Pfizer Korea submitted an application to the Ministry of Food and Drug Safety (MFDS) for authorization for a Covid-19 vaccine booster that fights the Omicron variant.
On Monday, the MFDS said it started reviewing Pfizer Korea’s application for an import of Comirnaty 2 Inj. 0.1 mg/mL.
Comirnaty 2 Inj. is an mRNA vaccine designed to protect against the initial SARS-CoV-2 virus and the Omicron variant BA.1.
The vaccine booster aims to prevent Covid-19 infection in people aged 12 or more.
The MFDS said Comirnaty 2 was going through an accelerated review process.
On Aug. 5, Pfizer applied for a preliminary review of clinical data of Comirnaty 2, and the government is reviewing it.
With Pfizer’s application for marketing approval for the vaccine booster, the MFDS will review clinical, non-clinical, quality, and GMP data and seek advice from experts on the safety and efficacy of the vaccine.
Among locally available Covid-19 vaccines, no vaccine has been approved to fight the Omicron variant.
If Comirnaty 2 Inj. gets marketing approval, it will become the first bivalent Covid-19 vaccine.
SK Bioscience’s Covid-19 vaccine SKYCovione Multi Inj., which won the permit in June, is indicated for protection against the initial Covid-19 virus only.
SK Bioscience said it confirmed a booster’s high immune response against Omicron in a phase 1/2 extended trial and conducted a global study for booster vaccination.
Among Korean vaccine developers, Cellid received approval to conduct a phase 1/2 trial of AdCLD-CoV19-1 OMI, an investigational Omicron vaccine.