Vaccine News

The International AIDS Vaccine Initiative (IAVI) recently announced that clinical trial sites in the Lassa fever-endemic countries of Ghana, Liberia, and Nigeria were vaccinating volunteers in IAVI's C105 study of a Lassa fever vaccine candidate.

This study is designed to evaluate the vaccine candidate’s safety, tolerability, and immunogenicity at two different dosage levels in adults, including people living with HIV, as well as in adolescents and children two years of age and older. 

The IAVI C105 study results are expected in 2025. Should the vaccine candidate be found safe and efficacious, IAVI is committed to making its Lassa vaccine affordable and accessible to all needy populations.

As of August 28, 2024, no Lassa fever vaccine currently exists. However, several vaccine candidates are conducting research.

Lassa virus (LASV) is a zoonotic disease that causes the acute viral hemorrhagic illness called Lassa fever, for which treatment is limited.

People can get Lassa fever by contacting infected rats or their saliva, urine, or droppings. The U.S. CDC says that LASV can spread among people.

About 300,000 people fall ill across West Africa annually, though the actual disease burden is thought to be much higher. For these reasons, Lassa fever is featured in the World Health Organization’s R&D Blueprint and requires urgent action due to its potential to cause an outbreak of international concern.

Even though we cannot predict what will happen in the United States this upcoming flu season, by examining trends observed in the Southern Hemisphere this past season, we can gain valuable insights into what activity might occur during the forthcoming 2024-2025 Northern Hemisphere flu season.

The WHO's Global Respiratory Virus Activity Weekly Update N° 489 was posted on August 11, 2024, confirming in the Southern hemisphere, influenza activity remained elevated in countries in South America (due to influenza A(H3N2) and B viruses), Eastern Africa (due to A(H1N1)pdm09 viruses), Southern Africa (due to B viruses), and Oceania (due to A(H3N2) viruses). 

According to the U.S. Centers for Disease Control and Prevention (CDC), on August 26, 2024, during the 2024 Southern Hemisphere flu season, most countries experienced similar levels of flu activity compared to trends observed in prior seasons (2017‒2019 and 2022‒2023 flu seasons).

However, South American and Southern African countries experienced high influenza virus detection levels.

"Vaccination remains the best defense against flu, and even if vaccination does not entirely prevent the risk of flu, it can help reduce the severity of flu illness in people who get flu despite being vaccinated," the CDC wrote. 

"In the U.S., September and October are generally good times to be vaccinated against flu."

As of late August 2024, various influenza vaccines are available at health clinics and pharmacies in the U.S.

The journal Clinical Infectious Diseases recently published results from an extensive, observer-blinded, CLOVER phase 3 clinical trial that found a Clostridioides difficile vaccine candidate was safe, well tolerated, and reduced the severity of C difficile infection (CDI).

However, this vaccine did not reduce the incidence of CDI in at-risk adults.

Although the primary endpoint of this study was not met, PF-06425090 reduced symptom duration, CDI requiring medical attention, and CDI-directed antibiotic treatment, highlighting its potential to reduce CDI-associated healthcare burden, wrote these researchers on August 24, 2024.

The U.S. CDC says CDI causes substantial mortality and healthcare burden. In 2022, the incidence rate of CDI increased with age, and rates were higher in women.

As of August 27, 2024, no C difficile infection protection vaccines are available.

Tonix Pharmaceuticals Holding Corp. and Bilthoven Biologicals (BBio) today announced a collaboration to advance TNX-801, a mpox vaccine candidate.

TNX-801 (recombinant horsepox virus) is a live replicating, attenuated, single-dose vaccine candidate based on horsepox in preclinical development to prevent mpox and smallpox.

TNX-801 is based on technology that has the potential to be used as a viral vector platform from which recombinant versions can be developed to protect against other infectious diseases.

BBio is a global vaccine company that produces prophylactic and therapeutic vaccines and is part of the world’s largest vaccine manufacturer, the Cyrus Poonawalla Group, which includes the Serum Institute of India.

BBio has been selected by the European Union for its pandemic preparedness program of ‘ever warm’ vaccine manufacturing companies.

“The recent mpox outbreak exemplifies precisely why we built the pandemic preparedness facility at BBio,” said Jurgen Kwik, Chief Executive Officer of Bilthoven Biologicals, in a press release on August 26, 2024.

“The establishment of the 'ever-warm' facility for pandemic preparedness underscores the critical importance of readiness in the face of global health emergencies, such as mpox. This collaboration encapsulates the essential role of the facility in bolstering pandemic preparedness and response capabilities."

Tonix has received an official written response from a Type B pre-Investigational New Drug Application meeting with the U.S. Food and Drug Administration to develop TNX-801 as a potential vaccine to protect against mpox and smallpox diseases. 

Currently, four mpox / smallpox vaccines are in use globally.

The U.S. Food and Drug Administration has approved and granted emergency use authorization for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2 coronavirus.

Announced on August 22, 2024, the mRNA COVID-19 vaccines have been updated with this formula to more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death.

“Vaccination continues to be the cornerstone of COVID-19 prevention,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a press release.

These FDA actions relate to updated mRNA COVID-19 vaccines manufactured by ModernaTX Inc. and Pfizer Inc.

On August 19, 2024, Novavax Inc. announced, 'We are working productively with the FDA as they complete their review, including providing additional information as needed, and the FDA has committed to moving swiftly on regulatory authorization.'

'We expect authorization (protein-based vaccine) for peak vaccination season.'

The FDA states that vaccination is one of the most effective ways to prevent infectious diseases, disabilities, and deaths. In the U.S., routine childhood vaccines prevent many diseases, and immunization has reduced the occurrence of most vaccine-preventable diseases by over 95%.

With the 2024-2025 influenza season underway in the United States and cases of swine flu being reported in people attending county fairs, an innovative vaccine candidate may soon solve these severe health issues.

Emergex Vaccines Holding Limited recently announced that it received patent protection from the United States Patent and Trademark Office (USPTO) for its novel class of influenza vaccines.

This USPTO patent covers Emergex’s vaccine candidate, which comprises immunogenic peptides encoded by a negative sense open reading frame (ORF) from segment 8 of the influenza A genome. This vaccine can potentially provide long-term T-cell immunity against legacy strains of influenza A, seasonal variants, and heterosubtypic changes.

To Emergex’s knowledge, this represents the first known patent for viral peptides derived from antigenomic translation, suggesting that segment 8 of influenza A is ambisense (negative and positive sense ORFs).

In addition, this grants the company exclusive rights to develop a vaccine that incorporates these immune elements, offering a level of immune recognition that existing flu vaccines cannot provide because of composition or method of administration. 

Additionally, incorporating avian—and equine species-specific NEG8-derived peptides in a vaccine can potentially expand protection against zoonotic transmissions.

This is an essential feature of a universal flu shot. As influenza viruses change from year to year, influenza vaccines must be updated annually to include the viruses that will most likely circulate in the upcoming season.

Professor Thomas Rademacher, Co-Founder and Chief Executive Officer at Emergex, commented in a press release on August 22, 2024, “Our research into NEG8 has revealed exciting potential for a new approach to influenza vaccines. We believe that a vaccine composition including conserved NEG8-derived MHC class I peptides could protect against past, existing, and emerging human influenza viruses and prevent zoonotic influenza viruses from establishing themselves in the human population and causing a pandemic."

Emergex is set to advance its first-in-class influenza vaccine into the clinic, with Phase I trials anticipated to begin in the first half of 2025.

As of August 25, 2024, various U.S. FDA-approved cell, egg, and nasal flu shots are readily available at health clinics and pharmacies in the U.S.

Over 157 million flu shots were distributed during the 2023-2024 season.

In the U.S., flu vaccines for the 2024-2025 season will be trivalent, and most (91%) will be thimerosal-free or thimerosal-reduced vaccines. About 21% of flu vaccines will be egg-free.

Bavarian Nordic A/S recently announced it received a new contract of 440,000 doses to supply its MVA-BN® smallpox and mpox vaccine from an undisclosed European country. 

The Company confirmed all vaccines under this contract will be delivered in 2024.

Immediate access to these vaccines is essential since the mpox clade 1b outbreak is spreading in Africa.

Paul Chaplin, President & CEO of Bavarian Nordic, said in a press release on August 21, 2024, “Bavarian Nordic can still supply up to 10 million doses of our smallpox and mpox vaccine by the end of next year, with 2 million doses of this capacity available during the remaining part of this year.”

The MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic (JYNNEOS®, IMVANEX®, and IMVAMUNE®) is a non-replicating vaccine approved by several countries, including the United States.