MFDS Grants Emergency Use Authorization for Pfizer Bivalent Vaccine Targeting BA.4 and BA.5

[Image source=Yonhap News]

[Asia Economy Reporter Kim Young-won] Pfizer's vaccine targeting the BA.5 variant, which has become the dominant strain worldwide, has received emergency use authorization in South Korea.

On the 17th, the Ministry of Food and Drug Safety (MFDS) announced that it had granted emergency use authorization for Korea Pfizer's COVID-19 BA.4 and BA.5 targeted vaccine 'Comirnaty 2-dose 0.1 mg/mL (Tozinameran·Pfizer Tozinameran)' upon request from the Korea Disease Control and Prevention Agency. While Moderna and Pfizer vaccines targeting the Omicron BA.1 variant were approved domestically starting last month, this is the first approval for a vaccine targeting the BA.5 subvariant.

The vaccine authorized for emergency use is a bivalent vaccine that expresses antigens from both the original Wuhan strain and the BA.4·BA.5 variant viruses, with messenger RNA (mRNA) as the main component. Its efficacy and usage are for the prevention of COVID-19 in individuals aged 12 and older, intended for primary vaccination or additional doses at least three months after the previous dose.

Emergency use authorization is a system that allows the MFDS Commissioner to permit manufacturers or importers to produce or import medical products not yet approved domestically, upon request from the head of relevant central administrative agencies, to respond to public health crises such as infectious disease pandemics. Products previously authorized for emergency use in South Korea include COVID-19 treatments Paxlovid, Lagevrio, and Veklury (Remdesivir).

According to the MFDS, during the Central Pharmaceutical Affairs Deliberation Committee meeting on the 5th of this month, 'Comirnaty 2-dose 0.1 mg/mL (Tozinameran·Pfizer Tozinameran)' was reviewed considering that it shares the same mRNA platform, dosage, manufacturing method, and manufacturer as the previously approved Pfizer COVID-19 vaccines. The committee examined the immune response, safety, and post-market stability both domestically and internationally, concluding that the vaccine's efficacy and safety are acceptable.

Following the advisory from the Central Pharmaceutical Affairs Committee, the MFDS held the 'Public Health Crisis Response Medical Product Safety Management and Supply Committee,' composed of government and private sector members, to decide on the emergency use authorization. The committee reviewed and deliberated on ▲whether legal requirements were met ▲the advisory results from the Central Pharmaceutical Affairs Committee ▲the urgent need for rapid introduction for winter vaccinations, concluding that emergency use authorization was appropriate.

This vaccine has also received emergency use authorization or approval overseas. In the United States, it was authorized for emergency use on August 31, in Europe it received conditional marketing authorization on the 12th of last month, and Israel granted full approval on the 8th of last month.

An MFDS official stated, "We will thoroughly manage the quality of vaccines authorized for emergency use and strengthen additional measures to ensure safe use, including collecting information on side effects during administration."

This content was produced with the assistance of AI translation services.