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SINGAPORE, September 14: The Health Sciences Authority (HSA) today granted provisional approval for Moderna’s updated vaccine, which can target both the original Sars-CoV-2 coronavirus and the Omicron BA. 1 strain.
The U. S. pharmaceutical company’s Spikevax Bivalent Original/Omicron Covid-19 vaccine has been legal for use as a booster vaccine in others over the age of 18, the HSA said in a statement.
These other people must have already won their first round of COVID-19 vaccines.
In a separate statement, Moderna said it is working with HSA and the Singapore government to make the vaccine available to Singaporeans this month.
Moderna’s bivalent recall is a single dose comprising two parts of 25 micrograms each, one from the original Sars-CoV-2 virus and the other from the Omicron BA. 1 variant.
Its provisional approval was granted as a component of the Special Pandemic Access Route, which facilitates immediate access to new vaccines and medicines critical to a pandemic.
This is the first bivalent Covid-19 vaccine that has been in Singapore.
“Official vaccination recommendations for this booster vaccine will be issued through the Expert Committee on Covid-19 Vaccination and the Ministry of Health in due course,” HSA said.
He added that the benefits of the bivalent vaccine as a booster outweigh the risks. This was after a careful review of knowledge from Moderna’s preclinical studies, clinical trials in human volunteers, manufacturing and quality controls.
In making its decision, HSA also consulted with experts from its Drug Advisory Committee and Infectious Disease Expert Group, he said.
May be effective against other variants The clinical review of SAH was based on an ongoing trial at the time and third phase conducted by Moderna in other people over the age of 18.
The effects showed that the bivalent booster vaccine elicited a strong immune reaction opposite to the Omicron BA. 1 variant, while retaining the immune reaction opposite to the original Sars-CoV-2 virus.
Preliminary data from an exploratory study also suggested that the vaccine could increase antibodies opposed to Omicron BA. 4 or 5, as well as other variants such as Alpha, Beta, Delta and Gamma, HSA said.
Safety knowledge from clinical studies showed that the bivalent “is generally well tolerated” and that its protection profile is consistent with what is known from the original Spikevax vaccine, HSA added.
Adverse occasions were most commonly “mild to moderate,” HSA said. They refer to all the side effects that occur after receiving the vaccine, adding pain at the injection site, tenderness, fatigue, headaches, and muscle pain. HSA said those are expected reactions that die on their own within a few days.
He added that he will continue to monitor the protection of the vaccine and will require Moderna to present knowledge of the ongoing clinical trial. “HSA will take action and provide updates to the public if significant security issues are identified,” he said.