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Singapore Approves Pfizer’s Bivalent Covid-19 Vaccine For Over-12s
By CodeBlue | 25 October 2022
Singapore’s HSA has granted interim authorisation of a booster dose of the Pfizer-BioNTech original/ Omicron BA.4-5-adapted bivalent vaccine for individuals aged 12 years and older.
KUALA LUMPUR, Oct 25 — Singapore’s health regulators have authorised a bivalent formulation of Pfizer-BioNTech’s Covid-19 vaccine – which protects against the original SARS-CoV-2 strain and the Omicron variant – as a booster for individuals aged 12 years and older.
The Health Sciences Authority (HSA) of Singapore announced today that it granted Pandemic Special Access Route (PSAR) interim authorisation for the Comirnaty Bivalent (Original/Omicron BA.4/5) Covid-19 vaccine by Pfizer on October 11.
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“As the clinical study by Pfizer for Comirnaty bivalent (Original/Omicron BA.4/5) vaccine is still under way, the assessment of the efficacy of the vaccine was based primarily on an earlier Phase 3 clinical study conducted in individuals aged above 55 years with Comirnaty bivalent (Original/Omicron BA.1) vaccine,” HSA said in a statement.
“HSA considers such data as relevant taking into account that these Omicron subvariants are closely related. The study showed that the bivalent vaccine elicited a stronger immune response against the targeted Omicron BA.1 subvariant, while still maintaining an adequate response against the original SARS-CoV-2 strain.
“This indicates that bivalent vaccines provide a broader immunity and better protection against the SARS-CoV-2 virus.”
HSA also cited an ongoing Phase 2/3 study of the bivalent (original/ Omicron BA.4/5) vaccine, where a preliminary analysis in a subset of 80 participants aged 18 years and above showed consistent trends of higher immune responses against the Omicron BA.4/5 subvariant and continued response against the original SARS-CoV-2 strain.
“Additional results are expected as the study progresses and continues to generate more data.”
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