Japan Grants Special Approval to Comirnaty Vaccine

Fujiwara Yasuhiro, M.D., Ph.D., the Chief Executive Pharmaceuticals and Medical Devices Agency, announced on February 14, 2021, the first COVID-19 vaccine applied by Pfizer Japan Inc. was granted Special Approval for Emergency in Japan.

Pfizer Japan Inc. submitted the Comirnaty COVID-19 vaccine application on December 18, 2020.

With this Special Approval for Emergency, Japanese citizens can now start Comirnaty COVID-19 vaccination with prioritization to protect themselves against SARS-CoV-2. Special Approval for Emergency is the process under article 14-3 of the Pharmaceuticals and Medical Devices Act to approve a medical product swiftly in an emergency situation to protect public health.

The Agency confirmed 'intensive post-approval activities are planned to be carried out. For example, all vaccination cases to 10,000-20,000 healthcare workers, who are prioritized to receive vaccination first, will be followed up for symptoms and illnesses for about 1 month after vaccination. Also, a post-vaccination health status survey will be conducted in a questionnaire form in general vaccine recipients with prior informed consent. Results of these activities and other routine post-approval measures will be released publicly once available.'