The Biden administration says it is launching a new push to push the use of various effective COVID-19 treatments across the country. After months of shortages, federal officials say the drugs are now more widely available but are being underused.
As part of the new effort, the federal government plans to allow thousands more pharmacies to directly order highly effective COVID-19 treatments like Pfizer’s., which can reduce the risk of getting seriously ill. They also plan to launch additional “test-to-treat” sites, where Americans can be diagnosed and receive pills in one visit.
Paxlovid was first authorized by the Food and Drug Administration in December, andfirst. Now the pills are no longer in short supply, but they are still not reaching everyone who could benefit from treatment.
“It’s pretty clear from the uptake of Paxlovid and the rate of hospitalizations and deaths over the months that Paxlovid has been available, that there are still some people who could have benefited from these drugs,” an administration official told reporters. on Monday at a briefing to preview the announcement.
Federal officials have publicly expressed concern for weeks that treatments like Merck’s and Ridgeback’s antiviral pills Lagevrio and Eli Lilly’s monoclonal antibody bebtelovimab were not reaching enough Americans.
Officials said Monday that reported use of antiviral pills has more than doubled over the past month, from 22,000 courses a week to more than 55,000. That comes as cases and hospitalizations have begun to rise across the country, fueled by the highly contagious Omicron..
In New England, federal data has tracked the pace of new COVID-19 hospitalizations among patients 70 and older, the age group most vulnerable to severe COVID-19, since early April. The rate of new admissions is now higher than the peak reached during the variant Delta wave last year, but is still a fraction of the all-time highs during the winter Omicron wave.
“We certainly know that there is more room to move forward. We can save more lives by giving this drug to more people,” the official said.
Getting Paxlovid Antiviral Pills
Paxlovid treatment should start a few days after the first symptoms appear.
A course of treatment consists of three tablets taken twice a day, in the morning and in the evening, for five days, for a total of 30 pills. Initial clinical trials showed the drug reduced the risk of hospitalization or death from COVID-19 by 88%, compared to placebo.
Paxlovid cannot be taken at the same time as several medications that may reduce the effectiveness of the drug or cause life-threatening side effects.
Through contact with doctors and patients, officials say they hope more eligible Americans will act quickly to obtain the now plentiful antiviral pills on pharmacy shelves.
“A lot of providers early on with that scarcity mentality, when there were fewer courses available across the country, they really reserved this for just the people they thought would be the sickest of the sick,” an administration official told reporters. .
On Monday, the Centers for Disease Control and Prevention issued a health alert urging doctors to step up prescribing effective treatments for COVID-19 and imploring at-risk patients who test positive not to delay in contacting to his doctors, “even if his symptoms are mild.”
A “tranche” of more than 100,000 cycles of antiviral pills will be available for all federal government partner pharmacies to order directly, rather than through federal and local allocations. Officials say they hope the move will increase the number of sites with drugs in stock from 20,000 to 30,000.
That’s on top of efforts like the administration’s nationwide “test-to-treat” initiative launched in thousands of pharmacies earlier this year.
Following concerns that the program was inaccessible to Americans living in many parts of the country, officials said the administration plans to launch new “test sites to deal with federal support” beyond the 2,200 locations currently in the program.
“I think we’re going to be working very closely with these new federally supported sites, working directly with state, territorial and jurisdictional leaders to identify the places that need the most support,” an administration official said.
challenges and questions
Officials acknowledged that the new moves do not address some of the criticism leveled against the Biden administration’s treatment effort.
Despite objections from pharmacy trade groups, the FDA excludes most pharmacists from being able to prescribe Paxlovid or Lagevrio. For at-risk Americans who don’t have access to a “test-to-treat” pharmacy with a qualified provider available, this means some will have to make multiple trips to obtain pills.
“You have to develop symptoms of COVID, then you have to get a COVID-19 test, get the result of that test, find and go see a provider, get a prescription, and then fill that prescription. It’s six steps in five days.” said an official.
It also does not include an expansion of who is eligible to take the drugs under the FDA’s emergency use authorization.
Speaking at the Uniformed Services University earlier this month, Dr. Anthony Fauci, the president’s top medical adviser, hinted that Paxlovid could soon be expanded to lower-risk patients “to prevent them from possibly having prolonged COVID.”
Both Pfizer and Merck have also been running a variety of trials that could support expanding the use of antiviral pills to more people. Results could come soon from a trial evaluating Paxlovid in people who are exposed to the disease but have not yet developed symptoms, which was due to be completed earlier this month.
And administration officials at the briefing made no mention of the increasing reports of “rebound” or “relapse” symptoms (people who seem to recover from COVID-19 after taking antiviral pills, but then develop a new round of symptoms). that could lead to the evolution of SARS-CoV-2 resistance to treatments.
A Pfizer spokesman said the company continued to monitor data from its Paxlovid clinical trials, as well as real-world evidence, and “has not seen any resistance” to the drug.
In a statement, an FDA spokesperson acknowledged that the rebound reports “are important to further evaluate,” but reiterated that the drug appeared to be 88% effective in reducing the risk of hospitalization or death in its clinical trial.
“The FDA is evaluating reports of viral load recovery after completion of Paxlovid treatment and will share recommendations if appropriate,” said FDA’s Chanapa Tantibanchachai.