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For the first time, seniors can prepare to defend themselves against co-circulating influenza, respiratory syncytial virus (RSV), and the betacoronavirus that causes COVID-19.

Vaccines can provide life-saving protection against all three viral respiratory diseases, says the U.S. Centers for Disease Control and Prevention (CDC).

With the fall season's increasing number of cases, now is an excellent time to take action, says the CDC's new Director, Mandy K. Cohen, MD, MPH.

As of September 19, 2023, the CDC recommends these approved vaccines for older adults, who are at a higher risk of severe illness from these diseases.

Furthermore, clinicians play a vital role in ensuring that older adults know they can now protect themselves by encouraging them to stay current on respiratory vaccinations.

During today's Clinician Outreach and Communication Activity (COCA) webinar, CDC presenters will offer updates about the latest recommendations and clinical considerations for administering influenza, COVID-19, and RSV vaccines to adults 60 years and older and discuss resources and communication strategies that may help facilitate older adult vaccination.

At 2:00 PM – 3:00 PM ET., this COCA Webinar Link (ID: 160 602 0154,  Passcode: 493303)  https://www.zoomgov.com/j/1606020154 will become active, as will today's related presentation - Preparing for the Upcoming Respiratory Virus Season: Recommendations for Influenza, COVID-19, and RSV Vaccines for Older Adults.

 

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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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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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COVID-19 vaccines
Vidprevtyn protein based COVID-19 vaccine protect people from SARS-CoV-2 variants without antigen matching
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While the U.S. FDA issued various authorizations for mRNA COVID-19 vaccines yesterday, the only protein-based COVID-19 vaccine was included in the Advisory Committee on Immunization Practices (ACIP) meeting on September 12, 2023.

Dr. Filip Dubovsky, President Research & Development, Novavax Inc., presented updated data supporting the Novavax XBB.1.5 Vaccine.

This ACIP presentation included, but is not limited to, the following:

  • Non-human primate data demonstrates that Novavax vaccine technology induces broadly neutralizing antibodies with primary vaccination,
  • Neutralizing responses against XBB subvariants achieve levels comparable to homologous XBB.1.5 response,
  • Consistent responses against all variants including emerging XBB subvariants.

In summary, Dr. Dubovsky stated during today's webinar that non-clinical data supports the use of the Novavax XBB.1.5 vaccine, there are robust neutralizing responses against XBB subvariants and data that generate a polyfunctional Th1-biased CD4+ cellular immune response against XBB subvariants.

Novavax COVID-19 vaccine brands include Nuvaxovid, CovoVax, and NVX-CoV2373, and has been distributed in about 40 markets as of September 2023.

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The only imported quadrivalent seasonal influenza vaccine approved for use in individuals aged three years and older has been listed in 26 provinces and municipalities in China.

Clover Biopharmaceuticals, Ltd. today announced the launch of AdimFlu-S (QIS) in mainland China.

“The launch of AdimFlu-S in mainland China – our second commercialized product – strengthens Clover’s leading respiratory vaccine franchise and contributes to our financial sustainability and future growth,” said Joshua Liang, Chief Executive Officer and Executive Director of Clover, in a press release on September 12, 2023.

AdimFlu-S (QIS) is a quadrivalent split inactivated vaccine that can be used to prevent influenza. It contains hemagglutinin from four influenza virus strains (two A and two B).

This quadrivalent improves its ability to achieve high vaccine effectiveness, regardless of which influenza B strain becomes seasonally prevalent, compared to trivalent flu shot options, says the company.

AdimFlu-S gained approval from the China National Medical Products Administration in January 2022.

As of September 2023, over 100 flu shot candidates are in development globally.

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A team of researchers at MIT today announced they are working on making mRNA vaccines produce a more robust immune response at a lower dose.

Published in the journal Nature Biomedical Engineering on September 7, 2023, this study showed how MIT researchers delivered COVID-19 antigen and the antigen to boost the immune response without needing a separate adjuvant.

The researchers’ tests also showed that the vaccine induced a strong immune response when delivered intranasally compared to the response elicited by traditional intramuscular vaccination.

In mice, intramuscular or intranasal administration of nanoparticles with the lead ionizable lipid and with mRNA encoding for the fusion protein (either the spike protein or the receptor-binding domain of SARS-CoV-2 increased the titres of antibodies against SARS-CoV-2 tenfold with respect to the vaccine encoding for the unadjuvanted antigen.

“With intranasal vaccination, you might be able to kill Covid (SARS-CoV-2) at the mucus membrane before it gets into your body,” commented Daniel Anderson, a professor in MIT’s Department of Chemical Engineering and the senior author of the study in an MIT News article.

“Intranasal vaccines may also be easier to administer to many people since they don’t require an injection.”

The researchers believe the effectiveness of other types of mRNA vaccines now in development, including vaccines for cancer, could be improved by incorporating similar immune-stimulating properties.

If further developed for use in humans, this type of mRNA vaccine could help to reduce costs, reduce the dosage needed, and potentially lead to longer-lasting immunity, wrote these researchers.

The National Institutes of Health and Translate Bio funded the research.

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Since Ebola virus disease (EVD) impacts everyone in an outbreak area, another agency has approved a preventive vaccine for young children.

Merck today announced that the European Commission (EC) approved an expanded indication for the ERVEBO® vaccine for active immunization of individuals one year of age or older to protect against EVD caused by Zaire ebolavirus.

ERVENO was previously approved for use in the European Union for individuals 18 or older. 

The U.S. FDA recently issued similar approval for young children.

ERVEBO is approved in the European Union, United Kingdom, United States, Canada, Switzerland, and ten countries in Africa.

ERVEBO is a live recombinant viral vaccine with a vesicular stomatitis virus backbone that protects people from Zaire ebolavirus. This vaccine does not protect people from the Sudan ebolavirus or the Marburg virus.

Dr. Eliav Barr, senior vice president, head of global clinical development, and chief medical officer, Merck Research Laboratories, commented in a press release on September 7, 2023, “When outbreaks of Ebola virus disease occur, they can quickly become a public health crisis. We are proud to play a role, alongside the global public health community, in helping to prepare for potential outbreaks of Zaire ebolavirus.”

In January 2021, Merck confirmed an agreement with UNICEF to establish the world’s first global Ebola vaccine stockpile to support future Zaire ebolavirus (EBOV) outbreak preparedness and response efforts.

Over 500,000 doses of ERVEBO have been delivered to the stockpile, administered by the International Coordinating Group on Vaccine Provision.

The initial EBOV case was confirmed in 1976 in the African countries of South Sudan and the Democratic Republic of Congo. Recent data suggest EBOV outbreaks may originate from human-to-human transmission instead of spillover events.

The U.S. Centers for Disease Control and Prevention published a list of EBOV Cases and Outbreaks as of August 2023.

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While there are no approved human vaccines for Lyme disease, results from a new study show a booster dose can produce a strong immune response in children, adolescents, and adults.

France-based Valneva SE and Pfizer Inc. today announced positive pediatric and adolescent immunogenicity and safety data for their Lyme disease vaccine candidate, VLA15, when given as a booster.

The VLA15-221 Phase 2 clinical trial showed a strong anamnestic antibody response for all serotypes in pediatric (5 to 11 years of age) and adolescent participants (12 to 17 years of age), as well as in adults (18 to 65 years of age), one month after administration of a booster dose (month 19).

Depending on the primary vaccination schedule (month 0-2-6 or month 0-6), participants seroconverted after the booster dose, yielding seroconversion rates of 95.3% and 94.6% for all outer surface protein A (OspA) serotypes in all age groups, respectively.

Additionally, OspA antibody titers were significantly higher one month after the booster dose compared to one month after the primary schedule, with 3.3- to 3.7-fold increases (Geometric Mean Fold Rises) in adults, 2.0- to 2.7-fold increases in adolescents and 2.3- to 2.5-fold increases in children for all serotypes.

“Protection against Lyme disease is important for anyone who lives or spends time outdoors in areas where Lyme disease is endemic. This data from the VLA15-221 study is vital to improve our understanding of how vaccination may help to protect both adults and children from this potentially devastating disease,” commented Annaliesa Anderson, Ph.D., Senior Vice President and Head of Vaccine Research and Development at Pfizer, in a press release on September 7, 2023.

These results follow six-month antibody persistence data in children and adults reported for the VLA15-221 study in December 20222 and positive immunogenicity and safety data reported in April 20223.

Pfizer aims to submit a Biologics License Application to the U.S. Food and Drug Administration and a Marketing Authorisation Application to the European Medicines Agency in 2026, subject to positive Phase 3 data.

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The Coalition for Epidemic Preparedness Innovations (CEPI) and the International Vaccine Institute (IVI) recently renewed a multi-year collaboration to accelerate the development of vaccines against emerging infectious diseases.

Under the renewed CEPI-IVI Implementing Partnership Agreement announced on September 1, 2023, IVI will provide technical services for CEPI-funded projects, leveraging IVI’s expertise and capabilities at their headquarters in Korea.

And help accelerate vaccine development against pathogens with epidemic or pandemic potential, and in support of CEPI’s 100 Days Mission, a goal to reduce the time taken to develop safe and effective vaccines against pathogens with pandemic potential to 100 days.

To this end, IVI will support CEPI across a variety of projects, including providing strategic, technical, and scientific support for clinical development and manufacturing of vaccines, standards, and assay development, and capacity-building initiatives that strengthen local resources to help establish or improve research preparedness and emergency evidence generation for future outbreaks.

CEPI's 5-year plan lays out a $3.5 billion roadmap to compress vaccine development timelines to 100 days, develop a broadly protective vaccine against COVID-19 and other betacoronaviruses, and create a "library" of vaccine candidates for use against known and unknown pathogens.

CEPI has also invested in new platform technologies for rapid vaccine development against unknown pathogens (Disease X).

Before the recent pandemic, beginning in 2027, CEPI focused on developing vaccines against the Ebola, Lassa, MERS, Nipah, Rift Valley Fever, and Chikungunya viruses. 

CEPI's plan is available at https://endpandemics.cepi.net.

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