The application is based on global Phase II/III trials that Japan was part of, Pfizer said in a statement.
With COVID-19 cases surging again, Japan is betting heavily on oral treatments to keep serious infections and deaths at bay. Prime Minister Fumio Kishida said last week he aimed to distribute the Pfizer pills next month after securing 2 million doses during a December call with Chief Executive Albert Bourla.
The government has already started distributing molnupiravir antiviral pills after agreeing to pay Merck & Co. Inc. and its partner Ridgeback Biotherapeutics about $1.2 billion for 1.6 million courses. Japan’s Shionogi & Co. Ltd is working on its own pill, with plans to supply 1 million doses this year.
The highly infectious Omicron variant is driving a surge in COVID-19 cases. Japan recorded 18,859 new infections on Thursday, according to a tally by national broadcaster NHK, the most since Sept. 2 during what was the country’s fifth wave of the pandemic.