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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.
A recent measles case in Christian County, Kentucky, has been associated with Ohio’s ongoing measles outbreak, according to Kentucky Cabinet of Health and Family Services spokesman Brice Mitchell on January 20, 2023.
WAVE3.com reported Mitchell indicated several other Kentucky residents are being monitored for measles symptoms.
The U.S. Centers for Disease Control and Prevention (CDC) says measles symptoms appear 7 to 14 days after contact with the virus, and rashes appear 3 to 5 days after the first symptoms.
Measles isn’t just a little rash.
According to the CDC, measles can be dangerous, especially for young children.
The good news is measles is a vaccine-preventable disease.
Recently, the city of Louisville, Kentucky, and the Jefferson County Public Schools began conducting measles vaccination clinics for about 10,000 unvaccinated students.
On January 18, 2023, local media reported on-campus measles clinics at Iroquois High School, Marion C. Moore School, Newcomer Academy, and Fern Creek High School on February 7, 2023.
Since June 2022, the Health Department of the City of Columbas, Ohio, and Franklin County Public Health have reported (85) confirmed measles cases in children, of which (36) were hospitalized as of January 24, 2023.
The CDC reported there were 121 measles cases in six U.S. jurisdictions in 2022.
During 2021, a total of 49 measles cases were reported by five jurisdictions.
Measles outbreaks continue to be reported worldwide, which is why the CDC recommends being fully vaccinated before visiting measles-outbreak countries such as India and Nigeria.
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 U.S. Department of State updated its Level 3 Travel Advisory for the federal republic of Nigeria, located in west Africa.
Local media reported people should exercise caution around events in Lagos State from Jan. 23-24, 2023. And plan for localized transport disruptions.
As of January 23, 2023, the State Department says Do Not Travel to certain areas due to civil unrest:
- Borno, Yobe, Kogi, and northern Adamawa states,
- Bauchi, Gombe, Kaduna, Kano, Katsina, and Zamfara states,
- Coastal areas of Akwa Ibom, Bayelsa, Cross River, Delta, and Rivers states (except Port Harcourt).
Furthermore, the U.S. Consulate in Lagos provides all routine and emergency services to U.S. citizens in Nigeria. The U.S. Embassy Abuja can only provide emergency assistance to U.S. citizens in Abuja.
U.S. citizens in Nigeria who require assistance should contact [email protected] or +234 1 460 3410.
Additionally, they should enroll in the Smart Traveler Program to receive alerts and facilitate extraction during emergencies.
From a health perspective, the U.S. Centers for Disease Control and Prevention (CDC) advises future Nigeria visitors to speak with a travel vaccine advisory about one month before departure.
The CDC has recently issued various Travel Health notices for Nigeria's disease outbreaks, such as yellow fever, polio, measles, and Mpox.
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]).
The U.S. Centers for Disease Control and Prevention (CDC) published Key Updates for Week #2, ending January 14, 2023. This CDC report highlights both good and unfortunate news.
The Weekly U.S. Influenza Surveillance Report says seasonal influenza activity continues to decline across the U.S., with three regions below their outpatient respiratory illness baselines for the first time since October 2022.
And the majority of influenza viruses tested are in the same genetic subclade as and antigenically similar to the influenza viruses included in this season’s influenza vaccine, which remain available at most clinics and pharmacies in the U.S.
Furthermore, the National Center for Health Statistics Mortality Surveillance data available on January 19, 2023 shows that overall flu-related fatalities have decreased for the past four weeks.
During week #2, there were 2,954 pneumonia, influenza, and/or COVID-19 (PIC) deaths.
Among those PIC deaths, 1,422 had COVID-19 listed as an underlying or contributing cause of death on the death certificate, 1,281 documented pneumonia, and 251 listed influenza.
Unfortunately, the CDC also confirmed six additional influenza-associated pediatric fatalities have occurred during the 2022-23 flu season. This news increases the total of 85 pediatric flu deaths reported so far this season.
During the last flu season, there were only 45 pediatric fatalities related to the flu.
The CDC says an annual flu shot remains the best way to protect against influenza infections and can also prevent serious outcomes in people who get vaccinated but still get sick with the flu.
CDC recommends that everyone ages six months and older get an annual flu vaccine as long as flu activity continues, which could be several additional months.
So far this flu season, 171.52 million doses have been distributed in the U.S.
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.
