SINGAPORE: An updated COVID-19 vaccine by Moderna targeting newer Omicron subvariants was approved by the Health Sciences Authority (HSA) on Friday (Oct 13).
The updated Spikevax vaccine can be given to anyone aged 6 months and avove.
This is the second updated COVID-19 vaccine to be authorised by HSA after Pfizer-BioNTech's updated Comirnaty vaccine was approved on Sep 12.
Health Minister Ong Ye Kung said last week that Singapore is experiencing a new COVID-19 wave, with more people expected to fall sick and be hospitalised in the coming weeks.
According to the latest Ministry of Health (MOH) data, there were 16,250 COVID-19 cases in the week starting Oct 1. This was higher than the 15,336 cases in the week before.
The spate of cases is driven by mostly two variants - the EG.5 and its sub-lineage HK.3 - both of which are descendants of the XBB Omicron variant, said Mr Ong.
"The updated Spikevax vaccine works in the same way as the original vaccine," said HSA on Friday.
In line with international recommendations, the updated vaccine comprises a single component that corresponds to the Omicron XBB.1.5 variant.
This means the vaccine continues to protect against current Omicron subvariants.
"There are no other changes to the quality, safety, and efficacy of the vaccine and the updated vaccine is expected to retain the favourable benefit-risk balance of the original Spikevax monovalent vaccine," said HSA.
In reviewing the updated vaccine, the authority considered the "extensive data" from previous versions of the Spikevax vaccine, as well as additional data.
This additional data demonstrated that the updated vaccine could "enhance the immune responses against the predominant circulating Omicron subvariants", including XBB.1.5, EG.5 - or Eris - and the emerging BA.2.86.
"Based on the totality of evidence, and with the support of the Medicines Advisory Committee and the Panel of Infectious Diseases Experts, HSA has assessed that the overall evidence supported authorisation of the updated Spikevax vaccine."
Regular updating of approved COVID-19 vaccines will be necessary as the virus continues to evolve and new variants emerge.
Such changes include replacement of strain, antigen or coding sequence, in accordance with international recommendations.
"This approach has been established for seasonal influenza vaccines which are updated every six months," said the authority.
It added that it will actively monitor and review the effectiveness and safety data of the vaccine.
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The updated Spikevax vaccine can be given to anyone aged 6 months and avove.
This is the second updated COVID-19 vaccine to be authorised by HSA after Pfizer-BioNTech's updated Comirnaty vaccine was approved on Sep 12.
Health Minister Ong Ye Kung said last week that Singapore is experiencing a new COVID-19 wave, with more people expected to fall sick and be hospitalised in the coming weeks.
According to the latest Ministry of Health (MOH) data, there were 16,250 COVID-19 cases in the week starting Oct 1. This was higher than the 15,336 cases in the week before.
The spate of cases is driven by mostly two variants - the EG.5 and its sub-lineage HK.3 - both of which are descendants of the XBB Omicron variant, said Mr Ong.
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"The updated Spikevax vaccine works in the same way as the original vaccine," said HSA on Friday.
In line with international recommendations, the updated vaccine comprises a single component that corresponds to the Omicron XBB.1.5 variant.
This means the vaccine continues to protect against current Omicron subvariants.
"There are no other changes to the quality, safety, and efficacy of the vaccine and the updated vaccine is expected to retain the favourable benefit-risk balance of the original Spikevax monovalent vaccine," said HSA.
In reviewing the updated vaccine, the authority considered the "extensive data" from previous versions of the Spikevax vaccine, as well as additional data.
This additional data demonstrated that the updated vaccine could "enhance the immune responses against the predominant circulating Omicron subvariants", including XBB.1.5, EG.5 - or Eris - and the emerging BA.2.86.
"Based on the totality of evidence, and with the support of the Medicines Advisory Committee and the Panel of Infectious Diseases Experts, HSA has assessed that the overall evidence supported authorisation of the updated Spikevax vaccine."
Regular updating of approved COVID-19 vaccines will be necessary as the virus continues to evolve and new variants emerge.
Such changes include replacement of strain, antigen or coding sequence, in accordance with international recommendations.
"This approach has been established for seasonal influenza vaccines which are updated every six months," said the authority.
It added that it will actively monitor and review the effectiveness and safety data of the vaccine.
Continue reading...