Coronavirus Breaking News

The coronavirus disease COVID-19 is currently reaching pandemic levels in various countries.

Jan 31, 2023 • 12:38 pm CST
WHO Offices 2023

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. 

Jan 31, 2023 • 8:31 am CST
by Thorsten Frenzel

The first randomized, placebo-controlled, single-blind clinical study of Ondine Biomedical Inc.'s Steriwave™ nasal photodisinfection was published in Frontiers in Cellular and Infection Microbiology.

This limited study, announced on January 31, 2023, met its primary endpoint, with a highly significant decrease in viral infectivity recorded as early as two days after treatment (p<0.0001).

Steriwave therapy also significantly improved the immune-protective status of treated patients, as measured by PCR testing one week after treatment (over six times fewer PCR-positive patients compared to controls).

The study was conducted at the Clínica Universidad de Navarra in Spain during the sixth Omicron outbreak in late 2021 and early 2022. Over 90% of the patients recruited into the study were fully vaccinated.

Ondine is seeking to offer a therapeutic approach to those patients who test positive but are not yet symptomatic or to those individuals who have had known exposure to a COVID-19 patient.

Currently, there are no U.S. FDA-approved approaches for killing the coronavirus while it is still located in the nose and throat.

Ondine Biomedical Inc. is a Canadian life sciences company innovating in the field of photodisinfection therapies.

Jan 30, 2023 • 11:19 am CST
from Pixabay

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.

Jan 28, 2023 • 1:08 pm CST
KFF Jan 2023 the Percentage who Currently Have Long COVID is Declining

The Kaiser Family Foundation's (KFF) recent analysis of the Household Pulse Survey says there is still a great deal of uncertainty about long COVID and whether there will be increased long COVID cases.

Estimates of the effects of long COVID on the workforce range from about 500,000 to as many as 4 million people, as of January 26, 2023.

The recent KFF online survey administered by the Centers for Disease Control and Prevention found that the percentage of respondents who have had COVID-19 and currently report long COVID symptoms declined from 19% in June 2022 to 11% in January 2023.

And the share of people who have ever reported long COVID fell from 35% to 28% over the same period.

Among people with long COVID, 79% report having limitations to their day-to-day activities, and 27% characterize the limitations as significant. 

Previously, the Department of Health and Human Services released in August 2022, a National Research Action Plan on long COVID aimed at providing a call to action for public and private researchers to accelerate their work.

And the federal RECOVER initiative aims to understand how people recover and why some people don’t. 

Jan 27, 2023 • 1:22 pm CST
WHO report previous seven days, 16 to 22 January 2023

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.

Jan 27, 2023 • 12:54 pm CST
by Ellie from Pixabay

Roche and its subsidiary TIB Molbiol, recently announced they had developed a COVID-19 PCR test for researchers that detects and differentiates the latest variant of concern, XBB.1.5.

The XBB.1.5 variant is prevalent in the U.S. and is quickly spreading to other countries.

XBB.1.5 is a sub-variant of a SARS-CoV-2 beta coronavirus variant named XBB.

Differentiating emerging variants and understanding their similarities and mutations empowers experts to make predictions about treatment strategies.

The VirSNiP SARS-CoV-2 Spike F486P test is for use on the LightCycler® 480 II and cobas® z 480.

“Roche continues to develop timely diagnostic innovations related to COVID-19 by providing valuable insights - helping scientists and physicians understand this new strain, how it differs from other variants, and the impact it may have on public health,” said Matt Sause, CEO of Roche Diagnostics, in a press release on January 26, 2023.

“Since the start of this global health crisis, Roche has been committed to bringing effective diagnostic solutions to address unmet needs to healthcare communities worldwide.”

The research-use-only test, VirSNiP SARS-CoV-2 Spike F486P, adds to the broad suite of COVID-19 test kits developed by Roche and TIB Molbiol.

In the U.S., the Food and Drug Administration has authorized numerous COVID-19-related tests as of January 27, 2023.

Jan 27, 2023 • 9:51 am CST
by P. Rawny from Pixabay

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.

Jan 26, 2023 • 12:58 pm CST
by Bishnu Sarangi

The Lancet Regional Health South East recently published the results from a peer-reviewed study that determined the safety and immunogenicity of homologous or heterologous boosters with COVISHIELD™ or COVAXIN® vaccines, which are often used in India.

On January 23, 2023, this study found in the COVISHIELD™ primed group, the seropositivity 28 days post booster in the heterologous COVAXIN® arm was 99% and non-inferior to the homologous COVISHIELD™ arm, which was also 99% (difference 0%; 95% CI: −2.8% to 2.7%).

The study's interpretation wrote homologous and heterologous boosting with COVISHIELD™ or COVAXIN® in COVISHIELD™ or COVAXIN® primed individuals are immunogenic and safe.

And a heterologous boost with COVISHIELD™ after COVAXIN® prime offers the best immune response among the four combinations evaluated.

Funding for this study originated from the Azim Premji Foundation and Bill and Melinda Gates Foundation.

Additionally, the Biological E. Limited CorbeVax® vaccine, based on classical protein subunit vaccine technology, has been deployed in India.

And on January 25, 2023, Bharat Biotech's iNCOVACC® novel replication-deficient adenoviral vector-based was commercially launched. iNCOVACC is an intranasal vaccine that stimulates a broad immune response neutralizing IgG, mucosal IgA, and T cell responses.

Jan 24, 2023 • 8:40 am CST
by Michal Jarmoluk

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.

Jan 23, 2023 • 4:31 pm CST
by F1 Digitals

According to an Original Investigation published in the JAMA Network Open on January 20, 2023, about 41% of adults with impaired immune systems had received a 4th mRNA vaccine dose.

And less than 1% had received the recommended five doses as of August 2022.

'Our results highlight a substantial gap in adherence to CDC recommendations for mRNA monovalent COVID-19 booster doses,' wrote these researchers.

Certain types of immunocompromising conditions reported a higher probability of 4th-dose receipt, including organ transplant, congenital immunodeficiency, HIV/AIDS, and chemotherapy.

The study authors wrote that many Americans were confused about vaccination recommendations because COVID-19 vaccination guidelines often changed during the pandemic.

"Given the increased risk for severe COVID-19 in this vulnerable population and the well-established additional protection afforded by booster doses, targeted and tailored efforts to ensure that immunocompromised individuals remain up to date with COVID-19 booster dose recommendations are warranted," the researchers wrote.

This study was sponsored by Pfizer, a company producing mRNA vaccines. Corresponding Author: Sara Y. Tartof, Ph.D., MPH, Department of Research and Evaluation, Kaiser Permanente Southern California (sara.y.tartof@kp.org).

Jan 20, 2023 • 2:37 pm CST
by Gerd Altmann

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.

Jan 20, 2023 • 1:08 pm CST
from Pixabay

Reuters recently reported a World Health Organization (WHO) committee is scheduled to meet on January 27, 2023, to consider whether the COVID-19 pandemic still represents a global emergency.

This Emergency Committee advises WHO Director-General Tedros Adhanom Ghebreyesus, who determines if an outbreak represents a Public Health Emergency of International Concern. 

In addition to COVID-19, the recent Mpox, Ebola, and Polio outbreaks have been declared emergencies by the WHO.

The WHO posted a podcast explaining how the WHO decides that an outbreak or an event constitutes a Public Health Emergency of International Concern. And what actions does that trigger in countries?

Jan 20, 2023 • 11:21 am CST
WHO COVID-19 Pandemic Update Edition 126 (Jan. 19, 2023)

Globally, the World Health Organization (WHO) reported Edition #126 that nearly 2.8 million new cases and over 13,000 related fatalities were reported in early January 2023.

Moreover, these amounts decreased by 7% and increased by 20%, respectively, compared to the previous 28 days, as of January 19, 2023.

At the regional level, the number of newly reported weekly cases decreased or remained stable across five of the WHO regions: the African Region (-40%), the European Region (-35%), the South-East Asia Region (-17%), the Region of the Americas (-12%), and the Western Pacific Region.

While case numbers increased in the Eastern Mediterranean Region (+6%). 

This WHO update includes cases and fatalities reported by China through the International Health Regulations as of January 15, 2023, but does not include COVID-19-related fatalities for the period of December 8, 2022, to January 12, 2023, as the WHO awaits detailed provincial data disaggregated by a week of reporting.

 

Jan 16, 2023 • 10:01 am CST
from Pixabay

Clover Biopharmaceuticals, Ltd. today provided updates on the commercial launch for SCB-2019 (CpG 1018/Alum) in China in multiple provinces and municipalities, expected to begin in Q1 2023.

Given the scale and impact of the ongoing COVID-19 outbreaks across China, Clover now anticipates a significant and sustained long-term annual booster market opportunity in China for Clover’s premium and broadly protective COVID-19 vaccine.

“Clover transformed into a commercial-stage, vaccines-focused biotech company with proven R&D capabilities in 2022. In 2023, we are focused on launching our vaccine in multiple countries and working with health authorities in China and globally to increase booster coverage for vulnerable populations,” said Joshua Liang, Chief Executive Officer and Executive Director of Clover, in a press release on January 15, 2023.

“We also plan to expand our mid- to late-stage vaccine pipeline for near-term value creation by leveraging our established vaccine development and proven cross-border collaboration capabilities.”

Concurrent with its commercial launch in China, Clover plans to conduct real-world effectiveness studies, with data potentially available in H2 2023.

These studies could provide valuable insight into preventing severe disease, hospitalization, and death due to COVID-19 caused by newly circulating Omicron variants in at-risk populations.

This data can strengthen SCB-2019’s commercial value and competitive positioning.

Dr. Nicholas Jackson, President of Global Research and Development of Clover. “We are excited to share our development plans to build a leading respiratory vaccine franchise and establish a presence in the pediatric vaccine market in China and the Asia Pacific, further strengthening Clover’s competitive advantages and contribution to global health.”

Jan 14, 2023 • 3:36 pm CST
by Sang Hyun Cho

The State of Kentucky recently announced a panel of the Sixth Circuit U.S. Court of Appeals affirmed a lower court's ruling that said vaccine mandates were unconstitutional. The mandate requires workers contracting with the federal government to wear face masks and be vaccinated for COVID-19.

A federal judge in Louisville, Kentucky, blocked the U.S. government's rule in November 2021 for Kentucky, Tennessee, and Ohio.

"The Sixth Circuit's decision is a resounding victory against federal overreach into the personal medical decisions of Kentuckians," Kentucky Attorney General Daniel Cameron said in a statement on January 12, 2023.

The Fifth Circuit U.S. Court of Appeals issued a similar ruling for Indiana, Louisiana, and Mississippi in December 2022.

The U.S. Centers for Disease Control and Prevention (CDC) says certain workers are at risk for exposure to severe and sometimes fatal diseases.

If you work directly with patients or handle material that could spread infection, you should get appropriate vaccines to reduce the chance that you will get or spread vaccine-preventable diseases.

And protect yourself, your patients, and your family members by ensuring you are up-to-date with recommended vaccines, including COVID-19, says the CDC.