SINGAPORE: The Health Sciences Authority (HSA) on Wednesday (Sep 14) granted interim authorisation for the first bivalent COVID-19 booster vaccine in the country.
The Spikevax Bivalent Original/Omicron COVID-19 jab by Moderna comprises two components that target the original SARS-CoV-2 strain and the Omicron BA.1 variant respectively.
It is an updated version of the Moderna COVID-19 vaccine that is based only on the original SARS-CoV-2 strain, said HSA in a news release.
It is authorised for use as a booster in individuals aged 18 years and above, who have received primary series COVID-19 vaccination.
The interim authorisation was granted under Singapore’s Pandemic Special Access Route (PSAR).
Health Minister Ong Ye Kung told Parliament on Tuesday that MOH is bringing Pfizer-BioNTech and Moderna’s new bivalent vaccines into the country, under agreements with the pharmaceutical companies.
The bivalent vaccines target both the ancestral strain of COVID-19 and the Omicron variant, which includes the BA.4 and BA.5 strains.
The Moderna booster shot is a single dose comprising two components: 25 micrograms targeting the original SARS-CoV-2 strain and 25 micrograms targeting the Omicron BA.1 variant.
Official vaccination recommendations using this booster will be issued by the Expert Committee on COVID-19 Vaccination and the Ministry of Health (MOH) in due time, added HSA.
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.
In making this regulatory decision, HSA added that it also consulted experts from its Medicines Advisory Committee and Panel of Infectious Diseases Experts.
The authority said its clinical review was based on an ongoing Phase 2/3 trial conducted by Moderna in individuals aged 18 years and above.
The results showed 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 from an exploratory analysis 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,” it added.
“Hence, it could be reasonably expected 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 that the bivalent vaccine was generally well-tolerated and 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 site pain and/or tenderness, fatigue, headache and muscle pain.
“These reactions are generally associated with vaccinations and expected as part of the body’s natural response to build immunity against COVID-19. They usually resolve on their own within a few days,” said HSA.
HSA will continue to actively monitor the safety of the vaccine and require Moderna to submit data from the ongoing clinical study, to ensure that the benefits of the vaccine continue to outweigh the risks when used during the COVID-19 pandemic.
The authority added that it will take the necessary actions and provide updates to the public if significant safety concerns are identified.
Dr Mimi Choong May Ling, chief executive officer of HSA, said the COVID-19 pandemic has “evolved significantly” with recent surges around the world due to the rapid spread of highly transmissible variants such as Omicron.
“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.”
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