 PM

The Health Sciences Authority (HSA) granted interim authorisation for the first bivalent COVID-19 booster vaccine in the country on Wednesday (Sep 14).

Individuals aged 18 years and above who have received primary series vaccination with COVID-19 vaccines will soon be able to use it as a booster vaccine, said HSA in a press release.

The Spikevax Bivalent Original/Omicron COVID-19 vaccine by Moderna comprises two components – 25 micrograms targeting the original SARS-CoV-2 strain and 25 micrograms targeting the Omicron BA.1 variant.

It is an updated version of the Moderna COVID-19 vaccine that is based only on the original SARS-CoV-2 strain.

To ensure the safety and efficacy of the vaccine, HSA said that it has carefully reviewed the data from Moderna’s pre-clinical studies, clinical trials in human volunteers, manufacturing and quality controls, and assessed that the benefits outweighed the risks for use of the bivalent vaccine as a booster to protect against COVID-19 as the virus continues to evolve.

The clinical review was based on an ongoing Phase 2/3 trial conducted by Moderna in individuals aged 18 years and above.

It showed results that the bivalent booster vaccine elicited a strong immune response against the Omicron BA.1 variant, while preserving the immune response against the original SARS-CoV-2 strain.

The preliminary data also suggested that the vaccine may stimulate antibodies against Omicron BA.4/5, as well as other variants such as Alpha, Beta, Delta and Gamma.

With regards to reactions to the vaccine, HSA said that “the adverse events were mostly mild-to-moderate” and will “usually resolve on their own within a few days”. Such effects include injection site pain and/or tenderness, fatigue, headache and muscle pain.

“Updated COVID-19 vaccines such as bivalent vaccines are expected to offer broader immunity against circulating variants, while retaining critical protection against severe disease and death.

“HSA, as the authority protecting and advancing public health and safety, will continue to conduct rigorous and efficient assessments to facilitate the Singapore population’s access to critical vaccines and medicines,” shared Chief Executive Officer of HSA, Dr Choong May Ling, Mimi.

Official vaccination recommendations using this booster vaccine will be issued by the Expert Committee on COVID-19 Vaccination and the Ministry of Health in due time, said HSA.

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