WASHINGTON — President Joe Biden and his administration want Americans and their doctors to know the country has an adequate supply of the covid-19 antiviral treatment Paxlovid and no longer needs to be rationed.
Supply of the Pfizer diet, approved in December, was initially very limited, but is now much more plentiful as covid-19 cases across the country have declined and manufacturing has increased. The White House is now working to raise awareness of the pill and take steps to make it easier to access.
Paxlovid, when given within five days of the onset of symptoms, has been shown to lead to a 90% reduction in hospitalizations and deaths in patients most at risk of serious illness. About 350 Americans now die from the coronavirus every day, up from more than 2,600 at the height of the omicron wave earlier this year.
A senior administration official said use of antiviral treatment had “more than doubled” in recent weeks, but the government had a larger supply that could save lives and prevent serious illnesses. was prescribed in a timely manner.
The United States has ordered enough pills for 20 million people, a supply that is expected to last for several more months. The administration has warned that further deliveries are dependent on Congressional approval of additional funding for the Covid-19 response.
The administration plans to highlight the relative abundance of the drug this week, and government officials will step up outreach to patients and providers.
The Food and Drug Administration has authorized Pfizer’s drug for patients ages 12 and older who have a positive covid-19 test and early symptoms and are at the highest risk for serious outcomes. They include the elderly and those with obesity and heart disease, although 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 route for the drug. The federal government now relies on states to determine where the supply goes, and about 20,000 sites sell the pill, including 2,000 so-called test-to-treat sites that can provide the treatment immediately after a positive test result.
The administration believes the pharmacy channel, which it used to increase the availability of covid-19 vaccines more than a year ago, will also make antiviral pills more accessible to people.
Meanwhile, an oral covid-19 drug produced by Japanese company Shionogi & Co. for patients with mild symptoms is not expected to be approved any time soon despite initial expectations that it would be the first domestically developed coronavirus drug. on the shelves of pharmacies.
The company filed for fast-track approval in late February, aiming to bring the drug to market by the end of March.
However, the approval process is ongoing, with some experts saying there is not enough clinical data to prove the drug’s effectiveness.
“It is important for domestic companies to develop drugs against Covid-19,” Health, Labor and Welfare Minister Shigeyuki Goto said on Friday. “We want to support development to achieve early commercialization of these drugs.”
Goto announced that the government would provide up to $482 million in additional support for Shionogi.
Shionogi applied to the Ministry of Health, Labor and Welfare on Feb. 25 for permission to produce and sell his drug. It had planned to manufacture 1 million doses of the drug by the end of March, subject to approval. However, the ministry has not set a date for future deliberations.
“We hoped to be able to ease the restrictions further if a drug similar to those used to treat seasonal flu becomes widely available. But it looks like it will still take some time,” said a Tokyo government official in charge of measures. infection. .
The interim clinical trial data that Shionogi published at the time of its application did not clearly demonstrate the drug’s effectiveness, which is believed to be the reason for the lack of progress in the review process.
A comparison of participants in the treatment group, which received the drug, and the control group, which received the placebo, confirmed a reduction in viral load among participants in the treatment group, but no significant difference in improvement overall 12 symptoms, including fatigue and fever.
Shionogi partly attributed this to the omicron variant of the coronavirus, saying “it was difficult to get meaningful results due to the characteristics of the variant”, which often causes no or only mild symptoms.
The expedited approval sought by Shionogi allows drugs to be reviewed based on interim clinical trial data. However, the system was originally designed with rare and incurable diseases in mind.
Four requirements must be met under the expedited approval framework: the treatment involves a serious illness; the efficacy or safety of the drug is significantly superior to existing treatments; large-scale clinical trials are difficult to conduct; and some level of efficacy and safety has been demonstrated in interim trials.
“Current data suggests that Shinogi’s treatment is not superior to existing drugs, so it may 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 in medical administration.
The company will also be able to apply for emergency use authorization under a new system whereby interim authorization will be granted if a drug’s safety is confirmed in interim trials and its efficacy is “presumed”.
The system was designed because Japan lagged behind Europe and the United States in the development of vaccines and drugs against covid-19.
Tsuguya Fukui, director of Tokyo Medical University’s Ibaraki Medical Center, who helped design the system, said there was no “presumption of efficacy” for Shionogi’s drug at this stage. .
If more clinical data is added and sufficient efficacy is demonstrated, the ministry is more likely to move the deliberations forward.
Shionogi is conducting the final phase of clinical trials with a variety of participants between the ages of 12 and 69. It has already administered the drug to more than 1,200 participants and plans to complete its analysis and submit data to the ministry by the summer.
Back in the US, 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 coming weeks bought their tickets before a federal judge in Florida overturned the requirement to wear masks at airports and during flights on Monday. This requirement, designed to limit the spread of covid-19, was due to expire on May 3 anyway.
United Airlines CEO Scott Kirby said his airline would be flexible with people with weakened immune systems or who are worried about mask-optional flying for any other reason.
“We work with these customers… to find another option, give them credit, or if they never want to fly again, [the company is] willing to give them a refund,” Kirby said on NBC.
A United spokesperson said customers, except those on the lowest “economy base” fares, can delay their travel plans for any reason at no additional cost. He said passengers with special circumstances should call the airline’s customer service number.
American Airlines CEO Robert Isom said Thursday that the airline has yet to send many refund requests.
“But as we do at all of these events, we’re reviewing our policies and… asking them to contact our reservations office, and we’ll make sure we accommodate them appropriately,” Isom said. .
A Delta Air Lines spokesperson said customers wishing to cancel travel should contact the airline. Decisions on how to handle such requests are made on a case-by-case basis, he said.
Southwest, Alaska, JetBlue, Spirit and Frontier did not respond to inquiries.
On Thursday, the Justice Department announced it would appeal the Florida judge’s decision overturning 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 provided by David Koenig and Zeke Miller of The Associated Press and Manami Nishida and Kiyohiko Yoneyama of The Japan News (WPNS).