The MFDS begins preliminary screening for COVID-19 vaccine

Review 90 days before the expected date of application for permission

The fastest commercialization speed among domestic and foreign COVID-19 vaccines

It is scheduled to apply for permission as early as next year

It was revealed that the domestic health authorities have begun a preliminary review of the COVID-19 vaccine that AstraZeneca is developing.

 

It is explained that applications for domestic approval are expected after three months as soon as possible.

 

Among vaccines currently being developed at home and abroad, it is the fastest for domestic product approval.

 

The MFDS announced on the 27th that AstraZeneca formed a dedicated approval review team for the COVID-19 vaccine being developed and began preliminary review of non-clinical test data.

 

The COVID-19 vaccine being developed by AstraZeneca is a vaccine jointly developed with The Jenner Institute in the UK, and is currently being evaluated for its rapid commercialization.

 

In Korea, SK Bioscience has signed a contract to consign the vaccine.

 

The MFDS is operating one of ‘Go’ Expedited Programs for rapid approval of COVID-19 treatment and vaccine.

 

For products that are expected to apply for permission, 'permission exclusive review team' was formed 90 days before the scheduled application date.

 

And it has a system to proceed with the preliminary examination.

 

Accordingly, the data will be reviewed in advance under the assumption that the AstraZeneca-developed COVID-19 vaccine is applied for approval after 3 months.

 

It plans to review not only non-clinical data but also clinical data in progress overseas.

 

An official from the MFDS said, "AstraZeneca has the only COVID-19 vaccine that is undergoing pre-examination by the approval team." And he added that it plans to review the data before applying for permission.

 

Meanwhile, in Korea, 'INO-4800' of the International Vaccine Institute and 'GX-19' of Genexine are currently in phase I/IIa as a vaccine for COVID-19.

 

The MFDS said that it will continue to monitor development trends, such as clinical trials of COVID-19 treatments and vaccines, and provide support for items such as product approvals, special manufacturing, and imports necessary for domestic introduction.

 

In addition, the MFDS said it will do its best to ensure that the Korean people receive treatment opportunities.