WASHINGTON -- The FDA is carefully considering the malaria and rheumatology drug hydroxychloroquine (Plaquenil) as a treatment for COVID-19, FDA Commissioner Stephen Hahn, MD, said Thursday.
Hydroxychloroquine is among several drugs already approved for other indications that the president wants the FDA to look at as possible COVID-19 treatments, Hahn said at a White House coronavirus task force briefing. "We want to do that in the setting of a clinical trial -- a large, pragmatic clinical trial -- to actually gather that information and answer the question that needs to be asked and answered."
The drug is currently approved for malaria and also for rheumatoid arthritis and systemic lupus erythematosus, which is its main use in the U.S. It's therefore available to be prescribed off-label, and some clinicians have already said they're using it on COVID-19 patients. But neither Hahn nor other task force members addressed whether enough hydroxychloroquine is on hand to treat large numbers of coronavirus cases.
Convalescent plasma and the immune globulin that it contains is another possible treatment the agency is considering, Hahn added. "FDA's been working for some time on this," he said. "If you've been exposed to coronavirus and you're better -- you don't have the virus in your blood -- we could collect the blood, concentrate that and have the ability, once it's pathogen-free, to give that to other patients, and the immune response could potentially provide a benefit to patients. That's another thing we're looking at; over the next couple of weeks, we'll have information and we're really pushing hard to try to accelerate that." Such treatments have been effective in Ebola, for example.
That therapy is more "medium short-term, and that will be a bridge to other therapies that will take 3-6 months to develop," he continued. "This is a continuous process; there is no beginning and end to each of this; we're pushing this through."
Hahn also mentioned the work FDA is doing to develop a COVID-19 vaccine, emphasizing that "we expect it to take 12 months to get to completion where we could actually approve a vaccine," he said. "This is record time for the development of a vaccine."
Vice President Mike Pence, who is leading the task force, gave an update on testing. "We want the American people to know that testing is available in all 50 states, and is becoming increasingly available literally every hour of the day," he said. "I'm pleased to receive a report today that tens of thousands of tests are being performed every day ... State and private labs are now required by law to report all coronavirus testing directly to the CDC, to give the American public and also give our researchers timely and important information." He emphasized that asymptomatic people shouldn't seek a test because "we want to make sure testing is available for people who are experiencing symptoms."
Task force coordinator and Ambassador at Large Deborah Birx, MD, noted that although the public will be seeing the numbers of COVID-19 cases increase dramatically over the next 2-3 days as more tests become available -- this week, the national case count has been rising 40% or more daily -- that shouldn't be a cause for concern. "The number of 'test positives' is increasing; that's a dramatically important signature that everybody is doing their job," with patients with mild symptoms staying home and those with serious symptoms getting tested.
"Our 'test positive' rates are now in the 10%-to-11% range," she continued. "That still means that 90% of the illnesses out there -- even the severe ones -- are non-COVID-19."
She also emphasized that the outbreak remains highly localized in the U.S., with more than 50% of cases coming from three states, "which is why we continue to prioritize testing in those states. In addition, 50% of the cases come from 10 counties."
Regarding personal protective equipment, "we continue to work with healthcare providers, businesses, and state leadership to ID available supplies, not merely in the federal stockpile but much more importantly across the private sector," said Pence. Several private companies "have now greatly increased by the tens of millions their production of N95 masks that will give our healthcare workers the protection they need." He applauded construction companies who have been donating their N95 masks to hospitals.
On ventilators, "we've been working with healthcare providers around America, and suppliers, and literally identified tens of thousands of ventilators that can be converted to treat patients," Pence said. "We remain increasingly confident we'll have the ventilators we need as the coronavirus makes its way across America."
Surgeon General Jerome Adams, MD, used the briefing as an opportunity to remind people to donate blood. "As an anesthesiologist still practicing at Walter Reed ... I know that donating blood is an essential part of caring for patients," he said. "Blood centers are open now and in need of your donation." He reminded would-be donors that the centers are taking extra precautions such as spacing beds 6 feet apart, disinfecting surfaces between donations, and checking staff members' temperatures.
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