WASHINGTON -- President Joe Biden and his administration want Americans and their doctors to know that the country has an ample supply of the covid-19 antiviral treatment Paxlovid and that it no longer needs to be rationed.
Supply of the Pfizer regimen, approved in December, was initially very limited, but it is now far more abundant as covid-19 cases across the country have fallen and as manufacturing has increased. The White House is now moving to raise awareness of the pill and taking steps to make it easier to access.
Paxlovid, when administered within five days of symptoms appearing, has been proved to cause a 90% reduction in hospitalizations and deaths among patients who are most likely to get severe disease. About 350 Americans are now dying each day from the coronavirus, down from more than 2,600 during the height of the omicron wave earlier this year.
A senior administration official said usage of the antiviral regimen has "more than doubled" over the past few weeks, but the government has more supply that can save lives and prevent serious disease if prescribed in a timely fashion.
The U.S. has ordered enough pills for 20 million people, a supply that is estimated to last for several more months. The administration has warned that subsequent deliveries are dependent on Congress approving additional covid-19 response funding.
The administration is planning to highlight the relative abundance of the drug this week, and government officials will be stepping up their outreach to patients and providers.
The Food and Drug Administration authorized Pfizer's drug for patients ages 12 and older who have a positive covid-19 test and early symptoms and who face the highest risk of severe outcomes. They include older people and those with conditions like obesity and heart disease, though the drug is not recommended for patients with severe kidney or liver problems.
The effort includes expanding the availability of the pills by providing a direct-to-pharmacy ordering pathway for the drug. The federal government now relies on states to determine where the supply goes, and about 20,000 locations carry the pill, including 2,000 so-called test-to-treat locations that can provide the treatment immediately after a positive test result.
The administration believes the pharmacy channel, which it used to boost availability of covid-19 vaccines more than a year ago, will similarly make the antiviral pills more available to people.
JAPANESE DRUG
Meanwhile, an oral covid-19 medicine produced by Japan-based Shionogi & Co. for patients with mild symptoms is not expected to be approved soon despite initial expectations that it would be the first domestically developed coronavirus drug on pharmacy shelves.
The company filed an application for fast-track approval in late February, aiming to release the medicine by the end of March.
However, the approval process is ongoing, with some experts saying there is insufficient clinical data to prove the drug's efficacy.
"It's important for domestic companies to develop covid-19 drugs," Health, Labor and Welfare Minister Shigeyuki Goto said Friday. "We want to support the development to realize the early commercialization of such drugs."
Goto announced that the government will provide up to $482 million in additional support to Shionogi.
Shionogi applied to the Health, Labor and Welfare Ministry on Feb. 25 for approval to produce and sell its drug. It had planned to manufacture 1 million doses of the medicine by the end of March, subject to approval. However, the ministry has not set a date for future deliberations.
"We'd been hoping we would be able to further relax restrictions if a drug just like ones to treat seasonal flu was widely available. But it seems it's still going to take a while," a Tokyo government official in charge of infection measures said.
Intermediate clinical trial data that Shionogi released at the time of its application failed to clearly demonstrate the drug's efficacy, which is thought to be the reason for the lack of progress in the review process.
A comparison of participants in the treatment group, who received the drug, and the control group, who received the placebo, confirmed a reduction in the virus load in treatment-group participants but no significant difference regarding the overall improvement of 12 symptoms, including fatigue and fever.
Shionogi partly attributed this to the omicron coronavirus variant, saying that "it was difficult to obtain significant results due to the characteristics of the variant," which often causes no symptoms or only mild symptoms.
The fast-track approval sought by Shionogi allows for drugs to be reviewed based on intermediate clinical trial data. However, the system was originally designed with rare and intractable diseases in mind.
Four requirements must be met under the fast-track approval framework: the treatment involves a critical illness; the efficacy or safety of the drug is significantly superior compared to existing treatments; large-scale clinical trials are difficult to conduct; and a certain level of efficacy and safety has been demonstrated in intermediate trials.
"Current data suggests Shinogi's treatment is not superior to existing drugs, so it might not be possible to apply the [fast-track] approval framework," according to Shunsuke Ono, an associate professor at the University of Tokyo and an expert on medical administration.
The company will also be able to apply for emergency-use approval under a new system through which provisional approval will be granted if the safety of a drug is confirmed in intermediate trials and its efficacy is "presumed."
The system was devised because Japan has lagged Europe and the United States in the development of covid-19 vaccines and medicine.
Tsuguya Fukui, the director of the Tokyo Medical University Ibaraki Medical Center who was involved in the design of the system, said there is no "presumption of efficacy" regarding Shionogi's drug at this stage.
If more clinical data is added and sufficient efficacy is demonstrated, then the ministry is more likely to advance deliberations.
Shionogi is conducting the final stage of clinical trials with a variety of participants ages 12 to 69. It has already administered the drug to more than 1,200 participants and expects to complete its analysis and submit data to the ministry by summer.
AIRLINE OPTIONS
Back in the U.S., airlines say they are offering options, including refunds in some cases, for people worried about flying now that other passengers aren't required to wear face masks.
Many people who will be flying in the next few weeks bought their tickets before a federal judge in Florida on Monday struck down the requirement to wear masks in airports and during flights. That requirement, designed to limit the spread of covid-19, was due to expire anyway on May 3.
United Airlines CEO Scott Kirby said his airline will be flexible with people who have weak immune systems or are concerned about mask-optional flying for any other reason.
"We are working with those customers ... to find another option, give them a credit, or if they just don't ever want to fly again, [the company is] actually willing to give them a refund," Kirby said on NBC.
A United spokesman said customers except those on the lowest-priced "basic economy" fares can delay their travel plans for any reason with no extra fee. He said passengers with special circumstances should call the airline's customer-service number.
American Airlines CEO Robert Isom said Thursday that the airline hasn't fielded many refund requests yet.
"But like we do in all these events, we are taking a look at our policies and ... asking them to get in touch with our reservations office, and we will make sure that we accommodate them in an appropriate fashion," Isom said.
A Delta Air Lines spokesman said customers who wish to cancel a trip should contact the airline. Decisions about how to handle those requests are made on a case-by-case basis, he said.
Southwest, Alaska, JetBlue, Spirit and Frontier did not reply to inquiries.
On Thursday, the Justice Department said it would appeal the Florida judge's ruling striking down the mask mandate, which was put in place by the Centers for Disease Control and Prevention and enforced by the Transportation Security Administration.
Information for this article was contributed by David Koenig and Zeke Miller of The Associated Press and by Manami Nishida and Kiyohiko Yoneyama of The Japan News (WPNS).