TOKYO -- Japan's health ministry on Thursday approved Pfizer's COVID-19 pill Paxlovid for patients with mild to moderate symptoms, making it the second such oral medication to receive the fast-track treatment.
The government has already set aside doses of Paxlovid for 40,000 people, and delivery of the pills to health care facilities will start on Monday.
Along with vaccines, the government sees the pills as crucial to keeping COVID-19 at manageable levels. Pfizer is due to supply the government with 2 million courses of the treatment this year.
"Patients who are elderly or have underlying conditions will have another treatment option, contributing to our response" to COVID-19, Health Minister Shigeyuki Goto told reporters Thursday.
The Ministry of Health, Labor and Welfare first received Pfizer's application for approval on Jan. 14. Paxlovid underwent fast-track consideration since it had already been authorized for emergency use in the U.S. and the European Union's drug regulator had recommended the pill for approval.
A government expert panel approved Merck's antiviral pill molnupiravir for treating COVID in December.
Paxlovid will be given to patients at risk of suffering serious COVID symptoms. The pill is recommended to be taken within five days of the onset of symptoms.
The five-day treatment course stipulates two doses a day at three pills per dose. Paxlovid should not be taken together with about 40 types of drugs, including those treating high blood pressure and high cholesterol.
For this reason the government will proceed with caution in distributing Paxlovid. Prescriptions for the pill will initially be filled almost exclusively at in-house dispensaries within the approximately 2,000 hospitals in Japan designated for coronavirus patients. Starting Feb. 28, the drug will be available at conventional pharmacies.
Clinical studies show that Paxlovid reduces the risk of hospitalization and death by 88% when taken within five days of the onset of symptoms. Pfizer has said the pill is effective in inhibiting the replication of the omicron variant in vitro.
Although a direct comparison cannot be made, molnupiravir has been shown to cut the risk of hospitalization and death by 30%. Paxlovid is expected to exhibit a higher degree of efficacy.
The arrival of the COVID pill has ushered in a new phase in the global scramble for medical resources. The U.S. has a deal with Pfizer to supply Paxlovid for 20 million people. The first 10 million courses will be procured by July, with the rest due by September.
The British government sealed a contract with Pfizer for 2.75 million courses. Japan will receive a supply of molnupiravir for 1.6 million people.
Yet there are concerns that supplies will remain tight in the short term. Pfizer plans to make enough Paxlovid for 120 million people by the end of the year. But the expected output for the first half will be only 30 million courses due to the length of time it takes to synthesize the active substance.
"That means that in the beginning, we will have, in the first quarter, more constraints in terms of availability," Pfizer Chairman and CEO Albert Bourla said in January. The remaining 90 million courses would be delivered in the latter half of the year, he added.
Neither Pfizer nor the government has disclosed any specific details on Japan's supply schedule.
At this stage, it remains uncertain whether the COVID pills would suffice to serve the growing number of COVID-19 patients who need them. Because of the omicron wave, the cumulative number of cases in Japan stands at approximately 3.6 million people -- twice the total number recorded at the end of December.
Over the span of the week ending Feb. 1, about 60,000 seniors aged 60 and over became infected. This age group is at high risk of developing serious complications from the disease.
Paxlovid is in high demand due to its reported efficacy rates. Newly feasible treatment options will be necessary to maintain a stable amount of supplies.
Meanwhile, Japanese drugmaker Shionogi & Co. is moving forward with late-stage clinical trials for its own COVID pill, known as S-217622. The company could apply for conditional early approval from the health ministry this month.
"We'll scale up production for 400,000 to 500,000 courses by the end of February," Shionogi President Isao Teshirogi said.
Shionogi plans to make 1 million courses by the end of March. From April, the company will put infrastructure in place to produce more than 10 million courses in a year.