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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.

0 min read
Manufacturer: 
Pfizer
Reviewer: 
Robert Carlson, MD
Holly Lutmer PharmD
Vaccine: 
TicoVac Tick-Borne Encephalitis Vaccine
VIS: 
PDF
Availability: 
Europe, UK, USA, Canada
Generic: 
FSME-Immun
Drug Class: 
Vaccine
Find Price: 
Discounts
Clinical Trial Phase II: 
Evaluation of Immunogenicity of Different Tick Borne Encephalitis (TBE) Fast Protective Traveler Schemes With Inactivated TBE Wh
Clinical Trial Phase III: 
Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years
Clinical Trial Phase IV: 
TBE Seropersistence up to 10 Years After First Booster in Adults
Lab Test: 
CDC
Condition: 
Tick-borne encephalitis
Availability Link: 
PfizerPro
Last Reviewed: 
Friday, May 9, 2025 - 11:55
Brand: 
TICOVAC
Accession Number: 
DB16611
Status: 
Approved
Manufacturer Country ID: 
US
FDA First In Class: 
Yes
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Yes
Side Effects: 
UK
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Ingredients
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USA
EU
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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
Reviewer: 
Robert Carlson, MD
Last Reviewed: 
Thursday, November 13, 2025 - 08:25
Description: 
Zaire Ebolavirus vaccines are approved and Sudan vaccine candidates are in development in 2025
Condition: 
Ebola

Ad26.ZIKV.001 Zika Vaccine

Ad26.ZIKV.001 Zika Vaccine

Ad26.ZIKV.001 Zika Vaccine candidate is a replication-incompetent human adenovirus serotype 26 (ad26) vector. Ad26.ZIKV.001 is an adenovirus serotype 26 vector encoding ZIKV M-Env, administered in 1- or 2-dose regimens of 5 × 1010 or 1 × 1011 viral particles (vp) or placebo. A study published in August 2022 reported that the viral vector vaccine (Ad26.ZIKV.001), seroconversion rate (100%), and GMT peaked after two shots with both low- and high-dose vaccines. 

Janssen Vaccines & Prevention B.V. is the vaccine candidate study sponsor.

Ad26.ZIKV.001 Vaccine Indication

Ad26.ZIKV.001 Zika Vaccine candidate is indicated to induce neutralizing antibodies to prevent Zika virus (ZIKV) infection. ZIKV, a mosquito-borne flavivirus responsible for congenital Zika syndrome (CZS), was first isolated from rhesus monkeys in the Zika forest in Uganda in 1947.ZIKV is transmitted via Aedes aegypti mosquitoes and may cause severe congenital disease after maternal-fetal transmission.

Ad26.ZIKV.001 Vaccine Dosage

In this phase 1 clinical trial, researchers found t doses of Ad26.ZIKV.001 was safe, causing mild to moderate reactogenicity and inducing persistent neutralizing antibody responses. The single dose had lower peak antibodies but was durable after one year. 

Ad26.ZIKV.001 Vaccine News

October 28, 2022 - Current Advances in Zika Vaccine Development.

April 13. 2021 - Phase I Trial Of An Adenovirus Vector Vaccine for Zika Virus Shows High Immunogenicity And Safety

February 16, 2021 - A phase 1 trial of the Ad26.ZIKV.001 Zika vaccine candidate revealed no safety concerns. The antibodies peaked 14 days after the second vaccine and remained high for at least one year.

February 16, 2021 - Estimating the Effect of Discontinuing Universal Screening of Donated Blood for Zika Virus in the 50 U.S. States.

August 24, 2018 - RESEARCH ARTICLE: Adenoviral vector type 26 encoding Zika virus (ZIKV) M-Env antigen induces humoral and cellular immune responses and protects mice and nonhuman primates against the ZIKV challenge. In NHP, a single immunization with a typical human dose of 1x1011 vp of Ad26.ZIKV.M-Env also induced Env-binding and ZIKV neutralizing antibodies and Env and M specific cellular immune responses associated with complete protection against viremia from ZIKV challenge as measured in plasma and other body fluids. Together, these data provide the rationale to progress the Ad26.ZIKV.M-Env candidate vaccine to clinical testing.

Ad26.ZIKV.001 Clinical Trials

Clinical Trial NCT03356561: A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.ZIKV.001 in 100 Healthy Adult Volunteers - Last Update Posted on October 15, 2019.

On May 16, 2021, the Annals of Internal Medicine reported on the clinical trial. All regimens were well tolerated, with no safety concerns identified. In both 2-dose regimens, ZIKV neutralizing titers peaked 14 days after the second vaccination. However, this study was limited since it was conducted in a nonendemic area, so it did not assess safety and immunogenicity in a flavivirus-exposed population. Conclusion: If the need for a ZIKA vaccine reemerges, Ad26.ZIKV.001 is a promising candidate based on its safety and immunogenicity profile.

0 min read
Manufacturer: 
Janssen Vaccines
Reviewer: 
Robert Carlson, MD
Holly Lutmer PharmD
Vaccine: 
Ad26.ZIKV.001 Zika Vaccine
Generic: 
Ad26.ZIKV.001
Drug Class: 
Vaccine
Clinical Trial Phase I: 
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Ad26.ZIKV.001 in Healthy Adult Volunteers
Condition: 
Zika
Last Reviewed: 
Wednesday, January 3, 2024 - 13:40
Status: 
Candidate

Rabivax-S Rabies Vaccine

Rabivax-S Rabies Vaccine May 2023

Rabivax-S has been developed on Vero ATCC CCL81 cells using Pitman Moore (PM3218) strain. It is an inactivated vaccine that is freeze-dried until ready for immunization. The vaccine was tested in a GLP toxicology study following all the GMP requirements. Further, it underwent clinical trials in preexposure and postexposure settings and was found safe and immunogenic.

Rabies vaccines like RabAvert, Rabipur, or Rabivax efficiently induce long-lasting immunity, triggering neutralizing antibodies' production, but several doses are required. Regrettably, rabies vaccination is not included in the vaccines covered by the Expanded Programme on Immunization, and they are expensive and not affordable in developing countries.

Serum Institute of India Pvt. Ltd. (SII) is an Indian biotechnology and biopharmaceutical company that produces Rabivax-S.

Rabivax-S Indication

RABIVAX-S is indicated for the prevention of rabies in children and adults. It can be used before or after exposure, as a primary immunization, or as a booster dose. Rabivax is administered intramuscular and/or intra-dermal. Suppose an individual who has been fully immunized in the past is exposed to Rabies. In that case, the recommended PEP schedule is one dose of Rabies vaccine injected intramuscularly (1 ml) or intradermally (0.1 ml) on day 0 and day 3.

Rabivax-S News

May 20, 2022 - Improper vaccinations could re-introduce rabies into the U.S., warned the Centers for Disease Control and Prevention.

October 20, 2020 - An Overview of Current Uses and Future Opportunities for Computer-Assisted Design of Vaccines for Neglected Tropical Diseases.

March 3, 2017 - Study: Development of a new purified Vero cell rabies vaccine (Rabivax-S) at the Serum Institute of India Pvt Ltd.

September 14, 2016 - A randomized non-inferiority clinical study to assess post-exposure prophylaxis by a new purified vero cell rabies vaccine (Rabivax-S) administered by intramuscular and intradermal routes. Conclusions: Rabivax-S was well tolerated and showed immunogenicity comparable to a licensed rabies vaccine by both IM and ID routes in post-exposure prophylaxis.

Rabivax-S Clinical Trials

Clinical Trial NCT03741270: Safety of Rabivax-S for Preexposure Prophylaxis: Last Update Posted: September 24, 2019.

People with frequent or continuous rabies virus exposure should be vaccinated against the disease (preexposure prophylaxis). This includes people who work with rabies virus in research or diagnostic laboratories or vaccine production facilities, veterinarians, staff, animal control, and wildlife workers in areas where rabies is endemic. Veterinary students in clinical placements and externships are included in this category, DVM students at Ross University School of Veterinary Medicine (RUSVM) are vaccinated against rabies in their 7th semester (final pre-clinical semester). Vaccinations are done by RUSVM Health Services using Rabivax-S, produced by the Serum Institute of India (study co-sponsors). Previously unvaccinated studentreceivedve three vaccine injections on days 0, 7, and 21-28. The study aims to generate additional data on the safety and tolerability of Rabivax-S administered as preexposure prophylaxis to this population.

0 min read
Manufacturer: 
Serum Institiure of India PVT
Reviewer: 
Robert Carlson, MD
Holly Lutmer PharmD
Vaccine: 
Rabivax-S Rabies Vaccine
VIS: 
PDF
Availability: 
India
Generic: 
Rabies Vaccine, Human I.P. (Freeze-dried)
Drug Class: 
Vaccine
Clinical Trial Phase IV: 
Safety of Rabivax-S for Pre-exposure Prophylaxis
Lab Test: 
CDC
Condition: 
Rabies
Last Reviewed: 
Wednesday, May 17, 2023 - 06:50
Brand: 
RABIVAX-S
Status: 
Approved
Manufacturer Country ID: 
IN
Countries: 
India
Rate Vaccine: 
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ACI-35.030 Alzheimer’s Disease Vaccine

ACI-35.030 Alzheimer's Disease Vaccine

ACI-35.030 Alzheimer's Disease vaccine candidate is designed to elicit antibodies against phosphorylated pathological Tau protein. It is designed to reduce and facilitate the clearance of related Tau aggregates, slowing the progression of Tau-pathology and/or treating the underlying Tauopathy. The ACI-35.030 anti-pTau vaccine candidate is being developed in collaboration with Janssen Pharmaceuticals, Inc. (Janssen), part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

ACI-35.030 is a first-in-class vaccine candidate designed to generate a specific antibody response against pTau proteins in the brain. pTau is a key component of Alzheimer's disease. It can be measured in plasma to identify who is at risk of developing Alzheimer's disease up to 20 years before the onset of clinical symptoms. Anti-pTau antibodies generated by ACI-35.030 can potentially reduce the spread and seeding of Tau pathology, a major hallmark of AD.

On February 11, 2021, Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "These remarkable data show that ACI-35.030 can generate unprecedented antibody responses against pTau in an elderly population, with very high antigen-specific titers. Importantly, it generated a much stronger antibody response than a direct injection of exogenous antibodies." On November 30, 2022, AC Immune SA announced that based on the Phase 1b/2a interim data, ACI-35.030, a potential first-in-class anti-phosphorylated-Tau (pTau) vaccine candidate, has been selected for further development.

LAUSANNE, Switzerland-based AC Immune SA is a Nasdaq-listed clinical-stage biopharmaceutical company that aims to become a global leader in precision medicine for neurodegenerative diseases.

ACI-35.030 Indication

ACI-35.030 Alzheimer's Disease (AD) vaccine candidate is indicated to reduce the spread and seeding of Tau pathology, a major hallmark of AD. Immunization with anti-Tau vaccines has become an essential strategy for treating AD and other neurodegenerative diseases characterized by Tau pathology. ACI-35.030 is the first AD vaccine candidate designed to generate a specific antibody response against pathologic phospho-Tau (pTau) proteins in the brain. Anti-pTau antibodies generated by ACI-35.030 can potentially reduce the spread and seeding of Tau pathology throughout the brain, says the Company.

ACI-35.030 News 2020 - 2022

November 30, 2022 - The Company announced data presented at CTAD 2022 confirm the excellent clinical performance of the ACI-35.030 vaccine candidate. This new clinical data shows that ACI-35.030 has been selected for further development, representing significant progress for the anti-pTau vaccine candidate.

February 15, 2022 - AC Immune SA announced new interim 10-week data from the high-dose cohort of a placebo-controlled Phase 1b/2a trial evaluating ACI-35.030, a first-in-class phosphorylated-Tau (pTau) vaccine candidate in participants with early AD. Results indicate that the induced immune response selectively targets pTau, as shown by an increase in the anti-pTau/anti-Tau IgG ratio up to week 10. In this interim data set to week 10, median levels of antibodies reactive with pathological Tau (ePHF) were boosted with both the first and second vaccine injections. Safety data support ACI-35.030's favorable safety and tolerability profile, as no clinically relevant safety concerns have been observed.

August 31, 2021 - "The top-line results of the Lauriet Phase II clinical trial of semorinemab are remarkable in that it is the first time we have seen a therapeutic effect by a monoclonal anti-Tau antibody therapy," said Andrea Pfeifer, chief executive officer of AC Immune. "We also are excited that this is the first time a monoclonal antibody has had a therapeutic impact on cognition in the mild-to-moderate AD patient population."

February 11, 2021 - AC Immune's Alzheimer's Vaccine Generates Potent Anti-pTau Antibody Response in a Phase 1b/2a Study "These remarkable data show that ACI-35.030 is capable of generating unprecedented antibody responses against pTau in an elderly population, with very high antigen-specific titers. Importantly, it generated a much stronger antibody response than a direct injection of exogenous antibodies. As pathological pTau is present as a precursor many years before Tau accumulation in the brain is detectable via brain imaging, such results highlight the significant promise of ACI-35.030 as an early intervention for AD, especially when combined with cutting-edge pTau diagnostics that would enable the identification of people at risk of developing Tau-driven disease.

We look forward to continuing to advance ACI-35.030 in our collaboration with Janssen Pharmaceuticals, Inc., as we aim to bring this potentially breakthrough vaccine to patients," said Prof. Andrea Pfeifer, CEO of AC Immune SA.

January 25, 2021 - Barron's article: The Covid-19 Vaccine Offers a Road Map for Tackling Dementia. Here's How.

July 16, 2020 - AC Immune SA announced initiating the second-highest dosing group in the Company's Phase 1b/2a clinical trial evaluating ACI-35.030 to treat Alzheimer's disease (AD). The decision to advance to the higher dosing group follows encouraging interim safety, tolerability, and immunogenicity results from the initial dosing group.

May 4, 2020 - Dear Investor, 2020 continues to be an important and eventful year for AC Immune and the entire field of neurodegenerative diseases, even in the context of the challenges posed by the COVID-19 pandemic. With the publication of our Q1 2020 results, we have again confirmed our strong cash position of CHF 277.9 million. This provides the Company with a solid foundation and a cash runway extending through at least Q1 2024 without including any potential future milestone payments from partnerships. Moving forward, we remain on track to meet multiple value-creating milestones this year, with five clinical readouts expected. Of these readouts, we are particularly excited about the anticipated announcement of the first Phase 2 proof-of-concept data for semorinemab, an anti-Tau antibody, achieved through our partnership with Genentech, a member of the Roche group.

ACI-35.030 Alzheimer's Disease Vaccine Clinical Trials

ACI-35.030 clinical studies.

Clinical Trial NCT04445831: A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Tau Targeted Vaccines in 56 Participants With Early Alzheimer's Disease - Last update posted on June 4, 2021. On November 12, 2021, AC Immune presented interim results for this Phase 1b/2a trial. ACI-35.030 treatment led to the strong induction of antibodies specific for pathological forms of Tau, such as pTau and its aggregated form, enriched paired helical filaments (ePHF).

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Manufacturer: 
AC Immune
Reviewer: 
Robert Carlson, MD
Vaccine: 
ACI-35.030 Alzheimer’s Disease Vaccine
Availability: 
N/A
Generic: 
ACI-35.030
Clinical Trial: 
https://www.acimmune.com/pipeline/clinical-trials/
Drug Class: 
anti-pTau vaccine
Clinical Trial Phase I: 
Interim Phase 1b/2a
Clinical Trial Phase II: 
A Study to Evaluate the Safety, Tolerability and Immunogenicity of Tau Targeted Vaccines in Participants With Early Alzheimer's
Condition: 
Alzheimer’s Disease
Last Reviewed: 
Wednesday, December 6, 2023 - 13:20
Status: 
Candidate
Manufacturer Country ID: 
Switzerland
FDA First In Class: 
Yes

Meningococcal Vaccines

Meningococcal Vaccines April 2025

There are three types of meningococcal vaccines licensed by the U.S. Food and Drug Administration (FDA): Meningococcal conjugate (MenACWY) in 2005 and Serogroup B meningococcal (MenB) vaccines in 2015. According to the U.S. CDC, about 88% of adolescents aged 13–17 had received at least one MenACWY dose.

Internationally, the European Medicines Agency (EMA) and the U.K. NHS have approved vaccines such as MenQuadfi and Hib/MenC. The Global Roadmap for Defeating Meningitis by 2030 was endorsed by the World Health Assembly and launched in 2021. According to a research report published in 2022, the meningococcal vaccine market is expected to reach approximately U.S. $5.91 billion by 2030.

Quadrivalent Meningococcal Conjugate (MenACWY) Vaccines

Menactra vaccine is for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. Menactra vaccine is approved for use in individuals nine months through 55 years of age.

Menveo® vaccine is indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. It is approved for use in people aged two months through 55.

MenQuadfi® vaccine is indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. MenQuadfi is approved for those two years of age and older.

Serogroup B Meningococcal (MenB) Vaccines

Trumenba vaccine is used for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. Trumenba is approved for individuals aged 10-25 years.

Bexsero® is a vaccine against Neisseria meningitidis serogroup B, which causes invasive diseases. The vaccine was approved for use in 2015 for individuals aged 10 through 25. 

Two additional licensed meningococcal vaccines are no longer available in the United States: 1) a quadrivalent (serogroups A, C, W, and Y) meningococcal polysaccharide vaccine (MPSV4) (Menomune – A/C/Y/W-135) and 2) a combined Haemophilus influenzae type b and meningococcal serogroups C and Y conjugate vaccine (Hib-MenCY-TT) (MenHibrix).

Meningococcal Pentavalent Vaccines

GlobalData projects the collective revenue for pentavalent vaccines to reach approximately $555 million in the U.S. by 2029.

Pfizer Inc.'s PENBRAYA™ (meningococcal groups A, B, C, W, and Y vaccine) is a pentavalent vaccine that combines the components from two meningococcal vaccines, Trumenba® (meningococcal group B vaccine) and Nimenrix® (meningococcal groups A, C, W-135, and Y conjugate vaccine), to help protect against the five most common meningococcal serogroups that cause the majority of M.D. globally. PENBRAYA is administered as a two-dose series given six months apart. On October 25, 2023, Jennifer Collins, MD, MSc, presented a Summary of EtR and proposed recommendations for Pfizer's MenABCWY vaccine.

Serum Institute of India Pvt. Ltd. MenFive® (NmCV-5) is a pentavalent vaccine targeting the A, C, W, Y, and X serogroup. In July 2023, the WHO prequalified MenFive®. Nigeria became the first country in the world to offer the multivalent conjugate vaccine Men5CV. In September 2023. the WHO's SAGE then advised all countries in the meningitis belt to introduce the new vaccine, which it described as Men5CV, into their routine immunization programs.

GSK's PENMENVY (Meningococcal Groups A, B, C, W, and Y Vaccine), for use in individuals aged 10 through 25, combines Bexsero (meningococcal group B vaccine) and Menveo (meningococcal group A, C, W-135, and Y conjugate vaccine). On April 15, 2025, the ACIP voted to recommend that persons over 10 years old receive a single dose.

 

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Eupolio Polio Vaccine

Eupolio Polio Vaccine 2022

Eupolio Polio Vaccine is a Sabin-Inactivated Polio Vaccine (Sabin-IPV). The main advantage of using attenuated Sabin poliovirus strains in IPV production is that there is a lower biosafety risk than wild-type polioviruses used to manufacture conventional IPVs, which has the potential to pose a biosafety hazard in case they escape from the manufacturing facility.

Eupolio is the first Sabin-IPV to obtain WHO prequalification in late December 2020. The main advantage of using attenuated Sabin poliovirus strains in IPV production is that there is a lower biosafety risk compared to wild-type polioviruses used to manufacture conventional IPVs, which has the potential to pose a biosafety hazard in case they escape from the manufacturing facility.

LG Chem initiated the development of Eupolio™ in 2014 and invested in the construction of state of the art WHO Global Action Plan III compliant manufacturing facility in Osong, Korea.
 
Eupolio™ demonstrated excellent phase III results in 2019, inducing high antibody titers against both wild-type and Sabin polioviruses, which will also protect against circulating vaccine-derived polioviruses (cVDPV) that make up the majority of polio cases in recent years.

LG Chem rapidly developed clinical products and processes through active facility investment since the beginning of the vaccine development. The Bill and Melinda Gates Foundation, the largest health-related support organization in the world, had provided a total of US$57.6 million in support funds for the Eupolio and Eupolio-based Mixed Vaccine Projects since 2017 by highly recognizing LG Chem's capabilities.

Since its establishment in 1947, LG Chem has continuously achieved growth through endless challenges and innovations as Korea’s leading chemical company.

Eupolio Indication

Eupolio is indicated to protect both wild-type and Sabin polioviruses, which will also protect against circulating vaccine-derived polioviruses (cVDPV) that make up most of the polio cases in recent years.

Eupolio News 2019-2021

January 8, 2021 - LG Chem announced that it had signed a contract with UNICEF to supply US$80 million worth of polio vaccine Eupolio from 2021 to 2022. The contract will make LG Chem one of the top three suppliers of polio vaccines to UNICEF as the company will account for more than 20 percent of UNICEF's procurement volume.

January 7, 2021 - LG Chem to Contribute to Global Polio Eradication with Eupolio™, the First Sabin Inactivated Polio Vaccine to Receive WHO Prequalification. WHO prequalification of Eupolio™ is a major milestone in ongoing efforts towards global polio eradication. It will help close the gap between demand and supply of safe and effective Inactivated Polio Vaccine (IPV) for millions of infants in need of immunization against poliovirus.

October 15, 2019 - WHO-UNICEF Consultation with OPV/IPV Manufacturers, National Authorities for Containment, and National Regulatory Authorities.

March 11, 2019 - LG Chem announced that it would receive support from the Bill & Melinda Gates Foundation to develop a hexavalent vaccine to prevent six diseases ― diphtheria, tetanus, whooping cough (pertussis), hepatitis B, Haemophilus influenzae type B, and polio.

Eupolio Clinical Trials

LG Chem continues to test Eupolio vaccines in clinical trials.

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Manufacturer: 
LG Chem
Reviewer: 
Robert Carlson, MD
Holly Lutmer PharmD
Vaccine: 
Eupolio Polio Vaccine
Availability: 
WHO prequalified
Generic: 
Sabin-IPV
Drug Class: 
Vaccine
Condition: 
Polio
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Eupolio will be supplied to 70 countries worldwide, including ones in the Middle East, Africa, and Southeast Asia
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Monday, June 6, 2022 - 06:00
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HPV Vaccines

Human Papillomavirus (HPV) Vaccines 2025

The World Health Organization (WHO) recommends vaccinating against human papillomavirus (HPV) to prevent infections and associated cancers. As of April 15, 2025, six licensed HPV vaccines protect men and women against cancers caused by HPV. These bivalent, quadrivalent, and nonavalent HPV vaccines are available in 140 countries. The WHO has prequalified five HPV vaccines.

In the U.S., the Centers for Disease Control and Prevention (CDC) has recommended HPV vaccination for women since 2006 and for men since 2011. The current CDC HPV vaccination schedules were updated in 2025. HPV vaccine availability status in the U.S. is posted at View-Hub. On April 15, 2025, Carla L. DeSisto, PhD, MPH, presented: Reduced number of doses for HPV vaccination series: ACIP Work Group progress and literature update.

HPV Vaccines Approved

Gardasil - Merck's Gardasil® vaccine contains four HPV types: 6, 11, 16, and 18. It was approved in China for both men and women in 2025.

Gardasil 9® consists of HPV proteins Types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

Cervarix—GlaxoSmithKline's Cervarix is a non-infectious recombinant, AS04-adjuvanted vaccine that contains recombinant L1 protein, the major antigenic protein of the capsid of oncogenic HPV types 16 and 18.

Cecolin—Innovax Biotech Ltd.'s Cecolin HPV bivalent vaccine protects women against HPV 16 and 18. Cecolin 9 is a second-generation nonavalent HPV 6/11/16/18/31/33/45/52/58 vaccine approved for one dose.

Wa Biotechnology's recombinant bivalent HPV vaccine is effective against HPV strains 16 and 18. China's National Medical Products Administration approved it in March 2022.

Yuxi Zerun Biotechnology Co., Ltd. Walrinvax® two-dose HPV vaccine was approved in China in February 2024 and prequalified by the WHO in August 2024.

Cervavac is the Serum Institute of India's quadrivalent human papillomavirus vaccine (qHPV), authorized in India for 9-to 26-year-olds. Local availability began in 2023. 

HPV Vaccine Candidates

PDS Biotech's Versamune® HPV (formerly PDS0101) is conducting multiple phase 2 studies in 2024.

RGVax - The U.S. FDA completed its review of the investigational new drug application for its licensed monovalent component, HPV16 RG1-VLP, and concluded that a Phase 1 clinical trial might proceed as of March 29, 2023. RGVax is a chimeric HPV VLP platform that displays 360 copies of the highly conserved, neutralizing HPV epitope. PathoVax LLC licensed the underlying RGVax foundational technology from Johns Hopkins Univers. Transgene's TG4001 HPV16 vaccine candidate uses an attenuated and modified poxvirus as a vector that expresses the HPV16 E6 and E7 proteins and interleukin-2. Data presented on June 5, 2023, demonstrates that Transgene's TG4001 could induce a specific immune response against the antigens vectorized within this vaccine.

Nykode Therapeutics announced positive results from the Phase IIa trial of its cervical cancer vaccine, VB10.16, delivered in combination with atezolizumab to 52 participants. Patients who received the vaccine were tracked for 1 year, with a median overall survival of 16.9 months. A second, more extensive trial of VB10.16 in cervical cancer is set to begin in 2023.

VGX-31 - Inovio's investigational immunotherapy vaccine includes DNA plasmids targeting the E6 and E7 proteins of HPV types 16 and 18.

INO-3107 - INOVIO announced positive interim results from an ongoing Phase 1/2 clinical trial evaluating INO-3107. The results showed a statistically significant improvement in the clinical endpoint, the number of surgical interventions required to control papilloma growth. INO-3107 was also well-tolerated and immunogenic in the trial.

VTP-2 - Vaccitech's ChAdOx1-HPV immunotherapy for high-risk HPV infection and low-grade cervical intraepithelial neoplasia. The platform has a differentiated ability to induce CD8+ T cells and cells of the immune system that naturally clear HPV-infected cells in cervical tissue. In addition, VTP-200 targets six early proteins from five high-risk HPV groups and therefore covers more HPV types than any other immunotherapy previously tested. Data from the first 58 women enrolled who reached their 6-month timepoint in the HPV001 phase 1/2study were reviewed internally, and the trial will continue as planned to the 12-month primary endpoint.

HB-201 - HOOKIPA Inc.'s monotherapy uses an arenavirus backbone (LCMV for HB-201) to express the antigen, an E7/E6 fusion protein derived from HPV16+.

VB10.16 - Nykode Therapeutics is developing a potential first-in-class, off-the-shelf therapeutic cancer vaccine for HPV16-positive cancers.

REC603 - Jiangsu Technology's REC603 is a recombinant HPV 9-valent vaccine used in a phase 3 clinical trial. The REC604a is equipped with the novel adjuvanted BFA04 independently developed by the Company, which aims to reduce the vaccination dose by enhancing the immunogenicity and cross-protection effects.

Defence Therapeutics Inc. developed the AccuVAC-PT007, a protein-based vaccine targeting the E7 oncoprotein of the HPV virus. 

LinKinVax is conducting a first-in-human Phase I/IIa clinical trial with CD40HVac, a new therapeutic vaccine candidate in immuno-oncology targeting dendritic cells against head and neck cancer associated with HPV. The first patient was dosed with CD40HVac for HPV-positive oropharyngeal cancer on September 18, 2023.

Genexine GX-188E (tirvalimogene teraplasmid) is a DNA therapeutic vaccine fused with encoding both E6 and E7 antigens and the extracellular domain of Flt3L to target and activate dendritic cells. A Multi-Center, Open-label Phase Ib-II Trial of the Combination of GX-188E Vaccination and Pembrolizumab in Patients with Advanced, Non-Resectable HPV-Positive Cervical Cancer.

PDS Biotechnology PDS0101 is a novel investigational HPV-targeted immunotherapy that stimulates a potent targeted T-cell attack against HPV-positive cancers. The VERSATILE-002 Phase 2 trial is for the treatment of recurrent or metastatic HPV16-positive head and neck cancer.

Precigen, Inc. presented PRGN-2009 AdenoVerse™ immunotherapy alone and in combination with an investigational anti-PDL1/TGF-Beta Trap checkpoint inhibitor in patients with recurrent/metastatic HPV-associated cancers (NCT04432597) in Abstract #2628.

Aston Sci. received Phase 2 Clinical Investigational New Drug approval from the U.S. FDA on September 12, 2023, for the AST-201 vaccine, which was explicitly designed for ovarian cancer.

HPV Vaccine Doses

The WHO's global recommendation for one-dose HPV vaccine schedules in 2022 significantly reduced barriers to scaling up vaccination programs. The Americas Region and the Regional Office for Africa also issued recommendations for the single-dose vaccination schedule. On April 11, 2022, the WHO's Strategic Advisory Group of Experts on Immunization concluded that a single-dose HPV vaccine provides virus protection comparable to that of 2-dose schedules. The UK's Joint Committee on Vaccination and Immunisation announced on August 5, 2022, that one HPV dose is as effective as two doses in preventing HPV-related cancers in adolescents. The CDC's recommendations for 2 or 3 HPV vaccinations were updated in 2023. 

According to estimates from the WHO, the switch to a single-dose vaccine schedule resulted in an additional six million girls vaccinated against HPV in 2023. That year, 27% of girls aged 9 to 14 years received a single dose of the HPV vaccine, compared with 20% in 2022. As of 2024, 57 countries, up from 37 last year, had adopted the new vaccination schedule.

HPV Vaccine Effectiveness

The Journal of the National Cancer Institute published results from a study in January 2024 that found no cases of invasive cancer among women in Scotland who were immunized at 12 or 13 years of age, irrespective of the number of bivalent vaccine doses. Women vaccinated at 14 to 22 years of age and given three doses of the bivalent vaccine showed a significant reduction in incidence compared with all unvaccinated women (100,0002/100,000 [95% confidence interval (CI) = 2.1 to 4.6] vs. 8.4 [95% CI = 7.2 to 9.6]).

A study published by the Journal of Infectious Diseases on October 12, 2023, found genital HPV infections within 24 months in abCI: 33.4 48.433.4-48.4) of unvaccinated young women in new heterosexual relationships. Other sexually transmitted disease vaccine news is posted at this link. 

Lauri E. Markowitz, M.D. Division of Viral Diseases, U.S. CDC Advisory Committee on Immunization Practices presented on June 23, 2022, which summarized: 'There are now data on 1-dose HPV vaccination, including efficacy data from a randomized controlled trial with 18-month follow-up. In addition, long-term follow-up from other studies suggests a long duration of protection (>10 years) with a single dose. And Julia Gargano, Ph.D., presented: 'Impact of the US HPV vaccination program on HPV-associated outcomes. Declines in HPV16/18 prevalence have translated into declines in cervical precancer incidence in young women.' 

A systematic review of 138 peer-reviewed studies, published between March 2016 and March 2020, within MEDLINE, EMBASE, and Google Scholar, involving 14 years of follow-up data, details the Impact and effectiveness of GARDASIL through immunization programs in 23 countries across Africa, Asia, Europe, Australia, South America, and North America. The most significant reductions were observed in younger age groups (14-17 years), with up to 73% reduction in CIN3+ among vaccinated females. Consistent with previous reviews, declines in the incidence of anogenital warts continue to be observed in vaccine-targeted female age groups, with more pronounced decreases (up to 88%) in younger age groups.

HPV Vaccination and HIV

A peer-reviewed study published on October 1, 2022, found that MSM with HIV would benefit from Gardasil 9 immunization, particularly the youngest and those with prior gonococcal infection.

HPV Vaccination and Pregnant Women

HPV vaccination is not recommended for use by women during pregnancy. 

HPV Cancer and Men

The Lancet Global Health pre-released a September 2023 report showing that almost 33% of men over 15 are infected with at least one genital HPV type, and 20% are infected with one or more high-risk or oncogenic HPV types.

HPV Cancers

In 2024, patients aged 65 and older had the most significant increase (32.2%) in HPV diagnoses. The Global HPV Consortium, which focuses on accelerating the prevention of HPV and eliminating cervical, throat, anal, and other HPV cancers, was launched on September 4, 2023, and is led by the Sabin Vaccine Institute as its Secretariat. The Lancet Oncology reported in September 2023 that African countries are home to 19 of the 20 countries with the highest burden of cervical cancer. 

HPV Vaccine Cost

The HPV vaccine is the most expensive of all routinely recommended pediatric vaccines, according to a July 2023 study. This study found that net returns from HPV vaccine cost reimbursements are lowest for family physicians ($0.34/dose) and highest for pediatricians ($5.08/dose). Furthermore, reimbursement for HPV vaccine costs by private payers is adequate; however, return margins are small for non-pediatric specialties. The CDC reported in August 2023 that HPV vaccination initiation fell among adolescents insured by Medicaid and remained lowest among the uninsured, two of the four groups that constitute the Vaccines for Children population. The Vaccines for Children Program Vaccine Price List was updated in 2025.

Insight Partners stated that the HPV vaccine market is projected to reach $5.73 billion by 2028, growing at a CAGR of 5% from 2022 to 2028. HPV vaccine prices and discount information are posted at InstantRx™.

CONTENT SOURCES:  World Health Organization, US Centers for Disease Control and Prevention, FDA, research studies, manufacturer announcements, and the Vax-Before-Travel news network, reviewed by healthcare providers, such as Dr. Bob Carlson.

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Robert Carlson, MD
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Pneumosil Pneumococcal Vaccine

Pneumosil® Pneumococcal Vaccine 2023

Pneumosil® a sterile suspension of saccharides of the capsular antigens of 10 Streptococcus pneumoniae serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F, and 23F individually conjugated by using 1 cyano-4-dimethylamino pyridinium tetrafluoroborate chemistry (CDAP) to non-toxic diphtheria CRM197 protein.

The polysaccharides are chemically activated and then covalently linked to the protein carrier CRM197 to form the glycoconjugate. Individual conjugates are compounded, and then polysorbate 20 and aluminum phosphate are added to formulate the vaccine, said PATH.org.

PNEUMOSIL is more affordable than the existing PCVs and provides comparable protection by targeting the most prevalent serotypes of the bacterium causing serious illness in developing countries. As a PCV, PNEUMOSIL is similar to the pediatric pneumococcal vaccine already on the market and targets serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F & 23F.

According to research published in The Lancet in January 2023, Pneumosil was found to be as safe and effective against invasive and mucosal pneumococcal disease in a phase 3 clinical trial as the 10-valent PHiD-CV (Synflorix) and 13-valent PCV13 (Prevenar 13) vaccines in infants.

“Pneumosil has been extensively evaluated in five randomized and controlled clinical trials, and has demonstrated comparable safety and immunogenicity against licensed pneumococcal vaccines across diverse populations of India and Africa, where Pneumosil was administered to adults, toddlers and infants using different vaccination schedules,” Vardhan was quoted as saying in the statement.

Serum Institute of India Pvt. Ltd. is the world's largest vaccine manufacturer by several doses produced and sold globally (more than 1.5 billion doses), which includes Polio vaccine as well as Diphtheria, Tetanus, Pertussis, Hib, BCG, r-Hepatitis B, Measles, Mumps, and Rubella vaccines.

Pneumosil Indication

Pneumosil is indicated against invasive disease, pneumonia, and acute otitis media caused by Streptococcus pneumoniae serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F, and 23F in infants and toddlers from 6 weeks up to 2 years of age.

Vaccines help prevent pneumococcal disease, an illness caused by Streptococcus pneumoniae bacteria says the U.S. CDC. Pneumococcal disease is common in young children, but older adults are at the greatest risk of serious illness and death. CDC recommends pneumococcal vaccination for all children younger than 2 years old and adults 65 years or older. In certain situations, older children and other adults should also get pneumococcal vaccines.

Pneumosil Dosage

The dosage of Pneumosil is 0.5 ml, given intramuscularly, with care to avoid Injection into or near nerves and blood vessels. The product is a suspension containing an adjuvant, which needs to be shaken vigorously immediately before obtaining a homogenous, whitish turbid liquid in the vaccine container.

The vaccine should be given by intramuscular injection only.

Pneumosil News 2023

April 22, 2022 - News article: Time well spent: The complex journey of a life-saving vaccine.

April 6, 2021 - The Serum Institute of India confirmed it would supply the first indigenously developed pneumococcal conjugate vaccine to the Centre. The doses will be sent to government medical store depots in Kolkata, Mumbai, and Karnal. SII intends to supply 2.4 crore doses of the vaccine to the Health Ministry by December 2021. The supply order was issued on February 3, 2021, in the name of Prakash Kumar Singh, the Director of Government and Regulatory Affairs at the Pune-based SII.

December 28, 2020 - Serum Institute of India announced the launch of India's first indigenously developed pneumococcal vaccine -- Pneumosil -- in the Union's presence of Health Minister Harsh Vardhan. Pneumosil has been developed through collaboration spanning over a decade among the Serum Institute, PATH, and the Bill and Melinda Gates Foundation. This significant milestone aims to improve pneumococcal conjugate vaccine affordability and enable sustainable access for low-and middle-income countries.

December 19, 2019 - PNEUMOSIL®, a vaccine against a leading cause of deadly childhood pneumonia—the pneumococcus bacterium—has achieved prequalification by the World Health Organization. Developed through a collaboration spanning over a decade between Serum Institute of India, Pvt., Ltd. and PATH and with funding from the Bill & Melinda Gates Foundation, the vaccine is expected to protect children on par with other pneumococcal conjugate vaccines at a price that is more affordable for low- and middle-income countries.

March 6, 2019 - Pfenex Inc. announced that Serum Institute of India Private Limited had completed a pivotal Phase 3 study for Pneumosil®, a 10-valent pneumococcal conjugate vaccine. Serum Institute indicates all primary and secondary objectives were met. Following a review of the Complete Study Report and product dossier by the Drug Controller General of India, Serum Institute has received an export license for Pneumosil.

Pneumosil Pneumococcal Vaccine Clinical Trials

Clinical Trial NCT03197376: Phase 3 Study of 10-valent Pneumococcal Conjugate Vaccine (PNEUMOSIL) in Healthy Infants. Last Update Posted: July 14, 2020.

This study will examine the consistency of 3 batches of the Pneumosil vaccine by looking at infants' immune response. The study will also compare the immunogenicity of the Pneumosil vaccine to another WHO-prequalified vaccine, Synflorix.

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SERUM INSTITUTE OF INDIA PVT. LTD.
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Robert Carlson, MD
Holly Lutmer PharmD
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Pneumosil Pneumococcal Vaccine
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10-valent Pneumococcal Conjugate Vaccine
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SII
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Tuesday, March 7, 2023 - 05:20
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Pneumosil
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Approved
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IN
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SSI
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India
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UV1 Cancer Vaccine

UV1 Cancer Vaccine Clinical Trials, Efficacy, Indication, Side Effects

Ultimovacs ASA's UV1 is a peptide-based vaccine inducing a specific T-cell response against the universal cancer antigen telomerase. As a universal cancer vaccine, UV1's unique action mechanism can apply to most cancer types. Unlike algorithm-selected vaccine peptides, the UV1 peptides contain epitopes documented by cancer patients' immune systems. In addition, the UV1 universal cancer vaccine candidate leverages the high prevalence of the human telomerase (hTERT) to effectively cross the dynamic stages of the tumor's growth and microenvironment.

Immune responses against several hTERT epitopes, including novel hTERT epitopes not present in the vaccines, were detected in blood samples from long-term surviving patients following vaccine treatment but not in patients without clinical benefit. Based on these data, three peptides to elicit robust T cell responses across different cancer types were selected as the UV1 vaccine components.

UV1 is being developed as a therapeutic cancer vaccine, which may serve as a platform for use combined with other immunotherapy that requires an ongoing T cell response for their mode of action. In addition, UV1's unique mechanism of action can apply to most cancer types. UV1 consists of long, synthetic peptides that induce CD4+ T cells displaying a Th1 cytokine profile. By directing the immune system to hTERT antigens in over 80% of all cancers, UV1 drives CD4 helper T cells to the tumor to activate an immune system cascade to increase anti-tumor responses.

On March 2, 2024, Ultimovacs ASA announced that the results from the randomized controlled Phase II clinical trial, NIPU, were published in the European Journal of Cancer. On August 5, 2024, Ultimovacs announced the topline results from the Phase II FOCUS trial (NCT05075122). The topline data readout demonstrated that adding UV1 to the standard of care pembrolizumab did not lead to clinical benefits in progression free survival or overall survival in those late-stage HNSCC patients, therefore, the study did not meet its primary and secondary endpoints. Ultimovacs is also investigating UV1 in ovarian cancer in the ongoing Phase II DOVACC trial, which evaluates a combination of olaparib and durvalumab +/- UV1 vs. olaparib alone as second-line maintenance treatment for patients with high-grade BRCA-negative ovarian cancer. Topline results are expected in the first half of 2025, well within the current financial runway, which reaches the fourth quarter of 2025.

Oslo, Norway-based Ultimovacs ASA is a pharmaceutical company (OSE ULTI) developing novel immunotherapies against cancer. The lead product candidate is UV1, a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase and immune activation for a prostate cancer-specific therapeutic. The Company's clinical studies are listed here.

UV1 Cancer Vaccine Indication

The UV1 telomerase peptide vaccine has demonstrated robust immune response induction and promising clinical activity in several malignancies. Ultimovacs has a long-standing commitment to the development of UV1-based treatments for melanoma. Malignant melanoma is a skin cancer with a significant and unmet medical need for improved therapies. More than 130,000 new cases of melanoma are diagnosed worldwide every year, and an estimated 50,000 people die from metastatic melanoma every year.

UV1 Cancer Vaccine News

October 17, 2023 - "For patients with malignant mesothelioma, few treatment options are available after first-line chemotherapy. The NIPU study showed that patients receiving UV1 vaccination as an add-on to nivolumab and ipilimumab experienced an increased objective response rate and a clinically meaningful prolonged survival. These encouraging results provide a foundation for advancing further clinical development with UV1 vaccination in mesothelioma patients," said Principal Investigator of the NIPU clinical trial, Professor Åslaug Helland, MD, Ph.D.

October 12, 2023 - Jens Bjørheim, Chief Medical Officer at Ultimovacs, stated in a press release, "The UV1-103 study treats the same patient population as our Phase II study INITIUM. As we await data from the first three randomized UV1 Phase II trials in the near-term, we are increasingly optimistic about UV1's potential to benefit cancer patients."

June 19, 2023 - "We are very encouraged to observe a 67% overall survival rate at 3-year follow-up in this Phase I study, which treats the same patient population as our UV1 Phase II study, INITIUM. These data further strengthen the previously reported results from the study, including good safety for UV1 and a remarkable 33% complete response rate in patients with metastatic malignant melanoma where surgery is not an option. The data continue to show that UV1 in combination with pembrolizumab has promising signs of efficacy," said Jens Bjørheim, Chief Medical Officer at Ultimovacs. 

October 25, 2022 - Ultimovacs ASA announced that the first patient had been randomized in the LUNGVAC study. The study in non-small cell lung cancer is the fifth Phase II clinical trial in which UV1 is being investigated in combination with checkpoint inhibitors.

October 18, 2022 - Ultimovacs ASA presented clinical endpoints and biomarker results from patients in the UV1-103 Phase I trial.

June 30, 2022 - Ultimovacs ASA announces the completed recruitment of 154 patients in the INITIUM trial. INITIUM is Ultimovacs' Phase II clinical trial of its universal cancer vaccine UV1 combined with the checkpoint inhibitors ipilimumab and nivolumab in metastatic malignant melanoma. Consistent with INITIUM's event-driven design, topline progression-free survival results will be disclosed after the progression of cancer or death has been observed in 70 patients.

February 17, 2022 - Ultimovacs ASA announced its fourth-quarter 2021 results. A private placement was completed on October 26, 2021, raising gross proceeds of MNOK 270 (net MNOK 259.0).

December 15, 2021 - Ultimovacs ASA announced that the first patient had been enrolled in a randomized Phase II clinical trial (DOVACC) assessing the impact of the UV1 telomerase vaccine on ovarian cancer's standard of maintenance care. Topline data from DOVACC is expected in 2023.

December 2, 2021 - Ultimovacs ASA announced that the U.S. FDA had granted orphan drug designation for the Company's universal cancer vaccine UV1 to treat stage IIB – IV melanoma. UV1 is used as an add-on therapy to checkpoint inhibitors ipilimumab and nivolumab. UV1 is currently being studied as a first-line treatment for metastatic melanoma in a Phase II trial named INITIUM.

November 11, 2021 - Ultimovacs ASA announced its third-quarter 2021 results. Highlights for the third quarter of 2021: Ultimovacs reported that UV1 would be investigated in a Phase II clinical trial in combination with pembrolizumab in non-small cell lung cancer. A private placement was completed on 26 October 2021, raising gross proceeds of MNOK 270. Total cash and cash equivalents were reduced by MNOK32.9 during Q3-21 and amounted to MNOK 347.8 as of 30 September 2021.

November 9, 2021 - The Company announced UV1 vaccine combined with ipilimumab was found in a clinical trial to induce immune responses in 91% of melanoma patients. And the immune responses persist and are detectable for up to 5 years.

October 26, 2021 - Ultimovacs announced that UV1 would be investigated in a Phase II clinical trial with pembrolizumab in non-small cell lung cancer (NSCLC). The LUNGVAC trial will be a multi-center, randomized, open-label trial sponsored by Drammen Hospital, a leading oncology research center in Norway. The trial will enroll approximately 138 patients and be conducted at 8-10 clinical centers in Norway.

October 21, 2021 - Ultimovacs ASA announced its universal cancer vaccine, UV1, combined with checkpoint inhibitors, has received Fast Track designation from the U.S. FDA to treat unresectable or metastatic melanoma as an add-on therapy to pembrolizumab or as an add-on therapy to ipilimumab. Ultimovacs is evaluating UV1 as an add-on therapy to ipilimumab and nivolumab as first-line treatment for unresectable or metastatic melanoma in a Phase II study named INITIUM.

October 13, 2021 - Ultimovacs ASA announced continuing positive topline clinical trial results. The 24-month follow-up data compares favorably with an earlier large-scale study of pembrolizumab alone, which showed an overall survival rate of 58% after 24 months and median progression-free survival of 5.5-11.6 months.

August 20, 2021 - The Company posted the 'Enabling the Immune System to Fight Cancer' presentation - Encouraging results from the Phase I clinical trial of UV1 combined with pembrolizumab in malignant melanoma. And it announced its second-quarter 2021 results.

June 1, 2021 - Ultimovacs announced a peer-reviewed article published in The Journal of Translational Medicine that outlines the mechanistic rationale for combining UV1 with two checkpoint inhibitors, ipilimumab and nivolumab. The dual use of ipilimumab and nivolumab was recently approved as first-line therapy in malignant pleural mesothelioma (MPM), with few therapeutic options available. However, Haakensen et al. explain in the article that observed response rates with checkpoint inhibitors have been moderate in MPM compared to documented performance for the combination of checkpoint inhibitors in other cancers, suggesting that checkpoint inhibitors alone may be insufficient to trigger an immune response.

May 11, 2021 - Ultimovacs ASA announced the publication in Frontiers in Immunology of its positive long-term Overall Survival data from the Phase I trial evaluating the Company's universal cancer vaccine, UV1, in combination with checkpoint inhibitor ipilimumab in patients with metastatic malignant melanoma. As published in the journal, in addition to the achievement of the primary endpoints of safety and tolerability, 50% of the patients were still alive at the data cut-off, supporting the combination of the Company's proprietary UV1 vaccine with ipilimumab, a CTLA-4 checkpoint inhibitor, and standard-of-care treatment, in this late-stage patient population.

December 22, 2020 - Ultimovacs ASA - Initiates FOCUS Phase II Trial for Universal Cancer Vaccine, UV1, Head and Neck Cancer Patients Receiving Pembrolizumab. The FOCUS trial is Ultimovacs' fourth Phase II clinical trial with UV1 and comes in addition to the collaboration Phase II trial announced in May 2020.

February 4, 2020 - Study: Combining UV1 and ipilimumab is safe and induces clinical melanoma responses. The high proportion of immunological responders and early induction of detectable immune responses suggest synergism.

UV1 Cancer Vaccine Clinical Trials

UV1 has been tested in several clinical trials, maintaining a positive safety and tolerability profile and encouraging efficacy signals.

The phase II clinical trial results, NIPU, were published in the European Journal of Cancer. The open-label, multi-center Phase II trial was sponsored by Oslo University Hospital with support from Bristol-Myers Squibb and Ultimovacs. The study did not meet its primary endpoint of improved progression-free survival (PFS) based on blinded independent central review (BICR). Analyses on the secondary endpoints, objective response rate (ORR) by BICR and overall survival (OS), showed a significant benefit of adding the UV1 vaccine to ipilimumab and nivolumab. Local assessment demonstrated an improved PFS among patients in the vaccine arm for all histological subtypes combined, and new subgroup analysis shows further improvement for the epithelioid subtype. The epithelioid subtype represents approximately 70% of all patients with mesothelioma. The safety profile confirms the good safety profile for the UV1 vaccine.

Building on Phase I results, Ultimovacs is enrolling INITIUM, its Phase II clinical trial evaluating UV1 combined with ipilimumab and nivolumab in patients with metastatic malignant melanoma. The Company expects to announce the trial's primary endpoint data in 2H2022. In addition, Ultimovacs has an ongoing and fully-enrolled Phase I trial evaluating UV1 combined with pembrolizumab, a PD-1 checkpoint inhibitor, as a first-line treatment in metastatic malignant melanoma patients. Ultimovacs anticipates announcing data on the primary endpoints for the NIPU and INITIUM studies in 2H2022 and the DOVACC and FOCUS studies in 2023.

Clinical analyses from the UV1-103 study announced on October 18, 2022, indicate efficacy in patients with low levels of PD-L1, a critical predictive biomarker associated with lower efficacy for pembrolizumab and other anti-PD-1 therapies in some tumor types. In addition, the analyses showed robust responses in patients treated with the combination of UV1 and pembrolizumab, regardless of patients' PD-L1 status. In addition to the sub-analysis of the PD-L1 status, the study also evaluated four other key predictive biomarkers, including baseline tumor mutational burden (TMB), predicted neoantigens, interferon-gamma (IFN-gamma) gene signature, and levels of tumor-infiltrating lymphocytes. The analyses of these five biomarkers signal efficacy in patients treated with UV1 in combination with pembrolizumab, regardless of the tumor phenotype.

On October 12, 2023, Ultimovacs announced encouraging overall survival data from cohort 1 in the UV1-103 Phase I clinical trial in malignant melanoma. No further deaths have been reported among the patients in cohort 1 who were alive at the 3-year follow-up, reaffirming an encouraging trend of durable overall survival benefit from UV1 vaccination. Ultimovacs has previously reported data showing a complete response rate in the UV1-103 study of 33% (complete disappearance of tumors) and an objective response rate of 57% (full or partial disappearance of tumors). On October 17, 2023, the first demonstration of universal cancer vaccine efficacy and therapeutic impact in a randomized Phase II clinical trial supported further clinical development. The UV1 cancer vaccination combined with ipilimumab and nivolumab reduced the risk of death by 27%, meeting the protocol predefined threshold for statistical significance in a hard-to-treat patient group with currently no standard-of-care treatment options. 

Ultimovacs ASA - positive topline results from the first cohort of 20 patients in its ongoing US-based Phase I clinical trial evaluating the Company's lead candidate, UV1, combined with a PD-1 checkpoint inhibitor, pembrolizumab, as a first-line treatment in patients with metastatic malignant melanoma. The results confirm the achievement of the primary safety and tolerability endpoints and indicate initial signs of clinical response.

UV1 is being tested in different randomized Phase II trials: The INITIUM trial is an Ultimovacs-sponsored, global, randomized Phase II trial for patients with metastatic malignant melanoma; The NIPU trial is a randomized, multi-center Phase II trial in which the universal cancer vaccine, UV1, is investigated in combination with the checkpoint inhibitors, ipilimumab, and nivolumab, as second-line treatment in mesothelioma. In addition, a third Phase II clinical trial will evaluate UV1 in a new cancer indication combined with indication-specific standard-of-care cancer therapies different from those tested in INITIUM (malignant melanoma, 154 patients) and NIPU (mesothelioma, 118 patients).

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Manufacturer: 
Ultimovacs ASA
Reviewer: 
Robert Carlson, MD
Holly Lutmer PharmD
Vaccine: 
UV1 Cancer Vaccine
Availability: 
TBD
Generic: 
UV1
Clinical Trial: 
https://ultimovacs.com/technology/clinical-studies
Drug Class: 
Peptide-based vaccine
Find Price: 
Discounts
Clinical Trial Phase I: 
Safety of UV1 Vaccination in Combination With Ipilimumab in Patients With Unresectable or Metastatic Malignant Melanoma
Clinical Trial Phase II: 
Olaparib, Durvalumab and UV1 in Relapsed Ovarian Cancer (DOVACC)
Lab Test: 
CDC
Condition: 
Cancer
Last Reviewed: 
Tuesday, August 6, 2024 - 06:50
Status: 
Candidate
Manufacturer Country ID: 
NO
FDA First In Class: 
Yes
Ingredients: 
Overview
Countries: 
Norway - pending
USA - pending