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Sinovac Biotech Ltd. today announced the enrollment for a Phase Ⅲ clinical trial on a bivalent vaccine candidate to prevent Hand, Foot, and Mouth Disease (HFMD) caused by both Enterovirus 71 (EV71) and Coxsackievirus 16 (CA16).
As of December 16, 2024, no multivalent vaccines against HFMD have been approved for marketing worldwide.
SINOVAC is also developing a vaccine to prevent HFMD caused by EV71, CA16, CA10, and CA6.
According to the U.S. CDC, non-polio enteroviruses cause about 10 to 15 million infections and tens of thousands of hospitalizations each year in the United States.
HFMD can be caused by several enteroviruses, which often exhibit low cross-immunogenicity, leading to insufficient protection. HFMD is very contagious and mainly affects children under 5 years old, accounting for at least 90% of the total HFMD patients. Most people recover on their own in 7 to 10 days.
To ensure the United States is well stocked with Anthrax vaccines, the Biomedical Advanced Research and Development Authority (BARDA) today announced a $50 million option to Emergent BioSolutions Inc. for the acquisition of CYFENDUS® (Anthrax Vaccine Adsorbed, Adjuvanted), a U.S. FDA approved vaccine.
Vaccine deliveries will begin in late 2024 and be complete by April 2025.
While Anthrax is rare in the U.S., occasional outbreaks happen in wild and domestic grazing animals such as cattle or deer, says the U.S. CDC.
Most people will never be exposed to any of the four types of Anthrax. However, jobs, hobbies, and activities can put some people at higher risk of exposure.
Furthermore, the U.S. government remains concerned about the exposure to Bacillus anthracis, the cause of Anthrax, which is a likely agent for bioterrorism. In 2001, letters with powdered anthrax spores were mailed in the U.S., causing 22 infections and five related fatalities.
“An anthrax emergency continues to be a significant public health threat due to its ability to be easily disseminated, lethality, and potential for widespread impact,” said Paul Williams, senior vice president, products head at Emergent, in a press release on December 16, 2024.
“This procurement award further bolsters anthrax preparedness and demonstrates Emergent’s commitment to public health preparedness.”
This new BARDA award follows a previously announced contract modification of $30 million to supply CYFENDUS.
Bavarian Nordic A/S today announced an agreement with Serum Institute of India Pvt. Ltd. ("SII") for its MVA-BN® mpox vaccine.
Under the agreement revealed on December 16, 2024, the companies will undertake a technology transfer of the current manufacturing process for MVA-BN (JYNNEOS®) to SII to enable the supply of the mpox vaccine for the Indian market. Furthermore, upon the relevant regulatory approvals, SII will perform contract manufacturing of MVA-BN, ensuring global access even during outbreaks of mpox.
SII's multifunctional production and one of the most extensive facilities in Pune, India, has an annual capacity of 4 billion doses.
In a press release, SII's CEO Adar Poonawalla said, "The recent mpox outbreak underscores the critical need for a swift and coordinated response. Partnering with Bavarian Nordic on the MVA-BN mpox vaccine reflects our shared commitment to protect millions at risk. Leveraging our manufacturing strength and rapid response capabilities, we aim to enhance epidemic preparedness and expand access to life-saving vaccines, safeguarding vulnerable populations and easing the global burden of mpox."
Bavarian Nordic continues to explore additional opportunities to establish partnerships, including with local African manufacturers, to ensure equitable access to MVA-BN.
Local media recently reported that since 2022, 33 confirmed cases of Mpox have been reported in India. And a Surveillance Program has been recently instructed to intensify surveillance of Mpox patients at airports. India confirmed its first case of the clade Ib mpox strain in late September 2024.
Since it was approved to protect people from smallpox in 2019, the JYNNEOS brand is now commercially available at many clinics and pharmacies.
From an efficacy perspective, U.S. CDC research published in the journal Emerging Infectious Diseases, Volume 30, Number 10—October 2024, concluded the estimated effectiveness of the 2-dose JYNNEOS vaccine was about 80% against clade 2.
A study announced in March 2024 showed that JYNNEOS antibodies waned within a year.
Vaccine efficacy data against clade I mpox is pending.
As many winter vacationers are finalizing plans to visit warm Central American beaches, the U.S. Department of State issued a high-level advisory for the Republic of Honduras.
As of December 10, 2024, the State Department's Level 3 advisory warns against traveling to the Gracias a Dios Department, Honduras's most eastern department, due to civil unrest. This department's infrastructure is weak, government services are limited, and police and military presence is scarce.
In December 2022, the Government of Honduras declared a "State of Exception." That declaration remains in effect in 2024 and has been modified to include more cities.
However, some locations in Honduras were found welcoming for visitors this winter.
The State Department's advisory states: "There is a concentration of resources around resort areas in the Bay Islands, which include Roatan, Utila, and Guanaja, and these areas are better policed."
If you visit Honduras, enroll in the Smart Traveler Enrollment Program to receive digital alerts and make locating you in an emergency easier. If U.S. citizens need assistance while in Honduras, the U.S. Embassy in Tegucigalpa is located at Avenida La Paz, Tegucigalpa, M.D.C.
From a health perspective, the Honduran Ministry of Health declared a national emergency in Honduras due to the increased risk of the mosquito-transmitted dengue virus in June 2024.
As of December 15, 2024, over 175,000 dengue cases and 153 related fatalities have been reported this year.
Additionally, Honduras has reported chikungunya and zika patients in 2024.
For disease prevention, an approved chikungunya vaccine (Valneva SE's IXCHIQ®) is available at many travel clinics and pharmacies in the U.S., but no vaccine is offered for dengue or zika.
Novavax, Inc. today announced progress in advancing its corporate growth strategy through its partnership with Sanofi, a Paris, France based company.
Novavax has achieved a milestone associated with its Phase 2/3 clinical trial for its COVID-19 vaccine in children, triggering Sanofi's first $50 million milestone payment.
Novavax's COVID-19 vaccine is included in Sanofi's two combination vaccine candidates for the prevention of influenza and COVID-19, for which Phase 1/2 trials were initiated, and the U.S. FDA Fast Track designation was recently granted in the U.S.
n addition to milestones for the stand-alone COVID-19 vaccine, the agreement also includes combination products developed by Sanofi including Novavax's COVID-19 vaccine, which present a potential opportunity of up to an additional $350 million for Novavax in future milestones.
In addition, stand-alone COVID-19 sales and potential sales of any Sanofi combination products would net Novavax ongoing tiered royalties.
Further, Novavax is eligible to receive up to $200 million for the first four products created by Sanofi utilizing its Matrix-M adjuvant and up to $210 million in milestone payments for each product, including Matrix-M thereafter, plus ongoing royalties for all Sanofi products utilizing Matrix-M.
The Queensland Public Health and Scientific Services, Communicable Diseases Branch, recently issued a public health alert about measles outbreaks.
As of December 13, 2024, measles cases have been reported among travelers to Victoria, Western Australia, and Queensland this year.
This alert stated clinicians in Australia should be alert for signs and symptoms of measles, particularly in international travelers or those close contacts potentially exposed to measles.
To alert the global community, the U.S. CDC reissued a Level 1 - Practice Usual Precautions, Travel Health Advisory, regarding measles outbreaks in 56 countries. As of late November 2024, this CDC alert did not include Australia.
As of December 6, 2024, the U.S. CDC reported 283 measles cases in 32 jurisdictions this year.
The CDC wrote that travelers are at risk of measles if they have not been fully vaccinated at least two weeks before departure or have not had measles in the past and have traveled internationally. In the U.S., measles vaccines are generally available at travel clinics and pharmacies.
