[Asia Economy Reporter Yuri Choi] Moderna's bivalent COVID-19 vaccine, developed to respond to the Omicron variant, has passed the first hurdle for product approval.
According to the Ministry of Food and Drug Safety (MFDS) on the 2nd, at the COVID-19 vaccine safety and efficacy verification advisory committee (hereafter referred to as the verification advisory committee) meeting held the previous day regarding the clinical trial results of 'Moderna Spikevax 2 weeks,' there was unanimous agreement that both the efficacy and safety of this product were at an acceptable level.
This vaccine is a bivalent vaccine developed to respond to both the original COVID-19 virus and the Omicron variant. Moderna Korea applied for product approval from the MFDS on July 29.
Seven experts, including infectious disease specialists and vaccine and pharmaceutical experts, attended this verification advisory committee meeting, which is the first step for product approval.
The verification advisory committee concluded that the efficacy was proven as superiority was confirmed when comparing the neutralizing antibody immune response after the bivalent vaccine booster with that of the existing vaccine. Safety was also judged to be at a similar level to the existing vaccine.
The MFDS plans to consult experts on the safety and efficacy of the vaccine and make a final decision on approval after promptly and thoroughly reviewing the submitted data and other materials.
So far, for COVID-19 vaccines and treatments, the MFDS has decided on product approval through a 'triple consultation' process involving the verification advisory committee, the Central Pharmaceutical Review Committee, and the final inspection committee.
However, the MFDS plans to simplify some procedures and conduct a rapid approval review for Moderna's bivalent COVID-19 vaccine. This is in consideration of the fact that Moderna's COVID-19 vaccine has already been approved domestically.
An MFDS official said, "Moderna's COVID-19 vaccine has already been approved in Korea," adding, "Unless there are special circumstances, we do not plan to conduct the triple consultation for Moderna's bivalent COVID-19 vaccine."
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