Cancer Vaccine Breaking News

The U.S. Centers for Disease Control and Prevention (CDC) recently announced it had granted 13 funding awards to establish a first-of-its-kind national network, the Outbreak Analytics and Disease Modeling Network (OADMN).

The OADMN's goal is to improve speed, accuracy, and use of data & analytics during health emergencies, which is an important step towards ensuring Americans have the information they need to keep themselves and their families safe during outbreaks.

Many of these awardees are leading a consortium of collaborators to design, prototype, test, and scale up advances in data modeling tools and technology that can be used to support public health decision-makers at all levels of government.

"The collaboration with our public health, private, and academic partners over the last year to advance the science of disease forecasting and deliver decision support to leaders has been instrumental in improving outbreak response," said Dr. Dylan George, Director, Center for Forecasting and Outbreak Analytics, in a press release on September 22, 2023. 

The grantees will be organized into three categories of performance, supporting three priority program actions:

• Innovators: these grantees will develop methods, tools, technologies, and other products to support emergency response.
• Integrators: these grantees will take lessons learned and techniques from Innovators and test them in small-scale deployments.
• Implementors: these grantees will take tested best practices and scale up to larger jurisdictions and partners.

The funding 13 recipients comprising OADMN in September 2023 include:

Emory University

Northeastern University

The University of North Carolina at Chapel Hill

Kaiser Permanente Southern California

Carnegie Mellon University

University of Michigan School of Public Health

University of California, San Diego

University of Minnesota

Clemson University

University of Utah

International Responder Systems

The University of Texas at Austin

The Johns Hopkins University

Note: The OADMN effort is in addition to the U.S. government's Disease X initiative.

BioArctic AB and Eisai announced today that LEQEMBI® Intravenous Infusion had been approved in Japan as a treatment for slowing the progression of mild cognitive impairment and mild dementia due to Alzheimer's disease (AD).

LEQEMBI is a humanized immunoglobulin gamma 1 monoclonal antibody (mAbs) directed against aggregated soluble and insoluble forms of Aβ.

LEQEMBI is the first and only approved treatment shown to reduce the rate of disease progression and slow cognitive and functional decline by selectively binding to and eliminating the most toxic Aβ aggregates that contribute to neurotoxicity in AD.

Japan is the second country to approve LEQEMBI, following the Food and Drug Administration (FDA) approval in the U.S. in July 2023.

"The approval of LEQEMBI in Japan is another important step in the fight against Alzheimer's disease," said Gunilla Osswald, CEO of BioArctic, in a press release on September 25, 2023.

Eisai serves as the lead of LEQEMBI development and regulatory submissions globally, with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

BioArctic has the right to commercialize lecanemab in the Nordic region, and currently, Eisai and BioArctic are preparing for joint commercialization in the region.

According to the Alzheimer's Association, AD is a degenerative brain disease caused by complex brain changes following cell damage, leading to dementia.

As of September 2023, The U.S. FDA, the European Medicines Agency, and the United Kingdom's NHS have not authorized preventive AD vaccines.

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.

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.

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. 

While there are no approved vaccines to prevent human immunodeficiency virus (HIV) infection, several vaccine candidates are progressing in clinical studies.

As an example, Vir Biotechnology, Inc. today announced that the first participant has been dosed in a Phase 1 clinical trial evaluating the safety, reactogenicity, and immunogenicity of VIR-1388, an investigational novel T cell vaccine for the prevention of HIV.

VIR-1388 is based on the human cytomegalovirus (HCMV) vector platform. It is designed to stimulate the body to produce immune cells known as T cells that recognize several HIV proteins in a way that differs from prior investigational HIV vaccines.

“HIV continues to be a major global public health challenge with no approved vaccines despite decades of research efforts,” said Carey Hwang, M.D., Ph.D., Vir’s Senior Vice President, Clinical Research, Head of Chronic Infection, in a press release on September 20, 2023.

“We are hopeful that our unique approach will help close the longstanding public health gap in HIV prevention.”

VIR-1388 was developed using applied learnings from VIR-1111, the Company’s initial investigational proof-of-concept HIV T cell vaccine based on HCMV.

The U.S. National Institute of Allergy and Infectious Diseases and the Bill & Melinda Gates Foundation financially support the clinical study. 

The U.S. CDC’s Morbidity and Mortality Weekly Report publishes public health information and recommendations on HIV.

As the mpox outbreak ends in most countries, other health agencies restock their reserves in case of a smallpox outbreak.

On September 13, 2023, Bavarian Nordic A/S announced that it had been awarded another contract to supply its MVA-BN® smallpox vaccine to rescEU, a strategic reserve within the European Union (EU).

This order follows an initial contract awarded in June 2023 and is also for delivery in 2024.

The vaccines will be stockpiled in another EU country, thus expanding the EU's capability to respond to medical countermeasures to its member states and other countries participating in the rescEU, an EU Civil Protection Mechanism. 

Paul Chaplin, President & CEO of Bavarian Nordic, commented in a press release, "We are pleased to continue supporting the initiative from the EU to build a stockpile of smallpox vaccines across Europe."

"This secures another order for next year, confirming an ongoing demand, but also the transition to stockpiling for future outbreaks, which we see as a growing trend with other countries and organizations."

The new contract is valued at more than EUR 11 million.

The MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic vaccine is marketed as IMVANEX® in Europe, IMVAMUNE® in Canada, and JYNNEOS® in the U.S.

In addition to smallpox, the U.S. Food and Drug Administration, Health Canada, and the European Commission have also approved the vaccine for use against mpox. It is the only vaccine having obtained this dual approval to date.

In the U.S., over 1.2 million doses of JYNNEOS have been distributed since the global mpox outbreak began in May 2022. Since then, about 113 countries have reported over 89,000 mpox cases.

Recently, a significant increase in mpox cases has been observed in the South-East Asia Region.

MVA-BN is a non-replicating smallpox vaccine developed in collaboration with the U.S. government to ensure the supply of a smallpox vaccine for the entire population, including immunocompromised individuals who are not recommended vaccination with traditional replicating smallpox vaccines.

RescEU was established by the European Commission as a safety net to protect citizens from disasters and manage emerging risks. It includes, among others, reserves of medical countermeasures which can be deployed in chemical, biological, radiological, and nuclear emergencies.