Japan has granted fast-track approval to U.S. drug maker Pfizer Inc.’s COVID-19 pill, the heath minister said Thursday, as the country struggles to slow fast-spreading omicron infections.
The approval came less than a month after Pfizer applied in mid-January, an exceptional speed in a country where foreign drug approvals usually take much longer.
Health Minister Shigeyuki Goto said the availability of Pfizer's Paxlovid pill gives high-risk patients, including elderly people and those with underlying health issues, greater treatment options.
The approval comes as surging cases among elderly patients are starting to overwhelm hospitals in Tokyo and other metropolitan areas, and delayed booster vaccinations have reached only about 8% of the population.
Most of Japan's 47 prefectures are currently under a mild version of a state of emergency. On Friday, Prime Minister Fumio Kishida announced plans to extend current restrictions in Tokyo and 12 other areas for three more weeks until March 6.
Japan is counting on oral treatments to help reduce serious cases and deaths, and Kishida said the government has secured 2 million doses of the Pfizer pills. Goto said distribution of the Pfizer pills will begin Monday.
Kishida is facing growing criticism over the slow rollout of booster vaccines. He recently set a target of 1 million doses by the end of February, but experts say it may be too late.
The Pfizer pill, a combination of the antiviral drugs nirmatrelvir and ritonavir, is the second COVID-19 oral treatment Japan has approved, after Merck & Co.'s antiviral pill molnupiravir.
Japan’s Shionogi & Co. is also in the final stage of clinical testing of its own pill. The company plans to supply 1 million doses this year.
