Vaccine News

CSL and self-amplifying mRNA (sa-mRNA) pioneer Arcturus Therapeutics today announced that Japan's Ministry of Health, Labor and Welfare (MHLW) granted approval and authorization for their updated sa-mRNA COVID-19 vaccine, KOSTAIVE®.

According to the September 13, 2024, press release, KOSTAIVE is the world's first commercially available sa-mRNA COVID-19 vaccine for adults 18 and older.

Unlike conventional mRNA vaccines, sa-mRNA vaccines instruct the body to make more mRNA and protein to boost the immune response.

"We believe KOSTAIVE® has the potential to change the paradigm for COVID-19 vaccines in Japan," commented Jonathan Edelman, M.D., Senior Vice President, Vaccines Innovation Unit, CSL. 

"Today's approval further demonstrates CSL's promise to pursue, develop, and deliver new innovative treatment options to protect public health."

Meiji Seika Pharma, CSL's exclusive partner in Japan, will begin vaccine distribution next month.

Following a peak in July 2024, MHLW data indicates COVID-19 cases in Japan have rapidly declined as of early September.

To avoid diseases such as Japanese encephalitis (IXIARO®), measles, and rubella, the U.S. CDC recommends speaking with a travel vaccine expert at least one month before visiting Japan.

 CSL, including three businesses: CSL Behring, CSL Seqirus, and CSL Vifor, provides lifesaving products to patients in more than 100 countries and employs 32,000 people. 

The U.S. Centers for Disease Control and Prevention (CDC) today published updated recommendations from the Advisory Committee on Immunization Practices (ACIP) regarding the use of 21-Valent Pneumococcal Conjugate Vaccine Among U.S. Adults.

On September 12, 2024, the CDC's MMWR confirmed the U.S. Food and Drug Administration approved 21-valent pneumococcal conjugate vaccine (PCV) (PCV21; CAPVAXIVE; Merck Sharp & Dohme, LLC) for adults aged ≥18 years.

PCV21 does not contain certain serotypes that are included in other licensed pneumococcal vaccines but adds eight new serotypes. It is recommended for all adults aged ≥65 years and adults aged 19–64 years with certain risk conditions for pneumococcal disease if they have not received a PCV or whose vaccination history is unknown.

Previously, options included either 20-valent PCV (PCV20; Prevnar20; Wyeth Pharmaceuticals, Inc.) alone or a 15-valent PCV (PCV15; VAXNEUVANCE; Merck Sharp & Dohme, LLC) in series with 23-valent pneumococcal polysaccharide vaccine (PPSV23; Pneumovax23; Merck Sharp & Dohme, LLC).

Additional recommendations for the use of PCV20 exist for adults who started their pneumococcal vaccination series with 13-valent PCV (PCV13; Prevnar13; Wyeth Pharmaceuticals, Inc.).

On June 27, 2024, ACIP recommended a single dose of PCV21 for adults aged ≥19 for whom PCV is currently recommended. Indications for PCV have not changed from previous recommendations.

This report summarizes the evidence considered for these recommendations and provides clinical guidance for using PCV21.

In the U.S., various healthcare providers offer pneumococcal vaccines.

While there is an approved Ebola virus disease (EVD) vaccine, the U.S. government continues to invest in human monoclonal antibody (mAb) therapy during Zaire ebolavirus outbreaks in Africa.

The initial Zaire Ebolavirus disease (EVD) case was confirmed in 1976, Since then, more than 30 EVD outbreaks have been reported.

Emergent BioSolutions Inc. announced today that it was awarded a contract modification executing an option period by the Biomedical Advanced Research and Development Authority (BARDA), valued at $41.9 million, for drug substance engineering and scale-up process validation, long-term stability, and commercial readiness in support of its ongoing scale-up program for Ebanga™, a licensed glycoprotein (EBOV GP)-directed mAb treatment for EVD.

“Emergent is proud to continue to advance the Ebanga™ (ansuvimab-zykl) development and scale up to its next phase,” said Paul Williams, senior vice president of products business, Emergent, in a press release on September 12, 2024. 

This mAb binds to a portion of the Ebola virus's surface called the glycoprotein, which prevents the virus from entering a person's cells. Ebanga's efficacy has not been established for other species of the Ebolavirus and Marburgvirus.

Under the terms of the contract, Emergent will complete activities to advance the development of Ebanga™ treatment through post-licensure commitments, including the transfer of technology as part of manufacturing scale-up, submission of a supplemental Biologics License Application to the U.S. Food and Drug Administration (FDA), and completion of stability studies.

The existing 10-year contract consists of a base period of performance with two option periods for advanced development valued at approximately $121 million and option periods for procurement of Ebanga™ treatment over five years valued at up to $583 million. Execution of this option period is in line with Emergent’s planned program performance and critical path for developing the Ebanga™ treatment.  

BARDA is part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services.

With the 2024-2025 Respiratory Syncytial Virus (RSV) season detected in Florida, recent research confirms the newly approved passive immunization monoclonal antibody offers infants significant protection.

On September 11, 2024, a study conducted in Spain and published by the American Academy of Pediatric Association concluded that Beyfortus™ (Nirsevimab) could effectively protect a broad infant population against RSV infection: a 63.1% reduction in acute bronchiolitis-related hospital admissions (95% confidence interval [CI], 60.9% to 65.2%) and a 63.1% reduction in pediatric intensive care unit admissions (95% CI, 58.1% to 67.9%).

In clinical trials, Beyfortus was reported to be about 90% (95% CI = 75%–96%) protective against RSV-associated hospitalization in infants in their first RSV season. 

As of March 2024, the U.S. CDC reported that among females with an infant under eight months old, 41.3% reported that their infant received Beyfortus.

Beyfortus is currently recommended for newborn children in Australia, Canada, China, Europe, Japan, and France. 

Alopexx, Inc. today announced a collaboration with India-based Bharat Biotech for the co-development and commercialization of the broad-spectrum antimicrobial vaccine, AV0328.

AV0328 is a synthetic vaccine designed to target poly N-acetyl glucosamine (PNAG), a substance found on the surface of a wide range of bacterial, fungal, and parasitic pathogens.

In preclinical studies, targeting PNAG has shown effectiveness in preventing and treating infections caused by over 15 different pathogens.

A phase I, first-in-human clinical trial, has been completed, demonstrating that AV0328 is well-tolerated with no serious adverse events observed. The vaccine-induced antibodies are capable of killing a wide range of PNAG-expressing pathogens, reaffirming their potential as a broad-spectrum antimicrobial solution.

Dr. Krishna Ella, Executive Chairman of Bharat Biotech, commented in a press release on September 11, "024: We are proud to collaborate with Alopexx to bring AV0328 to the regions (India) where it is most needed."

"Our goal is to develop solutions to reduce antimicrobial resistance through vaccination. This collaboration aligns with our mission to provide safe, affordable, and high-quality vaccines to combat infectious diseases globally."

The companies will co-develop and commercialize AV0328 in India and other licensed territories as part of the collaboration.

This Review discusses evidence that vaccines can play a major role in fighting antimicrobial resistance (AMR).

Different health organizations have highlighted the emergence and spread of AMR as a global threat. Pathogens resistant to AMR cause substantial morbidity and death. As resistance to multiple drugs increases, novel and effective therapies and prevention strategies are needed, wrote researchers in 2022.

The Los Angeles County Department of Public Health (LACDPH) recently confirmed a locally acquired case of dengue fever in a person living in the City of Baldwin Park. 

Dengue fever is transmitted primarily through the bite of infected Aedes mosquitoes.

As of September 9, 2024, this is the third locally acquired case of dengue fever in California and the first identified by the Los Angeles County Department of Public Health. Previous locally acquired cases of dengue fever in the greater LA area were identified in Long Beach and Pasadena in 2023.

The LACDPH stated the risk of transmission of dengue virus to the general population in Los Angeles County remains low. 

As of September 5, 2024, the U.S. CDC reported that 53 jurisdictions, led by Florida, New Jersey, New York, and Puerto Rico, have reported 4,369 dengue cases this year. In 2023, 52 U.S. jurisdictions reported 2,343 dengue cases.

The CDC wrote that these local dengue cases reinforce the presence of infected mosquitoes and underscore the importance of preventive measures to control the spread of this virus.

As of September 10, 2024, dengue vaccines are not offered in the United States.

Evaxion Biotech A/S today announced new clinical phase 2 data for its lead compound EVX-01. The data show that 11 out of 16 patients had objective clinical responses, equaling a 69% Overall Response Rate, and 15 out of the 16 patients had reduced tumors.

This topline data is part of a one-year interim analysis of the ongoing phase 2 trial assessing EVX-01 in combination with Merck & Co., Inc. anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with advanced melanoma.

EVX-01 is a personalized peptide-based neoantigen cancer vaccine/therapy (immunotherapy) for the first-line treatment of multiple advanced solid cancers. This combo therapy is tailored to target each patient's unique tumor profile and immune characteristics. It engages the patient’s immune system to fight off cancer by mounting a targeted response against tumors.

"A huge unmet medical needs remain in the field of melanoma, and we believe that EVX-01 could be an improved treatment option for patients. We look forward to presenting the complete one-year dataset at ESMO, discussing the data with potential partners, and advancing the phase 2 trial towards its completion next year,” says Christian Kanstrup, CEO of Evaxion, in a press release on September 9, 2024.

In the completed Phase 1/2a clinical trial, vaccine-induced T cells were detected in all patients.