Coronavirus Breaking News

According to new data published today by the Pan American Health Organization (PAHO), the Region of the Americas reported 3,113,022 arboviral disease cases in 2022.

Of those cases, 90.1 % were dengue, 8.7 % were chikungunya, and 1.2 % were Zika virus.

Regarding related fatalities, dengue infections produced 1,289 deaths, chikungunya was 87, and Zika produced 2 deaths last year.

It is worth noting that in 2022 dengue peaked at week #17, whereas chikungunya peaked in week #18, and the Zika virus circulation was more robust in the first semester.

Country-specific data on case counts and completeness can be found at https://www.paho.org/plisa.

While dengue has two approved preventive vaccines available in certain countries, chikungunya and Zika candidates remain in various stages of human clinical trials as of January 26, 2023.

TG Therapeutics, Inc. today announced the commercial launch of BRIUMVI™, for treating relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.   

BRIUMVI is the first and only anti-CD20 monoclonal antibody (mAbs) approved for patients with RMS that can be administered in a one-hour infusion following the starting dose.

BRIUMVI targets a unique epitope on CD20-expressing B-cells and was designed to lack specific sugar molecules normally expressed on the antibody.

Removing these sugar molecules, a process called glycoengineering allows for efficient B-cell depletion at low doses.

BRIUMVI was approved by the U.S. Food & Drug Administration based on data from Phase 3 trials, which demonstrated superiority over teriflunomide in significantly reducing the annualized relapse rate (the primary endpoint), the number of T1 Gd-enhancing lesions and the number of new or enlarging T2 lesions.

Michael S. Weiss, the Company's Chairman and CEO stated in a press release on January 26, 2023, "Our team has been working hard to make BRIUMVI available as quickly as possible, and we are pleased to announce that BRIUMVI is now available to healthcare providers and patients."

"We continue to be highly focused on ensuring patients who benefit from BRIUMVI can easily access treatment."

RMS is a chronic demyelinating disease of the central nervous system. It includes people with relapsing-remitting multiple sclerosis and people with secondary progressive multiple sclerosis who continue to experience relapses.

The results from the ULTIMATE I & II trials were published on August 25, 2022, in The New England Journal of Medicine.

The launch of BRIUMVI includes an extensive patient support program designed to support patients through their treatment journey. More information about the BRIUMVI Patient Support program can be accessed at www.briumvi.com.

TG Therapeutics was founded with one goal in mind—to leverage scientific advances in B-cell biology to develop novel treatments for patients.

EverGlade Consulting today announced that Sabin Vaccine Institute successfully secured up to $214 million in funding from the U.S. government to advance the development and production of single-dose vaccine candidates for Ebola Sudan and Marburg virus diseases.

Currently, no licensed vaccines against either virus cause hemorrhagic fever and kill approximately half the people infected.

There are U.S. Food and Drug Administration-approved vaccines for a different ebolavirus known as Zaire.

BARDA, part of the U.S. Department of Health and Human Services' Administration for Strategic Preparedness and Response, will initially invest $35 million to produce up to 100,000 doses of the ChAd3-SUDV Ebola Sudan virus vaccine candidate.

These vaccines may be part of ongoing U.S. preparedness efforts and response to future global outbreaks.

The contract also includes funding to manufacture Sabin's Marburg virus vaccine, ChAd3-MARV, which will generate doses that could be used in trials and response to a future Marburg virus outbreak.

Andrew Stiles, Principal at EverGlade, said in a press release on January 25, 2023, "The recent Ebola Sudan outbreak in Uganda emphasized the critical need for better preparedness."

The initial Ebola virus disease (EVD) case first appeared in 1976.

The recent Sudan Ebolavirus outbreak in the Republic of Uganda was declared on September 20, 2022, and was declared ended in early 2023.

Detailed ebola vaccine information is posted at PrecisionVaccinations.com/Ebola.

Peru's Culture Ministry website recently posted a notice that it had closed the country's most famous tourist attraction "to protect the safety of tourists and the population in general."

As of January 21, 2023, the 15th-century ancient ruins of Machu Picchu were not accepting future visitors to this mountaintop site, as the train service was recently closed.

There are a number of hiking routes along the Inca Trail to reach Machu Picchu, however, it takes about five days to reach the top.

Traditionally, over 2,000 people visit Machu Picchu daily.

Machu Picchu is located in the Eastern Cordillera of southern Peru on a 2,430-meter mountain ridge.

Cusco, Peru, where Machu Picchu is located, has been the site of some civil unrest in 2023.

The local airport, Alejandro Velasco Astete, was closed recently.

But, flights are expected to resume at Arequipa's Alfredo Rodriguez Ballon International Airport on January 26, 2023. According to the U.S. Embassy Peru, U.S. citizens should contact the appropriate airline for flight rescheduling.

For emergencies involving American citizens in Peru, please email [email protected] or call +51-1-618-2000. And U.S. citizens are advised to register in STEP to receive alerts and messages from the U.S. Embassy in Lima.

The JAMA Network Open recently published an Original Investigation that found 41% of adults with impaired immune systems had received a 4th mRNA vaccine dose.

However, only 1% had received their recommended 5th dose

'Our results highlight a substantial gap in adherence to recommendations for mRNA monovalent COVID-19 booster doses,' wrote these researchers on January 20, 2023.

"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 added.

Immunocompromised individuals (i.e., persons with immunocompromising conditions or who are taking immunosuppressive medications) often mount weaker immune responses to vaccines and experience higher rates of vaccine failure compared with immunocompetent individuals.

As of January 2023, both the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention have progressively amended COVID-19 vaccine authorizations and recommendations to include additional COVID-19 vaccine doses for immunocompromised individuals.

Disclosures: Pfizer, a company producing mRNA vaccines, sponsored his study. Corresponding Author: Sara Y. Tartof, Ph.D., MPH, Department of Research and Evaluation, Kaiser Permanente Southern California ([email protected]).

HUTCHMED Limited today announced it entered into an exclusive license agreement with a subsidiary of Takeda Pharmaceutical Company Limited to further the global development, commercialization, and manufacture of fruquintinib.

Fruquintinib is orally administered and has the potential to be used across subtypes of metastatic colorectal cancer (“CRC”), regardless of biomarker status.

It is a highly selective and potent inhibitor of vascular endothelial growth factor receptors -1, -2, and -3.

CRC is a type of cancer that starts in either the colon or rectum.

Although early-stage CRC can be surgically resected, metastatic CRC remains an area of high unmet need with poor outcomes and limited treatment options. 

HUTCHMED confirmed on January 23, 2023, it will receive up to US$1.13 billion, including US$400 million upfront on closing, as well as potential regulatory, development, and commercial sales milestone payments, plus royalties on net sales.

“Fruquintinib has the potential to change the treatment landscape for patients with refractory metastatic CRC who need additional treatment options. We look forward to utilizing our development and commercial capabilities to expand the potential of this innovative medicine to patients beyond China,” commented Teresa Bitetti, President of the Global Oncology Business Unit at Takeda, in a related press release.

Positive results of FRESCO-2, the global Phase III multi-regional clinical trial of fruquintinib in refractory metastatic CRC, were presented at the European Society for Medical Oncology Congress in September 2022. FRESCO-2 met its primary endpoint of improving overall survival in patients with metastatic CRC and was generally well tolerated.

According to the International Agency for Research on Cancer, CRC is the third most prevalent cancer worldwide, associated with more than 935,000 deaths in 2020.

In the U.S., an estimated 155,000 patients were diagnosed with CRC, and there were 54,000 related fatalities.

HUTCHMED stated it would continue to focus on progressing late-stage clinical trials and the commercialization of fruquintinib in mainland China in collaboration with Eli Lilly and Company, where it is approved under the brand name ELUNATE® for the treatment of patients with metastatic CRC who have been previously treated with fluoropyrimidine, oxaliplatin, and irinotecan, including those who have previously received anti-vascular endothelial growth factor therapy and/or anti-epidermal growth factor receptor therapy (RAS wild type).

ELUNATE has been included in the China National Reimbursement Drug List since January 2020 and was commercially launched in China in November 2018.

The Pan American Health Organization (PAHO) recently reported that since the initial cholera cases (Vibrio cholerae O1) in the greater Port-au-Prince area in October 2022, the Haitian Ministry of Health has reported a total of 24,232 suspected cases and 483 registered fatalities.

As of January 14, 2023, the Ouest Department, which includes the municipalities of Port-au-Prince, Cité-Soleil, and Carrefour, continues to report the highest number of cases, with 67% (N=10,836) of all suspected cases reported.

During a similar time frame, a total of 19 confirmed cases have been reported in the Dominican Republic (DR), with five of them imported from Haiti. 

In a press release on January 15, 2023, the DR's Ministry of Public Health urged residents not to be alarmed and to remain attentive to the issued reports.

The latest PAHO risk assessment of the Cholera event in La Hispaniola Island (Haiti and the Dominican Republic) assesses the event as very high risk locally, moderate at the regional level, and low at the global level.

The U.S. Centers for Disease Control and Prevention (CDC) stated in 2022, vaccination may be considered for children and adults traveling to areas of active cholera transmission.

As of January 2023, cholera vaccines remain unavailable in the U.S.

Cholera is rare in travelers but can be severe. Certain factors may increase the risk of getting cholera or having severe disease. The CDC says avoiding unsafe food and water and washing your hands can also help prevent cholera.

Furthermore, the U.S. Department of Stated announced in December 2022 do not travel to Haiti due to civil unrest. U.S. citizens should depart Haiti now in light of the current security and health situation and infrastructure challenges.

Furthermore, clinicians should be prepared to treat cholera cases in travelers returning to the U.S. in 2023.