The COVID-19 Pandemic in Japan: Treatments, Vaccines & Remote Study Audits

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Writing in the August edition of DIA’s Global Forum, Kotone Matsuyama of the Nippon Medical School gives a run-through of Japan’s response to the COVID-19 pandemic, from the organisation and communication of the country’s public health apparatus to the rollout of treatments and vaccines and the growing use of remote auditing tools in clinical studies.
Patients with COVID-19 in Japan were first identified in February 2020. This was only the first wave. A state of emergency was issued, and a lockdown of major cities was implemented from April 7 to May 25. Gradually, the second wave was confirmed in the summer of 2020. The third wave occurred around October 2020, and the state of emergency was reissued on January 7, 2021.

These important developments and consequent actions taken in response were overviewed by IFAPP, IFAPP Academy, and JAPhMed in the webinar COVID-19 Pandemic in Japan: Facts and Expectations sponsored by DIA Japan and reviewed below.

 

Organization and Communications

During the pandemic, Japan’s distinguishing characteristic has been that public health centers coordinate hospitalization and accommodate treatment for COVID-19 patients. The Prefecture is the organizational level above the public health center and stores this patient and treatment information in the central government’s database. Initially, the government issued outbreak notifications through the press based on the Infectious Diseases Control Law, but sometimes failed to collect and disseminate the most accurate data. Now, hospital and other health center professionals in Japan can confirm the outbreak situation immediately and manage the medical care provision system through these stored data by accessing the government website.In terms of morbidity, Japan is similar to South Korea and Indonesia in death cases per one million population, at a rate only 5% that of the US.

 

COVID-19 Treatments and Vaccines in Japan

From a regulatory point of view, “Tokurei approval” provides special emergency approval for a product. This Tokurei approval system allows the Ministry of Health, Labour and Welfare to approve a drug with Pharmaceutical Affairs and Food Sanitation Council consultation without formal review. Tokurei approval is applied in a situation requiring urgent use of the drug to control the prevalence of a disease which can be life-threatening or seriously damaging to health. Thus far, this Tokurei approval system has been applied to two vaccines for novel influenza (H1N1) in January 2010, to remdesivir in May 2020, and to the Comirnaty vaccine in February 2021. Two more vaccines were also approved in May 2021 using the Tokurei system.According to the Guidance for Medical Practice for COVID-19 (Ver 4.1), Japan has two recommended treatments for COVID-19: remdesivir (RNA synthetic enzyme inhibitor) and dexamethasone (steroidal anti-inflammatory drug, SAD). As of February 2021, Japan has 14 medical devices and 43 in vitro tests for COVID-19 diagnosis and treatment. The Chief Executive of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has issued nine statements titled PMDA’s Efforts to Combat COVID-19 during the pandemic.

“Zero-based thinking,” or “thinking outside the box,” was deemed to be another key success factor in the rapid development of COVID-19 treatments and vaccines. It is important to have a high tolerance for uncertainty when tackling unprecedented challenges. For example, the relevant parties should collaborate to generate new social-beneficial innovative values across and beyond the boundaries established between academia, industry, and health authorities. In our current, highly uncertain circumstances, attitudes toward uncertainty are critical. Perceptions of acceptable and unacceptable risk have been changed by these unprecedented challenges, which may open the door for a “new normal,” both in Japan and globally, in the future.

 

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