California Governor Gavin Newsom issued an executive order on August 24, 2020, to help increase the availability of CLIA-waived COVID-19 disease testing. This Order allows the California Department of Consumer Affairs, in consultation with the California Department of Public Health, to issue waivers permitting pharmacists and pharmacy technicians to conduct CLIA-waived COVID-19 tests, which detect the presence of the coronavirus.
Coronavirus Breaking News
The coronavirus disease COVID-19 is currently reaching pandemic levels in various countries.
As of August 27, 2020, the U.S. FDA has authorized 226 coronavirus diagnostic tests, which include 182 molecular tests, 40 antibody tests, and 3 antigen tests.
The global coronavirus pandemic continues to have a serious impact on many people, including cancer patients, said the American Cancer Society (ACS) on August 21, 2020. Some cancer patients might be at increased risk of serious illness from a SARS-CoV-2 infection because their immune systems could have been weakened by cancer and its treatments.
To answer some of the related questions, the ACS published a FAQ listing, which can be found at this link.
An update to a living rapid-review published by the Annals of Internal Medicine published on August 27, 2020, found evidence on face mask effectiveness for respiratory infection prevention is stronger in healthcare than community settings. Previously, randomized trials in community settings found possibly no difference between N95 versus surgical masks and probably no difference between surgical versus no mask in the risk for influenza or influenza-like illness, but compliance was low.
Update #2 found 'no new studies evaluated the effects of face mask use and risk for SARS-CoV-2 infection in community settings.'
Note: The authors of this manuscript are responsible for its content. Statements in the manuscript do not necessarily represent the official views of or imply endorsement by AHRQ or HHS. No industry conflicts of interest were disclosed.
People living with HIV who are admitted to the hospital with COVID-19 disease were found 'no more likely to die than those without HIV' concluded a recent study in New York City, published by Clinical Infectious Disease. This limited study included (88) COVID-19 patients who did not differ significantly by HIV status, age, gender, or race/ethnicity due to the study's matching algorithm.
In reaction to the massive number of COVID-19 disease fatalities reported by 'nursing homes in the USA, the US Centers for Medicare & Medicaid Services (CMS) announced on August 26, 2020, sweeping regulatory changes that require nursing homes to test staff and offer testing to residents for the SARS-CoV-2 coronavirus. The new CMS rules also require hospitals to provide COVID-19 cases and related data to the U.S. Department of Health and Human Services.
Facilities that do not comply with the new CMS requirements may face enforcement sanctions, such as civil money penalties in excess of $400 per day, or over $8,000 for an instance of noncompliance.
According to TASS reporting on August 27, 2020, Moscow Mayor Sergey Sobyanin wrote in his blog 'Any Moscow resident over 18 years of age can apply to participate in the no-charge, phase 3 of trials. And these trials will 'allow participants to obtain the permanent registration certificate for the (Sputnick V) vaccine, as well as widen the circle of potential recipients, including the residents over 60 years old.'
"We also created a special mobile application with a self-observation diary. Some study participants will receive electronic bracelets to measure arterial blood pressure and body temperature," Sobyanin said.
CDC Director Dr. Robert Redfield released a statement late on August 26, 2020: “Everyone who needs a COVID-19 test, can get a test. Everyone who wants a test does not necessarily need a test; the key is to engage the needed public health community in the decision with the appropriate follow-up action," reported CNBC. And, 'coronavirus 'testing may be considered for all close contacts' of COVID-19 patients.'
The CDC guidance now states: “If you have been in close contact (within 6 feet) of a person with a COVID-19 infection for at least 15 minutes but do not have symptoms: You do not necessarily need a test unless you are a vulnerable individual or your healthcare provider recommends you take one.”
Additionally, during a video discussion, Dr. Redfield said the 'southern state outbreaks may be coming to an end. And hopes all states are prepared for the incoming 2020-2021 flu season.'
Abbott announced on August 26, 2020, that the U.S. FDA issued authorization for its BinaxNOW™ COVID-19 Ag Card rapid test for detection of COVID-19 disease infection. It is highly portable, about the size of a credit card), affordable ($5), and provides results in 15 minutes.
Additionally, Abbott is launching a mobile app named NAVICA™ available at no charge, which enables people who test negative for coronavirus to display a temporary digital health pass that is renewed each time a person is tested through their healthcare provider.
Montreal based Laurent Pharmaceuticals Inc. announced on August 27, 2020, that it has received approval from the U.S. FDA to start enrolling patients in Phase 2 randomized placebo-controlled trial testing once-a-day oral LAU-7b as a potential treatment against COVID-19 disease. LAU-7b has shown potent antiviral effects in-vitro against both SARS-CoV-2 and MERS-CoV coronaviruses.
“The main objective of this study is to demonstrate that LAU-7b is a safe and effective treatment option for COVID-19 patients that are at risk of lung complications because of their age, underlying condition, or both,” stated Dr. Radu Pislariu, CEO of Laurent Pharmaceuticals.
AstraZeneca announced on August 25, 2020, a Phase I trial of AZD7442 was launched. This early-stage study is a combination of two monoclonal antibodies (mAbs) in development for the prevention and treatment of COVID-19 disease. Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the mAbs were optimized with half-life extension and reduced Fc receptor binding.
'The half-life extended mAbs should afford at least 6-months of protection from COVID-19.'
In the July 15, 2020, publication of Nature, the mAbs were shown preclinically to block the binding of the SARS-CoV-2 virus to host cells and protect against infection in cell and animal models of disease.
A new study published by The Lancet on August 24, 2020, found cancer patients with a leukemia diagnosis more than doubled the likelihood of death from COVID-19 disease when hospitalized. 'As a consequence of advice given to people who are clinically susceptible to COVID-19, there have been sweeping changes in management for all cancer types during the past few months, including shortening of radiotherapy, switching from intravenous to oral chemotherapy regimens, and modifications in immunotherapy use.'
A New York Times announced on August 26, 2020, a new survey of more than 1,500 American colleges and universities has revealed at least 26,000 coronavirus cases and 64 related fatalities, since the pandemic began in December 2019. This analysis includes athletic teams, such as Baylor, Clemson, and Louisville, reporting coronavirus cases in their athletic departments.
The U.S. CDC proposed guidelines on August 26, 2020, for distributing a SARS-CoV-2 coronavirus vaccine in the USA. The guidelines were unveiled during a presentation at the CDC’s Advisory Committee on Immunization Practices meeting, which would prioritize healthcare workers, essential personnel, and vulnerable Americans, such as the elderly and those with underlying health conditions.
The CDC also said it is preparing for the possibility of distributing different kinds of coronavirus vaccines at the same time.
The U.S. FDA issued an emergency use authorization on August 26, 2020, for the first antigen test where results can be read directly from the testing card, a similar design to some pregnancy tests. A healthcare provider swabs the patient’s nose and twirls that sample on a test card with a testing reagent added. After waiting 15 minutes, the healthcare provider reads the results directly from the testing card. One line indicates a negative result; 2 lines indicate a positive result.
“This new COVID-19 antigen test is an important addition to available tests because the results can be read in minutes, right off the testing card. This means people will know if they have the virus in almost real-time,” said Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.