- Abbott Labs on Monday announced that it received an emergency use authorization (EUA) from FDA for the company's blood test for the novel coronavirus, called AdviseDx. Abbott says the test can detect an antibody called immunoglobulin M, which indicates whether a person has been exposed to or recently infected by the virus and can help providers to determine whether a person has recovered from a coronavirus infection. Robert Ford, Abbott's president and CEO, in a statement said, with this most recent test, "Abbott has developed tests to detect the virus at each stage of infection so doctors and their patients are equipped with knowledge of how they are responding to the virus and progressing through recovery" (Weixel, The Hill, 10/12; Maddipatla, Reuters, 10/12).
- HHS on Tuesday announced that it awarded $481 million to Cue Health to help the company scale up production of its rapid molecular test for the coronavirus. Cue will increase its production of the tests to 100,000 per day, and the company plans to provide the federal government with six million tests and 30,000 testing instruments by March 2021. The test, which received an EUA from FDA in June, is able to detect the novel coronavirus within around 20 minutes from a sample collected via a nasal swab (Roy/Chander, Reuters, 10/13; Feuer, CNBC, 10/13).
- HHS Secretary Alex Azar last week said he believes drugmakers could develop 100 million doses of a vaccine against the new coronavirus for the United States by the end of this year, and the Trump administration expects to have "enough [doses] to cover every American by March or April 2021." An official with Operation Warp Speed, the administration's coronavirus vaccine development effort, confirmed that country is on track to have at least 100 million doses of an experimental coronavirus vaccine manufactured by the end of the year, and there could be at least 700 million doses available by March or April 2021. The official added that distribution of a vaccine will depend on whether and when FDA authorizes a coronavirus vaccine candidate for use in the United States (King, FierceHealthcare, 10/8; Mishra, Reuters, 10/8; Guzman, "Changing America," The Hill, 10/8; Wang, Inside Health Policy [subscription required], 10/9).
- Russian authorities on Wednesday announced that the country has approved a second vaccine against the novel coronavirus, after receiving positive results from early-stage studies—which haven't yet been released to the public, the Associated Press reports. Officials said the new vaccine, called EpiVacCorona, was developed by the Vector Institute and was tested in 100 people between the ages of 18 and 60 in trials that lasted just over two months. In comments to the media, the vaccine's developers said trials showed the inoculation produced enough antibodies to protect participants from coronavirus infection, and the resulting immunity to the virus can last up to six months (Litvinova, Associated Press, 10/14; Neuman, NPR, 10/14).
- University Hospitals on Monday announced a pilot program that will give health care providers at UH Cleveland Medical Center two sleep pods "designed to safely provide individuals with comfort, privacy, and a place to decompress" as they grapple with the coronavirus epidemic. The pods are 43.5 square feet and feature a twin-size bed, charging stations, sound-blocking curtains, and a tablet that allows providers to reserve the pods. The pilot program will last 10 months. HOHM, which partnered with University Hospitals to design the pods, said the company intends to expand the pods to other hospitals (Anderson, Fox8, 10/12).
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