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As the global mpox outbreak continues impacting people in 2023, a leader in mRNA vaccines intends to enter the market with an innovative vaccine.

This announcement is essential since numerous vaccine breakthrough cases related to currently approved mpox vaccines have been reported worldwide in 2023.

BioNTech SE today announced a strategic partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) to advance the development of BNT166 for the prevention of mpox.

CEPI will provide up to $90 million to support the development of mRNA-based vaccine candidates.

BNT166 is part of BioNTech's efforts to develop novel prophylactic vaccines for various infectious diseases with a high medical need.

BioNTech aims to develop a prophylactic mRNA-based mpox vaccine with a favorable safety profile that can be manufactured at scale.

"The 100 Days Mission aims to accelerate the development of a vaccine against a novel virus with pandemic potential to just 100 days. BioNTech's world-class scientists, technology, and facilities can make a vital contribution. Achieving this mission and potentially preventing the next pandemic will require gathering a wealth of knowledge and data about the performance of the latest vaccine platforms, like mRNA, which can enable rapid responses to emerging infectious threats across a broad range of viruses," commented Richard Hatchett, M.D., Chief Executive Officer of CEPI in a press release on September 18, 2023.

The BNT166 vaccine candidates encode surface antigens expressed in the monkeypox virus's two infectious forms to efficiently fight virus replication and infectivity.

The phase 1/2 clinical trial will evaluate the safety, tolerability, reactogenicity, and immunogenicity of two mRNA-based multivalent vaccine candidates for active immunization against mpox.

This study will enroll participants with and without prior known or suspected smallpox vaccination history.

Since eradicating smallpox in 1980, the global population-level immunity against the Orthopoxvirus viral family, including mpox, has been waning. 

Mpox is a vaccine-preventable, sexually transmitted disease caused by a member of the Orthopoxvirus viral family, an infectious disease that can lead to severe, life-threatening complications.

BioNTech and CEPI also confirmed today that they are committed to enabling equitable access to the outputs of this partnership. Any licensed vaccines developed due to this strategic partnership are expected to be available at affordable prices in low- and middle-income countries.

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Western Australians were recently told to be alert following a confirmed measles case in a traveler from Bali.

Infected while overseas, the person received care at a Perth metropolitan hospital and has spent time in the Perth and Midwest regions while infectious.

People who have visited an exposure location and times listed here should be vigilant for symptoms 18 days after exposure.

As of September 13, 2023, the Government of Western Australia's Health Department's Acting Director of Communicable Diseases, Dr. Jelena Maticevic, said public health staff contacted people exposed and where they are known.

"While there is no ongoing risk of measles at those locations, anyone who has visited one of the exposure locations at the same time as the case should monitor for symptoms and see a doctor if symptoms develop," Dr Maticevic added.

Western Australia reported its first measles cases in three years on April 20, 2023.

Due to high vaccination coverage, measles has been eliminated from Australia for around 25 years. Small outbreaks can occur, sparked by residents or visitors who get infected while overseas.

During September 2023, measles outbreaks continued to be reported in various countries, including the United States.

For example, India has confirmed 46,231 measles cases over the past year.

In the U.S., the Centers for Disease Control and Prevention (CDC) reported on September 8, 2023, a total of 22 measles cases were reported by 14 jurisdictions this year.

The CDC recommends international travelers speak with a healthcare provider about vaccination options before visiting measles-outbreak countries.

According to Statista, Western Australia is a popular place to visit.

In 2022, around 4.3 million domestic overnight visitors traveled to Perth, Australia. That same year, over 15 million domestic tourists went to Perth for the day.

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Nipah Virus Vaccine

Nipah Virus Vaccines May 2025

The World Health Organization (WHO) states that it is developing Nipah vaccine candidates that encompass live-attenuated and replication-defective recombinant vaccine platforms based on poxviruses, VSV, adenovirus, measles, rabies, and virus-like particles, as well as subunit vaccines. As of May 29, 2025, no vaccine or treatment for the Nipah virus (NiV) has been authorized by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA), but clinical trials are ongoing.

In June 2023, the Coalition for Epidemic Preparedness Innovations (CEPI) invested US$ $100 million in four Nipah vaccine candidates: Auro Vacc, PATH, Public Health Vaccines, the University of Tokyo, and the University of Oxford.

Nipah Virus Vaccine Candidates

On March 30, 2025, Gennova Biopharmaceuticals Limited confirmed its work with Houston Methodist Research Institute to develop a self-amplifying mRNA Nipah vaccine candidate. Coalition for Epidemic Preparedness Innovations provides up to $13.38 million in funding for this self-amplifying mRNA vaccine candidate.

On May 30, 2024, Auro Vaccines LLC published the Phase 1 study results for its Nipah Virus vaccine candidate, Hev-Sg-Vults. The induction of antibodies within one month of vaccination, along with the persistence afforded by subsequent doses, suggests that the vaccine candidate has the potential for reactive outbreak control and preventive use.

As of January 11, 2024, the ChAdOx1 NipahB vaccine is being developed by researchers at the University of Pandemic Sciences Institute. Fifty-one people aged 18 to 55 will participate in the first-in-human phase 1 clinical trial, which is being led by the Oxford Vaccine Group within the Department for Paediatrics (Miss Ella Morey, [email protected]) and funded by the CEPI. The study (ISRCTN87634044) will run over the next 18 months, with further trials expected to follow in a Nipah-affected country. NPJ reported in 2022 that ChAdOx1 NiV vaccination protects against lethal Nipah Bangladesh virus infection in African green monkeys. Vaccinated animals showed no signs of disease and were unable to detect infectious viruses in tissues or on all but one swab. No limited antibodies against fusion protein or nucleoprotein antigen could be seen 42 days post-challenge, suggesting that vaccination induced a robust protective immune response, preventing extensive virus replication. In 2019, a study reported that a single-dose ChAdOx1-vectored vaccine protects against Nipah in Bangladesh and Malaysia in Syrian hamsters.

Modern Inc.'s mRNA-1215 Nipah virus vaccine. The phase 1 clinical trial was updated in 2023.

Public Health Vaccines LLC sponsors PHV02, a live, attenuated, recombinant vesicular stomatitis virus vector vaccine candidate expressing the Nipah virus (Bangladesh strain) and the Ebola virus glycoprotein. The VSV-NiVG vaccine offers broad protection against NiV disease. It affords protection after a single injection, protecting against both homologous and heterologous challenges using the licensed VSV-EBOV vector as a backbone. The phase 1 clinical trial was last updated on March 14, 2023.

The International Centre for Diarrhoeal Disease Research in Bangladesh also studies survivors to better understand the body's response to the virus and support vaccine development. CEPI will provide up to $980,000 to support the research.

PhylexBioSciences's second-generation nanoparticle mRNA vaccine technology directly applies to developing a Nipah virus vaccine. The mRNA vaccine candidate encodes for a nanoparticle displaying 60 copies of the antigen based on the head domain of the G protein of the Nipah virus. On September 22, 2023, Phylex published proof of principle directly applicable to the development of a Nipah virus vaccine.

Nipah Outbreaks

Nipah is a zoonotic disease that is spread between animals and people by fruit bats, according to the U.S. National Institutes of Health (NIH). Nipah and henipavirus diseases are considered priority pathogens by the World Health Organization (WHO) because of their potential to cause public health emergencies.

 

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Nipah virus vaccine candidates are in development in 2025
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China has now classified mpox as a Class B infectious disease as cases surged in August 2023.

The South China Morning Post reported on September 15, 2023, that The Class B category also includes diseases such as COVID-19, HIV/Aids, dengue, and rabies.

The National Health Commission of the People's Republic of China announced the change would take effect next week with upgraded prevention and control measures against mpox spreading in the local population.

Data from the Chinese Centre for Disease Control and Prevention (CCDC) website indicates there were 501 confirmed mpox cases across 25 provinces in August 2023. That compared with 491 cases in July and 106 in June.

The CCDC website says Mpox is a zoonotic infectious disease caused by the monkeypox virus (MPXV) and is characterized by fever, a rash, and swollen lymph nodes. The virus was first isolated from a specimen of a suspected smallpox patient from the Democratic Republic of the Congo in 1970.

Suspected and confirmed cases of mpox should be promptly transported to medical institutions for isolation and treatment. If their clinical symptoms improve significantly and the lesions have scabbed, they can opt to stay at home in China until the scabs fall. 

During home quarantine, patients should reside in a single room and avoid immediate contact with family members, says the CCDC.

The website says there is no vaccine available on the Chinese mainland to prevent mpox as of September 2023.

As of September 2023, over 1.2 million (1st and 2nd) JYNNEOS® (MVA-BN, IMVANEX®, IMVAMUNE®) vaccine doses had been administered in the U.S.

Mpox outbreaks in 2023 include countries in Africa, the Americas, France, Japan, Portugal, South Korea, Spain, and Taiwan. And in cities such as Chicago, Denver, London, and New York City.

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Polio vaccines 2023
Global Polio Eradication Initiative 2023 goals are unachievable
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A new investigational universal influenza vaccine candidate has begun a phase 1 clinical trial at the National Institutes of Health’s Clinical Center in Maryland.

The National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. NIH, sponsors this limited study. It will evaluate the investigational vaccine for safety and its ability to elicit an immune response.

The flu shot candidate, FluMos-v2, was designed by researchers at NIAID’s Vaccine Research Center.

“An ideal universal influenza vaccine could be taken less frequently than once a year and protect against multiple strains of influenza virus. With each new universal influenza vaccine candidate and clinical trial, we take another step closer to that goal,” said Acting NIAID Director Hugh Auchincloss, M.D., in a September 15, 2023 press release.

FluMos-v2 is designed to induce antibodies against various influenza virus strains by displaying part of the influenza virus hemagglutinin protein in repeating patterns on self-assembling nanoparticle scaffolds.

Exposure to these harmless fragments of virus proteins prepares the immune system to recognize and fight the virus. When tested in animals, the experimental vaccine resulted in robust antibody responses.

It is an adaptation of an earlier universal flu vaccine candidate, FluMos-v1, which began first-in-human testing in 2021 and is still undergoing phase 1 trials.

As of September 16, 2023, hundreds of flu vaccine candidates are conducting sponsored clinical trials seeking participants.

Further information about the new trial is available at clinicaltrials.gov using the identifier NCT05968989.

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There was one state reporting above-average influenza detections last week.

According to the U.S. Centers for Disease Control and Prevention (CDC) week #36 report, last week's seasonal flu rates were low nationally, with 253 (.07%) positive specimens.

However, the Texas Department of State Health Services (DSHS) reported (1.01%) of influenza samples tested were positive as of September 15, 2023.

The number of Texas regions reporting increased flu activity was four, while three reported decreased activity.

While the 2023-2024 flu season has not officially begun, the current season continues producing related fatalities.

As of September 14, 2023, the National Center for Health Statistics Mortality Surveillance listed pneumonia as an underlying or contributing cause of death on 1,029 death certificates and 12 listed influenza last week.

During the current flu season, 174 influenza-associated pediatric deaths have occurred.

Last season, Texas reported a total of 9,871 pneumonia and influenza-related deaths.

For most persons older than six months, only one dose of an influenza vaccine is recommended by the CDC. And vaccination should ideally be offered during September or October.

However, the CDC says vaccinations should continue throughout the flu season as long as viruses are circulating.

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CDC 2022-23 Influenza Season Week 36 ending Sep 09, 2023
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As the Northern Hemisphere heads into its fall respiratory season, most European countries are seeing an end to the recent COVID-19 wave.

Consultation rates of patients presenting to general practitioners with respiratory illness/acute respiratory infection increased in several countries in September 2023 but remained similar to the low levels observed in the same period last year.

The European Centre for Disease Prevention and Control (ECDC) reported for week #36, there was a decrease in COVID-19 cases at the EU/EEA level, which is an inversion of the increasing trend observed in the previous weeks.

Of 19 countries reporting data as of September 14, 2023, twelve reported decreases in COVID-19 cases.

And the impact on severe disease and mortality remained limited in these European countries.

Of countries reporting COVID-19-related hospitalizations and deaths, one reported an increase in hospital admissions, and one reported an increase in fatalities.

Globally, as of September 13, 2023, the World Health Organization (WHO) reported there have been 770,563,467 confirmed cases of COVID-19, including 6,957,216 deaths since the pandemic began in late 2019.

As of September 5, 2023, a total of 13,500,135,157 vaccine doses have been administered.

The WHO has Listed twelve different COVID-19 vaccines during the pandemic.

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CSL Seqirus today announced new data will be presented at the European Scientific Working Group on Influenza Conference taking place from 17-20 September 2023 in Spain.

Data from various studies, including real-world evidence, economic and cost-effectiveness modeling, and clinical studies across seasonal and pandemic influenza, will be shared as posters and oral presentations.

"At CSL Seqirus, public health protection is at our core and is what drives us to safeguard at-risk communities against seasonal and pandemic influenza threats," said Raja Rajaram, M.D., Head of Global Medical Strategy, CSL Seqirus, in a press release on September 15, 2023.

"Delivering on our promise means continually gathering and analyzing data to assess the value and impact of our vaccines, and we look forward to sharing results from many of these studies at ESWI that emphasize the national, regional, and global impact."

Influenza is a contagious seasonal respiratory disease that may cause severe illness and life-threatening complications in some people.

On September 4, 2023, the World Health Organization published Influenza Update N° 453, indicating that influenza detections remained low globally, with activity in many Southern Hemisphere and Oceania countries.

As of September 15, 2023, the new flu and Respiratory Syncytial Virus seasons have begun to impact people in the United States.

An updated overview of influenza vaccines targeting the 2023-2024 flu viruses is posted at Precision Vaccinations.

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About 4 billion people eagerly await a vaccine to prevent and/or treat herpes virus infections, a global Sexually Transmitted Disease (STD).

According to the World Health Organization, an estimated 3.7 billion people have herpes simplex virus type 1 (HSV-1) infection, the leading cause of oral herpes.

Additionally, an estimated 491 million people have herpes simplex virus type 2 (HSV-2) infection, the main cause of genital herpes.

Recently, a worldwide leader in mRNA technologies launched a phase 1/2 clinical trial to address this massive market.

Moderna Inc.'s mRNA-1608 is an HSV-2 therapeutic vaccine candidate conducting a study (mRNA-1608-P101) with 300 healthy adults with recurrent HSV-2 Genital Herpes.

This randomized, observer-blind, controlled, dose-ranging study launched in the United States on September 6, 2023, and is forecasted to be completed on June 4, 2025.

Moderna has selected study locations in Alabama, Arizona, and California. The email contact is [email protected]. Or visit Trial Search for additional clinical studies.

With mRNA-1608, Moderna aims to induce a strong antibody response with neutralizing and effector functionality combined with cell-mediated immunity. 

On February 18, 2022, Moderna stated that it expects an HSV-2 vaccine could provide cross-protection against HSV-1.

As of September 15, 2023, there is no herpes vaccine candidate approved by the U.S. Food and Drug Administration.

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