August 20, 2020

Covid-19 roundup: FDA won't authorize blood plasma to treat Covid-19—yet

Daily Briefing

    Federal scientists are working to create a strain of the novel coronavirus that could be used in human challenge trials, FDA authorizes emergency use of the first saliva-based coronavirus diagnostic test that doesn't require specialized collection equipment, and more.

    • CDC in a release issued Friday clarified its guidance suggesting that people infected with the novel coronavirus can continue to test positive for the pathogen for up to three months after their initial diagnosis and not be infectious to others during that period, after some media reports suggested the guidance implied that people are immune to reinfection for three months after their initial diagnosis. CDC said, "Contrary to media reporting … science does not imply a person is immune to reinfection with [the coronavirus] in the three months following infection" (Axelrod, The Hill, 8/14; Walker, MedPage Today, 8/17; CDC release, 8/14).
    • CMS on Monday released new guidance stating that, starting Sept. 1, hospitals who seek Medicare reimbursements for treating patients with Covid-19, the disease caused by the new coronavirus, will need to include proof of a positive coronavirus test result in a patient's medical record to be eligible for the payment. CMS said the test must be conducted prior to admitting the patient or within 14 days of the patient's admittance, though the test doesn't have to be performed at the hospital. CMS said it will have special considerations for cases in which a positive coronavirus test was conducted more than 14 days prior to a patient's admission to the hospital. If hospitals meet the requirements, they could be eligible for Medicare's 20% add-on payment for inpatient hospital Covid-19 care. CMS said the new requirements are intended to combat fraud (King, FierceHealthcare, 8/19; Morse, Healthcare Finance News, 8/18; Ellison, Becker’s Hospital CFO Report, 8/18).
    • CVS Health has partnered with Delta Air Lines to expand the air line's coronavirus testing program for employees using CVS' Return Ready diagnostic test. In addition, CVS' Aetna division has separately partnered with Lyft and the National School Boards Association to donate $100,000 toward providing rides to school for students in high-risk areas throughout the United States, as families adjust to "whatever the new school year looks like during" America's coronavirus epidemic, CVS said (Gangitano, The Hill, 8/18; Anderson, Beckers Hospital Review, 8/17).
    • Facebook last week announced that it removed seven million posts containing misinformation about the coronavirus and Covid-19 from its Facebook and Instagram platforms between April and June to quell the rapid spread of potentially dangerous inaccuracies regarding the virus. The company said it also attached warning notes to 98 million Facebook posts that contained misinformation about the coronavirus and Covid-19 during that period. The company said those posts were misleading but not considered dangerous enough to meet standards for removal (Lerman, Washington Post, 8/11).
    • FDA last week had been readying an emergency use authorization (EUA) for blood plasma donated by individuals who've recovered from coronavirus infections as a treatment for Covid-19, but a group of leading federal health officials—including NIH Director Francis Collins and Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID)—stepped in to stop the authorization, according to senior Trump administration officials, the New York Times reports. The group of top health officials said existing data on the potential treatment has not yet shown whether it benefits people fighting Covid-19, and H. Clifford Lane, clinical director of NIAID, said the authorization is on hold while FDA reviews more data. Lane, who also urged FDA to hold off on issuing the EUA, added that FDA still could issue an EUA for the experimental treatment soon. According to the Times, FDA had drafted the EUA after a clinical trial sponsored by NIH and conducted by the Mayo Clinic, which involved more than 35,000 patients, suggested that treating patients with severe cases of Covid-19 using recovered coronavirus patients' blood plasma was associated with lower mortality rates. The trial did not have a control group, however, making it hard for researchers to discern whether the experimental treatment caused the lower death rates (Weiland et al., New York Times, 8/19; Garde/Herper, STAT News, 8/13).
    • FDA last week issued the first EUA for a saliva-based coronavirus diagnostic test that does not require specific swabs or collection devices. The test, called SalivaDirect and developed by the Yale School of Public Health, could help to boost the United States' capacity for providing coronavirus tests by reducing the need for specialized testing supplies, which have been short supply. "Providing this type of flexibility for processing saliva samples to test for [coronavirus] infection is groundbreaking in terms of efficiency and avoiding shortages of crucial test components like reagents," FDA Commissioner Stephen Hahn said in a release (Lienhard, Inside Health Policy, 8/17 [subscription required]; Silverman/Joseph, STAT News, 8/15).
    • On Monday, FDA issued an alert to laboratory technicians and providers warning that Thermo Fisher Scientific's TaqPath genetic coronavirus test could have in inaccurate results because of issues with laboratory equipment and software used to conduct the tests. FDA recommended that providers and technicians use the latest updated instructions and software created by the company to conduct the tests to ensure results are accurate. A spokesperson for Thermo Fisher said the company is working with FDA "to make sure that laboratory personnel understand the need for strict adherence to the instructions for use," and the company's data shows that most users "follow our workflow properly and obtain accurate results" (Perrone, Associated Press, 8/17).
    • Fauci on Friday said NIAID scientists are working to create a strain of the new coronavirus that could be used in human challenge trials of potential vaccines against the virus. In a controlled human challenge trial, researchers would administer a potential vaccine to a small number of healthy volunteers and intentionally infect those volunteers with the new coronavirus. The trials have long been controversial, and they're especially contentious when it comes to coronavirus vaccines because there currently is no approved treatment for Covid-19, which can cause death. While there are no drugmakers currently conducting human challenge trials for coronavirus vaccine candidates, some have said they would consider launching such trials if necessary. NIH in a statement to Reuters said, "Should there be a need for human challenge studies to fully assess candidate vaccines or therapeutics for [the novel coronavirus], NIAID has begun investigations of the technical and ethical considerations of conducting human challenge studies." Separately, Fauci called such trials "Plan C or Plan D," and said creating the new coronavirus strain was a preliminary step in case they are needed. "You generally do (human challenge trials) if you don't have enough infections in the community at any given time to get a signal from the vaccine," Fauci explained, adding, "Unfortunately for us, we don't have that problem—we have a lot of infections" (Steenhuysen, Reuters, 8/14; Johnson, Washington Post, 8/14).
    • Paul Mango, deputy chief of staff for policy at HHS, last week said the federal government will cover the costs of potential coronavirus vaccines and their distribution and is working with private health insurers to ensure the vaccines will be available to Americans with no out-of-pocket costs. "What we're hoping is that every American will not only get a free vaccine distributed to many different outlets, but also will not have to pay for the administration of that vaccine," Mango said. On Friday, HHS announced that, as part of the Trump administration's Operation Warp Speed initiative, the department has established an agreement with McKesson to distribute potential coronavirus vaccines. According to Inside Health Policy, HHS and McKesson reached the agreement under an existing contract that McKesson has with CDC that allows the company to distribute vaccines during a pandemic, as the company did about 10 years ago during the H1N1 pandemic. Under the agreement, CDC will direct McKesson to distribute coronavirus vaccines and supplies to health care providers that will administer the inoculations. Separately, CDC, the Department of Defense, and other federal agencies are working with officials in California, Florida, Minnesota, North Dakota, and Philadelphia to create plans to distribute potential coronavirus vaccines and prioritize which individuals will have access to the vaccines first, the Washington Post reports. Officials will share the plans with other states and localities to serve as models for distribution (Hopkins, Wall Street Journal, 8/13; Mills-Gregg, Inside Health Policy, 8/17 [subscription required]; Hopkins, Wall Street Journal, 8/14; Sun, Washington Post, 8/14).
    • HHS last week announced that it has provided a total of $6.5 million to two diagnostic laboratory companies, Aegis Sciences and Sonic Healthcare USA, to increase the capacity for coronavirus testing in the United States. HHS said the funding will allow the companies to bolster staffing and their infrastructures for conducting coronavirus tests using equipment supplied by Beckman Coulter Life Sciences and Thermo Fisher, with the goal of providing an additional one million tests each week by early next month (Roy, Reuters, 8/13; Morse, Healthcare Finance News, 8/13; HHS release, 8/13).
    • Deborah Birx, who is coordinating the White House's coronavirus task force, on Monday said HHS plans to return control of the department's coronavirus database back to CDC at some point. Birx said CDC currently is working with HHS "to build a revolutionary new data system, so it can be moved back to the CDC and they can have that regular accountability with hospitals relevant to treatment and [personal protective equipment]," but she added that the system still needs work before HHS will transition ownership of the system to CDC (Dydra, Becker’s Health IT, 8/18; Mascarenhas, CNN, 8/17).
    • Regeneron Pharmaceuticals has entered an agreement with Roche Holding to have Roche manufacture and distribute an experimental treatment for Covid-19 that Regeneron is developing if the treatment gets regulatory approval. Researchers are evaluating the potential treatment, currently called REGN-COV2, in clinical trials, and Regeneron expects to have initial data from those trials by the end of September. Regeneron has said it could seek an EUA for the experimental treatment from FDA by the end of this year (Walker, Wall Street Journal, 8/19).
    • The World Health Organization (WHO) on Tuesday said young adults are becoming the main drivers of new coronavirus infections in many countries, sparking worry among experts who fear the United States could see another spike in new cases of the virus as schools and colleges throughout the country reopen, the Post reports. Takeshi Kasai, WHO's Western Pacific regional director, said, "The [pandemic] is changing," as "[p]eople in their 20s, 30s, and 40s are increasingly driving the spread." According to WHO, more than 50% of newly confirmed infections in Australia and the Philippines in recent weeks have occurred among people under age 40, as well as 65% of recently confirmed new coronavirus cases in Japan. Further, since younger individuals appear more likely to have asymptomatic coronavirus infections or mild cases of Covid-19 when compared with older people, it's more likely that many younger people infected with the coronavirus may not know they have it, Kasai said. "This increases the risk of spillovers to the most vulnerable: the elderly, the sick, people in long-term care, people who live in densely populated urban areas and underserved rural areas," Kasai added (Wan/Balingit, Washington Post, 8/18; Lovelace, CNBC, 8/18).

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