Coronavirus Breaking News

Australia-based CSL announced 'Multiple doses of the COVID-19 UQ-CSL V451 vaccine candidate have already been manufactured at the Broadmeadows facility and are held in readiness to progress the vaccine to Phase 2b/3 clinical trials.'

This press statement issued on November 8, 2020, indicates the University of Queensland produced vaccine candidate combines the adjuvant technology MF59 to improve immune response, reduce the amount of antigen needed for each vaccine, and enable more doses to be manufactured more rapidly.

The US CDC's updated data indicates about 157 million diagnostic tests, excluding antibody, and antigen tests were performed as of November 8, 2020. The states of California (18,813,961), New York (15,059,949), Florida (12,159,056), and Texas (9,633,805) lead the USA.

The overall infection rate in the USA this year is now 7%.

However, the percentage of respiratory specimens testing positive for the SARS-CoV-2 coronavirus increased to 8.2% during week #44, ending October 31, 2020.

A recent study published by the Brookings Institution reported that Taiwan was the primary country of 30 to experience economic growth during the early stages of the COVID-19 pandemic.

Keoni Everington, with the Taiwan News, reported on November 6, 2020, the study's authors highlight, "with the right policies" it is possible to achieve "good outcomes on both the GDP and COVID mortality."

As of November 8, 2020, Taiwan's population of over 23 million had reported just (7) fatalities related to COVID-19 during 2020.

The Russian Direct Investment Fund (RDIF) and the ChemRar group of companies announced on November 6, 2020, a permit was granted for the 'outpatient use' of the first Russian antiviral drug, Avifavir, which will be provided to patients free of charge. Avifavir has already been delivered to 15 countries around the world.

To meet the expected demand for Avifavir, these companies are doubling the capacity to produce 200,000 packs per month. Since June 2020, more than 60,000 packages of Avifavir were delivered to hospitals in 74 regions of the Russian Federation.

Avifavir is the world's first drug with the active ingredient favipiravir, registered for the treatment of new coronavirus infection. The effectiveness of antiviral drugs with favipiravir has been proven in (3) independent clinical studies in Russia with the participation of more than 700 patients with a confirmed diagnosis of COVID-19, as well as studies in Japan and other countries.

Kirill Dmitriev, CEO of the RDIF, noted in a media statement: “Obtaining a permanent registration certificate for the drug Avivavir opens up an opportunity for its outpatient use within the framework of the Russian Government's order, which, in turn, will help reduce the burden on medical institutions in the context of the ongoing COVID-19 pandemic.'

The U.S. Food and Drug Administration issued authorization for the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection. The FDA issued an emergency use authorization (EUA) for New Jersey-based GenScript USA Inc. cPass SARS-CoV-2 Neutralization Antibody Detection Kit, which specifically detects this type of antibody.

Although the FDA has previously issued EUAs to more than 50 antibody tests, those tests only detect the presence of binding antibodies.

Binding antibodies bind to a pathogen, such as a virus, but do not necessarily decrease the infection and destruction of cells. It’s important to note that the effect of neutralizing antibodies for SARS-CoV-2 in humans is still being researched.

Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, stated in a press release issued on November 6, 2020: “There are still many unknowns about what the presence of SARS-CoV-2 antibodies may tell us about potential immunity."

"But today’s authorization gives us another tool to evaluate those antibodies as we continue to research and study this virus. Patients should not interpret results as telling them they are immune, or have any level of immunity, from the virus.”

New research was published demonstrating that the immunodominant SARS-CoV-2 receptor binding motif is the least conserved region in the SARS-CoV-2 spike protein, allowing for the occurrence of mutations without disrupting human ACE2 (hACE2) binding, which mediates viral entry.

These researchers also characterize the virulence and fitness of N439K, a prevalent variant in the RBM that demonstrated resistance to human neutralizing monoclonal antibodies (mAbs), including one that is currently being evaluated in clinical trials.

The manuscript was developed by Vir Bio, in collaboration with the MRC-University of Glasgow Centre for Virus Research, which was published online on November 5, 2020, and has been submitted to a peer-reviewed journal for future print publication.

Vir Bio's VIR-7831 (GSK4182136) is conducting a phase 2/3 study. This antibody is a fully human anti-SARS-CoV-2 monoclonal antibody that was selected based on its potential to neutralize the virus in vitro, kill infected cells, provide a high barrier to resistance, and achieve high concentrations in the lungs (one of the major sites of infection).

“This study shows that the receptor-binding motif of SARS-CoV-2, a major target of neutralizing antibodies, is evolving at a higher rate than the rest of the receptor-binding domain and spike, and is resilient to change,” stated Herbert “Skip” Virgin, M.D., Ph.D., chief scientific officer of Vir, in a press release.