The U.S. CDC announced on September 30, 2020, the extension of the recent No Sail Order for cruise ships through October 31, 2020. This order continues to suspend passenger operations on cruise ships with the capacity to carry at least 250 passengers in waters subject to U.S. jurisdiction.
Coronavirus Breaking News
The coronavirus disease COVID-19 is currently reaching pandemic levels in various countries.
Sep 30, 2020 • 1:58 pm CDT
On September 29, 2020, an expanded collaboration was announced among the Serum Institute of India (SII), Gavi, and the Bill & Melinda Gates Foundation to accelerate the manufacture and delivery of up to an additional 100 million doses of safe and effective COVID-19 vaccines for low- and middle-income countries. This expansion brings the total number of vaccine doses to be covered by the partnership between SII, Gavi, and the Gates Foundation to an aggregate of up to 200 million doses.
SII stated it 'intends to manufacture COVID-19 preventive vaccines licensed from AstraZeneca and Novavax if they are successful in attaining full licensure and WHO Prequalification.'
Sep 30, 2020 • 1:46 pm CDT
The BMJ published a study on September 9, 2020, featuring an easy-to-use risk stratification score that was developed and validated based on commonly available parameters at hospital presentation. The 4C Mortality Score outperformed existing scores, showed utility to directly inform clinical decision making, and can be used to stratify patients admitted to hospital with COVID-19 into different management groups.
The 4C Mortality Score should be further validated with COVID-19 patients to determine its applicability in other populations, added these researchers.
Sep 30, 2020 • 8:54 am CDT
Germany based CureVac N.V. announced on September 29, 2020, that the first participant has been dosed in the CV-NCOV-002 Phase 2a clinical trial of its COVID-19 vaccine candidate, CVnCoV. The dose-confirmation study is being conducted in the countries of Peru and Panama and will enroll a total of 690 healthy participants.
The CVnCOV vaccine study participants will receive 2 vaccinations at intervals of 28-days. Different dose levels will be investigated, starting at 6 µg, with the aim to confirm safety and evaluate the reactogenicity of the vaccine in older adults.
Sep 30, 2020 • 8:27 am CDT
On September 29, 2020, researchers at The University of Texas at Austin College of Pharmacy released promising study results of a new method to treat the SARS-CoV-2 coronavirus that causes COVID-19. These Texas researchers found the antiviral niclosamide, when incorporated with human lysozyme as a carrier molecule, shows potential as an effective COVID-19 treatment when delivered directly to the airways.
Niclosamide, already U.S. FDA approved for other treatments, may serve as a promising alternative or additional therapy option to remdesivir (Veklury) for the treatment of COVID-19.
“We have demonstrated that administration of niclosamide-lysozyme particles to the airways of mice with established, lethal SARS-CoV-2 infection improves survival, greatly reduces lung tissue damage and significantly reduces viral loads in the lungs, brain, and kidneys,” says Dr. Ashlee Brunaugh, graduate research fellow.
Sep 30, 2020 • 6:40 am CDT
On September 30, 2020, the Russian Direct Investment Fund and the Pharco pharmaceutical groups in Egypt (Biogeneric Pharma) announced an agreement to secure the supply of 25 million doses of the Sputnik V vaccine to Egypt.
This new agreement will enable 25% of Egypt’s population to have access to the Sputnik V vaccine. In the future, it is planned to distribute Sputnik V to neighboring countries, stated this press release.
Sep 30, 2020 • 5:49 am CDT
New Jersey-based Becton, Dickinson, and Company (BD) announced on September 30, 2020, its 15-minute, point-of-care, SARS-CoV-2 antigen test for use on the BD Veritor™ Plus System has been CE marked to the IVD Directive (98/79/EC). BD stated it 'expects commercial availability of this new assay at the end of October 2020 for countries in Europe that recognize the CE mark.'
The BD Veritor Plus System is already in use across Europe to test for conditions such as Group A Strep, influenza A+B, and Respiratory Syncytial Virus.
Sep 30, 2020 • 5:05 am CDT
On Septemeber 30, 2020, the CEO of the Gates Foundation Mark Suzman stated: 'The only way to fully protect one nation is to protect every nation. And countries and companies are stepping up in unprecedented ways to make sure that the tools to fight this disease are available, affordable, and accessible to everyone who needs them.'
Furthermore, 'the Access to COVID-19 Tools Accelerator is the best shot we have for this. Created just 5-months ago, this collaboration is already delivering incredible results.'
As an example, a new agreement announced by the WHO on September 28, 2020, will provide 120 million rapid COVID-19 tests to low-and middle-income countries. With the Global Fund committing an initial US$50 million to enable countries to purchase the new tests.
Sep 30, 2020 • 4:44 am CDT
The metro area of Mumbai was reported by FirstPost on September 30, 2020, to have the highest coronavirus seroprevalence of any city in India, with 57.8% of samples from slums found positive for SARS-CoV-2 antibodies. The virus infection rate decreased to 17.4% for samples collected from non-slum areas.
Additionally, the Indian Council of Medical Research's (ICMR) 2nd nationwide serosurvey for antibodies against SARS-CoV-2, found over 7% of India's adult population seems to have been exposed to the coronavirus before the end of August 2020.
According to data from the ICMR on September 29, 2020, a cumulative total of 7,41,96,729 samples have been tested during 2020.
Sep 29, 2020 • 5:33 am CDT
On September 29, 2020, the Russian Direct Investment Fund (RDIF) announced more than 50 countries in Asia, the Middle East, Latin America, Europe, and the Commonwealth of Independent States have applied for access to the Sputnik V vaccine. The RDIF had announced earlier supply agreements with Mexico for 32 million doses, with Brazil for up to 50 million doses, India for 100 million doses, and Uzbekistan for up to 35 million doses.
Kirill Dmitriev, CEO of the RDIF stated: "... is ready to supply Sputnik V vaccine to countries of the region as novel coronavirus infection is our common enemy which can be defeated only by joining our efforts”.
Post-registration clinical trials of the Sputnik V vaccine involving 40,000 volunteers are currently ongoing with the first results expected to be published in October-November 2020, stated the RDIF press release.
Sep 29, 2020 • 4:10 am CDT
According to a non-peer-reviewed study published on September 21, 2020, the transmission of the SARS-CoV-2 virus in Manaus, located in the Brazilian Amazon, increased quickly during March 2020, and then began to decline. The seroprevalence rate fell due to antibody waning. After correcting for this trend, these researchers estimate a final epidemic size of 66%.
Although non-pharmaceutical interventions and changes in population behavior may have helped to limit SARS-CoV-2 transmission in Manaus, the unusually high infection rate suggests that 'herd immunity' played a significant role in determining the size of the COVID-19 epidemic in Brazil.
As of September 28, 2020, Manaus (pop. of 1.8 million) had reported 4,031 fatalities related to COVID-19 during 2020.
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Sep 29, 2020 • 3:47 am CDT
The World Health Organization (WHO) announced in Geneva on September 28, 2020, a new program to supply low- and middle-income countries (LMICs) with 120 million rapid antigen tests to detect the SARS-CoV-2 virus. WHO Director-General Tedros Adhanom Ghebreyesus, Ph.D., stated the program is vital to LMIC testing capacity.
"These (Abbott and SD Biosensor) tests provide reliable results in approximately 30 minutes, rather than hours or days, at a lower price with less sophisticated equipment."
WHO guidance published on September 11, 2020, highlights the value of these tests in areas where community transmission is widespread and where nucleic acid amplification-based diagnostic testing is either unavailable or where test results are significantly delayed.
Sep 29, 2020 • 3:19 am CDT
The US Centers for Disease Control and Prevention (CDC) COVID Data Tracker published data as of September 28, 2020, indicating there have been 111,348,492 diagnostic tests reported, excluding antibody and antigen tests, performed to confirm if a person has a SARS-CoV-2 coronavirus infection.
Overall, this new CDC data indicates the USA has a virus infection positivity rate of 8% during 2020.
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Sep 29, 2020 • 3:07 am CDT
California based Sorrento Therapeutics, Inc. released preclinical data on September 28, 2020, reporting on COVI-GUARD™ (STI-1499) and COVI-AMG™ (STI-2020; Affinity Matured COVI-Guard) neutralizing antibodies (nAbs) against the SARS-CoV-2 virus, as well as a D614G virus variant infection.
Dr. Slobodan Paessler’s laboratory at the University of Texas Medical Branch at Galveston has generated promising preclinical animal data for STI-1499 and STI-2020 nAbs in a Syrian golden hamster model infected with SARS-CoV-2. Both nAbs demonstrated potent neutralizing activities against SARS-CoV-2 virus infection in preclinical models.
STI-1499 nAb has been cleared by the U.S. FDA for a Phase 1 clinical trial in hospitalized COVID-19 patients. STI-2020 is an affinity-matured version of the COVI-GUARD nAb and has demonstrated a greater than 50-fold increase in potency in vitro experiments.
The potency of both nAbs and their ability to mitigate SARS-CoV-2 infection from the lungs in a Syrian golden hamster model is very impressive, strongly supporting further development of these antibodies,” stated Dr. Henry Ji, CEO of Sorrento, in a press release.
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Sep 28, 2020 • 8:01 pm CDT
The U.S. FDA granted Emergency Use Authorization on September 24, 2020, for Hologic’s Panther Fusion® SARS-CoV-2 test, which identifies the coronavirus causing COVID-19 by testing individuals without symptoms or other reasons to suspect COVID-19 infection. The assay is the first widely available, high-throughput molecular diagnostic test specifically authorized for screening asymptomatic people.
“Accurately identifying individuals early in the course of infection - so they can quarantine before passing on the virus - is critical to stemming the spread of this pandemic,” said Kevin Thornal, president at Hologic, in a September 28, 2020, press statement. “The high accuracy of molecular testing has made it the gold standard for infectious disease detection, and recent data demonstrate that Hologic’s molecular coronavirus tests are among the most sensitive available.”
Hospital, public health, and reference laboratories will run Hologic’s new test on the Panther Fusion systems that are already in wide use across the USA.
