Coronavirus Breaking News

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

Jan 14, 2023 • 1:32 pm CST
by Michael Gaida from Pixabay

Earlier today, WHO Director-General Dr. Tedros Adhanom Ghebreyesus spoke to the director of China’s National Health Commission, Minister Ma Xiaowei.

The WHO confirmed in a media statement on January 14, 2023; it appreciates this telephonic meeting and the public release of information about the pandemic in the country.

Chinese officials provided information to WHO and in a press conference on various topics, including outpatient clinics, hospitalizations, patients requiring emergency treatment and critical care, and hospital deaths related to COVID-19 infection.   

WHO is analyzing this information, which covers early December 2022 to January 12, 2023, and allows for a better understanding of the epidemiological situation and the impact of this wave in China.

The overall epidemiology—reflecting a rapid and intense wave of disease caused by known sub-variants of Omicron with higher clinical impact on older people and those with underlying conditions—is similar to waves of infection experienced by other countries, as is the increased pressure on health services.

Nevertheless, the reported data indicate a decline in case numbers, hospitalizations, and those requiring critical care.

The WHO has requested a more detailed breakdown of data by province over time.   

While the Chinese Center for Disease Control and Prevention has earlier reported that Omicron sublineages BA.5.2 and BF.7 are currently circulating, WHO continues to ask that other sequences be shared with open access databases such as GISAID for deeper phylogenetic analyses and continued collaboration with technical groups working on virus evolution, clinical care, and beyond.

The WHO stated it would continue to work with China, providing technical advice and support and analyzing the situation. 

Note: The unedited, complete media statement is available at this WHO link.

Jan 14, 2023 • 6:36 am CST
by Ahmed Gomaa

Every time a serious new COVID-19 virus variant emerges, Gilead Inc. virologists Charlotte Hedskog and John Bilello, alongside their teams, mobilize as so-called "variant hunters."

They aim to determine whether COVID-19 therapeutics will remain active against new strains. The process demands perseverance and collaboration, as the results broadly affect treating people worldwide with COVID-19.

"It can be a challenging process for sure as some variants are harder to find," says Charlotte, Senior Research Scientist on the Clinical Virology team, in a media release on January 12, 2023.

But the teams of experts are up to the task. Since COVID-19 began to emerge and spread globally in late 2019 and early 2020, scientists have tested more than 15 genetic variants of SARS-CoV-2, which causes COVID-19.

"This is a process that involves many people with a commitment to collaboration - internally and externally," says John, Director of Virology, who leads the COVID-19 Discovery Virology team. "We all rely on each other to find these isolates and identify which ones to go after."

The full unedited news article is posted at this link.

Jan 12, 2023 • 5:00 am CST
by Gerd Altmann

The World Health Organization (WHO) Emergency Committee announced it is scheduled to meet on January 27, 2023, to debate whether the SARS-CoV-2 coronavirus pandemic remains represents a public health emergency on a global level or not.

This committee advises WHO Director-General Tedros Adhanom Ghebreyesus, who is responsible for making this decision, reported Livemint.

According to recent data published by the WHO, the pandemic has been decreasing in most countries.

On January 11, 2023, the WHO Weekly Epidemiological Report Edition 125 data shows another reduction in COVID-19 cases and fatalities of 9% and 12%, respectively.

 

 

Jan 11, 2023 • 11:53 am CST
WHO Situation Update Edition 125 Jan. 11, 2023

The World Health Organization (WHO today issued a Rapid Risk assessment regarding the XBB.1.5 coronavirus variant. The XBB.1.5 variant is a sublineage of XBB, which is a recombinant of two BA.2 sublineages.

Based on its genetic characteristics and early growth rate estimates, XBB.1.5 may contribute to increases in case incidence.

As of January 11, 2023, the WHO stated in a media release that the overall confidence in the assessment is low, as growth advantage estimates are only from one country, the United States of America (USA).

From October 22, 2022, to January 11, 2023, 5,288 sequences of the Omicron XBB.1.5 variant have been reported from 38 countries.

Most of these sequences are from the USA (82.2%), the United Kingdom (8.1%), and Denmark (2.2%).

Globally, nearly 2.9 million new COVID-19 cases and over 11,000 related fatalities were reported for the week ending January 8, 2023.

This Edition 125 data represents a reduction in weekly cases and deaths of 9% and 12%, respectively, reported the WHO on January 11, 2023.

Jan 10, 2023 • 3:23 pm CST
by Yann from Pixabay

Butantan Institute today announced the CoronaVac® Covid-19 received the definitive registration of use granted by the Hong Kong Department of Health on December 22, 2022. 

As a result, the immunizer was definitively registered in Asian territory as a pharmaceutical product for use from the age of three, following the rules of the Pharmacy and Poisons Board.

The Hong Kong Government announced earlier that a total of the three types of COVID-19 vaccines (Comirnaty ancestral strain vaccine (30 micrograms/dose), Comirnaty bivalent vaccine, and CoronaVac vaccine are being supplied in Hong Kong by two drug manufacturers, namely Fosun Pharma and Sinovac.

"The official registration of COVID-19 vaccines provided in Hong Kong reflects that the relevant vaccines are safe and efficacious and that the relevant supporting data is sufficient."

"Nevertheless, we call upon members of the public who have not yet received suitable doses of vaccine to get the suitable doses as soon as possible for self-protection, in particular high-risk persons such as the elderly and the young," the spokesman added in a press release.

Around the world, about 3 billion doses of CoronaVac have already been distributed in more than 60 countries. 

The vaccine was the first against Covid-19 to be applied to Brazilians, with 112 million doses delivered by Butantan by the beginning of 2023.

Jan 10, 2023 • 12:11 pm CST
by Markus Winkler from Pixabay

There are several new scientific developments regarding COVID-19 that might be useful to you for navigating the pandemic, wrote Katelyn Jetelina, Ph.D., an epidemiologist trying to make sense of this pandemic world.

All stem from different COVID-19 "story threads" I've written before. So, a quick round-up was posted by Jetelina at this substack link.

Separately, the U.S. CDC's Data Tracker publishes various information that is perpetually updated.

And the WHO publishes weekly epidemiological updates (Jan. 4, 2023) on the ongoing COVID-19 pandemic.

Jan 10, 2023 • 10:11 am CST
by Walkerssk from Pixabay

New research indicates the coronavirus that caused COVID-19 has been found on airplanes once again reported The Star on January 2, 2023.

According to the National Public Health Laboratory Malaysia, scientists who analyzed wastewater samples from 29 flights arriving in Kuala Lumpur from June through December 2022 found the SARS-CoV-2 coronavirus in 28 of them.

To mitigate this risk, the Malaysian Ministry of Health announced that effective December 30, 2022, all travelers arriving in Malaysia would be required to undergo testing as supplementary surveillance to identify countries at risk for spreading the SARS-CoV-2 virus. 

For U.S. citizens visiting Malaysia, the local U.S. Embassy publishes updated COVID-19 information.

Jan 10, 2023 • 7:01 am CST
WHO weekly report Jan. 2023

The World Health Organization (WHO) recently confirmed more than 3 million new COVID-19 cases and 10,000 related fatalities had been reported from December 26, 2022, to January 1, 2023.

This represents a reduction in weekly cases and deaths of 22% and 12%, respectively.

As of January 1, 2023, over 656 million confirmed cases and over 6.6 million fatalities had been reported globally since the pandemic began in 2020.

The WHO's full epidemiological update is posted at this link.

Jan 10, 2023 • 6:27 am CST
by NeShea Jenifer

Ocugen Inc. announced positive results from the Phase 2/3, an observer-blind, immuno-bridging, and broadening the study of the COVID-19 vaccine, COVAXIN™.

Invented by Bharat Biotech in India, COVAXIN (BBV152) is a whole-virion inactivated COVID-19 vaccine that uses the same vero cell manufacturing platform used in the production of polio vaccines for decades.

This study enrolled 419 U.S. adult participants that were randomized 1:1 to receive two doses of COVAXIN™ or placebo, 28 days apart.

Approximately 24% of tested participants in the U.S. were vaccine-naïve.

COVAXIN was found to be well-tolerated in vaccine-naïve individuals and individuals previously vaccinated with mRNA vaccines in the U.S., with no vaccine-related serious adverse events, thrombotic events, or cases of myocarditis or pericarditis

Blinded safety data are also available for one month following vaccination.

There were no deaths related to potential immune-mediated medical conditions. 

“The successful completion of this study represents an important milestone to the ongoing management of COVID-19,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen, in a press release on January 9, 2023.

“Given that a portion of the public remains hesitant to receive mRNA vaccines, this COVID-19 vaccine ... may provide an important additional vaccine option.”

COVAXIN is currently approved for adults in India and authorized under emergency use in 25 countries, with more than 350 million doses administered to adults outside the U.S.

And COVAXIN is listed by the World Health Organization but not approved by the U.S. Food and Drug Administration as of January 10, 2023.

Jan 3, 2023 • 9:47 am CST
by Leopold Böttcher

RedHill Biopharma Ltd. today announced the publication of positive data from a Phase 2 study of once-daily oral investigational RHB-107 (upamostat) in non-hospitalized symptomatic COVID-19 patients.

The peer-reviewed International Journal of Infectious Diseases published the study's results that showed RHB-107 successfully met the primary endpoint of safety and tolerability and delivered promising efficacy results, including faster recovery from severe COVID-19 symptoms and 100% reduction in hospitalization due to COVID-19.

"It is highly satisfying to see this study and the exciting results it produced published in this important journal. These data, achieved despite a small overall sample size, are impressive. Showing both safety and efficacy signals, in a highly convenient once-daily oral therapy, positively positions investigational RHB-107 as a potentially very useful treatment for COVID-19 outpatients to reduce symptom severity and prevent disease progression and hospitalization," said Terry F. Plasse MD, Medical Director at RedHill, in a press release on January 3, 2022.

"Given the growing awareness of the limitations of existing options for early treatment of COVID-19, it is vital that we do not stop our efforts to bring new options forward – especially those in which we have already observed broad-acting, host-directed variant-agnostic abilities."

Study data showed a 100% reduction in hospitalization due to COVID-19, with zero patients (0/41) on the RHB-107 arms versus 15% (3/20) hospitalized on the placebo-controlled arm (nominal p-value=0.0317).

The study also showed an approx. 88% reduction in reported new severe COVID-19 symptoms after treatment initiation, with only 2.4% of the RHB-107 treated group (1/41) versus 20% (4/20) of patients in the placebo-controlled arm (nominal p-value=0.036) reporting new severe COVID-19 symptoms.

Further analysis showed faster recovery from severe COVID-19 symptoms with a median of 3 days to recovery with upamostat vs. eight days with placebo.

The company also announced advanced discussions are ongoing regarding the inclusion of once-daily oral RHB-107 in a multinational platform trial for COVID-19 outpatients.

And discussions for external non-dilutive funding for Phase 3 COVID-19 development, in addition to the platform study, are also advancing.

Dec 15, 2022 • 3:08 pm CST
WHO

Globally, the number of new weekly COVID-19 cases remained stable (+2%) during early December 2022 compared to the previous week, reported the World Health Organization (WHO).

As of December 14, 2022, the WHO reported over 3.3 million new cases last week.

At the regional level, the number of newly reported weekly cases decreased or remained stable across five of the six WHO regions: African Region (-73%), South-East Asia (-33%), European (-11%), Eastern Mediterranean (-2%), and the Western Pacific Region (+3%).

While case numbers increased in one WHO region: the Region of the Americas (+27%). 

Furthermore, the number of new weekly fatalities increased by over 10% compared to the previous week, with over 9,700 new fatalities reported.

As of December 11, 2022, the WHO says there have been over 645 million confirmed cases and over 6.6 million fatalities reported globally during the pandemic.

Updated COVID-19 vaccine, antibody, and antiviral news are posted at CoronavirusToday.

Dec 14, 2022 • 3:10 pm CST
by Kanenori

Shionogi & Co., Ltd. announced that Shionogi has entered into an additional purchasing contract of Xocova® with the Ministry of Health, Labour, and Welfare (MHLW) on December 12, 2022.

Xocova is an oral antiviral agent administered once daily for five days that suppresses the replication of the SARS-CoV-2 beta coronavirus by selectively inhibiting the viral 3CL protease.

The company says Xocova is the first antiviral agent in Japan to show clinical symptomatic efficacy for five typical Omicron-related symptoms and antiviral efficacy in patients with mild to moderate SARS-CoV-2 infection, regardless of risk factors or vaccination status during the Omicron-dominant phase of the epidemic. 

This contract is for the Japanese government to purchase additional Xocova tablets for 1 million courses.

As stated in the recent administrative notice of the MHLW, beginning December 15, 2022, medical institutions and pharmacies selected by each prefecture will be able to prescribe and prepare Xocova®.

Shionogi's press release indicates plans to deliver this additional quantity by the end of 2022.

Since Xocova received emergency approval in Japan in November 2022, Shionogi will diligently collect clinical safety information and promptly provide that information to medical institutions.

Additional oral antiviral news targeting SARS-CoV-2 is posted at CoronavirusToday.com/Antivirals.

Dec 10, 2022 • 8:29 am CST
PublicDomainPictures

The French National Authority (HAS) for Health issued a favorable opinion on the booster use of the new adjuvanted VidPrevtyn® Beta vaccine from Sanofi/GSK.

HAS recalled on December 8, 2022, that the protection provided by COVID-19 vaccines diminishes over time.

HAS calls for action: the booster should be carried out now to produce its full effect for the holiday season.

HAS thus recalls that the administration of this additional dose (regardless of the number of doses already administered previously) is recommended three months after the last booster for people over 80 and immunocompromised and six months for all others: people over 60, those under 60 who have comorbidities, pregnant women, as well as those around them. 

If a person has been infected with SARS-CoV-2, this reminder must be done at least three months after infection.

They note that to date, only 23% of people aged 80 and over and 38% of people aged 60-79 are sufficiently protected.

On November 10, 2022, the European Commission granted marketing authorization to VidPrevtyn® Beta.

An independent public authority of a scientific nature, HAS aims to develop quality in the health, social and medico-social fields for the benefit of people.

Dec 8, 2022 • 10:19 am CST
by Kevin Lopez

The U.S. Food and Drug Administration today announced it amended the emergency use authorizations of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children as young as six months of age.

“Based on available data, the updated, bivalent vaccines are expected to provide increased protection against COVID-19,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a press release on December 8, 2022.

“Parents and caregivers can be assured that the FDA has taken a great deal of care in our review, and we encourage parents of children of any age who are eligible for primary vaccination or a bivalent COVID-19 vaccine booster dose to consider seeking vaccination now as it can potentially help protect them from COVID-19 during a time when cases are increasing.”

For the authorization of a single booster dose of the Moderna COVID-19 Vaccine, Bivalent for children six months through 5 years of age, the FDA relied on immune response data that it had previously evaluated from a clinical study in adults. 

In addition, the FDA analyzed data from a clinical study that compared the immune response among 56 study participants 17 months through 5 years of age who received a single booster dose of monovalent Moderna COVID-19 Vaccine at least six months after completion of a two-dose primary series of the vaccine to the immune response among approximately 300 study participants 18 through 25 years of age who had received a two-dose primary series of monovalent Moderna COVID-19 Vaccine in a previous study which determined the vaccine to be effective in preventing COVID-19.

The immune response to the booster dose of the monovalent Moderna COVID-19 Vaccine in the 17 months through 5 years age group was comparable to the immune response to the two-dose primary series in the adult participants. 

With today’s action, the monovalent Pfizer-BioNTech COVID-19 Vaccine is no longer authorized as the third dose of the three-dose primary series in children six months through 4 years of age.

The amended authorizations were issued to Moderna TX Inc. and Pfizer Inc.

Dec 6, 2022 • 11:58 am CST
by Gerd Altmann

Sorrento Therapeutics, Inc. announced today it received clearance from the U.S. FDA to initiate clinical trials with STI-1557, its next-generation mRNA vaccine against SARS-CoV-2 Omicron variants.

This mRNA vaccine candidate incorporates a mutation in the furin cleavage site that prevents the S1 subunit cleavage from the spike protein from anchoring on the muscle cell membrane.

The modification was introduced to prevent the leakage of the S1 subunit from the expressed spike protein (S protein) into the blood circulation, which is known in part to potentially cause undesirable side effects in vital organ tissues following the administration of the current FDA-approved mRNA vaccines.

The mRNA is encapsulated in a Sorrento proprietary lipid nanoparticle formulation to protect mRNAs from degradation and enable the potent translation of the S protein in host cells after intramuscular delivery, thus inducing an adaptive immune response.

The preclinical work that supported this investigational new drug application was published online in Molecular Therapy Nucleic Acids on November 3, 2022, a Cell Press partner journal, and will appear in the December 2022 print issue.

Additional COVID-19 vaccine news is posted at CoronavirusToday.com/Vaccines.