HSA grants interim approval for Moderna’s bivalent Covid-19 vaccine that targets Omicron variant

SINGAPORE — The Health Sciences Authority (HSA) on Wednesday (Sept 14) granted interim authorisation for Moderna's updated vaccine, which can target both the original Sars-CoV-2 coronavirus as well as the Omicron BA.1 strain.

The Spikevax Bivalent Original/Omicron Covid-19 vaccine by the American pharmaceutical firm has been authorised for use as a booster vaccine in individuals aged 18 and older, HSA said in a statement.

These individuals must have already received their primary series of Covid-19 vaccinations.

In a separate statement, Moderna said that it is working with the HSA and the Singapore Government to make the vaccine available to people in Singapore this month.

The Moderna bivalent booster shot is a single dose comprising two components of 25 micrograms each, one targeting the original Sars-CoV-2 virus and another targeting the Omicron BA.1 variant.

Its interim approval was granted under the Pandemic Special Access Route, which facilitates early access to critical novel vaccines and medicine during a pandemic.

This is the first bivalent Covid-19 vaccine that has been approved in Singapore.

“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,” HSA said.

It added that the benefits of using the bivalent vaccine as a booster outweigh the risks. This was after a careful review of data from Moderna’s pre-clinical studies, clinical trials in human volunteers, manufacturing and quality controls.

In coming to its decision, HSA had also consulted experts from its medicines advisory committee and panel of infectious diseases experts, it said.

MAY BE EFFECTIVE AGAINST OTHER VARIANTS

HSA’s clinical review was based on an ongoing trial in its second and third phase conducted by Moderna in individuals aged 18 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 virus.

Preliminary data from an exploratory analysis also suggested that the vaccine may stimulate antibodies against Omicron BA.4 or 5, as well as other variants such as Alpha, Beta, Delta, and Gamma, HSA said.

Safety data from the clinical studies showed that the bivalent was “generally well-tolerated” and its safety profile consistent with what is known for the original original Spikevax vaccine, HSA added.

Adverse events were mostly “mild-to-moderate”, HSA said. These refer to any side effects that occur after taking the vaccine, including injection site pain, tenderness, fatigue, headache and muscle pain. HSA said that these are expected reactions that usually resolve on their own within a few days.

It added that it will continue to monitor the safety of the vaccine and will require Moderna to submit data from the ongoing clinical study. 

“HSA will take the necessary actions and provide updates to the public if significant safety concerns are identified,” it said.