Pfizer first drugmaker to seek COVID-19 vaccine approval in Japan

Japan Times -- Dec 18
Major U.S. drugmaker Pfizer Inc. on Friday filed for a fast-track approval in Japan of its COVID-19 vaccine, marking the first such application made in the nation, with industry sources saying the formal approval could come within months amid the ongoing novel coronavirus pandemic.

The U.K. and the U.S. have already started this month administering the firm's mRNA vaccine, developed jointly with Germany’s BioNTech SE, and this week Singapore became the first Asian country to grant approval for its use.

Friday’s application came about two months after Pfizer started the first two phases of the drug's three-phase clinical trial in Japan, conducted on 160 Japanese age 20 to 85.

In a statement, the Japanese subsidiary of the New York-based firm said it expected to compile data by February and submit its findings to Japanese regulators soon after.

Pfizer says it has already submitted data to the health ministry showing that its vaccine was 95% effective in preventing COVID-19 in broader late-stage trials, which enrolled more than 43,000 participants in the U.S., Germany, Turkey, South Africa, Brazil and Argentina, of which 5% were Asian.

The health ministry in July signed a basic agreement with Pfizer to obtain vaccines for 60 million people, roughly half of all residents, by the end of June next year. The Diet passed a revised Immunization Act earlier this month to make the vaccinations free of charge and allow the government to compensate pharmaceutical companies for any adverse health consequences.

- Japan Times