MFDS: "Overseas Developed Vaccines Subject to Expedited Procedures Upon Domestic Introduction" (Update)

AstraZeneca COVID-19 Vaccine, Preliminary Data Review Begins

AstraZeneca's COVID-19 vaccine produced for clinical trials

[Asia Economy Reporter Choi Dae-yeol] The government has decided to apply procedures that can shorten the review period when introducing novel coronavirus disease (COVID-19) vaccines developed overseas into the country in the future.

The Ministry of Food and Drug Safety (MFDS) announced on the 27th that it has formed a dedicated approval team to conduct a preliminary review of non-clinical trial data related to the vaccine being developed by the global pharmaceutical company AstraZeneca. The MFDS is operating the 'Go Rapid Program' to encourage the development of COVID-19 treatments and vaccines and to shorten the approval review period, and it has decided to apply this program to the COVID-19 vaccine being developed by the company.

This program is a system that forms a dedicated approval team and conducts a preliminary review 90 days before the expected application date for products anticipated to apply for approval. Yang Jin-young, deputy director of the MFDS, explained at a briefing that "if the approval application is made after completing all procedures such as clinical trials, there is a possibility that the review may be delayed," and added, "If the MFDS reviews in advance, it can grant approval more quickly later on."

While some countries such as China and Russia are administering COVID-19 vaccines without completing clinical trials, Western countries are still in the final stages of clinical trials. Companies like AstraZeneca, as well as Moderna and Pfizer from the United States, are progressing rapidly. In the case of AstraZeneca, it has signed a consignment contract with SK Bioscience, a domestic vaccine manufacturer, and the Korean government in case of successful future development. This means there is a possibility of supplying a certain portion domestically.

According to the MFDS, as of today, there are a total of 26 clinical trials approved domestically, including 24 for treatments and 2 for vaccines. Seven trials, including the antiviral treatment remdesivir, which received formal approval, have been completed, and 19 trials are currently ongoing. Treatments under development include antiviral drugs, neutralizing antibody treatments, plasma fractionation treatments, and immunomodulators, with some pharmaceutical companies such as Bukwang Pharmaceutical recruiting patients and starting trials. Among domestically developed vaccines, Genexine is recruiting patients and conducting clinical trials. The MFDS has revised the considerations released to expedite COVID-19 vaccine clinical trials by adding data requirements and design methods for phase 3 clinical trials, post-marketing considerations, and overseas COVID-19 vaccine guidelines.