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RSVPreF3-Mat RSV prefusion F protein-based maternal vaccine development discontinued
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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.

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WHO Marburg disease case map 2024
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Recurrent Urinary Tract Infection Vaccine Referral

Recurrent Urinary Tract Infection Vaccine Referral

The Uromune™ MV140 vaccine experimental Recurrent Urinary Tract Infection (rUTI) inactivated oral spray vaccine is approved for use by adults in various countries. Uromune initially became available in Spain and is now available in 26 countries, including England, Europe, and Mexico.

Please complete the form below to receive a rUTI vaccine referral. Please note that as of 2025, Uromune is not available in the United States. This means that to become immunized against rUTIs, you would need to travel internationally.

This self-administered rUTI vaccine contains four whole-cell inactivated bacteria suspended in water. Uromine vaccination has been found in research studies to reduce the number of UTIs and increase the time to the next UTI from 48 days to 275 days.

 

Travel Vaccination Services 2025

While traveling abroad in 2025, various health agencies recommend travel vaccines when visiting disease-endemic areas.

 

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UTI oral spray Uromune MV140 vaccine is offered in various countries in 2025.
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According to the latest weekly update by the Global Polio Eradication Initiative (GPEI), Afghanistan reported its second wild poliovirus type 1 (WPV1) case of 2024.

This polio patient is from Nuristan province in the eastern part of the country.

Five WPV1-positive environmental samples were reported: four in Nangarhar and one in Kandahar.

As of April 14, 2024, Afghanistan is one of the two countries in the Middle East where WPV1 is still endemic.

The total number of WPV1 cases reported in 2023 remains six.

During 2024, various countries deployed the type 2 novel oral polio (nOPV2) vaccine produced by Indonesia's Biofarma.

This oral polio vaccine (OPV) has been 'triple-locked' using genetic engineering to prevent it from becoming harmful and producing a gut reaction. As a result, nOPV2 is reported to be more genetically stable than approved OPVs, with a lower risk of reversion to neurovirulence and less likely to mutate and cause paralysis.

Over the past two years, about 1.1. billion nOPV2 vaccines have been administrated worldwide. The GPEI says international travelers should speak with a healthcare provider about their polio vaccine options, including booster doses.

The inactivated polio vaccine is offered in the United States at various clinics and pharmacies.

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GPEI polio case map April 2024
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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.

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US CDC Yellow Book 2024 African Meningitis Belt map
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Nationally, weekly flu hospital admissions have been decreasing since January 2024, but small outbreaks continued to be reported in April 2024.

On April 12, 2024, the U.S. Centers for Disease Control and Prevention (CDC) reported outpatient respiratory illness declined and is below baseline for the first time since late October 2023, while HHS regions 1, 5, and 7 remain above their region-specific baselines.

From a local perspective, the Walgreens Flu Index™ - Week Ending April 6, 2024, identified these ten Designated Market Areas with Flu Activity:

  1. Omaha, Neb.
  2. Lincoln & Hastings-Kearney, Neb.
  3. El Paso, Texas (Las Cruces, N.M.)
  4. Davenport, Iowa-Rock Island-Moline, Ill.
  5. Lansing, Mich.
  6. Oklahoma City, Okla.
  7. Columbus-Tupelo-West Point-Houston, Miss.
  8. Ft. Smith-Fayetteville-Springdale-Rogers, Ark.
  9. Harlingen-Weslaco-Brownsville-McAllen, Texas
  10. Knoxville, Tenn.

The CDC's Weekly U.S. Influenza Surveillance Report also confirmed that five influenza-associated pediatric deaths occurring during the 2023-2024 season were reported to the CDC during Week 14, bringing the season total to 138 pediatric deaths.

Furthermore, the CDC recommends people speak with a healthcare provider about late-season flu shot options. Various egg, cell, and nasal-based influenza vaccines remain available at community pharmacies in the U.S.

Note: The Walgreens Flu Index displays information regarding flu activity compiled using retail prescription data for antiviral medications used to treat influenza.

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Walgreens Flu Index map April 6, 2024
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measles cases US
Measles outbreaks in Chicago, New York, California
Whooping cough
Pentavalent vaccine protects people from Diphtheria, Pertussis, Tetanus, Hepatitis B, Hemophilus influenza type B
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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."

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by Gerd Altmann
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