Vaccine News

Soligenix, Inc. announced today that the Office of Orphan Products Development of the United States Food and Drug Administration (FDA) has granted orphan drug designation to the active ingredient in MarVax™, the subunit protein vaccine of recombinantly expressed Marburg marburgvirus (MARV) glycoprotein, for "the prevention and post-exposure prophylaxis against MARV infection."

MARV is a member of the Filoviridae family, which also includes Sudan and Zaire ebolaviruses. MARV outbreaks were first recognized in 1967 In Germany and Serbia, and continue in 2024.

MarVax was developed with Dr. Axel Lehrer at the University of Hawaiʽi at Mānoa.

In addition to providing a seven-year term of market exclusivity upon final FDA approval, orphan drug designation also positions Soligenix to be able to leverage a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive FDA user fees for the potential submission of a Biologics License Application, and certain tax credits.

The U.S. Orphan Drug Act assists companies in developing safe and effective therapies for treating rare diseases and disorders that affect fewer than 200,000 people in the U.S.

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix, commented in a press release on April 15, 2024, "Elements of this subunit vaccine platform... indicate its broad applicability."

"We have also demonstrated the ability to package more than one vaccine antigen in a single vaccine, particularly against MARV and Sudan ebolavirus where there are currently no available vaccines."

"The FDA's decision to grant orphan drug designation to both the MARV and Sudan ebolavirus vaccine candidates signifies an important step for Soligenix as we continue to advance the program and adds significantly to the existing patent estate surrounding this novel technology and the filovirus program." 

As of April 2024, several MARV vaccine candidates are conducting early-stage clinical studies.

Nigeria has made history by becoming the first country to introduce a new vaccine called Men5CV, which the World Health Organization (WHO) has recommended.

On April 12, 2024, the WHO confirmed Men5CV is effective against five strains of the meningococcus bacteria, and it is being used to protect people in Nigeria.

Nigeria is one of Africa's 26 meningitis hyper-endemic countries, situated in the area known as the African Meningitis Belt. Last year, there was a 50% jump in annual meningitis cases reported across Africa.

In Nigeria, a recent outbreak of Neisseria meningitidis (meningococcus) serogroup C outbreak led to 1,742 suspected meningitis cases, including 101 confirmed cases and 153 deaths in seven of 36 Nigerian states.

"Meningitis is an old and deadly foe, but this new vaccine holds the potential to change the trajectory of the disease, preventing future outbreaks and saving many lives," said Dr Tedros Adhanom Ghebreyesus, WHO Director-General, in a press release.

"Nigeria's rollout brings us one step closer to our goal to eliminate meningitis by 2030."

Meningitis is a severe infection that leads to the inflammation of the membranes (meninges) surrounding and protecting the brain and spinal cord. The WHO says there are multiple causes of meningitis, including viral, bacterial, fungal, and parasitic pathogens.

Bacterial meningitis is the most serious, can also result in septicemia, and can seriously disable or kill within 24 hours those that contract it. 

In a single shot, the new vaccine offers a powerful shield against the five major strains of the meningococcal bacteria (A, C, W, Y, and X).

Gavi, the Vaccine Alliance, is funding the vaccine and emergency vaccination activities. The alliance supports lower-income countries with routine vaccination against meningitis and also funds the global meningitis vaccine stockpile.

It has become clear that Brazil is currently facing its largest dengue fever outbreak. While two dengue vaccines have been approved for use in the country, each one has its own set of issues.

As of April 12, 2024, vaccine producers are focused on protecting more Brazilians against the virus over the next year.

Sanofi Pasteur's Dengvaxia vaccine is meant for individuals aged 9-45 who already have dengue. It requires three doses and pre-administration testing.

On the other hand, Takeda's second-generation QDENGA® (TAK-003) two-dose vaccine is also approved for use, but it has already sold out its production for 2024. 

As of January 2024, the Ministry of Health forecasted that 5.2 million doses will be delivered in 2024. Unfortunately, that amount will leave millions of people unprotected this year.

Furthermore, an article published by The New England Journal of Medicine in January 2024 stated that the Butantan-DV single-dose vaccine candidate offers protection against all four dengue virus serotypes without regard to dengue baseline serostatus and across a wide age range.

In addition to the logistical and economic benefits, Butantan-DV rapid protection may be necessary if Brazil's dengue outbreak accelerates.

The development of this novel tetravalent dengue vaccine began at Butantan Institute in 2010, using a formulation created by researchers affiliated with the U.S. NIH.

Based on recent phase 3 clinical trial results, Butantan Institute plans to submit a report to ANVISA in 2024, applying for the vaccine's registration. 

"The cost of dengue in Brazil is absurd," virologist Maurício Lacerda Nogueira said in a press release in February 2024.

"The (Butantan-DV) vaccine is expected to reduce mortality and hospitalizations due to the disease, so the Brazilian government's investment of several hundred million reais in developing an indigenous vaccine will have a huge impact on public health."

According to the Pan American Health Organization (PAHO) Situation Report No. 12, the dengue fever outbreak in 2024 is setting unfortunate records. 

Twenty-two countries and territories in the Region of the Americas reported the circulation of dengue serotypes. Brazil, Costa Rica, Guatemala, Honduras, Mexico, and Panama report the simultaneous circulation of all four dengue subtypes.

Between epidemiological weeks 1 and 11 of 2024, 3,665,589 suspected cases of dengue were reported in the Americas.

This figure represents an increase of 286% compared to the same period in 2023.

In the Southern Cone subregion. 410,296 new suspected dengue cases were reported last week, representing an increase of 342% compared to the same week in 2023.

While Brazil has reported the most dengue cases, Argentina presented a 67% increase in cases compared to the four previous epidemiological weeks.

The Caribbean is also reporting a significant increase in dengue cases this year.

As of April 11, 2024, there is good news regarding dengue protection. Both approved dengue vaccines are available in the Americas.

The second-generation dengue vaccine QDENGA® is available in Argentina, Brazil, and other countries, but not the United States.

Recent reports indicate that the yellow fever (YF) virus, which is transmitted by mosquitoes, will continue to have a severe impact on human health in 2024.

According to the U.K.'s Travel Health Pro reporting on April 4, 2024, in South America, there have been seven confirmed cases of YF, out of which four have been fatal, including three in Colombia and two in Guyana and Peru, respectively.

In Brazil, six cases of yellow fever, including four deaths, have been confirmed this year in Minas Gerais, Espírito Santo, and São Paulo.

While vaccination for YF is one of the most successful public health interventions to prevent the disease, most international travelers remain unprotected.

Public health leaders in the United Kingdom, the United States, and the World Health Organization recommend pre-trip yellow fever vaccination for all travelers aged nine months and above who are visiting areas with a risk of yellow fever unless the vaccine is not advised for medical reasons.

In 2017, the U.S. Centers for Disease Control and Prevention expanded its yellow fever vaccine recommendations for travelers to Brazil because of a large outbreak in multiple states.

As of April 11, 2024, the YF-VAX® vaccine is offered at certified clinics and pharmacies in the U.S. Internationally, the Stamaril vaccine is offered in various countries.

These vaccine providers also offer travel-related vaccination services for diseases such as dengue, influenza, measles, and polio.

As the world battles the resurgence of measles outbreaks, most vaccination campaigns are reactive.

According to an announcement by Ginkgo Bioworks, an AI-enabled measles forecasting model may soon empower proactive public health measures, such as immunization campaigns.

Announced today, Ginkgo's epidemiological modeling experts and Northeastern University researchers were awarded a grant from the Bill & Melinda Gates Foundation to develop a forecasting model to assess the risk of measles outbreaks and inform decision-making for timely interventions.

This innovative model will draw upon traditional and non-traditional data, including public health reports, travel patterns, economic activity, and other factors, and utilize AI approaches such as machine learning and deep learning to structure and analyze a multitude of data sources to produce actionable insights.

Matt McKnight, General Manager for Biosecurity at Ginkgo Bioworks, commented in a press release on April 10, 2024, "If we wait until large pockets of measles show up in hospital systems to launch public health responses, we are missing a critical window to act and slow the spread of this debilitating and highly contagious disease."

"Modern data and AI tools can shift the biosecurity and public health paradigm from reactive to proactive by helping global health leaders make more timely, effective decisions to prevent outbreaks from happening in the first place."

Measles is a highly contagious and often severe disease that most commonly affects children. While the widespread availability of measles vaccines has dramatically reduced the disease burden over the past several decades, cases are on the rise in the U.S. in 2024.

The majority of measles cases imported into the United States occur in unvaccinated residents who become infected during international travel, says the U.S. CDC.

For example, a substantive, ongoing measles outbreak has occurred in Chicago, Illinois, over the past two months.

Transgene and NEC Corporation today announced that new data will be presented on TG4050, an individualized neoantigen cancer vaccine, at the American Association for Cancer Research (AACR) Annual Meeting.

TG4050 is being evaluated in a randomized multicenter Phase I/II trial as a single agent in the adjuvant treatment of HPV-negative head and neck cancers. 

Key findings of the poster presentation obtained in the Phase I part of the trial (NCT04183166) include, but are not limited to, the following:

All 16 patients who received TG4050 are disease-free after a median 18.6-month follow-up. Out of the 16 patients in the control observation arm, three patients have relapsed. For this head and neck cancer patient population and with the current standard of care (chemoradiotherapy), approximately 40% of patients are expected to relapse within 24 months following surgery and adjuvant therapy. Also, the tumor immune contexture, expression of immune factors, mutational burden, and tumor infiltrates are associated with challenging prognoses.

Specific cellular immune responses were detected in the 16/17 patients who received TG4050 (16 patients from the treatment arm and one from the observation arm treated after relapse) using stringent testing conditions.

TG4050 induced persistent immune responses against multiple targets in several patients. T-cell responses were maintained beyond 211 days (7 months) after the initiation of the treatment. 

Dr Oliver Lantz, Head of the clinical immunology laboratory at Institut Curie, commented in the April 9, 2024, press release, "The immunological data generated by TG4050 demonstrate a robust and specific cellular immune response, even under stringent measurement criteria."

"The diversity, depth, and duration of these responses were most certainly a key factor in preventing relapse in the patients treated with TG4050."

According to statements, Transgene and NEC are preparing a randomized Phase II extension of this trial, slated to start in the second quarter of 2024.

The U.S. CDC says cancers of the head and neck include cancers that start in several places in the head and throat. Cancer is a disease in which cells of the body grow out of control.

About 70% of cancers in the oropharynx (which includes the tonsils, soft palate, and base of the tongue) are linked to human papillomavirus, a common sexually transmitted virus, says the CDC.