September 15, 2022
SINGAPORE – The Health Sciences Authority (HSA) on Wednesday granted interim authorisation for the use of Moderna’s Spikevax bivalent Covid-19 vaccine, which targets both the original Sars-CoV-2 strain and the Omicron BA.1 variant.
The bivalent vaccine has been authorised for use as a booster for people aged 18 and above who have already received their primary series vaccination.
HSA did not say when the new vaccine will be made available here.
However, in a media release, Moderna said it is working with HSA and the Government to make its bivalent vaccine “available to people in Singapore during September”.
Official recommendations for this booster vaccine will be issued by the Expert Committee on Covid-19 Vaccination and the Ministry of Health in due time, HSA said.
The authority said it had consulted experts from its Medicines Advisory Committee and Panel of Infectious Diseases Experts in making its decision.
“HSA 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,” it said.
HSA said its clinical review was based on an ongoing trial by Moderna on individuals aged 18 and above, which showed that the new vaccine produced a strong immune response against the Omicron BA.1 variant while also maintaining its response against the original strain.
Preliminary data also suggests that the vaccine could stimulate antibodies against the Omicron BA.4 and BA.5 variants, as well as others such as the Delta and Gamma variants, it added.
The safety of the new bivalent vaccine is comparable to that of Moderna’s original Covid-19 vaccine, with mostly mild-to-moderate side effects such as pain at the injection site, as well as fatigue and muscle pain.
These reactions are expected as part of the body’s natural response to build immunity against Covid-19 and usually resolve on their own within a few days, HSA said.
It said it 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.
It will take necessary actions and provide updates to the public if significant safety concerns are identified.
HSA chief executive Choong May Ling said: “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.”
Infectious diseases expert Leong Hoe Nam said the new vaccine is a welcome addition to the Republic’s fight against Covid-19.
Relying on older vaccines when new variants of the coronavirus have emerged is “akin to using old weapons against an evolved enemy”, he added.
“Everyone should be updated in their vaccines, especially those not boosted,” said Dr Leong.
On Tuesday, Health Minister Ong Ye Kung said his ministry will bring in bivalent vaccines from Pfizer-BioNTech, as well as Moderna, under agreements with the respective pharmaceutical firms.