Singapore grants interim authorisation for first bivalent COVID-19 booster vaccine

Singapore grants interim authorisation for first bivalent COVID-19 booster vaccine

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

The Spikevax Bivalent Original/Omicron COVID-19 vaccine by Moderna comprises two elements that target the initial SARS-CoV-2 strain and the Omicron BA. one variant respectively.

It is an updated version of the Noua COVID-19 vaccine that is based only at the original SARS-CoV-2 stress, said HSA in the news release.  

It is authorised for use as a booster shot in individuals from the ages of 18 years and above, who have received primary series vaccination with COVID-19 vaccines.  

The interim authorisation had been granted under Singapore’s Pandemic Special Gain access to Route (PSAR).


The booster shot is a single dosage comprising two components: 25 micrograms concentrating on the original SARS-CoV-2 strain and 25 micrograms targeting the Omicron BA. 1 version.

Official vaccination recommendations using this enhancer vaccine will be released by the Expert Panel on COVID-19 Vaccination and the Ministry associated with Health (MOH) in due time, additional HSA.  

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

In making this particular regulatory decision, HSA added that it also consulted experts from the Medicines Advisory Committee and Panel associated with Infectious Diseases Specialists.

The power said its scientific review was based on an ongoing Phase 2/3 trial conducted by Moderna in people aged 18 yrs and above.

The results showed that this bivalent booster shot elicited a strong immune response against the Omicron BA. 1 variant, while preserving the immune response contrary to the original SARS-CoV-2 strain.

“The first data from a good exploratory analysis furthermore suggested that the shot may stimulate antibodies against Omicron PURSE. 4/5, as well as other variants such as Alpha, Beta, Delta, and Gamma, ” it additional.  

“Hence, it could be reasonably anticipated that the bivalent booster vaccine can enhance the immunity against the Omicron variants, while maintaining the base protection conferred by the original vaccine. ”

Safety data from the clinical studies showed the fact that bivalent vaccine had been generally well-tolerated as well as the safety profile was consistent with what is known for the original Spikevax vaccine.  

“The adverse events were mostly mild-to-moderate, such as injection web site pain and/or tenderness, fatigue, headache plus muscle pain.  

“These reactions are generally associated with vaccines and expected included in the body’s natural reaction to build immunity towards COVID-19. They usually resolve on their own within a few days, ” said HSA.  

HSA will continue to positively monitor the basic safety of the vaccine plus require Moderna to submit data through the ongoing clinical study, to ensure that the benefits of the vaccine continue to outweigh the risks when used during the COVID-19 outbreak.  

The particular authority added it will take the necessary actions and provide updates towards the public if significant safety concerns are usually identified.