- AstraZeneca on Monday announced it has started enrolling patients for a late-stage clinical trial of the coronavirus vaccine candidate the company is developing along with researchers from Oxford University. The study will involve 30,000 participants who will receive either two active doses of the vaccine, called AZD1222, four weeks apart, or a placebo (Maddipatla, Reuters, 8/31; Kane, CNN, 9/1).
- CDC Director Robert Redfield last week said that CDC and FDA will work together to conduct "heightened safety monitoring" of any coronavirus vaccine that receives either full FDA approval or an emergency use authorization (EUA). Paul Mango, deputy chief of staff for policy at HHS, said everyone who receives the vaccine will be monitored for side effects and, if long-term side effects are shown, regulators will pull the vaccine from the market (Wang, Inside Health Policy, 8/28 [subscription required]).
- The Covid-19 Treatment Guidelines Panel, which is part of NIH, on Tuesday announced that it has reviewed all available research on convalescent plasma and determined that "[t]here [is] insufficient data to recommend either for or against the use of convalescent plasma for the treatment of Covid-19," the disease caused by the novel coronavirus. The panel added that convalescent plasma "should not be considered standard of care" for treating the disease. The statement comes less than two weeks after FDA—in a controversial move—issued an EUA for convalescent plasma as an experimental treatment for Covid-19 (Edwards, NBC News, 9/1; Fox, CNN, 9/2; Sullivan, The Hill, 9/1).
- The ECRI Institute in a report published last week said a rapid point-of-care test for Covid-19 that tests a patient's breath could be available by the fall of 2020. ECRI said the test would take less than a minute to administer and would cost between $50 and $100 per kit. ECRI added that the test potentially could be a "gamechanger" in how patients are screened for Covid-19 (Lienhard, Inside Health Policy, 8/26 [subscription required]).
- The Federal Emergency Management Agency (FEMA) on Tuesday said it will no longer provide funding for schools to purchase cloth face masks. FEMA said it believes masks are needed for the basic operation of schools this fall and therefore don't qualify as emergency equipment that are eligible for FEMA funding. According to NPR, which obtained a recording of a call between state officials and representatives from FEMA, face masks and personal protective equipment in nonemergency settings will be classified by FEMA as "increased operating costs" and will not be covered by the federal government (Bowden, The Hill, 9/1; Wamsley, NPR, 9/1).
- Google on Wednesday made county-level, anonymized data on symptom searches available to the public and researchers. The data spans as far back as three years and include searches for up to 400 symptoms and conditions. These searches include symptoms of Covid-19, but also symptoms for conditions such as stress and diabetes, so researchers are able to learn more about the secondary health impacts of a variety of conditions (Kelly, Washington Post, 9/2).
- HHS Assistant Secretary for Health Brett Giroir on Tuesday said the department within the next two to three weeks will begin shipping rapid coronavirus tests to assisted living facilities. "The distribution plan will make sure there are enough tests in the system so that … individuals [at assistant living facilities] can get tested roughly along the same lines as [people in] the nursing homes," Giroir said (Alonso-Zaldivar, Associated Press, 9/1).
- HHS on Tuesday issued a statement saying the national stockpile of ventilators has reached maximum capacity, with nearly 120,000 ventilators available, and the federal government therefore will cancel some of its remaining orders for the devices. Carol Danko, a spokesperson for HHS, said the department "is balancing federal stockpile requirements with commercial market demand for ventilators," which will save "the U.S. taxpayer millions of dollars by halting delivery of additional ventilators that are no longer required" (Biesecker, Associated Press, 9/2).
- NIH on Wednesday announced it will award a total of $129.3 million to nine companies to assist them in increasing coronavirus testing and developing new testing technologies. NIH is awarding the funding as part of its Rapid Acceleration of Diagnostics program, which the agency launched in April with the goal of facilitating the development, commercialization, and implementation of coronavirus testing technologies. NIH said Aegis Sciences, Broad Institute, Ceres Nanoscience, Illumina, MatMaCorp, Maxim Biomedical, MicroGEM International, PathGroup, and Sonic Healthcare will received portions of the funding (Chander, Reuters, 9/2).
- Sanofi and GlaxoSmithKline (GSK) on Thursday announced they are launching a Phase I/II clinical trial for their protein-based coronavirus vaccine candidate. The companies said they expect to complete the trial by early December. They're aiming to enroll over 400 healthy participants ages 18 to 49 in the first phase, and at least 140 adults ages 50 and over in the later phase (Kar-Gupta, Reuters, 9/3; Branswell, STAT News, 9/3).
- The Trump administration in June privately alerted seven states where coronavirus cases had reached more than 100 cases per 100,000 residents, and where more than 10% of new coronavirus tests were positive, that they were "red zones" of high rates of coronavirus transmission, according to documents released by Democrats on the House Select Subcommittee on the Coronavirus Crisis. The documents also show that a number of states didn't implement recommendations from the White House coronavirus task force that had been made more than two months prior, including suggestions to mandate mask wearing and close bars. White House Communications Director Alyssa Farah said the administration had started a public health messaging campaign in July aimed at states with surging rates of coronavirus cases "to warn the public to follow mitigation practices to bring down the number of cases" (Ollstein, Politico, 8/31; Weixel, The Hill, 8/31).
- Uber on Tuesday announced that it will require some of its customers to take pictures of themselves wearing masks before they're allowed to take more trips in an Uber. Any customers flagged by drivers as having not worn a mask on previous trips will be required to verify that they are wearing a mask with a selfie before they're allowed to go on another ride, the company said. Uber said it will roll out the verification system in the United States and Canada by the end of the month (Axelrod, The Hill, 9/1).
- The University of Virginia Health System last week announced that it has designed a nasopharyngeal swab used in coronavirus tests, and that it will send 60,000 of the swabs throughout Virginia each week. The swab has received FDA's approval, and according to Amy Mathers, associate director of clinical microbiology at the health system, other health systems are free to replicate the swab's design and use it after conducting clinical trials (Anderson, Becker's Hospital Review, 8/27).
- Vir Biotechnology and GSK on Monday announced they're launching a Phase II/III study of VIR-7831, an antibody drug, as a potential treatment for Covid-19. The study will involve 1,300 patients from around the world who have an early-stage, symptomatic case of Covid-19. The trial is aimed at determining whether the drug is able to prevent the patients from requiring hospitalization. Vir and GSK said they expect to have initial results from the trial by the end of the year (Herper, STAT News, 8/31; Dearment, MedCity News, 8/31).
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