MFDS announces EUA application of new COVID-19 vaccine

In line with KDCA’s plans to start inoculation with Pfizer, Moderna, and Novavax’s vaccines in October

Vaccines including Novavax are expected to be granted emergency use authorization in line with the vaccination schedule

An emergency use authorization process is in progress for new COVID-19 vaccines so that the disease control authorities can inoculate using the vaccines in October.

 

On the 6th, the Ministry of Food and Drug Safety announced an application for emergency use approval of the ‘JN.1 variant-response recombinant protein vaccine for the prevention of COVID-19 caused by SARS-CoV-2 virus’.

 

The EUA system allows vaccines requested by the Commissioner of the Korea Disease Control and Prevention Agency to be manufactured and sold for a limited time if there is no approved product in Korea.

 

With the frequent reemergence of infectious diseases that threaten mankind, such as the swine flu and COVID-19, the U.S.

 

Food and Drug Administration (FDA) established the Emergency Use Authorization (EUA) system to exempt the authorization process of medical devices that are in urgent need due to infectious disease pandemics.

 

In Korea, the EUA was first introduced in 2016 for MERS, and during the COVID-19 outbreak, many vaccines and treatments were actively approved using the EUA system.

 

The EUA application notification this time is for 320,000 doses of a new COVID-19 vaccine, which is believed to be Novavax's JN.1 COVID-19 vaccine, which the KDCA signed an agreement for in July.

 

The KCDA said it has secured 5.23 million doses of Pfizer’s vaccine, 2 million doses of Moderna, and 320,000 doses of Novavax’s vaccine, as new COVID-19 vaccines to be used in the 2024-2025 season starting in October.

 

Two of the vaccines that the KDCA procured the most – Pfizer's Comirnaty JN.1 COVID-19 Inj (bretovameran) (Sars-coronavirus-2 mRNA vaccine) and Comirnaty JN.1 Inj (single-dose vial) - have already been granted marketing authorization in Korea.

 

Pfizer had first applied for marketing authorization of ‘Comirnaty Bivalent Inj,’ which is used for the existing pandemic variant, to expedite the approval of the new vaccine, by leaving a GMP review history in place.

 

To receive formal approval for their COVID-19 vaccines, the companies need to submit data on non-clinical trials, clinical trials, quality and risk management plans, and manufacturing and quality control for marketing authorization and review.

 

On the other hand, for EUA, the following requirements need to be satisfied: ▲ the applicant needs to be a drug manufacturer or importer; ▲ demonstrate that the drug is effective against the JN.1 variant of COVID-19 caused by the SARS-CoV2 virus; ▲ demonstrate that the safety and quality of the drug is ensured; ▲ and, in the case of imported products, the products need to have received measures equivalent to approval in a foreign country that conducts drug safety control at a level equal to or higher than that of Korea.

 

During the last COVID-19 outbreak, the EUA system was used to shorten the document preparation period from 30 days to 7 days, the protocol approval and clinical trial period from 90 days to 22 days, and the final review and approval period from 80 days to 30 days.