Vaccine News

ARS Pharmaceuticals, Inc. recently announced today that the European Commission (EC) has approved EURneffy® (adrenaline nasal spray) for the emergency treatment of allergic reactions for adults and children (≥30 kg) with severe allergies.

ARS Pharma anticipates that EURneffy will be made available in certain European Union Member States in Q4 2024. It is the first novel adrenaline delivery method approved in over three decades.

The pharmacodynamics and pharmacokinetics of 2 mg EURneffy were evaluated across a range of dosing conditions, including single and repeat dosing, self-administration by patients, dosing in pediatrics, and during multiple nasal conditions that can cause congestion and rhinorrhea such as nasal allergen challenge or infectious rhinitis caused by a cold/flu.

“Adrenaline is the only first-line treatment (not a preventive vaccine) for allergic reactions including anaphylaxis, yet there is significant underutilization of adrenaline due to the limitations of currently available therapy,” said Antonella Muraro, MD PhD, Professor of Food Allergy at the University of Padua, and lead author of the European Academy of Allergology and Clinical Immunology treatment guidelines for anaphylaxis, in a press release on August 26, 2024.

Type I severe allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only approved medication for these reactions in the European Union.

While adrenaline autoinjectors have been shown to be highly effective, well-published limitations result in many patients and caregivers delaying or not administering treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. Even if patients or caregivers carry an autoinjector, more than half either delay or do not administer the device when needed in an emergency, says the company.

UCLA Health recently announced it had received a $120 million commitment from surgeon, inventor, and philanthropist Dr. Gary Michelson and his wife, Alya, to kick-start the California Institute for Immunology and Immunotherapy, an innovative public-private partnership aimed at spurring breakthrough discoveries that prevent and cure diseases and catalyze economic growth and innovation in Los Angeles. 

Announced on August 27, 2024, the gift will be distributed via the Michelson Medical Research Foundation, designates $100 million to establish two research entities within the institute, each funded by $50 million,

One entity will focus on rapid vaccine development and the other on harnessing the microbiome to advance human health. The microbiome research will be conducted with the new UCLA Goodman-Luskin Microbiome Center.

In addition, the foundation, a part of the Michelson Philanthropies network of foundations, is funding a $20 million endowment to provide research grants to young scientists using novel processes to advance immunotherapy research, human immunology, and vaccine discovery.

“Immunology is the mediator of nearly all human diseases, whether we’re talking about cancer, heart disease, or Alzheimer’s,” Dr. Michelson said in a press release.

“The vision for this institute is to become a ‘field of dreams’ — the world’s leading center for the study of the immune system to develop advanced immunotherapies to prevent, treat, and cure all of the diseases that afflict people today and to end these diseases in our lifetime.

“Scientific research is the key to making possible longer and healthier lives,” Michelson added.

Bharat Biotech International Limited (BBIL) announced on X the launch of HILLCHOL (BBV131), a novel single-strain Oral Cholera Vaccine (OCV).

Like other OCVs, HILLCHOL is a two-dose vaccine, which BBIL says needs to be orally administered on Day 0 and Day 14. The vaccine is suitable for individuals aged above one year.

However, it differs from the other vaccines because it is a single-strain OCV. BBIL stated on August 27, 2024, that this feature enhances manufacturing ease and efficacy.

As of August 2024, there is a global shortage of OCVs.

BBIL's collaboration with MSDInvents, Wellcome Trust, and Hilleman Laboratories aims to address the critical shortage of OCVs.

Currently available OCVs include Valneva SE's DUKORAL®.

The U.S. Centers for Disease Control and Prevention (CDC) recently confirmed there is an outbreak of Zika virus in the state of Maharashtra, India.

The Times of India recently reported 113 confirmed Zika cases, of which 100 are from Pune district, including pregnant women.

On August 22, 2024, the CDC published a Level 2 - Practice Enhanced Precautions, Travel Health Notice, offering specific Zika advice.

The CDC says all travelers to Maharashtra should prevent mosquito bites and sexual transmission of the Zika virus during and after travel. Zika virus is most commonly spread to people by the bite of an infected Aedes species mosquito.

If you are planning pregnancy, you should delay pregnancy following travel to India based on the timeframes to prevent sexual transmission.

If you are pregnant, you should avoid travel to Maharashtra. If travel is unavoidable, you should strictly follow Zika prevention recommendations from your healthcare provider.

Infection during pregnancy can cause certain birth defects, says the CDC.

Furthermore, travelers to Maharashtra should seek medical care immediately if they develop fever, rash, headache, joint or muscle pain, or red eyes during or after travel.

In addition to India, there have been over 40,000 Zika cases confirmed in the Region of the Americas in 2024.

There is currently no vaccine to prevent a Zika infection.

However, Valneva SE's VLA1601 second-generation Zika vaccine candidate has progressed in clinical trials.

CancerVax, Inc. announced today that the Company has recently filed a new patent application, which includes Smart mRNA Technology.

The Company’s new patent application describes a customizable nanoparticle containing Smart mRNA that can DETECT, MARK, and KILL only cancer cells.

By forcing cancer cells to “look” like well-immunized diseases such as measles or chickenpox, we intend to harness the body’s natural immunity to kill cancer cells effectively.

For example, anyone who has had chickenpox, or been vaccinated for chickenpox, has lifetime immunity to the disease. We intend to activate and harness this natural immunity to fight cancer.

Dr. Adam Grant, Principal Scientist at CancerVax and co-inventor of this new technology commented in a press release on August 27, 2024, “In the creation of this new technology, we have been using cutting-edge machine learning and artificial intelligence algorithms to identify genetic signatures that differentiate cancer cells from healthy cells."

"We can quickly load these signatures into our Smart mRNA for immediate lab testing. Not only does this speed up innovation, but it drastically reduces the current laborious and iterative drug discovery process. Only recently have the scientific tools and data been available to allow us to discover and innovate this technology."

"As a computational biologist by training, I have watched the advancement of drug delivery systems over the years, and the availability of next-generation sequencing data sets grow to the point where we can now design new and exciting drugs that we believe can change the game in cancer treatments.”

Dr. Grant continued, “Our natural immune system is an expert at identifying and eradicating foreign pathogens. When a pathogen is eliminated from the body, our immune system remembers it if it infects the body again."

"Our Universal Cancer Treatment Platform harnesses this extraordinary immune system capability by marking cancer cells with something the immune system already knows, such as measles. This way, the immune system can easily kill the cancer cells, just as it would with measles."

"In contrast to other cancer therapies, our technology employs the full power of the body’s immune system. It has the potential to turn “cold” tumors into “hot” tumors, overcoming a major hurdle in treating cancer patients with existing immunotherapies."

We look forward to validating our hypotheses using in-vivo models and refining our technology shortly.”

Immorna Biotherapeutics Inc. today announced that it has received a $3.8 million grant from the Bill & Melinda Gates Foundation to support the clinical development of JCXH-108.

JCXH-108 is a Respiratory Syncytial Virus (RSV) monovalent vaccine candidate based on Immorna’s proprietary mRNA and ‘Ready-to-Use’ lipid nanoparticle technologies.

Available data suggest that the mRNA-RTU-LNP vaccine can achieve approximately 18 months of shelf-life at 2-8 °C, over two months of stability at room temperature, and at least 8 hours of in-use stability in the clinical setting. The enhanced stability is expected to significantly reduce the logistics complexity associated with mRNA vaccine storage, transportation, and distribution, hence enhancing this mRNA vaccine's accessibility.

The grant provides staged financial support to expedite JCXH-108’s clinical trials and clinical development of the multi-dose vial vaccine, the marketing application in the U.S., and the World Health Organization Pre-Qualification.

Dr. Zihao Wang, Co-Founder and CEO of Immorna, commented in a press release on August 26, 2024, “I believe that, if successfully approved for marketing, JCXH-108 may help protect millions of susceptible individuals and their families from the deadly diseases associated with RSV infection, which is particularly meaningful .... where RSV infection is prevalent."

"We are on track to enroll the first subject for our clinical trial by the end of August 2024."

As of August 2024, the U.S. CDC has approved three RSV vaccines and one monoclonal antibody. These products are available at clinics and pharmacies for the RSV 2024-2025 season.

The World Health Organization (WHO) today launched a global Strategic Preparedness and Response Plan to stop outbreaks of human-to-human transmission of the mpox virus. The plan covers the six months of September 2024-February 2025, envisioning a $135 million funding need for the response.

This plan follows the declaration of a public health emergency of international concern by the WHO Director-General on August 14, 2024.

The WHO stated on August 26, 2024, to interrupt transmission chains, that strategic mpox vaccination efforts would focus on individuals at the highest risk, including close contact with recent cases and healthcare workers.

The WHO's Strategic Advisory Group of Experts on Immunization has recommended two vaccines against mpox disease. In the U.S., Bavarian Nordic's JYNNEOS® vaccine is available.