The Biden administration says it is launching a new push to increase the use of more effective COVID-19 treatments nationwide. After months of shortages of supplies, federal officials say the drug is now more readily available but still underused.
As part of the new effort, the federal government plans to allow thousands of more pharmacies to order highly effective COVID-19 treatments like Pfizers., which may reduce the risk of becoming seriously ill. They also plan to launch additional “test-to-treat” sites where Americans can be diagnosed and receive the pills in a single visit.
Paxlovid was first approved by the Food and Drug Administration in December, andinitially. Now the pills are no longer sparse, but they still do not come to everyone who could benefit from treatment.
“It is quite clear from the admission of Paxlovid and the number of hospitalizations and deaths during the months that Paxlovid has been available that there are still some people who could have benefited from these drugs,” said an official in administration to reporters Monday in a briefing to view the message.
Federal officials have publicly expressed concern for weeks that treatments such as Paxlovid, Merck and Ridgeback’s Lagevrio antiviral pills and Eli Lilly’s bebtelovimab monoclonal antibody did not reach enough Americans.
Officials said Monday that the reported use of the antiviral pills has more than doubled over the past month, from 22,000 courses a week to over 55,000. It comes as cases and hospitalizations have begun to rise nationwide, driven by the highly contagious Omicron.
In New England, federal data has followed the pace of new COVID-19 hospital admissions, which have increased among patients aged 70 and older – the age group most vulnerable to severe COVID-19 – since early April. The number of new admissions is now higher than the peak reached over the Delta variant last year, but is still a fraction of the record highs during this winter’s Omicron wave.
“We certainly know there is more room to go. We can save more lives by giving this medicine to more people,” the official said.
Get Paxlovid antiviral pills
Paxlovid treatment should be started within a few days after the first development of symptoms.
A course of treatment consists of three tablets, taken twice a day, morning and evening for five days, for a total of 30 pills. Preliminary clinical trials showed that the drug reduced the risk of COVID-19 hospitalization or death by 88% compared with placebo.
Paxlovid cannot be taken at the same time as several medicines which may reduce the effect of the medicine or lead to potentially fatal side effects.
Through outreach to physicians and patients, officials say they hope more eligible Americans will act quickly to get the now abundant antiviral pills on pharmacy shelves.
“Many providers early in the scarcity mindset, where there were fewer courses available across the country, really reserved this only for the people who 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 warning urging physicians to step up prescribing effective COVID-19 treatments – and urging at-risk patients to test positive not to delay contacting their physicians, “even if your symptoms is mild. “
A “tranche” of more than 100,000 courses of the antiviral pills will be made available to all federal government pharmacy partners for ordering directly instead of through federal and local allocations. Officials say they expect the move will increase the number of sites with drugs in stock from 20,000 to 30,000.
It comes on top of efforts like the administration’s nationwide “test-to-treat initiative,” which was launched at thousands of pharmacies earlier this year.
Concerned that the program was inaccessible to Americans living in many parts of the country, officials said the administration plans to launch new “federally supported Test-to-Treat sites” in addition to the 2,200 sites currently in place. the program.
“I think we’re going to work really closely with these new federally supported sites, working directly with state, territorial and jurisdictional management to identify the sites that need more support,” said an administration official. .
Challenges and questions
Officials acknowledged that the new measures do not address some of the criticisms raised against the Biden administration’s treatment efforts.
Despite objections from pharmacy trade groups, the FDA excludes most pharmacists from prescribing Paxlovid or Lagevrio. For vulnerable Americans without access to a “test-to-treat” pharmacy that has a qualified provider available, this means that some will have to take several trips to get the pills.
“You need to develop COVID symptoms, you need to subsequently get a test for COVID-19, get the result of that test, find and go to a provider, get a prescription and then fill out that prescription. It’s six steps out of five days, said an official.
Nor does it include an extension of who is eligible to take the drugs under the FDA’s emergency use permit.
In a speech at Uniformed Services University earlier this month, Dr. Anthony Fauci, the president’s senior medical adviser, said Paxlovid could soon be extended to lower-risk patients “to prevent them from getting long-term COVID.”
Both Pfizer and Merck have also run a number of trials that may support an expansion of the use of the antiviral pills to more people. Results could soon come from a trial that evaluated Paxlovid in people who are prone to the disease but who have not yet developed symptoms that should have been completed earlier this month.
And administration officials at the briefing did not bring up growing reports of “rebound” or “relapse” symptoms – people who appear to recover from COVID-19 after taking the antiviral pills but later get a new round of symptoms – which can lead to SARS-CoV-2 developing resistance to the treatments.
A spokesman for Pfizer said the company continued to monitor data from their clinical trials with Paxlovid as well as real-world evidence and has “seen no resistance” to the drug.
In a statement, an FDA spokesman acknowledged that rebound reports “are important to evaluate further”, but reiterated that the drug worked 88% effectively to reduce the risk of hospitalization or death in its clinical trials.
“The FDA is evaluating the reports of viral load rebound after completing Paxlovid treatment and will share recommendations if appropriate,” said FDA Chanapa Tantibanchachai.