Coronavirus Breaking News

The World Health Organization (WHO) Weekly Epidemiological Update #128 overviews the global, regional, and country-level COVID-19 cases and related fatalities.

Epidemiologic trends in recent weeks have been dominated by data from the Western Pacific Region, notably in China.

Globally, nearly 20 million new COVID-19 cases and over 114,000 fatalities were reported in the last 28 days (Jan. 29, 2023), a decrease of 78% and an increase of 65%, respectively, compared to the previous 28 days.

And the Region of the Americas reported about 2.4 new cases in the last 28 days, a 35% decrease compared to the previous period.

Additionally, the CDC COVID Data Tracker continues reporting decreases in cases in the U.S. as of February 3, 2023.

Since the pandemic began in late 2019, over 753 million confirmed cases and over 6.8 million fatalities had been reported by the WHO.

The WHO Director-General today announced the Report from the fourteenth meeting of the International Health Regulations (2005) (IHR) Emergency Committee regarding the COVID-19 pandemic, which took place held on January 27, 2023.

Dr. Tedros Adhanom Ghebreyesus, the Director-General, acknowledged the Committee’s views that the COVID-19 pandemic is probably at a transition point and appreciates the advice of the Committee to navigate this transition carefully and mitigate the potential negative consequences.

Achieving higher levels of population immunity globally, either through infection and/or vaccination, may limit the impact of SARS-CoV-2 on morbidity and mortality, but there is little doubt that this virus will remain a permanently established pathogen in humans and animals for the foreseeable future.

However, the WHO Director-General determined that the event continues to constitute a public health emergency of international concern.

The Committee was informed that, globally, 13.1 billion doses of COVID-19 vaccines have been administered, with 89% of health workers and 81% of older adults (over 60 years) having completed the primary series.

Valeo Pharma Inc. recently announced that Health Canada has accepted for review of Veru’s New Drug Submission (“NDS-CV”) for sabizabulin for treating COVID-19 patients.

Sabizabulin is a novel dual antiviral and anti-inflammatory agent being developed for treating hospitalized moderate to severe COVID-19 adult patients at high risk for acute respiratory distress syndrome (ARDS) and death.

“Health Canada’s filing acceptance of NDS-CV application for sabizabulin is the first important regulatory milestone in the drug approval process. Given the current number of hospitalized COVID-19 patients and the burden on provincial healthcare systems, there is a need to continually seek innovative treatment options,” said Steve Saviuk, CEO, in a press release on January 26, 2023.

“We will continue working closely with Veru to ensure, if approved, access to sabizabulin at the earliest possible time.”

In the final analysis of the Phase 3 clinical study conducted by Veru Inc., sabizabulin showed a 51.6% reduction in deaths compared to placebo in hospitalized adult patients with moderate to severe COVID-19 at high risk for ARDS. Sabizabulin also showed a significant decrease in days in an ICU, days on mechanical ventilation, and days in the hospital.

As of January 30, 2023, Health Canada has approved various COVID-19 therapies.

The World Health Organization (WHO) recently reported (Edition 127) that over the last 28 days, over 11 million COVID-19 cases were reported globally, a decrease of 25%, compared to the previous 28 days.

As of January 22, 2023, over 664 million cases had been confirmed during the pandemic that started in late 2019.

However, remarks shared by the WHO's Director-General on January 27, 2023, at the 14th session of the Emergency Committee on the COVID-19 pandemic, indicate case reporting will soon expand to include data from China.

'When you last met in October 2022, the number of weekly reported deaths was near the lowest since the pandemic began – less than 10 thousand a week.

However, since the beginning of December 2022, the number of weekly reported deaths globally has been rising.

Last week, almost 40 thousand deaths were reported to WHO, more than half of them from China.

Today we will update our COVID-19 dashboard to incorporate cases and deaths reported by China in recent weeks.

In total, over the past eight weeks, more than 170 thousand deaths have been reported, stated Dr. Tedros Adhanom Ghebreyesus.

Additional WHO information is posted at this link.

The U.S. Food and Drug Administration (FDA) today announced it revised the Emergency Use Authorization for Evusheld™ to limit its use to when the combined frequency of non-susceptible SARS-CoV-2 coronavirus variants nationally is less than or equal to 90%.

According to the most recent CDC Nowcast data, these variants are projected to be responsible for more than 90% of current infections in the U.S.

Based on the revision on January 26, 2023, Evusheld is not currently authorized for use in the U.S. until further notice by the FDA.

This means that Evusheld is not expected to protect against developing COVID-19 if exposed to those variants.

The FDA stated it would provide further updates and consider additional action as new information becomes available. Any updates will be made available on FDA's website.

Evusheld remains authorized in Europe and other countries.

AstraZeneca's Evusheld is a Long-Acting antibody combination that protects people from developing COVID-19. It contains infection-fighting proteins, called monoclonal antibodies (mAbs), that stop the coronavirus from entering the body's cells and causing infection.

mAbs are laboratory-made proteins that mimic the immune system's ability to fight off harmful pathogens such as viruses, like SARS-CoV-2.

Dyadic International, Inc. today announced that it has initiated dosing in its Phase 1 clinical trial to demonstrate clinical safety and antibody response in humans for the DYAI-100 COVID-19 recombinant protein receptor binding domain booster vaccine candidate.

DYAI-100 is a C1-SARS-CoV-2 recombinant protein RBD vaccine produced using the Company's C1 platform.

Dyadic's lead technology, C1-cell protein production platform, is based on an industrially proven microorganism (named C1), which is currently used to speed development, lower production costs, and improve the performance of biologic vaccines and drugs at flexible commercial scales for the human and animal health markets.

Mark Emalfarb, President and CEO of Dyadic, stated in a press release on January 24, 2023, "The results from this first in human clinical trial are expected to accelerate the adoption of the C-1 protein production platform for both vaccine and therapeutic candidates."

"We continue to believe that the use of our industrially proven, highly productive C1 protein production platform to manufacture the recombinant protein antigen used in DYAI-100 represents a novel, highly efficient, and economical approach to rapidly manufacture large quantities of vaccines,” Mr. Emalfarb concluded.

A U.S.-based biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases recently announced that its protein-based COVID-19 vaccine gained another approval.

Novavax, Inc. confirmed on January 18, 2023, that its partner SK bioscience had received expanded approvals from the Korean Ministry of Food and Drug Safety (KMFDS) for Nuvaxovid™ (NVX-CoV2373) as a protein-based booster for active immunization to prevent COVID-19 in adults.

"We are pleased to collaborate with SK bioscience to offer our protein-based vaccine, Nuvaxovid, for use as a booster in adults regardless of previous vaccine history," said Stanley C. Erck, President and Chief Executive Officer, Novavax, in a related press release.

"This is an important step in ensuring broad access to diversified vaccine options."

The vaccine was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

Nuvaxovid contains purified protein antigen and can neither replicate nor can it cause COVID-19.

Novavax' COVID-19 vaccine is now authorized as a booster in more than 35 countries, and several others have policy recommendations allowing the use of the vaccine as a booster dose.

This COVID-19 was approved by the U.S. Food and Drug Administration in 2022, but not the Nuvaxovid brand. It is also approved by the European Medicines Agency and European Commission and under the Serum Institute of India Pvt. Ltd. CovoVax™ brand.