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A specialty vaccine company today announced the signing of a $32 million contract with the United States (U.S.) Department of Defense (DoD) for the immediate supply of its Japanese encephalitis (JE) vaccine, IXIARO®.
Under this new one-year contract with Valneva SE, the DoD can purchase additional doses for the next twelve months.
IXIARO® is the only JE vaccine approved for adults by the U.S. Food and Drug Administration (FDA).
Dipal Patel, Chief Commercial Officer of Valneva, commented in a press release on September 25, 2023, "We are excited to continue our long-term relationship with the DoD."
"The U.S. military has trusted IXIARO® for over ten years to help protect military personnel, their families, civilian government service personnel, and government contractors from this potentially deadly disease."
Japanese encephalitis is a deadly infectious disease found mainly in Asia. The disease is endemic in Southeast Asia, India, and China, a region with more than three billion population.
About 70,000 cases of JE are estimated to occur in Asia each year.
JE is fatal in approximately 30% of those who show symptoms, leaving half of the survivors with permanent brain damage.
In the U.S., Valneva markets and distributes IXIARO® directly to the military and private travel market.
IXIARO / JESPECT® is licensed for adults in Australia, New Zealand, Europe, Canada, Switzerland, Hong Kong, Singapore, Israel, Norway, Liechtenstein, Iceland, Singapore, Japan, the United Kingdom, and the Republic of Korea. In all other licensed territories, IXIARO/JESPECT is indicated for use by adults aged 18 years or older.
When comparing data from the past few influenza seasons, it appears the 2023-2024 flu season is starting slowly.
Globally, the World Health Organization's Influenza Update N° 454 confirmed influenza detections remained low. In the temperate zones of the northern hemisphere, indicators of influenza activity were reported at low levels or below the seasonal threshold in most reporting countries.
Within the United States, the Centers for Disease Control and Prevention (CDC) reported on September 22, 2023, that seasonal flu rates last week were low nationally, with 315 (0.8%) positive specimens reported.
Last week, 820 patients with laboratory-confirmed influenza were admitted to a hospital, an increased number since the previous report.
Separately, the U.S. National Center for Health Statistics mortality surveillance data published on September 21, 2023, confirmed 13 additional influenza-related deaths.
The FluView week #37 report confirmed two additional children died from flu-related illness. A total of 176 influenza-associated pediatric fatalities were reported during the 2022-2023 flu season.
The previous high was during the 2019-2022 flu season when 199 children died from influenza infections.
From a local perspective, the Walgreens Flu Index market-specific information indicates the top cities for influenza were led by the following:
1. Harlingen-Weslaco-Brownsville-McAllen, Texas
2. El Paso, Texas (Las Cruces, N.M.)
3. Columbus-Tupelo-West Point-Houston, Miss.
4. Corpus Christi, Texas
5. Puerto Rico
The CDC's new Director, Mandy K. Cohen, MD, MPH, recently posted a video on Instagram encouraging people to speak with a healthcare provider about flu shot options and when to be protected during the new flu season.
As of late September 2023, most pharmacies offer influenza vaccination appointments and walk-in services.
Since August 2023, the Indian state of Kerala has been experiencing its fourth Nipah virus outbreak.
Over the past two decades, the Nipah virus has spilled into humans in Bangladesh, India, Malaysia, the Philippines, and Singapore.
While no approved Nipah virus vaccines exist, several candidates are conducting clinical trials.
“The Nipah virus outbreak is a reminder of the increased risk of zoonotic diseases as the world population expands and encroaches into wild habitats. We have the technology to rapidly develop next-generation mRNA vaccines that will effectively fight against these new viruses”, commented Pascal Brandys, co-founder and CEO of Phylex BioSciences, in a press release on September 22, 2023.
“Our mRNA vaccine encoding for a highly immunogenic nanoparticle provides a flexible platform for rapid development of a new Nipah virus vaccine and will be of great value in combatting Nipah virus and other similar viruses.”
Phylex BioSciences published last year the proof-of-principle of its second-generation nanoparticle mRNA vaccine. The same technology is directly applicable to the development of a Nipah virus vaccine.
The second generation mRNA vaccine candidate encodes for a nanoparticle displaying 60 copies of the antigen-based upon the head domain of the G protein of the Nipah virus.
The anticipated advantages of the nanoparticle vaccine are superior immune response, long-term protection from cell-mediated immunity, and protection against virus dissemination in the brain.
Globally, an estimated two billion people worldwide are at risk for bat-borne Nipah virus outbreaks. The Nipah virus has a fatality rate exceeding 40%.
While Diphtheria is a vaccine-preventable disease, recent health alerts indicate various countries have under-vaccinated populations.
As of September 22, 2023, the U.S. Centers for Disease Control and Prevention (CDC) issued Travel Health Notices for Diphtheria outbreaks in the Republics of Guinea and Nigeria in Africa and Vietnam in East Asia.
As an example of recent outbreaks, during July and August 2023, a total of 5,898 suspected Diphtheria cases were reported from Local Government Areas in eleven Nigerian states.
The CDC says if you travel to any affected area, you should be up to date with your diphtheria vaccines. The U.S. agency recommends vaccinating everyone two months and older to protect against Diphtheria.
And if you have immunization questions, discuss the need for a booster dose with your healthcare professional before traveling abroad.
Diphtheria is a serious infection caused by strains of Corynebacterium diphtheriae bacteria that make a toxin that can cause people to get very sick.
This bacteria spread from person to person through respiratory droplets, like from coughing or sneezing, and from touching open sores or ulcers of people sick with Diphtheria.
For some people, respiratory Diphtheria can lead to death. Even with treatment, about 1 in 10 patients with respiratory Diphtheria die. Without treatment, up to half of patients can die from the disease, says the CDC.
Globally, Diptheria cases have been declining since 2019, when 22,986 cases were reported by the World Health Organization (WHO). In 2022, 5,856 cases were confirmed.
Furthermore, the WHO's current vaccination data indicates a high percentage for most countries, including the United States.
During the ongoing mpox outbreak, older smallpox vaccines were used to prevent infection and reduce disease severity in those at increased risk for infection.
However, the effectiveness of smallpox vaccination against mpox was unknown.
On September 21, 2023, the New England Journal of Medicine published a Correspondence that stated previous vaccination at a median of 13 years earlier with either a first- or second-generation smallpox vaccine reduced the likelihood of testing positive for orthopoxvirus, including mpox, among current or former military personnel for whom vaccination data were available.
The estimated vaccine efficacy was 72% for Dryvax (1st generation) and 75% for ACAM2000 (2nd generation).
Among the participants who tested positive for orthopoxvirus, 121 (41%) had been diagnosed with HIV infection (odds ratio, 2.34; 95% CI, 1.65 to 3.35).
Within the VA portion of the study, 19 of 186 participants (10%) required hospitalization; there were no deaths from mpox, and all the participants had an uneventful recovery.
The Department of Defense electronic laboratory data and the Veterans Affairs Corporate Data Warehouse identified eligible participants. The study was approved by the institutional review board of Emory University and was granted an exemption for consent.
The 2019 Lancet Commission on Tuberculosis laid out an optimistic vision for how to build a tuberculosis-free world through smart investments based on sound science and shared responsibility.
Since then, several significant strides have been made toward ending tuberculosis, according to a Review published by The Lancet on September 13, 2023.
With excellent short-course preventive regimens and several late-stage vaccine candidates, tuberculosis prevention is also on the cusp of a revolution.
These clinical tools are needed as more than 7 million people worldwide have died of tuberculosis in the past five years.
Still, much more can be done to implement the Commission's recommendations fully.
For example, the Bill and Melinda Gates Foundation and Wellcome pledged $550 million to support late-stage clinical trials for a new tuberculosis vaccine. The M72/AS01E (M72) subunit vaccine candidate is conducting phase 3 clinical research.
And in the United States, the 100-year-old BCG vaccine is considered for people who meet specific criteria.
According to the U.S. Centers for Disease Control and Prevention, BCG vaccination is considered for children under specific conditions.
The CDC reported in March 2023 that TB cases increased by 5% in 2022, with 60 U.S. states, the District of Columbia, and territories provisionally reporting 8,300 TB cases.
