The Health Sciences Authority (HSA) of Singapore has granted interim authorisation for the use of Spikevax bivalent COVID-19 vaccine by Moderna, which targets both the original Sars-CoV-2 strain, and the Omicron BA.1 variant.
The bivalent COVID-19 vaccine is authorized for use as a booster for people aged 18 years and above who have already received their primary series of COVID-19 vaccination. HSA did not say when the new COVID-19 vaccine will be made available. However, Moderna said it is working with HAS and the government of Singapore to make its bivalent vaccine available to people in the country during September 2022.
The HSA said it had consulted experts from the agency’s Panel of the Infectious Diseases Experts and Medicines Advisory Committee in making the decisions. According to HSA, it has carefully reviewed the data from pre-clinical studies, clinical trials in human volunteers, quality controls, and manufacturing of Moderna.
It assessed that the benefits outweighed the risks for use of the bivalent COVID-19 vaccine as a booster to protect against the disease as the virus continues to evolve. HSA said its clinical review was mainly based on an ongoing trial by Moderna on the individuals aged 18 year and above, which showed the new vaccine developed a strong immune response against the Omicron BA.1 variant, with maintaining its response against the original COVID-19 strain.