Vaccine News

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.

For the first time, messenger RNA (mRNA) immunotherapy will be studied in a phase 1 clinical trial for lung cancer in the UK, where the University College London Hospitals (UCLH) Clinical Research Facility is the lead research site.

As of August 23, 2024, a lung cancer patient at UCLH became the first person to receive a novel cancer vaccine candidate designed to prime the immune system to recognize and fight cancer cells.

Made by BioNTech SE, the investigational mRNA cancer immunotherapy/vaccine for non-small cell lung cancer (NSCLC) known as BNT116 is designed to enhance immune responses against targets primarily expressed by cancer cells.

This process reduces the risk of toxicity to healthy, non-cancerous cells—unlike chemotherapy, which often affects both cancerous and healthy cells.

UCLH consultant medical oncologist Siow Ming Lee, who leads the national study, said in a press release, “Lung cancer remains the leading cause of cancer deaths worldwide, with an estimated 1.8 million deaths in 2020."

“We are now entering this exciting new era of mRNA-based immunotherapy clinical trials to investigate lung cancer treatment, thanks to the foundation laid by the Office for Life Sciences within the Department for Science, Innovation and Technology and the Department for Health and Social Care.

The trial will enroll patients at different stages of NSCLC, from early-stage NSCLC before surgery or radiotherapy (Stages 2 and 3) to late-stage disease (Stage 4) or recurrent cancer.

The trial aims to establish the safety profile and safe dose of BNT116 monotherapy combined with established NSCLC treatments to see if it has a synergistic anti-tumor effect when given with these established chemotherapy or immunotherapy treatments.

Approximately 130 participants will be enrolled in the study across 34 research sites in seven countries, with six UK sites selected. Patients interested in participating in the trial should be directed to their GP or oncologist in the first instance, and their doctor can refer them to the study's trial centers to assess suitability.

BNT116 is also being evaluated in a Phase 2 trial as a first-line treatment for patients with metastatic NSCLC in combination with cemiplimab, a PD-1 inhibitor, and cemiplimab alone. 

Moderna, Inc. announced that the European Commission (EC) has granted marketing authorization for mRESVIA®, an mRNA respiratory syncytial virus (RSV) vaccine.

RSV is a highly contagious seasonal respiratory virus that causes an exceptionally high burden of disease in infants and older adults.

As of August 23, 2024, this EC authorization is indicated to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.

The marketing authorization is valid in all 27 EU member states, as well as Iceland, Liechtenstein, and Norway.

"The EC's approval of mRESVIA is an important milestone for public health and highlights Moderna's mRNA leadership," said Stéphane Bancel, Chief Executive Officer of Moderna, in a press release.

In the European Union, RSV is estimated to cause approximately 160,000 hospital admissions in adults each year, with 92% of these admissions occurring in adults aged 65 and over.

In the United States, the RSV season has already begun in Florida and is expected to spread throughout the U.S.

For the 2024-2025 RSV season in the U.S., three vaccines and one monoclonal antibody were approved by the U.S. FDA.

Cuba's Minister of Public Health, José Ángel Portal Miranda, recently announced over 400 Oropouche virus disease cases have been confirmed on the island since late May 2024.

According to Cuba Headlines reporting, Cuba ranks second in the Region of the Americas for the number of infections behind Brazil (7,284).

Infected biting midges and some mosquitoes are spreading the virus.

Currently, there are no efficient vector control measures for the Culicoides paranesis.

As of August 23, 2024, the U.S. Centers for Disease Control and Prevention (CDC) says there is no evidence of local transmission of Oropouche virus disease in the United States. However, various states, such as Florida (12), report travel-related cases.

The virus was first detected in 1955 in Trinidad and Tobago near the Oropouche River. Since then, outbreaks of the Oropouche virus have been reported in Bolivia, Brazil, Colombia, Ecuador, French Guiana, Panama, and Peru.

The incubation period for Oropouche virus disease is 3–10 days, says the U.S. CDC. Typically, the disease starts with the abrupt onset of fever (38-40°C), followed by a headache, chills, myalgia, and arthralgia.

People typically recover without long-term sequelae. However, there have been a few deaths reported and vertical transmission of Oropouche virus causing fetal deaths and congenital abnormalities.

The best way to protect themselves from Oropouche is to prevent bites from biting midges and mosquitoes.

According to the CDC's Level 2 Travel Health Advisory, updated on August 15, 2024, travelers to Cuba should prevent bug bites during visits to protect themselves from infection, as there are no vaccines to prevent Oropouche virus disease.

Note - Headlines was edited on Aug, 24, 2024,

Takeda Canada Inc. today annonced a new report, Enhancing Diagnosis, Access, Care, and Treatment, highlighting the urgent need for innovative funding models and collaboration to help accelerate Canada’s National Strategy for Drugs for Rare Diseases.

Nearly 200 novel drugs for rare diseases are being developed and are expected to launch in Canada within the next ten years. It’s estimated only 5% of rare diseases have an approved treatment.

A “rare” disease is any disease that affects a minimal number of individuals. It is often genetic, chronic throughout a patient’s life, and life-threatening. With rare diseases affecting relatively limited patients, innovative treatments are often unavailable.

The impact of rare diseases is significant, with approximately one in 12 Canadians, two-thirds of whom are children.

“Canadians living with rare diseases have every reason to be optimistic,” says Durhane Wong-Rieger, President & CEO of the Canadian Organization for Rare Disorders, in a press release on August 22, 2024.

“Hundreds of new therapies are being developed, many targeting the 95% of rare diseases with no known treatment! We must leverage the $1.5 billion Rare Disease Drug Strategy,

The journey toward appropriately managing a rare disease is long and challenging. On average, it takes 6 to 8 years before a patient receives a correct diagnosis; this time, they will see an average of eight physicians and receive two to three misdiagnoses.

Takeda also produces innovative products, such as QDENGA®, an approved two-dose vaccine that prevents dengue fever and/or severe dengue in adults caused by any of the four serotypes of the dengue virus.

This dengue vaccine is authorized in about 40 countries and does not require pre-admission testing.

According to real-world evidence published in The Lancet Infectious Diseases today, this analysis is the first to provide estimates of Merck's Ervebo® (rVSV-ZEBOV) vaccine against Zaire Ebolavirus disease amid the widespread use of the vaccine during a large outbreak.

Announced on August 20, 2024, these findings confirm that Ervebo is highly protective against 84% (95% credible interval, 70% to 92%) of Ebolavirus disease and supports its use during outbreaks, even in challenging contexts such as in the eastern Democratic Republic of the Congo (DRC).

This finding is essential since Ebolaviruses are endemic in the DRC.

In a related Editorial, the authors wrote the 2018–20 Ebola virus disease epidemic in the DRC resulted in 3,470 reported cases and remains the second-largest Ebolavirus outbreak in recorded history worldwide. The initial Ebola outbreak was in 1976. 

In November 2019, the World Health Organization prequalified the Ervebo vaccine. The U.S. Food and Drug Administration approved it on December 19, 2019.

Médecins Sans Frontières (Doctors Without Borders) funded this study.