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 vaccine 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 vaccine in individuals aged 18 years and above, who have received primary series vaccination with COVID-19 vaccines.
The interim authorisation was granted under Singapore’s Pandemic Special Access Route (PSAR).
The 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 vaccine 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.
Continue reading...
The Spikevax Bivalent Original/Omicron COVID-19 vaccine 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 vaccine in individuals aged 18 years and above, who have received primary series vaccination with COVID-19 vaccines.
The interim authorisation was granted under Singapore’s Pandemic Special Access Route (PSAR).
SINGLE DOSE
The 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 vaccine 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.
Continue reading...