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mRESVIA RSV Vaccine

mRESVIA® (mRNA-1345) RSV Vaccine Clinical Trials, Dosage, Efficacy, Side Effects

Moderna Inc.'s mRESVIA® (mRNA-1345) Respiratory Syncytial Virus (RSV) messenger RNA (mRNA) vaccine that encodes for a prefusion F glycoprotein and uses lipid nanoparticles (LNPs), eliciting a superior neutralizing antibody response. The prefusion conformation is a significant target of potent neutralizing antibodies, and the protein sequences are primarily similar across both RSV-A and RSV-B subtypes. This mRNA is entirely made in a laboratory and instructs your body to create small pieces of proteins. In addition, this RSV vaccine contains the mRNA code for the RSV glycoprotein F. It does not cause RSV infection but helps the body's immune system recognize and protect itself if it encounters the RSV virus. Furthermore, receiving Moderna's RSV vaccine prevents you from becoming infected with RSV.

Moderna initiated a rolling submission of a Biologics License Application (STN: 125796) for mRNA-1345 to the U.S. Food and Drug Administration (FDA). On May 31, 2024, the FDA approved mRESVIA. The FDA previously granted Fast Track and Breakthrough Designation designations for mRNA-1345 in adults older than 60. On August 23, 2024, the European Commission (EC) granted marketing authorization for mRESVIA in thirty European countries. On June 12, 2025, the FDA expanded the indications for individuals 18-59 years of age who are at increased risk for RSV. This approval expands the previous indication of mRESVIA, which was approved in May 2024 for adults aged 60 years and older.

On February 14, 2025, Moderna reported $15 million in mRESVIA sales in the fourth quarter of 2024, representing $25 million for the full year 2024.

Massachusetts-based Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology, and manufacturing and has allowed the development of therapeutics and vaccines. To learn more, visit www.modernatx.com.

mRESVIA (mRNA-1345) Vaccine Availability

Moderna expects to have mRESVIA available in the U.S. and Europe for the 2024/2025 RSV season.

mRESVIA (mRNA-1345) Vaccine Indication

The mRNA-1345 RSV vaccine candidate is indicated for the prevention of illness caused by RSV, a leading cause of respiratory disease in young children and older adults (65 years and older). RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lungs) and pneumonia (infection of the lungs) in children under one year of age. According to the U.S. CDC, RSV leads each year, on average, to approximately 58,000 hospitalizations among children younger than five years old, 177,000 hospitalizations among adults 65 years and older, and 14,000 deaths among adults 65 years and older.

mRESVIA (mRNA-1345) Vaccine Dosage

The data from a Phase 1 study in older adults ages 65-79 showed that a single mRNA-1345 vaccination of 50 µg, 100 µg, or 200 µg boosted neutralizing antibody titers against RSV-A by approximately 14-fold and against RSV-B by about 10-fold. The U.S. FDA updated the data.

mRESVIA (mRNA-1345) Vaccine Efficacy

Moderna's presentation to the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) on June 26, 2024, disclosed that mRESVIA (mRNA-1345) showed about 81% efficacy after 3.7 months but only 50% efficacy in preventing the illness after 18 months. On October 25, 2023, the ACIP confirmed the Work Group was reviewing the safety and efficacy of Moderna's mRNA-1345 for use in adults 60 and older. On February 29, 2024, the ACIP committee reviewed the results of the Pivotal Phase 2/3 clinical trial (36,557 Participants Enrolled in 22 Countries). The mRNA-1345 vaccine was generally well tolerated in >19,500 individuals with no safety concerns. The ACIP reviewed a Phase 1 trial: Concomitant administration of influenza and COVID-19 vaccines.

mRESVIA (mRNA-1345) Vaccine Safety

The U.S. FDA published an updated Package Insert. The NEJM published an ORIGINAL ARTICLE in December 2023 - Efficacy and Safety of an mRNA-Based RSV PreF Vaccine in Older Adults. A single dose of the mRNA-1345 vaccine resulted in no evident safety concerns. It led to a lower incidence of RSV-associated lower respiratory tract disease and RSV-associated acute respiratory disease than placebo among adults 60 years of age or older. (Funded by Moderna; ConquerRSV ClinicalTrials.gov number, NCT05127434) Moderna announced in July 2023 that the vaccine candidate was well-tolerated and had a favorable safety profile. Most solicited adverse reactions were mild or moderate, and the most commonly reported solicited adverse reactions in the mRNA-1345 group were injection site pain, fatigue, headache, myalgia, and arthralgia. Moderna presented: Safety and Efficacy of mRNA-1345, an mRNA-based Vaccine Against RSV, in Adults 60 Years and Older on February 23, 2023, at the 7th ReSViNET Conference. Conclusion: mRNA-1345 was well tolerated and had an acceptable safety profile; solicited adverse reactions were mostly grade 1 or grade 2 in severity.

mRESVIA (mRNA-1345) Vaccine News

June 12, 2025 - Stéphane Bancel, Chief Executive Officer of Moderna, stated in a press release, "We appreciate the FDA's review and thank all the participants in our clinical trial as well as the Moderna team for their dedication to protecting people against RSV."

August 23, 2024 - The EC marketing authorization follows the Positive Opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use. It is valid in all 27 EU member states, as well as in Iceland, Liechtenstein, and Norway.

June 28, 2024 - Moderna's chief Executive Officer said in a press release, "mRESVIA protects older adults from the severe outcomes of RSV infection, and it is the only RSV vaccine available in a pre-filled syringe designed to maximize ease of administration, saving vaccinators' time and reducing the risk of administrative errors."

May 31, 2024 - Stéphane Bancel, Chief EStéphane Bancel, Chief Executive Officer of Moderna. "mRESVIA safeguards older adults against severe RSV outcomes and is uniquely offered in a pre-filled syringe to enhance ease of administration, which can save healthcare professionals time and reduce administrative errors.

February 29, 2024 - Moderna Inc. presented an RSV vaccine update to the U.S. CDC's ACIP committee.

February 7, 2024 - Moderna Inc. posted: Respiratory Syncytial Virus (RSV): What You Need to Know.

July 5, 2023 - "We are proud to announce these filings for the use of our RSV vaccine candidate, mRNA-1345, in the European Union, Switzerland, Australia, and the U.S. RSV is a major cause of lower respiratory tract infections in older adults and significantly burden to health systems through hospitalizations and emergency care admissions," said Stéphane Bancel, Chief Executive Officer of Moderna, in a press release.

March 24, 2022 - Moderna confirmed that a Phase 1 RSV trial (mRNA-1345) is ongoing, evaluating tolerability, reactogenicity, and immunogenicity in children, younger adults, older adults, and women of childbearing age. In an interim analysis, mRNA-1345 boosted RSV-neutralizing antibodies and was well-tolerated at all doses in younger and older adults.

August 3, 2021 - Moderna, Inc. announced that the U.S. FDA had granted Fast Track designation for mRNA-1345, its investigational single-dose mRNA vaccine against RSV in adults older than 60.

April 14, 2021 - Moderna shared the first interim analysis of the Phase 1 study after 1-month post-vaccination of younger adults (18-49).

mRESVIA (mRNA-1345) Vaccine Clinical Trials

The pivotal ConquerRSV Phase 3 study of RSV in older adults (60+ years) the pivotal ConquerRSV study met both its primary efficacy endpoints, with vaccine efficacy (VE) of 83.7% (95.88% CI: 66.1%, 92.2%; p<0.0001) against RSV-LRTD as defined by two or more symptoms, and a VE of 82.4% (96.36% CI: 34.8%, 95.3%; p=0.0078) against RSV-LRTD defined by three or more symptoms. No Guillain-Barre Syndrome (GBS) cases have been reported with mRNA-1345 in the Phase 3 RSV trial. In addition to older adults, mRNA-1345 is being investigated in a fully enrolled, ongoing Phase 1 trial in pediatric populations.

Clinical Trial NCT04528719: A Dose Escalation Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1345 in Healthy Adults and Children Who Are Respiratory Syncytial Virus Seropositive. Estimated Completion Date: September 30, 2023. The study will be conducted in 2 phases: Phase 2 and Phase 3. In the Phase 2 segment, 400 and 2,000 participants will be randomly assigned to receive a single injection of either the mRNA-1345 vaccine at the selected dose or a placebo in a 1:1 randomization ratio.

On December 14, 2023, the New England Journal of Medicines published an Original Article that concluded a single dose of the mRNA-1345 vaccine led to a lower incidence of RSV-associated lower respiratory tract disease and RSV-associated acute respiratory disease than placebo among adults 60 years of age or older in a phase2/3 clinical trial. Vaccine efficacy was 83.7% (95.88% confidence interval [CI], 66.0 to 92.2) against RSV-associated lower respiratory tract disease with at least two signs or symptoms and 82.4% (96.36% CI, 34.8 to 95.3) against the disease with at least three signs or symptoms. Vaccine efficacy was 68.4% (95% CI, 50.9 to 79.7) against RSV-associated acute respiratory disease. Serious adverse events occurred in 2.8% of the participants in each trial group. On December 14, 2023, a New England Journal of Medicine op-ed discussed these results.

0 min read
Availability: 
United States, Canada, EU, Norway, Iceland, Liechtenstein, the United Arab Emirates, Qatar and Taiwan
Generic: 
mRNA-1345
Clinical Trial: 
https://conquerrsv.com/
Drug Class: 
mRNA Vaccine
Last Reviewed: 
Sunday, June 15, 2025 - 07:10
Brand: 
mRESVIA
Status: 
Manufacturer Country ID: 
FDA First In Class: 
Yes
Location tags: 

VC2 HSV Vaccine

VC2 Vaccine Description 2023

Rational Vaccines VC2 vaccine candidate is a live-attenuated, engineered version of HSV-1. The VC2 vaccine targets facial, ocular, and genital herpes caused by HSV-1 but may also protect against genital herpes caused by HSV-2. 

"VC2 is unique in that it is engineered to prevent the virus from entering the neurons, " said Dr. Gus Kousoulas, who recently joined Rational Vaccines as Vice President of Scientific Affairs. HSV typically infiltrates a person's neurons and remains latent within the nervous system, and can reactivate to cause substantial disease. Some patients can even be asymptomatic carriers, spreading the virus through skin contact while showing no signs of infection themselves."

A clinical study: "A Study of the Characteristics of Patients Diagnosed With Recurrent Symptomatic Genital Herpetic Disease," will be led by Dr. Rajul Patel, consultant physician for genitourinary and HIV medicine at Southampton University Hospital, Southampton, England. The trial will be conducted at Southampton University Hospital and Chelsea and Westminster Hospital, London, England. Last Update Posted: August 12, 2022.

Rational Vaccines is focused on revolutionizing the treatment and prevention of herpes to eradicate the disease. Led by a team of scientists, the Company is headquartered in Woburn, MA, with locations in Miami, FL, and Oxford, UK. For more information, please visit www.rationalvaccines.com.

VC2 Vaccine Indication

The VC2 vaccine candidate has demonstrated promise in the treatment of Herpes Simplex Virus 1 and 2 (HSV-1 and HSV-2) as well as facial and ocular herpes in several animal model studies.

VC2 Vaccine News

August 15, 2022 - Rational Vaccines launched a clinical trial to determine the baseline characteristics of patients diagnosed with recurrent symptomatic HSV-2. In addition to assessing the typical baseline characteristics of the population, the purpose of this study is also to determine the acceptance of clinical trial procedures and understand the interest of the target patient population to participate in a therapeutic Phase 1/2 HSV-2 vaccine study.

April 5, 2021 - Rational Vaccines announces a licensing agreement with Louisiana State University for a vaccine technology VC2, demonstrating great promise in treating HSV1 and HSV2. "We are so very excited about adding this incredible science to the Rational Vaccines arsenal and partnering with Louisiana State University in the fight against HSV," said Rational CEO Agustin Fernandez.

March 7, 2018 - Intramuscular vaccination of guinea pigs with the live-attenuated human herpes simplex vaccine VC2 stimulates a transcriptional profile of vaginal Th17 and regulatory Tr1 responses. 'Kousoulas said his team's research has demonstrated that the live-attenuated HSV-1 VC2 vaccine strain cannot establish latency in vaccinated animals and produces a robust immune response capable of completely protecting mice against lethal ocular and vaginal HSV-1 or HSV-2 infections. In addition, he said the guinea pig represents the best small animal model for genital HSV-2 disease.'

VC2 Clinical Trial

ClinicalTrials.gov Identifier: NCT05500053 - Determine the baseline characteristics of patients with the recurrent symptomatic genital herpetic disease. Determine the acceptance of patients of clinical trial procedures. Determine interest in participation in genital herpes vaccine trials.

0 min read
Vaccine: 
Clinical Trial: 
https://clinicaltrials.gov/ct2/show/NCT05500053?term=NCT05500053&draw=2&rank=1
Drug Class: 
Vaccine
Condition: 
Last Reviewed: 
Tuesday, January 10, 2023 - 09:05
Brand: 
VC2
Status: 
Manufacturer Country ID: 

Hajj and Umrah Vaccinations

Hajj Umrah Vaccination Requirements 2025

The Saudi Ministry of Health established vaccine requirements for pilgrims to obtain an Entry Visa for Hajj and to perform Umrah in the Kingdom of Saudi Arabia (KSA). Health regulations and vaccination requirements were updated in 2024. On October 21, 2024, the World Health Organization (WHO) and the KSA announced a new effort to expand the Hajj health smart card initiative that summarizes critical health information, such as immunization status. In 2024, about 250,000 pilgrims from Indonesia, Malaysia, and Oman were issued Hajj health cards as part of the pilot collaboration between WHO and the KSA.

Hajj 1445 vaccinations include the following vaccines:

COVID-19: The Ministry of Health of Saudi Arabia recognizes the World Health Organization's Listed COVID-19 vaccines.

Influenza: The Saudi Ministry of Health recommends that pilgrims be vaccinated against seasonal flu before arriving in the Kingdom of Saudi Arabia. This is particularly important for those at increased risk of severe influenza, including pregnant women, children under five years of age, the elderly, and individuals with underlying health conditions.

Meningococcal: Adults and children 9 months or older arriving for Umrah, Hajj, or seasonal work must submit a vaccination certificate showing they received the (ACYW135) vaccine, issued no more than 3 years and no fewer than 10 days before arrival in Saudi Arabia. In April 2025, 11 cases of invasive meningococcal disease in the KSA were reported to the WHO.

Additional diseases underscore the need for rigorous surveillance and targeted vaccination strategies to mitigate the risk of transmission during the Hajj. Suggested vaccinations include:

Dengue and Zika Viruses: Aircraft, ships, and other means of transportation arriving in KSA from countries affected with the Zika virus and/or Dengue Fever. Valid certificate indicating that disinsection was applied per the methods recommended by WHO. They may be subjected to inspection as a condition of granting free pratique.

Polio: All visitors from polio-endemic countries and from countries with re-established transmission should receive one oral polio vaccine (OPV) dose, regardless of age and vaccination status. Proof of vaccination at least 6 weeks before departure is required for visitors from polio-endemic and re-established-transmission countries to apply for an entry visa to Saudi Arabia, and travelers will also receive one dose of OPV at border points upon arrival in Saudi Arabia. In addition, irrespective of previous immunization history, all visitors under 15 years old arriving in Saudi Arabia will receive one dose of OPV at border points.

Yellow Fever: Under the International Health Regulations 2005, all travelers arriving from countries or areas at risk of yellow fever must present a valid International Certificate of Vaccination or Prophylaxis showing that the were vaccinated with either FY-Vax or Stamaril at least 10 days before arrival. In the absence of such a certificate, the individual will be placed under strict surveillance.

General Precautions: It is recommended that all pilgrims update their immunizations against vaccine-preventable diseases. These usually include diphtheria, tetanus, pertussis, measles, and mumps. Pilgrims planning travel to malaria-risk areas in Asia, Africa, and Latin America before or after Hajj or Umrah should seek advice.

Vaccinations for Pilgrims Within the Kingdom

Primary healthcare centers located in the Kingdom offer vaccinations.

Travel Vaccinations Saudi Arabia

The U.S. Department of State confirms that those wishing to travel to Saudi Arabia to visit Medina or perform Hajj/Umrah should review the U.S. Centers for Disease Control and Prevention (CDC) vaccine recommendations. If you travel to Saudi Arabia, ensure you are fully vaccinated before travel, says the CDC. The ECDC reported in 2023 that returning travelers from the Hajj should seek medical attention immediately if they experience symptoms suggestive of any infection.

4 min read
Last Reviewed: 
Thursday, December 11, 2025 - 15:05
Description: 
Hajj and Umrah pilgrims are required to be vaccinated before visiting the Kingdom of Saudi Arabia.
Travel: 

Rabies Vaccines

Rabies Vaccines 2025

Rabies is a vaccine-preventable viral disease found in more than 150 countries and territories, according to the World Health Organization (WHO). Two types of vaccines protect people against Rabies: nerve tissue and cell culture vaccines. Cell culture vaccines, which are more affordable and require less vaccine, have been developed recently. Unlike conventional, inactivated rabies vaccines, live-attenuated viruses are genetically modified viruses that can replicate in a vaccinated person without causing adverse effects while eliciting robust and effective immune responses against viral infection.

As of 2025, according to the WHO, intradermal immunization using cell-culture-based rabies vaccines is an acceptable alternative to standard intramuscular administration. In the United Kingdom, rabies vaccines must be inactivated or recombinant and approved for use in the country. 

Rabies Vaccines Approved

As of 2025, the WHO has pre-qualified rabies vaccines, including Bavarian Nordic's RabAvert vaccIVAX-S by Serum Institute of India Pvt. Ltd., VaxiRab N by Zydus Lifesciences Limited, and VERORAB by Sanofi Pasteur.

RabAvert is a vaccine that contains an inactivated rabies antigen, indicated for preexposure vaccination, primary and booster doses, and post-exposure prophylaxis against Rabies in all age groups.

Chirorab®, previously known as Rabipur, is an inactivated rabies virus of Flury LEP. Chiron Behring Vaccines is relaunching Rabipur, a purified chick-embryo-celline. It will continue manufacturing at its WHO-prequalified facility in Ankleshwar, Gujarat, India.

Rabipur is an inactivated rabies vaccine produced by Valneva SE, which has over 35 years of worldwide clinical experience.

Rabivax-S is a lyophilized vaccine manufactured by Serum Institute of India Pvt. Ltd. It contains inactivated, purified rabies antigen and was developed using Vero cells (ATCC CCL81), derived from the Pitman-Moore strain. The inactivated vaccine is freeze-dried until ready for immunization.

Rabies Vaccine Candidates

Rabies vaccine candidates are seeking participants for various clinical trials in 2025. 

YS Biopharma Co., Ltd. PIKA Rabies Vaccine utilizes the company's proprietary PIKA adjuvant technology, designed to produce a more robust immune response in a shorter timeframe than traditional rabies vaccines. On April 9, 2024, YS Bio announced positive interim results from the ongoing Phase 3 clinical trial, indicating that the PIKA Rabies Vaccine has successfully met the primary endpoints and has the potential to achieve best-in-class accelerated protection and meet the WHO's goal of a one-week rabies vaccine regimen to replace the conventional three- or four-week regimens. On June 1, 2023, the Food and Drug Administration of the Philippines approved a Phase 3 clinical trial, and on May 16, 2023, Pakistan issued study approval.

Replicate Bioscience announced on September 12, 2023, the dosing of the first participant in a Phase 1 trial of its RBI-4000 vaccine candidate for rabies prevention. The Trial marks the first time a human has been dosed with Replicate's next-generation srRNA technology, which will be a benchmark for its utility in this indication.

VitriVax, Inc. received a grant of up to $5 million from the Coalition for Epidemic Preparedness Innovations to develop further Atomic Layering Thermostable Antigen and Adjuvant (ALTA) technology, using Rabies as a vaccine target. ALTA® could replace multi-dose vaccines for protection against infectious diseases with a single-administration alternative.

Rabies Vaccine Preexposure Prophylaxis (PrEP)

The WHO recommends preexposure prophylaxis (PrEP) for individuals at high risk of exposure. The WHO position paper on rabies vaccines recommends a one-week, two-site intradermal post-exposure prophylaxis (PEP) schedule with 0.1 mL of vaccine injected on days 0, 3, and 7. The U.S. Centers for Disease Control and Prevention (CDC) updated its recommendations for rRabies post-exposure prophylaxis (PrEP) for humans, replacing the three-dose vaccination schedule with a two-dose program intended to protect people for at least three years. On May 6, 2022, the U.S. CDC published Use of a Modified Preexposure Prophylaxis Vaccination Schedule to Prevent Human Rabies: Recommendations of the Advisory Committee on Immunization Practices — United States, 2022. 

Rabies Vaccine Breakthrough Infections

A case report by Holzbauer et al. in the March 2023 issue of Clinical Infectious Diseases is not a situation of inappropriate prophylaxis; rather, it represents a textbook response to accurate exposure to Rabies. An 84-year-old awoke to a bat biting his finger. The man washed his finger with soap and water, as recommended. Post-exposure prophylaxis was initiated three days after exposure. He received a complete four-vaccine regimen and more than the recommended 20 IU/kg of human rabies immunoglobulin (the actual dose was reportedly 30.9 IU/kg, as determined by potency testing of the immunoglobulin used), partially injected into the bite site, with the remaining amount given intramuscularly. Yet, five months later, he developed clinical Rabies and succumbed to it.

Importation of Dogs Without Rabies

In the U.S., stray dog control programs were initiated in the 1940s, and routine rabies vaccination of owned dogs eliminated the canine rabies virus variant from circulation by 2008. The American Animal Hospital Association Canine Vaccination Guidelines were updated in 2022. As of August 2023, a valid CDC Rabies Vaccination and Microchip Record is needed to obtain a permit or make a reservation. The CDC does not accept foreign-issued pet passports or other certificates for rabies vaccinations administered outside the United States. Rabies-vaccinated dogs vaccinated in the U.S. by a U.S.-licensed veterinarian may re-enter the country from a high-risk country without a CDC Dog Import Permit if the dog has a current, valid U.S.-issued rabies vaccination certificate and an ISO-compatible microchip. The CDC has temporarily suspended the importation of dogs from high-risk countries with Rabies until July 31, 2024.

Rabies Vaccines Raccoons

The U.S. Department of Agriculture's Animal and Plant Health Inspection Service announced on August 4, 2023, that it will begin its annual distribution of RABORAL V-RG®, an oral rabies vaccine bait, in select areas in the eastern United States to prevent the spread of raccoon rabies. Raccoons, foxes (including red and gray varieties), skunks, and bats are considered primary carriers of the rabies virus in the United States.

5 min read
Last Reviewed: 
Wednesday, November 12, 2025 - 05:55
Description: 
Rabies vaccines are approved and offered worldwide in 2025
Condition: 

HSV-2 Vaccine (GSK4108771A)

HSV-2 Vaccine (GSK4108771A)

The herpes simplex virus type 2 (HSV-2) vaccine candidate (GSK4108771A) utilizes self-amplifying messenger RNA, "SAM" technology. To develop a SAM-based vaccine, GlaxoSmithKline (GSK) scientists designed a SAM molecule synthetically in a laboratory, using portions of the genetic code of a virus. However, in the SAM molecule, the genes linked to the virus's ability to cause infection are deleted and replaced with genes from target viruses that will produce the antigens for desired vaccines. 

The transport of nascent HSV particles from neuron cell bodies into axons and along axons to axon tips in the periphery is an essential component of this reactivation and reinfection. Two HSV membrane proteins, gE/gI, and US9, play a crucial role in these processes. Tiny balls of fat called lipid nanoparticles or LNPs will deliver the vaccine.

Using the body's cells to produce the vaccine means that GSK would only produce the SAM genetic platform and its delivery systems. Volumes may be much smaller than with traditional vaccines. The production process would be very similar for a wide variety of different vaccines, says GSK, potentially leading to substantial streamlining of the vaccine R&D process.

England-based GSK is the world's largest vaccine company by revenue, delivering vaccines that help protect people at all stages of life. Their R&D focuses on developing vaccines against infectious diseases that combine high-medical needs and strong market potential. The GSK vaccine portfolio has been helping to protect people from serious diseases for well over 100 years, with our Marietta (US) site dedicated to smallpox vaccine production since 1882.  

HSV-2 Vaccine (GSK4108771A) Indication

HSV-2 Vaccine (GSK4108771A) is indicated to prevent HSV.

HSV-2 Vaccine (GSK4108771A) Dosage

HSV-2 Vaccine candidate (GSK4108771A) dosage is being tested in a Phase 1 clinical trial. Four doses of the formulation will be administered intramuscularly on day one and day 57.

HSV-2 Vaccine (GSK4108771A) News

June 28, 2021 - GSK has terminated its phase 1 clinical trial to enable the development of an enhanced vaccine version.

May 5, 2021 - The U.S.-based Phase I, Single-blind, Randomised, Placebo-controlled, Dose Escalation Study to Evaluate the Reactogenicity, Safety, and Immune Response of an HSV Vaccine in Healthy (~60) Participants Aged 18-40 Years was last updated. Women of non-childbearing potential may be enrolled in the study. Women with childbearing potential may be enrolled in the study under certain conditions.

March 23, 2021 - GlaxoSmithKline (GSK) launched a limited phase 1 clinical trial for a herpes simplex virus type 2 (HSV-2) candidate known as HSV vaccine (GSK4108771A). This USA-based study will include sixty participants and was last updated on March 18, 2021. This first-time-in-human study intends to assess the reactogenicity, safety, and immunogenicity of four different dose levels of an experimental HSV-2 vaccine administered intramuscularly on a 0, 2-month schedule to healthy participants aged 18-40.

HSV-2 Vaccine (GSK4108771A) Clinical Trial

Clinical Trial NCT04762511: This clinical trial has been terminated. This Phase 1 study aims to assess the reactogenicity, safety, and immunogenicity of four different dose levels of an experimental herpes simplex virus type 2 (HSV-2) vaccine when administered intramuscularly on a 0, 2-month schedule. 

0 min read
Generic: 
GSK4108771A
Clinical Trial: 
https://us.gsk.com/en-us/research-and-development/clinical-trials/
Drug Class: 
Vaccine
Condition: 
Last Reviewed: 
Wednesday, June 19, 2024 - 05:35
Brand: 
HSV-2 vaccine (GSK4108771A)
Abbreviation: 
HSV-2
Status: 
Manufacturer Country ID: 
FDA First In Class: 
Yes

Travel Vaccine Certificates, Passports, Visa

Travel Vaccine Certificates, Passports, Visa, Green Card 2025

Various countries require proof of immunization as a prerequisite for obtaining a visa or entering their territory. Vaccine passports are digital credentials that confirm a person has been vaccinated against particular diseases. The World Health Organization (WHOGlobal Digital Health Certification Network (GDHCN) became effective in Europe on July 1, 2023. The GDHCN's digital capabilities may include verification of vaccinations, the International Patient Summary, verification of vaccination certificates within and across borders, and certification of public health professionals through the WHO Academy. The WHO published the Digital Documentation of Certificates: Vaccination Status and Test Results in 2021 and 2022, respectively.

In 2023, the WHO endorsed the European Union (EU) digital certification system. The EU Digital Certificate has been issued across 51 countries.

U.S. Passport, Security Notices, Health Advisories

The U.S. Department of State publishes information for visa and passport applications, as well as for countries, to help travelers assess their risks. If Americans are overseas and need emergency assistance, they should contact the nearest U.S. embassy or consulate, says the State Department. From Overseas, call +1 202-501-4444. Updated FAQs about U.S. passport and visa operations are on this State Department webpage. In addition, view travel requirements for countries edited by Sherpa. Choose a country on this map to begin your search.

The State Department launched the Bureau of Global Health Security and Diplomacy on August 1, 2023. The Bureau's overarching mission is to fortify the global health security architecture to effectively prevent, detect, control, and respond to infectious diseases, including HIV/AIDS. By leveraging and coordinating U.S. foreign assistance, the Bureau aims to foster robust international cooperation and enhance protection for the United States and the global community against health threats through strengthened systems and policies.

U.S. Transportation Security Administration

The U.S. Transportation Security Administration (TSA) provides a range of customer service resources to support travelers. PreCheck lanes are available at your airport; you can search for them using this link. The TSA has a team dedicated to answering questions related to prohibited and permitted items, identification requirements, and other related topics. AskTSA is available 365 days a year on these social media networks: X (@AskTSA), Facebook Messenger (www.fb.com/AskTSA), Apple Business Chat (AskTSA), and by texting "Travel" to AskTSA (275-872).

On May 6, 2025, the Turkish Directorate General of Civil Aviation issued a statement (UOD-2025/01warning airline passengers that standing up before the plane has come to a complete stop and vaping or smoking on board are prohibited. Turkish Airlines may fine violators around $70 per violation.

A 2023 report from the International Air Transport Association indicates an increase in the rate of reported unruly passenger incidents. Based on over 24,500 incident reports from more than 50 operators globally, there was one incident for every 480 flights in 2023, compared to one incident for every 568 flights in 2022.

U.S. Visa Waiver Program

The U.S. Visa Waiver Program is an international travel facility that allows citizens of select countries to visit the U.S. without requiring a traditional visa. Under this program, a person can stay in the U.S. for a maximum of 90 days. Under this program, even without a visa, there are certain conditions, such as possessing an e-passport and obtaining prior permission online through the Electronic System for Travel Authorization. Visitors must meet all of the requirements to travel to the United States on the VWP.

U.S. Green Card Applications

Effective January 22, 2025, the United States Citizenship and Immigration Services (USCIS) waived the requirement that applicants for adjustment of status to lawful permanent resident present documentation on their Form I-693, Report of Immigration Medical Examination and Vaccination Record, indicating that they received the COVID-19 vaccination. USCIS will not issue any Request for Evidence or Notice of Intent to Deny related to proving a COVID-19 vaccination. USCIS will not deny any adjustment of status application based on the applicant's failure to present documentation showing receipt of the COVID-19 vaccination.

International Certificates of Vaccination or Prophylaxis

The International Certificate of Vaccination or Prophylaxis (ICVP), also known as the yellow card, is required to enter various countries internationally. The WHO published a Country List to identify which countries require an ICVP.

REAL ID Act

All U.S. states, the District of Columbia, and four of five U.S. territories covered by the REAL ID Act and related regulations are issuing REAL ID-compliant licenses and identification cards. In addition, the Department of Homeland Security (DHS) announced in December 2022 its intent to extend the REAL ID full enforcement date by 24 months, from May 3, 2023, to May 7, 2025. The REAL ID Act establishes minimum security standards for state-issued driver's licenses and identification cards. Under the new regulations, beginning May 7, 2025, every traveler 18 years or older will need a REAL ID-compliant license or identification card, a state-issued enhanced license, or another TSA-acceptable form of identification at airport security checkpoints for domestic air travel. 

U.S. Customs and Border Protection

If you are a U.S. citizen planning to travel abroad, you must comply with the document requirements for that country. Each individual arriving in the U.S. must complete the CBP Declaration Form 6059B. Examples and a sample declaration form can be found on the Customs Declaration Form. Additionally, the U.S. Customs and Border Protection (CBP) One app serves as a single portal for mobile applications and services. 

As a result of the Bipartisan Budget Act of 2018, the Electronic System for Travel Authorization (ESTA) travel promotion fee was increased from $10 to $17, in addition to a $4 operation fee. CBP began collecting the new fee amount on May 26, 2022. Individuals with an approved ESTA do not have to reapply, as an ESTA is valid for up to two years. ESTA is an automated system that determines the eligibility of visitors to travel to the United States under the Visa Waiver Program (VWP). Authorization via ESTA does not determine whether a traveler is admissible to the United States. Instead, U.S. CBP officers determine the admissibility of travelers upon their arrival.

Global Entry Program

Global Entry is a U.S. Customs and Border Protection program that allows expedited clearance for pre-approved, low-risk travelers upon arrival in the USA. Members enter through automatic kiosks at select airports. Additionally, the Enrollment on Arrival (EoA) program enables Global Entry applicants who are conditionally approved to complete their interviews upon arrival in the United States. A list of participating EoA airports is posted on this webpage. While Global Entry aims to speed travelers through the process, members may still be selected for further examination when entering the USA.

United Kingdom Electronic Travel Authorization 2025

As of June 2025, the UK Global Health Insurance Card (GHIC) enables UK residents to access necessary state healthcare in the European Economic Area (EEA) and certain other countries on the same basis as a resident of those countries. In 2025, all individuals wishing to travel to and through the United Kingdom, except British and Irish citizens, will be required to obtain an Electronic Travel Authorization (ETA). You can get an ETA instead of a visa if you're coming to the UK for up to six months for tourism, visiting family and friends, or business purposes, or if you're transiting through the UK for up to three months. ETAs for the last two years, enabling you to travel to the UK as often as possible. Prospective travelers should apply for the United Kingdom ETA using this IVISA link. The application costs £10 (about $12.50) to apply. As of 2025, the UK offers information on passport eligibility, fees, and the application process, including renewal and update procedures.

Western Hemisphere Travel Initiative

The Western Hemisphere Travel Initiative (WHTI) is a joint plan between the U.S. Department of State and the Department of Homeland Security to implement the recommendations of the 9/11 Commission and the statutory mandates of the Intelligence Reform and Terrorism Prevention Act of 2004. As a result, U.S. citizens can present a passport, a Passport Trusted Traveler Program card (such as NEXUS or SENTRI), or a U.S. military ID. Military identification card when traveling on official, oral orders; U.S. Merchant Mariner Document when traveling with official maritime business.

Note that children must also present their passports when traveling by air. Lawful permanent residents must continue to carry a valid Permanent Resident Card. A visa is not required. However, the Indian tribal card cannot be used for air travel.

Pet Passport and Tips

An EU Pet Passport is a universal document issued by an official veterinarian in a European Union (EU) Member State or another designated country, containing official health information related to a specific pet. A passport is issued to a dog, cat, or ferret after it has been taken to an EU veterinarian and vaccinated. The purpose of the EU Pet Passport is to simplify travel between the EU Member States. An EU Pet Passport cannot be obtained in the U.S.

On December 14, 2022, the TSA offered tips for traveling with small pets through security checkpoints this holiday season. Furthermore, the USDA has requirements for importing pet dogs from foreign countries. In particular, dogs traveling to the U.S. from countries affected by specific diseases may need additional inspection and/or quarantine. Use this digital menu to determine if your destination State has particular import requirements.

Airline Compensation Policies

Issued by the U.S. on August 29, 2022, a digital dashboard ensures that travelers have access to U.S. airlines' services to mitigate passenger inconveniences when the cause of a cancellation or delay was due to circumstances within the airline's control.

Traveler-based Genomic Surveillance

The CDC's Traveler-based Genomic Surveillance (TGS) program anonymously collects two nasal swab samples from consenting international travelers arriving at U.S. airports. The nasal sampling multipathogen pilot program tests people for Flu A/B, RSV, SARS-CoV-2, and 30 additional priority pathogens. As of September 2023, the TGS program had enrolled more than 360,000 air travelers from more than 135 countries. As of November 6, 2023, Ginkgo Bioworks and XpresCheck will implement the program in selected airports. 

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Last Reviewed: 
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Vaccine certificates, digital passports and visas are required in 2025
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Content Creation Staff

Content Creation Team

The Precision Vax LLC Fact-Checkers and Contributing Experts have been led by medical director Dr. Robert Carlson and publisher Donald Hackett since 2016.

  • Holly Lutmer, PharmD, Senior Editor
  • Michelle Beall, PharmD
  • Beth Bolt, RPh
  • Chris Felton, PharmD
  • Lytle Germann, PharmD
  • Natasha Gildersleeve, PharmD
  • Ashton L. Goode, PharmD
  • Allison Hall, PharmD
  • Shane Kyral, PharmD
  • Kelley Lu, PharmD
  • Cynthia N Nguyen, PharmD
  • Paul Nguyen, PharmD
  • Lauren Ragan, PharmD
  • Danielle Reiter, RN
  • Kim Robenson, RPh
  • Chelsea K Sanchez, PharmD
  • John Paul Sanchez, PharmD
1 min read
Last Reviewed: 
Monday, March 6, 2023 - 04:55
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PVax founders deployed fact checking of doctor, pharmacist, and nurse reviewed health information in 1998.
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Zoonotic Influenza Vaccines 2023

Zoonotic Influenza Vaccines August 2023

Zoonotic influenza infections are caused by harmful germs, bacteria, parasites, and fungi, says the U.S. Centers for Disease Control and Prevention (CDC). These germs cause illnesses in people, birds, and animals, ranging from mild to severe infections, according to the World Health Organization (WHO). As of August 2023, the CDC says annual 'flu shots' do not prevent zoonotic influenza infections such as swine flu (H3N2) or Avian influenza (Bird Flu). In September 2023, the U.S. CDC published Volume 29, Number 9, Research: Interspecies Transmission of Swine Influenza A Viruses and Human Seasonal Vaccine-Mediated Protection Investigated in a Ferret Model - results reaffirm the need for continuous influenza A virus surveillance in pigs and identification of candidate human vaccine viruses.

The WHO's Pandemic Influenza Preparedness (PIP) Framework is a World Health Assembly resolution adopted in 2011 as a global approach to pandemic influenza preparedness and response. If a pandemic influenza A virus changes and becomes transmissible from person to person while retaining its capacity to cause severe disease, the consequences for public health could be significant. The CDC says the severity is unpredictable because human immune systems have not established natural defenses. The most recent pandemic occurred in 2009, caused by an influenza A (H1N1) virus. Estimates indicate that the pandemic caused up to 400,000 deaths globally, with about 12,000 people in the U.S. 

Pandemic Influenza Vaccine

In April 2007, the U.S. Food and Drug Administration (FDA) licensed the first inactivated influenza vaccine for people at increased risk of exposure to the H5N1 influenza virus subtype. It was derived from the A/Vietnam/1203/2004 influenza virus a, manufactured by Sanofi Pasteur Inc. Furthermore, four pandemic preparedness vaccines are authorized in Europe, which can be modified into pandemic influenza vaccines. The EMA conditionally Authorized AstraZeneca's Pandemic influenza vaccine H5N1 (P/LAIV) in May 2017 to prevent pandemic influenza in children and adolescents. Companies operating in the global swine flu vaccine market are Novartis AG, CSL Limited, Zydus Cadila, AstraZeneca plc, MedImmune, GlaxoSmithKline, Sanofi SA, Baxter, and Sinovac Biotech Ltd.

Bird Flu Vaccine

Avian influenza vaccine news is published on this webpage.

Swine Influenza (Swine Flu)

When a swine influenza virus (H3N2) is detected in a person, it is called a "variant influenza virus," says the CDC. When animal influenza viruses infect their natural host, they are named for that host, as in avian influenza viruses, swine influenza viruses, equine influenza viruses, etc. In 2005, human infection with the novel flu A virus became nationally notifiable in the United States. The term "swine flu" refers to swine influenza viruses infecting swine. There are different swine influenza virus subtypes and strains, some of which infect other animal species, including (rarely) humans. Most human infections with variant influenza viruses occur following proximity to swine. However, human-to-human transmission can occur, says the CDC. For recommendations on safe trade in animals and related products from countries affected by these influenza viruses, refer to WOAH guidance

The first swine influenza virus was found in pigs in 1918. Since 2005, 512 variant influenza virus infections (of different influenza A virus subtypes), including 37 (human infections with influenza A (H1N2)v viruses, were reported in the U.S. The CDC published an interactive analysis of Novel Influenza A Virus Infections in the U.S. A study (Volume 29, Number 9) published by the CDC in September 2023, results reaffirmed the need for continuous influenza A virus surveillance in pigs and identification of candidate human vaccine viruses.

On September 2, 2023, the Ministry of Health, Welfare, and Sport of the Netherlands notified the WHO of a laboratory-confirmed human infection with a swine-origin influenza A(H1N1) variant virus. On August 4, 2023, the CDC reported the first two U.S. human infections with swine flu viruses who attended different agricultural fairs in Michigan in 2023 and had exposure to pigs. On June 7, 2023, Brazil notified the WHO of a fatal laboratory-confirmed human case of infection with a swine-origin influenza A(H1N1) variant (v) virus in the inner state of Paraná. It's the third swine flu fatality. Taiwan's CDC reported its third H1N2 variant (H1N2v) influenza virus case in May 2023 involving girls who had contact with pig farms in central Taiwan. India reported 451 cases of H3N2 from January to March 5, 2023.

African Swine Fever

African Swine Fever (ASF) is a highly contagious and deadly viral disease affecting domestic and feral swine of all ages. The U.S. Department of Agriculture and the FDA say ASF cannot be transmitted from domestic and wild pigs to humans.

Langya Henipavirus

Langya henipavirus (LayV), also known as Langya virus, is a species of henipavirus detected in China's Shandong and Henan provinces. Media reports indicated that 35 people were infected from 2018 to August 2022. Hendra virus and Nipah virus from this genus are known to infect humans, with fruit bats as the natural host of both viruses.

5 min read
Last Reviewed: 
Thursday, September 14, 2023 - 11:25
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Zoonotic diseases such as swine and bird influenza pandemic in 2023.
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TicoVac Tick-Borne Encephalitis Vaccine

TicoVac Tick-Borne Encephalitis Vaccine Dosage, News, Side Effects, Usage

Pfizer's TicoVac™ (whole virus, inactivated) is an approved vaccine indicated for active immunization to prevent tick-borne encephalitis (TBE), marketed under the brand names FSME-Immun® (Encepur N) in Europe and TICOVAC™ in the United States  It was developed using a master 'seed' virus similar to the TBE virus found in nature  TicoVac's formulation has changed over time, including removing thimerosal and transitioning the production virus seed from mouse brain suspension to chick embryo fibroblast cells.

TicoVac vaccination induces neutralizing antibodies against the virus, as the sequence and structure of the virus subtype match those found in nature  The virus is inactivated using formaldehyde; therefore, the vaccine cannot cause disease TicoVac protects people from known TBE virus subtypes in children (from one year of age) and adults, including the European, Siberian, and Far Eastern subtypes. 

On August 13, 2021, Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) had approved TICOVAC™ (tick-borne encephalitis vaccine) for active immunization to prevent TBE in individuals 1 year of age and older.1 TICOVAC™is the only FDA-approved vaccine to help protect U.S. adults and children against the TBE virus when visiting or living in TBE endemic areas. DrugBank Accession Number: DB16611

TicoVac Approvals

The TicoVac vaccine has been used for over 20 years in Europe. On September 7, 2021, the U.S. Food and Drug Administration (FDA) published updated information on STN: 125740 (Pfizer Ireland Pharmaceuticals) TBE Vaccine and the BLA Clinical Review Memorandum. The U.K., Europe, and Canada also published updated information on the TicoVac vaccine. In 2025, TicoVac will be available in the U.S. at certain pharmacies.

TicoVac Vaccine for Travel

International travelers are recommended to complete the primary TicoVac Immunization Series at least seven days before visiting areas with potential TBE exposure  The risk for exposure to infected ticks is highest for persons in areas where TBE is endemic during the primary TBE virus transmission season of April–November  Based on approximately 20–25 million U.S. citizen trips to countries with TBE risk each year, a mean of <1 diagnosed TBE case each year  In Europe, a median of 36 traveler cases (range = 25–65 cases) were reported annually during 2014–2020.

U.S. CDC ACIP Presentations Regarding TicoVac Vaccine

In November 2023, the U.S. CDC published Morbidity and Mortality Weekly Report - Tick-Borne Encephalitis Vaccine: Recommendations of the Advisory Committee on Immunization Practices, United States, 2023  Susan Hills, MBBS, MTH Medical Epidemiologist Arboviral Diseases Branch Centers for Disease Control and Prevention, presented on February 23, 2022: Work Group activities since the last meeting and recommendations for consideration and vote  The CDC voted in the affirmative  On January 12, 2022, the U.S. CDC's Advisory Committee on Immunization Practices (ACIP) reviewed the following presentations: TICK-BORNE ENCEPHALITIS VACCINE Katherine Poehling, MD, MPH; TICK-BORNE ENCEPHALITIS VACCINE Susan Hills, MBBS, MTH; Evidence to Recommendations; Laboratory workers: Evidence to Recommendations - 46 laboratory-acquired infections globally, all before 1995.

TicoVac Vaccine Indication

TicoVac is a vaccine that prevents TBE in individuals one year and older  Tell your doctor if you or your child have ever been infected with or been vaccinated against Yellow fever, Japanese encephalitis, or Dengue viruses  Antibodies might be in your blood that can react with the Tick-Borne Encephalitis (TBE) Virus used in tests to measure your antibody levels  These tests could then give wrong results  The effect of TicoVac 0.5 ml during pregnancy or while breastfeeding is unknown.

TicoVac Vaccines Dosage

Primary Vaccination: Three doses: For intramuscular use only; Dosage and Vaccination Schedule - 1 through 15 years of age: each dose 0.25 mL; 16 years of age and older: each dose 0.5 mL  A booster dose (fourth dose) may be given at least three years after completion of the primary immunization.

TicoVac Vaccine Junior

TicoVac Junior is for individuals aged 1 to 15 who receive 0.25 mL. The first and second doses should be administered at intervals of 1 to 3 months.

TicoVac Vaccine Effectiveness

According to the U.S. CDC, no randomized controlled trials (RCTs) have been conducted to demonstrate the efficacy of the TBE vaccine in preventing clinical diseases  Vaccine effectiveness (VE) studies for the TBE vaccine using a different schedule, with a previous vaccine formulation or with VE assessed in combination with another TBE vaccine or both, have been published; however, no studies assessing VE of the TBE vaccine alone in its current formulation and according to the U.S. licensed schedule exist  A correlate of protection has not been formally established, and no standardized reference reagents are available.

TicoVac Side Vaccine Interactions

TicoVac drug interactions are listed at this link.

TicoVac Vaccine News

November 10, 2023 - The U.S. CDC published: Tick-Borne Encephalitis Vaccine: Recommendations of the Advisory Committee on Immunization Practices, United States, 2023.

July 9, 2022 - Scientific Results published findings of a study of the VE in Germany of the ENCEPUR (Bavarian Nordic) and FSME-IMMUN (Pfizer).

February 23, 2022—Katherine Poehling, MD, MPH, ACIP TBE Vaccine Work Group Chair, presented an update before a committee vote. The update reviewed considerations for using the TBE vaccine and proposed recommendations for laboratory workers and individuals who travel abroad.

September 29, 2021 - Katherine Poehling, M.D. The U.S. CDC's ACIP TBE Vaccine Work Group chair presented a review of TBE information, including its epidemiology, clinical presentation, diagnosis, treatment, and outcomes.

August 13, 2021—The U.S. Food and Drug Administration (FDA) approved TICOVAC for active immunization to prevent TBE in individuals one year and older. 

December 1, 2014 - Pfizer acquires Baxter's vaccine portfolio, including Neis Vac-C and FSME-IMMUN/TicoVac.

January 30, 2003 - Study: Tolerability of modified tick-borne encephalitis vaccine FSME-IMMUN "NEW" in children: results of post-marketing surveillance. These results demonstrate that, in routine medical practice, the FSME-IMMUN "NEW" vaccine, administered at a dose of 1.2 micrograms of antigen per 0.25 milliliters, is safe for the first vaccination in children.

TicoVac Vaccine Clinical Trials

Pfizer's TBE vaccine has been involved in over 26 clinical studies over the past 20 years  In clinical trials, the safety and immunogenicity of TICOVAC™ were assessed across two age groups (1-15 years of age and >16 years of age)  In these studies, seropositivity rates were 99.5% in 1-15-year-olds and 98.7-100% in adults >15 years following three doses  Clinical studies demonstrated that TICOVAC™ was generally well-tolerated, with no unexpected adverse events or vaccine-related serious adverse events observed  The most common adverse reactions across both age groups were local tenderness, headache, local pain, fever, restlessness, fatigue, and muscle pain.

Clinical Trial NCT00890422: Evaluation of Immunogenicity of Different Tick-Borne Encephalitis (TBE) Fast Protective Traveler Schemes With Inactivated TBE Whole Virus Vaccine (immunization) - Last Update Posted on April 29, 2009

Clinical Trial NCT00894686: Tick-borne encephalitis (TBE) Seropersistence After the First Booster and Response to the Second Booster in Children, Adolescents, and Young Adults.

Clinical Trial NCT00161863: Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years - Completed study - January 2003.

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Availability: 
Europe, UK, USA, Canada
Generic: 
FSME-Immun
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Vaccine
Last Reviewed: 
Friday, May 9, 2025 - 11:55
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TICOVAC
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mOJg231N

Ebola Vaccines

Ebola Vaccines 2025

Since 2014, Ebolavirus vaccine technologies have included replication-deficient adenovirus vectors, replication-competent vesicular stomatitis virus, human parainfluenza virus vectors, and virus-like nanoparticle preparations. The U.S. Biomedical Advanced Research and Development Authority (BARDA) has funded and is developing vaccine candidates against the six filoviruses. The World Health Organization (WHO) has approved Ebola vaccines to protect people against outbreaks of Zaire Ebolavirus since 2019.

As of March 2025, Sudan Ebolavirus vaccine candidates are in development. In 2024, ring vaccinations were introduced as an additional control measure for Ebola outbreaks. In 2021, the International Coordinating Group (ICG) on Vaccine Provision established a global Ebola vaccine stockpile.

Zaire Ebolavirus Vaccines

Zaire Ebolavirus vaccines have been approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the World Health Organization (WHO), and the United Kingdom. As of October 2024, the U.S. Centers for Disease Control and Prevention (CDC) recommends two licensed vaccines for the prevention of Ebola caused by Orthoebolavirus zairense: the rVSVΔG-ZEBOV-GP (ERVEBO) and the Ad26.ZEBOV and MVA-BN-Filo.

Merck's Ervebo® vaccine. Since its approval, 7,370 doses of the Ervebo vaccine have been administered in response to two EVD outbreaks in Africa. About 500,000 doses are stored in Switzerland. 

Johnson & Johnson Zabdeno and Mvabea (Ad26.ZEBOV, MVA-BN-Filo) Ebola vaccine regimen.

CanSinoBio's Ad5-EBOV vaccine.

U.S. NIAID/Nin collaborated to develop the 3-EBOV/MVA-BN-Filo vaccine.

MVA-BN (Mvabea®) was approved by the EMA in 2020 as part of a prime-boost vaccine regimen for the prevention of Ebola virus disease caused by the Zaire Ebolavirus in individuals aged 1 year and older.

Zaire Ebolavirus Vaccine Boosters

A study published by the journal Nature on September 3, 2024, guides booster vaccination recommendations and helps identify populations likely to benefit from Ebola revaccination.

Zaire Ebolavirus Vaccine Candidates

INOVIO's INO-4201 is a DNA vaccine candidate targeting the glycoprotein of the Zaire Ebola virus. It is designed to prevent ZEBOV infection. The candidate was evaluated in a Phase 1b clinical trial. INO-4201 was well-tolerated and boosted humoral responses in 100% (36 of 36) of treated participants. As of August 8, 2024, INOVIO anticipates submitting its revised protocol to the FDA for a Phase 2/3 clinical trial with INO-901 as a heterologous booster for the vaccine.

S.K. Biosciences entered into a development licensing agreement with Hilleman Laboratories in November 2023 the jointly develop a second-generation Zaire Ebola virus vaccine. "We look forward to working closely with MSD to accelerate broad access to the second-generation Zaire ebolavirus vaccine and help to improve vaccine coverage for populations in LMICs," said Dr. Raman Rao, CEO of Hilleman Laboratories.

The bivalent adenovirus vectored vaccine is conducting a phase 1 study (NCT05301504). The Sabin Vaccine Institute USA produces the ChAd3-SUDV monovalent adenovirus vector vaccine.

YF-EBO is a live YF17D-vectored dual-target vaccine candidate expressing EBOV glycoprotein (G.P.) as a protective antigen. A single dose of YF-EBO was sufficient to induce high levels of EBOV GP-specific antibodies and cellular immune responses that protected against lethal infection using EBOV GP-pseudotyped recombinant vesicular stomatitis virus (rVSV-EBOV) in interferon-deficient (Ifnar-/-) mice as a surrogate challenge model. Concomitantly induced yellow fever virus (YFV)-specific immunity protected Ifnar-/- mice against intracranial YFV challenge.

INOVIO announced on April 12, 2023, that an abstract had bee-4201 as an, la booster for rVSV-ZEBOV (Ervebo) at the, had been accepted for presentation at the 33rd European Congress of Clinical Microbiology and Infectious Diseases.

Sudan Ebolavirus Vaccine Candidates

As of April 26, 2025, no vaccines have been approved to protect people against the Sudan Ebola virus (SUDV). However, the WHO confirmed that candidate vaccines are being tested in the Solidarity Against Ebola human clinical studies, and the Vaccine Institute is developing a single-dose vaccine candidate for Sudan Ebolavirus. Based on the same cAd3 platform as its Marburg vaccine candidate, Sabin's Sudan ebolavirus vaccine was found to be promising in Phase 1 clinical and non-clinical studies. Results showed it to be safe while eliciting rapid and robust immune responses that lasted up to 12 months.

IAVI's rVSV Sudan ebolavirus vaccine candidate (IAVI C108, rVSVΔG-SUDV-GP) was confirmed on June 27, 2023. The first participants were vaccinated with an SUDV candidate in a first-in-human Phase I clinical trial in the U.S. In January 2025, about 2,160 doses of the vaccine candidate were being deployed in Kampala, Uganda.

Previously, BARDA issued financial awards to IAVI to support the development of rt IAVI's SUDV vaccine candidate.

Serum Institute of India's experimental Ebola virus vaccine.

GeoVax Labs, Inc.'s vectored vaccine, MVA-VL, P-SUDV, was genetically engineered to target Sudan Ebolavirus. Data published on July 25, 2022, demonstrates the MVA-VLP platform's single-dose protection and potency for use in emergencies to contain outbreaks.

Soligenix, Inc. proposes developing SuVax™, a single-vial, adjuvanted, heat-stable subunit vaccine to prevent filovirus infection for use in the event of a Sudan ebolavirus outbreak. On September 25, 2023, the thermostabilized bivalent and trivalent filovirus vaccine candidates demonstrated two-year stability at 40°C when formulated in a single vial, requiring reconstitution only with sterile water immediately before use. The filovirus vaccines represent the only recombinant subunit vaccines to date that have demonstrated complete protection against challenges with Zaire ebolavirus, Sudan ebolavirus, and Marburg marburgvirus in NHPs.

The U.S. government initially invested $35 million to produce up to 100,000 doses of ChAd3-SUDV. These vaccines may be part of ongoing U.S. preparedness efforts and response to future global outbreaks.

The National Institutes of Health Rocky Mountain Laboratories in Hamilton, Montana, developed a candidate for a vesicular stomatitis virus-based Sudan virus vaccine (VSV-SUDte). The investigators anticipate that administering VSV-SUDV at a dosage similar to that of VSV-EBOV would provide rapid protective immunity against SUDV.

VRC-EBOADC086-00-VP, a chimpanzee adenovirus serotype three vector-based Ebola vaccine, encodes wild-type glycoprotein from the Sudan strain of Ebolavirus and is administered intramuscularly. A Phase I Open-Label, Dose-Escalation Clinical Trial to Evaluate Two Doses of Safety, Tolerability, and Immunogenicity. In August 2023, a study found the cAd3-EBO S vaccine was safe at both doses, rapidly induced responses in most participants after a single injection, and was well tolerated. The rapid onset and durability of the vaccine-induced antibodies make this vaccine a strong candidate for emergency deployment in SDV outbreaks.

Ebolavirus Passive Immunization

The Lancet Infectious Diseases reported on November 30, 2023, that monoclonal antibodies (mAbs) were approved for emergency use by the U.S. FDA and used in clinical trials during the 2018–20 Ebola virus disease (EVD epidemic. These trials demonstrated that mAbs continued to increase the number of EVD survivors. The WHO recommended in 2022 that two monoclonal antibody treatments be used in the treatment of Ebola: mAb114 (Ansuvimab; Ebanga) and REGN-EB3 (Inmazeb). The U.S. National Institutes of Health (NIH) states that monoclonal antibodies (mAbs) are manufactured in a laboratory to combat a specific infection and are administered during an infusion. mAbs are different fromines, says the NIH.

On December 22, 2020, Ridgeback Biotherapeutics L.P. confirmed that the U.S. FDA approved Ebanga for the treatment of Ebola. The WHO issued a strong recommendation in August 2022.

On May 2, 2022, the U.S. FDA issued a priority review voucher for a material threat medical countermeasure (MCM) product application for INMAZEB (atoltivimab, maftivimab, and odesivimab-ebgn), manufactured by Regeneron Pharmaceuticals, Inc. As a result, the FDA approved Inmazed in October 2020.

On October 14, 2020, the U.S. Food and Drug Administration (FDA) approved an antibody cocktail from Regeneron that has been shown to reduce mortality rates associated with Ebola. The treatment, known as REGN-EB3, is a mixture of three monoclonal antibodies (atoltivimab, maftivimab, and odesivimab-ebgn) marketed under the brand name Inmazeb. Inmazeb is indicated for the treatment of infections caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to mothers who are RT-PCR positive for Zaire ebolavirus infection.

The U.S. Administration for Strategic Preparedness and Response announced on October 4, 2022, a $109.8 million contract with Mapp Biopharmaceutical Inc. for the advanced development and potential purchase of an mAb therapy to treat Sudan Ebolavirus.

The Lancet Infectious Diseases published results from an observational cohort study on November 30, 202. The study concluded that almost 25% of survivors were seronegative on discharge from the Ebola treatment center, and antibody concentrations decreased rapidly over time. These results suggest that monoclonal antibodies may negatively impact the production of anti-Ebola virus antibodies in survivors of Ebola virus disease, potentially increasing the risk of reinfection or reactivation.

Ebolavirus Treatments

Obeldesivir (ODV; GS-5245) is an orally administered ester prodrug of the parent nucleoside GS-441524 with broad-spectrum antiviral activity inhibiting viral RNA–dependent RNA polymerases. Results from a study published in March 2025 support the potential of ODV as an oral post-exposure prophylaxis with activity against filoviruses, such as the Ebola virus.

On April 8, 2024, RedHill Biopharma announced that its two novel, oral, host-directed investigational drugs, opaganib and RHB-107 (upamostat), demonstrated a robust synergistic effect when combined individually with remdesivir (Veklury®), significantly improving viral inhibition while maintaining cell viability. Opaganib is believed to be the first host-directed molecule to show activity in the EVD, having recently delivered a statistically significant increase in survival time in a separate U.S. Army-funded in vivo Ebola virus study. When administered to the animals within 24 hours of virus exposure once daily for ten days, the drug conferred complete protection against lethal infection with Sudan ebolavirus. On October 14, 2024, RedHill announced an agreement with the U.S. Government.

RHB-107 was recently accepted for inclusion in the ACESO PROTECT adaptive platform trial for the early treatment of COVID-19 patients in the outpatient setting. The 300-patient PROTECT Phase 2 RHB-107 arm has received FDA clearance to start. The study is being conducted in the U.S., Thailand, the Ivory Coast, South Africa, and Uganda, and is estimated to be completed by the end of 2024. RHB-107 met primary endpoints and demonstrated tolerability in the endpoint Phase 2 study, delivering promising efficacy results.

9 min read
Last Reviewed: 
Thursday, November 13, 2025 - 08:25
Description: 
Zaire Ebolavirus vaccines are approved and Sudan vaccine candidates are in development in 2025
Condition: