- Novavax, which has received $1.6 billion from the federal government under a deal to support development of a coronavirus vaccine, on Tuesday announced that two preliminary studies on its coronavirus vaccine candidate have produced encouraging results. According to Novavax, one study showed that 56 participants produced high levels of antibodies to the novel coronavirus after receiving the inoculation, and the participants didn't experience any severe side effects from the experimental vaccine. In addition, a separate study showed that the vaccine candidate robustly protected monkeys from becoming infected with the coronavirus. Public health experts noted that, while the data is promising, the results are preliminary and do not yet mean the vaccine candidate has been proven effective or safe for use in humans (New York Times, 8/4).
- Johnson & Johnson last week announced that it has started human clinical trials for its experimental coronavirus vaccine after early research showed that the inoculation protected a group of primates against the virus. The research, published last week in Nature, found that all but one of the animals injected with the vaccine candidate had immunity to the novel coronavirus when they were exposed to the pathogen six weeks later. According to the research, the one animal that did not develop immunity to the virus showed only low levels of the pathogen. As a result of the findings, the company in July began two separate human clinical trials, one in the United States and another one in Belgium, and it plans to begin the last phase of clinical trials, which will involve 1,045 people, in September (Axelrod, The Hill, 7/30).
- FDA Commissioner Stephen Hahn during an interview last week on NBC's "Today" show said patients should consult with their doctors to decide whether they should take the anti-malaria drug hydroxychloroquine as a potential treatment for Covid-19, the disease caused by the new coronavirus, although he acknowledged that data shows there are risks associated with the drug. "A doctor and a patient need to assess the data that's out there," Hahn said, "FDA does not regulate the practice of medicine, and that in the privacy of the doctor-patient relationship is where that decision [of whether to use hydroxychloroquine] should be made." Separately, HHS Assistant Secretary for Health Brett Giroir, who currently is serving as the Trump administration's coronavirus testing czar, during an interview on NBC's "Meet the Press" on Sunday said there's no evidence showing hydroxychloroquine is an effective treatment for Covid-19, adding, "We need to move on from that and talk about what is effective" (Axelrod, The Hill, 7/30; Warmbrodt, Politico, 8/2).
- President Trump last week in remarks at American Red Cross' national headquarters urged Americans who have recovered from a coronavirus infection to donate blood plasma to boost the nation's supply of convalescent plasma with antibodies to the virus, which could help patients fight Covid-19. According to the Washington Post, the antibodies in convalescent plasma are extracted from plasma donations and transfused to Covid-19 patients to help boost their immune systems. Previously, patients with Ebola, measles, and respiratory conditions have received convalescent plasma to help strengthen their immune responses to those pathogens, but research on the approach has offered mixed results—with some patients showing benefits when they receive the transfusions and others having limited responses (Johnson, Washington Post, 7/30).
- A senior Trump administration official last week said CDC and the Department of Defense (DOD) will jointly oversee the nationwide distribution of any coronavirus vaccine. The official said DOD is "handling all the logistics of getting the vaccines to the right place, at the right time, in the right condition," while CDC will track any side effects linked to the vaccination and "some of the communications through the state relationships [and] the state public health organizations." According to Politico, the administration's vaccine distribution plan represents a break with the longstanding precedent of CDC overseeing the distribution of vaccines during major disease outbreaks through a centralized ordering system for local and state public health officials (Owermohle, Politico, 7/30).
- GlaxoSmithKline (GSK) and Sanofi last week announced the federal government will pay them up to $2.1 billion under Operation Warp Speed to fund the development of a coronavirus vaccine and, if their vaccine candidate is proven safe and effective in clinical trials, guarantee production of 100 million doses of the inoculation. The companies said Sanofi is leading the experimental vaccine's development and will begin clinical trials on the candidate in September. GSK and Sanofi plan to launch late-stage clinical trials by the end of 2020 and, if the trials results are positive, seek regulatory approval for the vaccine candidate in the first half of 2021 (Herper, STAT News, 7/31; Walker, Wall Street Journal, 7/31).
- Alphabet on Friday announced that 20 U.S. states and territories are "exploring" using a tool developed by Google and Apple to launch coronavirus contact tracing apps. The tool uses Bluetooth signals to track people's encounters, and it anonymously notifies people if any one of their contacts has tested positive for the virus. Alphabet said 16 countries and regions outside of the United States have launched contact tracing apps using the tool. Google on Friday said the first U.S. apps using the tool will be available in the "coming weeks," but the company did not say which states would be launching the apps (Dave, Reuters, 7/31; Kelley, "Changing America," The Hill, 7/31).
- NIH on Friday announced that seven companies will receive nearly $250 million to develop coronavirus diagnostic tests under its Rapid Acceleration of Diagnostics program. Three of the companies—Mesa Biotech, Quidel, and Talis Biomedical—will develop point-of-care tests, and four—Fluidigm, Ginkgo Bioworks, Helix, and Mammoth Biosciences—will develop lab-based tests. Under the program, NIH hopes the seven companies will add six million tests per day by the end of 2020. NIH also is considering 20 additional companies for the program (Howell/Sherfinski, Washington Times, 7/31; Sheridan, STAT News, 7/31).
- Relief Therapeutics Holdings and NeuroRx on Sunday announced that severely ill Covid-19 patients recovered from respiratory failure in as few as four days after they took an experimental treatment, called RLF-100, for which FDA has granted a fast-track designation. The experimental treatment—which is patented by Relief Therapeutics and under development by NeuroRx—is a synthetic form of a natural peptide that protects people's lungs. The companies said doctors are using the experimental treatment on an emergency-use basis for patients who cannot be enrolled in their ongoing Phase 2/3 clinical trial involving 70 patients, and they're reporting rapid recoveries among their patients. For example, physicians at Houston Methodist Hospital have reported that a 54-year-old patient with Covid-19 who developed the disease while being treated for a double-lung transplant came off a ventilator within four days of using the experimental drug, the companies said. More than 15 other patients had similar results, according to the companies (Cohen, Reuters, 8/2).
- An Oxford University study of more than 9,000 health care workers suggests serology tests—which detect the presence of antibodies to the new coronavirus, indicating a previous infection—may not provide an accurate identify people who were infected, particularly if they had mild cases of Covid-19. Specifically, the researchers found 47% of the 903 health care workers who tested positive for antibodies had reported a loss of taste or smell, which are two symptoms of Covid-19, but another 30% of patients who reported a loss of taste or smell tested negative, with results slightly below the threshold for a positive test result. "You can see that below the cut-off, there is a rising proportion of people who report a loss of their sense of smell or taste, and this suggests that the test threshold is missing people with mild disease," said Tim Walker, one of the study's authors. "Of course, there will be plenty of people, too, who will have had no symptoms whatsoever and will still have antibodies" (Rigby, The Telegraph, 8/1).
- Eli Lilly on Monday announced that it has started a Phase 3 clinical trial to evaluate whether its experimental Covid-19 treatment can reduce infection and disease rates among residents and staff at long-term care facilities. The drugmaker said it will test its antibody-based drug at nursing homes where recent cases of Covid-19 have been diagnosed. The company hopes to enroll up to 2,400 participants (Loftus, Wall Street Journal, 8/3).
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