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ResVax RSV Vaccine Description for 2022

ResVax™ is an aluminum adjuvanted RSV fusion (F) protein recombinant nanoparticle vaccine for infants via maternal immunization.

Novavax developed its nanoparticle-based RSV vaccine for older adults and went through a large phase 2b clinical trial. However, in a large phase 3 trial, it was found ineffective. In light of the fact that the trial failed to meet its primary endpoints, the U.S. FDA and European Medicines Agency recommended conducting an additional Phase 3 clinical trial to confirm efficacy. As a result, Novavax is currently unblinding its next phase 3 trial in pregnant women. To accelerate RSV vaccine development, developers adopted the fail-fast approach.

The Bill & Melinda Gates Foundation (BMGF) has supported the Prepare trial for ResVax through a grant of up to $89.1 million; BMGF continues to financially support our efforts to conduct certain follow-up analyses of the Phase 3 data.

ResVax RSV Vaccine Indication

ResVax is indicated to prevent severe RSV disease, protecting infants as early as birth and during the first months of life when they are most at risk for hospitalization. RSV is the most common cause of lower respiratory tract infections and the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide.

ResVax is administered to the maternal participant as an intramuscular (IM) Injection of RSV F Vaccine at 28-36 weeks Estimated Gestational Age (EGA).

ResVax RSV Vaccine News For 2015 - 2022

March 14, 2022 - A peer-reviewed article concluded: In a double-blind, randomized, placebo-controlled trial, administering an RSV vaccine to pregnant mothers reduced antimicrobial prescribing among their infants by 12.9% over the first three months of life.

July 21, 2021 - ResVax missed its primary efficacy endpoint in the pivotal PREPARE study. While it hit key secondary endpoints, the EMA and FDA have requested an additional confirmatory efficacy study before considering approval. The elderly segment offers the most commercial potential because of the large population size, high coverage rates that can be achieved, and the likely requirement for repeat seasonal vaccination. ResVax also failed to meet its primary efficacy endpoint in this subgroup in the RESOLVE study,

August 12, 2019 - Novavax presented new data from Novavax Phase 3 Prepare Trial of ResVax Presented at 2019 IDSOG Annual Meeting.

June 10, 2019 - Novavax Provides Updates on the Global Pathways to Licensure for ResVax™

February 28, 2019 - Novavax Announces Topline Results from Phase 3 PrepareTM Trial of ResVax™ for Prevention of RSV Disease in Infants via Maternal Immunization.

April 2015 - RSV F Nanoparticle Vaccine: Biological Rationale, Summary of the Clinical Data and Path Forward.

ResVax RSV Vaccine Clinical Trials

ResVax RSV vaccine has completed four clinical trials to date.

Data from our Prepare trial, initiated in December 2015, was announced in February 2019. The Prepare trial was conducted to determine whether ResVax reduced the incidence of medically significant RSV-positive LRTI in infants through a minimum of the first 90 days of life and up through the first six months of life. While these data did not meet the trial’s primary efficacy endpoint, it did demonstrate efficacy against a secondary endpoint by reducing RSV LRTI hospitalizations in treated infants. ResVax is thus the first RSV vaccine to show efficacy in a Phase 3 clinical trial and, in addition, to show important effects against a variety of prespecified exploratory endpoints and post hoc analyses. This included an approximately 60% reduction in RSV-related severe hypoxemia and an about 74% reduction in RSV-related, radiographically confirmed pneumonia through Day 90. As in previous clinical trials, ResVax also showed favorable safety and tolerability results.

HSV529 Herpes Vaccine Description 2022

Sanofi Pasteur's HSV529 is a herpes vaccine candidate classified as a replication-defective virus. The virus possesses all the wild-type HSV virus components except two proteins UL5 and UL29, involved in viral DNA replication. 

This replication-defective HSV-2 vaccine can infect cells and result in a broader immune response. HSV529 uses a replication-defective mutant virus genetically altered to prevent the virus from replicating, says Sanofi.

Vaccine-elicited protection against HSV is challenging to achieve due to herpes viruses' ability to evade many aspects of the mammalian immune response.  Subunit vaccines, which consist of individual or small groups of viral antigens, remove the risk of complications resulting from the production of vaccine-associated infectious viral particles but are limited in the degree and scope of immunity produced in vaccinated individuals.  

The Sanofi Pasteur vaccine candidate HSV529 is derived from HSV-2 strain 186, produced in Vero cells expressing HSV2 UL5 and UL29. 

In October 2014, Sanofi Pasteur and Immune Design announced a collaboration: Sanofi Pasteur contributed HSV529, a clinical-stage replication-defective HSV vaccine product candidate, and Immune Design will contribute G103, its preclinical trivalent vaccine product candidate.

About Sanofi Pasteur, a Sanofi Company. The phase 1 study sponsor was the National Institute of Allergy and Infectious Diseases.

HSV529 Indication

The HSV529 herpes vaccine candidate is indicated to treat herpes simplex virus (HSV). Worldwide, about 400 million people are infected with herpes simplex virus type 2 (HSV-2), the predominant cause of genital herpes, says the CDC. The challenge of developing experimental vaccines that are both safe and effective has led to two opposing approaches in HSV vaccine development: increasing the efficacy of subunit vaccines and increasing live-attenuated vaccines' safety.

Genital herpes is an STD caused by two types of viruses. The viruses are called herpes simplex virus type 1 (HSV-1) and HSV-2. Genital herpes infection is common in the United States. The CDC estimates that, annually, 776,000 people in the United States get new genital herpes infections.

Of the more than 100 known herpes viruses, 8 routinely infect only humans: herpes simplex virus types 1 and 2, varicella-zoster virus, cytomegalovirus, Epstein-Barr virus, human herpesvirus 6, human herpesvirus 7, and Kaposi's sarcoma virus or human herpesvirus 8. A simian virus, called the B virus, occasionally infects humans. All herpes viruses can establish latent infection within specific tissues, which are characteristic of each virus.

HSV529 Dosage

Intramuscular injections deliver the HSV529 vaccine candidate as a 0.5 ml solution containing 1 x 10(7) plaque-forming units on day 0, one month after the first dose (day 30), and then six months after the first dose (day 180).

HSV529 Side Effects

Anyone can submit a side effects report to VAERS, including parents and patients. And healthcare providers are required by law in the USA to report to VAERS. Here is a link to report an adverse event.

HSV529 News

January 13, 2021 - The Study of the Safety of a Particular Herpes Vaccine in Adults With or Without Herpes Infection was updated.  This Phase I Study of the Safety of replication-defective Herpes Simplex Virus-2 Vaccine, HSV529, in Adults Aged 18 to 40 Years With or Without HSV Infection Start Date was September 26, 2013. The Biological: HSV529 vaccine was administered intramuscularly (deltoid muscle) as a 0.5 ml solution containing 1 x 10(7) plaque-forming units on day 0, one month after the first dose (day 30), and then six months after the first dose (day 180). The Sponsor is the National Institute of Allergy and Infectious Diseases, and the Collaborator is Sanofi Pasteur.

August 7, 2020 - The phase 2 study, 'Safety and Efficacy of 4 Investigational HSV 2 Vaccines in Adults With Recurrent Genital Herpes Caused by HSV 2 (HSV15)' was last updated on September 18, 2020.

January 10, 2020 - Phase 1 and 2 studies were posted. The studies' primary objectives are: To describe the safety profile of different investigational vaccine regimens against herpes simplex virus type 2 (HSV-2); To evaluate the efficacy of the investigational vaccine regimens concerning the frequency of herpes simplex virus (HSV) deoxyribonucleic acid (DNA) detection in the genital area (shedding rate) following a 2 dose vaccine schedule; To determine the proportion of participants free of HSV genital recurrence at 6 months after the 2-dose vaccine schedule. Allocation: Randomized, 381 participants.

August 2019 - This first-in-human study of the replication-defective HSV vaccine HSV529 showed that it was safe and well-tolerated, with evidence of immunogenicity in HSV-naive and previously infected subjects, and elicited neutralizing antibody and modest CD4+T-cell responses in HSV-seronegative vaccinees.

October 8, 2015 - Phase 1 Clinical Trial for HSV529 Vaccine in HSV-2 Seropositive Adults launches. Last updated on January 14, 2019.

October 16, 2014 - Sanofi Pasteur, the vaccines division of Sanofi and Immune Design Corp., a clinical-stage immunotherapy company, today announced that they have entered into a broad collaboration to develop a herpes simplex virus (HSV) immune therapy.

HSV529 Clinical Trials

HSV529 Herpes Vaccine has completed two Phase 1 clinical trials and is still active in a phase 1/2 trial.

INO-4500 DNA Vaccine Description 2022

INO-4500 is a DNA vaccine candidate. On November 17, 2022, the company discontinued the development of product candidates targeting Lassa Fever (INO-4500) following initial analyses of data from studies conducted by INOVIO and funded by CEPI.

In addition, INOVIO is leveraging its optimized plasmid design and delivery technology to develop DNA medicines to treat and prevent infectious diseases. INO-4500 is the first vaccine candidate for Lassa fever to enter human trials, says the company.

INOVIO's DNA medicines deliver optimized plasmids directly into cells intramuscularly or intradermally using one of INOVIO's proprietary hand-held CELLECTRA smart devices. INOVIO's DNA medicines are made using a process called SynCon®. SynCon uses a proprietary computer algorithm designed to identify and optimize the DNA sequence of the target antigen, whether it is a virus or a tumor. Once this sequence has been determined, the DNA is synthesized or reorganized, and manufacturing can begin, says the company.

DNA medicines are composed of optimized DNA plasmids, which are small circles of double-stranded DNA synthesized or reorganized by computer sequencing technology and designed to produce a specific immune response in the body.

On February 23, 2021, INOVIO announced the first participant was dosed in a Phase 1B clinical trial for INO-4500 in Ghana, Africa. The Phase 1B clinical trial (LSV-002) is ongoing at the Noguchi Memorial Institute for Medical Research in Accra, Ghana. It is the first vaccine clinical trial for Lassa fever to be conducted in West Africa.

Plymouth Meeting, Pennsylvania-based INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and diseases INOVIO has 15 DNA medicine clinical programs currently in development focused on HPV-associated diseases, cancer, and infectious diseases, including coronaviruses associated with MERS and COVID-19 diseases being developed under grants from the Coalition for Epidemic Preparedness Innovations and the U.S. Department of Defense.

INO-4500 Indication

The U.S. CDC says Lassa fever is an animal-borne, or zoonotic, acute viral illness. It is endemic in West Africa, including Sierra Leone, Liberia, Guinea, and Nigeria. Neighboring countries are also at risk, as the animal vector for the Lassa virus, the "multimammate rat" (Mastomys natalensis), is distributed throughout the region.

The illness was discovered in 1969 and is named after the town in Nigeria where the first cases occurred. An estimated 100,000 to 300,000 infections of Lassa fever occur annually, with approximately 5,000 deaths, says the CDC. Unfortunately, surveillance for Lassa fever is not standardized; therefore, these estimates are crude. However, in some areas of Sierra Leone and Liberia, it is known that 10-16% of people admitted to hospitals annually have Lassa fever, demonstrating the serious impact the disease has on the region.

INO-4500 Dosage

The INO-4500 vaccine is conducting clinical tests for the prevention of Lassa Fever. Inovio's proprietary Cellectra electroporation device injects this vaccine into the muscle or skin. Injection of the DNA plasmid into a patient generates robust in vivo monoclonal antibody production. Thus, this approach can potentially generate in vivo production of therapeutic antibodies.

INOVIO's Phase 1B clinical trial, LSV-002, dosing regimen involves two vaccinations at 0 and 28 days with either 1.0 mg or 2.0 mg dosing levels. This trial will inform dose selection for subsequent Phase 2 studies in West Africa.

INO-4500 News 2018 - 2022

March 22, 2022 - The UK NHS confirmed a systematic review examining preclinical and human pharmacokinetic data and found that the clinical evidence for ribavirin as a treatment for Lassa fever was limited. 

March 15, 2022 - The U.S. CC confirmed an outbreak of Lassa fever in Nigeria in Ondo, Edo, Bauchi, Ebonyi, Kogi, Taraba, Enugu, Benue, Gombe, Nasarawa, and the Delta States.

February 21, 2022 - The WHO stated 'Considering the seasonal increases of cases between December and March, countries in West Africa that have endemic Lassa fever are encouraged to strengthen their related surveillance systems to enhance early detection and treatment of cases and to reduce the case fatality rate, as well as to strengthen cross border collaboration.'

February 9, 2022 - The UK Health Security Agency press office confirmed two people had been diagnosed with Lassa fever in the East of England. Before these cases, 8 cases of Lassa fever were imported to the UK since 1980. The last 2 cases occurred in 2009. There was no evidence of onward transmission from any of these cases.

November 7, 2021 - The WHO Africa reported through October 2021 that Nigeria had confirmed 403 cases. A total of 79 individuals have died among those who had confirmed results, yielding a 19.6% CFR this year. The CFR during the same period in 2020 was 20.7%

October 26, 2021 - INOVIO announced its Phase 1B clinical trial for INO-4500, its DNA vaccine candidate for Lassa fever, and completed full enrollment of 220 participants. This trial is ongoing at the Noguchi Memorial Institute for Medical Research in Accra, Ghana. It is the first vaccine clinical trial for Lassa fever conducted in West Africa, where the viral illness is endemic.

February 23, 2021 - INOVIO announced the first participant was dosed in a Phase 1B clinical trial for INO-4500, its DNA vaccine candidate for Lassa fever, in Ghana. The Phase 1B clinical trial (LSV-002), ongoing at the Noguchi Memorial Institute for Medical Research in Accra, Ghana, is the first vaccine clinical trial for Lassa fever to be conducted in West Africa, where the infection is endemic.

October 11, 2018 - According to new research published in Nature Communications, a novel vaccine designed to protect people from Lassa fever and rabies showed promise in preclinical testing. The investigational vaccine, called LASSARAB, was developed and tested by scientists at Thomas Jefferson University in Philadelphia; the University of Minho in Braga, Portugal; the University of California, San Diego; and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

April 11, 2018 -  Inovio Pharmaceuticals, Inc. (NASDAQ: INO) and the Coalition for Epidemic Preparedness Innovations announced a partnership under which Inovio will develop vaccine candidates against Lassa fever and Middle East Respiratory Syndrome.

INO-4500 Clinical Trials 

Clinical Trial NCT04093076: INOVIO's Phase 1B clinical trial, LSV-002, will enroll approximately 220 adult participants 18-50 years old, with the primary endpoint of evaluating safety and immunogenicity in an African population. The dosing regimen involves two vaccinations at 0 and 28 days with either 1.0 or 2.0 mg dosing levels. In addition to providing valuable insights on the INO-4500 safety and immunogenicity profile, this trial will inform dose selection for subsequent Phase 2 studies in West Africa. Last Update Posted: February 25, 2021. Estimated study completion date: September 2022.

Clinical Trial NCT03805984:  Safety, Tolerability, and Immunogenicity of INO-4500 in Healthy Volunteers. This Phase 1 trial is a randomized, double-blinded, placebo-controlled, placebo-controlled trial to evaluate the safety, tolerability, and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation using the CELLECTRA® 2000 device in healthy adult volunteers. Last Update Posted: November 23, 2020. Actual completion date: October 21, 2020.

VAXNEUVANCE™ Pneumococcal Vaccine Clinical Trials, Dosage, Indication, News, Side Effects

The U.S. Food and Drug Administration (FDA) approved Merck's VAXNEUVANCE™ on July 16, 2021, for active immunization for the prevention of invasive pneumococcal disease (IPD) caused by 15 serotypes conjugated to a CRM197 carrier protein, including Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F, in adults. On June 22, 2022, the FDA approved (STN: 125741) an expanded indication for VAXNEUVANCE, which now includes children aged six weeks through 17 years. The FDA published a Package Insert, Patient Information sheet, and BLA Clinical Review Memorandum; STN: 125741.

On January 28, 2022, the U.S. CDC confirmed that using PCV20 alone or PCV15 in combination with PPSV23 is expected to reduce pneumococcal disease incidence in adults aged 65 years and older, as well as in those aged 19–64 years with certain underlying conditions. Natalie Banniettis, MD, FAAP, Senior Principal Scientist, Global Clinical Development, Merck Research Laboratories, Merck & Co., presented (V114, VAXNEUVANCE): Pediatric Clinical Development Program on February 24, 2022. Merck states that vaccinating with VAXNEUVANCE pneumococcal polysaccharides may not protect all vaccine recipients.

On December 15, 2021, the European Commission approved VAXNEUVANCE EMEA/H/C/005477 for use by adults. On October 24, 2022, the European Commission approved the expanded approval for infants, children, and adolescents aged 6 weeks to less than 18 years.

For more information on the VAXNEUVANCE vaccine, visit www.merck.com or this Merck webpage. The brand is trademarked in Canada. ATC code: J07AL02. U.S. Patent No. 8,192,746. 

VAXNEUVANCE Vaccine Revenues

On April 26, 2025, Merck announced that Vaxneuvance produced $230 million in revenues. Growth was primarily driven by higher demand in the Europe and Asia Pacific regions, partially offset by lower demand in the U.S. due to competitive pressure. On April 25, 2024, Merck announced that Vaxneuvance generated $219 million in revenues during the first quarter of 2024, representing a 106% increase from the prior year period. 

VAXNEUVANCE Vaccine Indication

VAXNEUVANCE is indicated for active immunization to prevent invasive disease caused by the S. pneumoniae serotypes contained in the vaccine in adults. According to the U.S. FDA disclosure, more than 90 types of pneumococcal bacteria can affect adults differently than children. Pneumococcal serotypes not in the currently licensed conjugate vaccine, such as 22F and 33F, are commonly associated with invasive pneumococcal disease. For example, serotypes 22F and 33F now account for 13% of the invasive pneumococcal disease seen among adults aged 65 and older in the U.S. and 7-12% of European adult cases.

Additionally, serotype 3 remains one of the leading causes of invasive pneumococcal disease in adults and children, despite being included in currently available pneumococcal vaccines. For example, in the U.S., the U.S. CDC says that 15% of invasive pneumococcal disease among adults aged 65 and older continues to be caused by serotype 3. And this ranges from 12 to 18% of adult cases across European countries.

Children under the age of 2 are particularly vulnerable to pneumococcal infection, and the incidence of invasive pneumococcal disease remains highest in the first year of life. There are 100 different types of pneumococcal bacteria, including serotypes 22F, 33F, and 3, which collectively represent more than a quarter of invasive pneumococcal disease cases in children under 5.

The U.S. CDC Advisory Committee on Immunization Practices (ACIP) met on October 20, 2021, and unanimously voted to update pneumococcal vaccination recommendations for adults 65 and older and those ages 19 to 64 with certain underlying medical conditions or other disease risk factors. In both groups, the ACIP voted to recommend vaccination with a sequential regimen of VAXNEUVANCE followed by PNEUMOVAX 23 or with a single dose of 20-valent pneumococcal conjugate vaccine. These updates would apply to adults who have not received a pneumococcal conjugate vaccine or whose previous pneumococcal vaccination history is unknown.

VAXNEUVANCE Dosage

Merck's VAXNEUVANCE is administered as an intramuscular injection. When PCV15 is used, the CDC recommends a minimum of one year between the administration of PCV15 and PPSV23. A minimum interval of 8 weeks can be considered for adults with an immunocompromising condition, a cochlear implant, or a cerebrospinal fluid leak to minimize the risk of IPD caused by serotypes unique to PPSV23 in these vulnerable groups. Adults who have only received PPSV23 may receive a PCV (either PCV20 or PCV15) ≥ one year after their last PPSV23 dose. When PCV15 is used in individuals with a history of receiving PPSV23, it must be followed by another dose of PPSV23.

VAXNEUVANCE Coadministration

The CDC confirmed PCV15, PCV20, or PPSV23 could be coadministered with QIV in an adult immunization program as concomitant administration (PCV15 or PPSV23 and QIV [Fluarix], PCV20, and adjuvanted QIV [Fluad]) has been demonstrated to be immunogenic and safe. However, slightly lower pneumococcal serotype-specific OPA GMTs or geometric mean concentrations were reported when pneumococcal vaccines were coadministered with QIV than when pneumococcal vaccines were given alone. Currently, there is no data on the coadministration of this vaccine with other vaccines (e.g., tetanus, diphtheria, acellular pertussis vaccine, hepatitis B, or zoster vaccine) among adults. Evaluation of coadministration of PCV15, PCV20, or PPSV23 with COVID-19 vaccines is ongoing.

VAXNEUVANCE Side Effects

Do not administer VAXNEUVANCE to individuals with a severe allergic reaction to any VAXNEUVANCE or diphtheria toxoid component. Additionally, individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to VAXNEUVANCE. The most commonly reported solicited adverse reactions in individuals 18 through 49 years of age were injection site pain (75.8%), fatigue (34.3%), myalgia (28.8%), headache (26.5%), injection site swelling (21.7%), injection site erythema (15.1%) and arthralgia (12.7%). The most commonly reported solicited adverse reactions in individuals 50 years of age and older were injection site pain (66.8%), myalgia (26.9%), fatigue (21.5%), headache (18.9%), injection site swelling (15.4%), injection site erythema (10.9%) and arthralgia (7.7%).

VAERS is a U.S. passive reporting system, meaning it relies on individuals to send in reports of their experiences with a vaccine. However, anyone, including parents and patients, can submit information to VAERS. Furthermore, healthcare providers are required by law to report to VAERS. People are also encouraged to report the adverse side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1–800–FDA–1088.

VAXNEUVANCE Availability

As of 2024, VAXNEUVANCE was available in the U.S., the U.K., and Europe. On April 27, 2023, Merck reported higher sales of VAXNEUVANCE, which increased to $106 million, primarily due to continued uptake in the pediatric indication following its launch in the U.S. 

VAXNEUVANCE News

June 13, 2023 - VAXNEUVANCE (V114) was found to be well-tolerated and safe for infants, according to a study published in the journal Pediatrics.

October 24, 2022 - Dr. Eliav Barr, SVP, head of global clinical development and chief medical officer, Merck Research Laboratories, stated in a press release: "With this (EC) approval, we are pleased to bring an important new PCV option to a vulnerable population in Europe, including infants less than one year of age, who typically experience the highest rates of disease."

September 16, 2022 - Dr. Eliav Barr, senior vice president, head of global clinical development, and chief medical officer, Merck Research Laboratories, stated, "We are pleased with the CHMP's positive opinion as it brings us one step closer to our goal of helping to protect against pneumococcal strains that pose a substantial risk to infants and children in Europe."

July 28, 2022 - The U.S. CDC's ACIP unanimously voted to provisionally recommend using VAXNEUVANCE as an option to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for children under 19 years according to the presently recommended PCV13 dosing and schedules.

December 15, 2021 - Merck announced today that the European Commission has approved VAXNEUVANCE for active immunization to prevent invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. The approval enables the marketing of VAXNEUVANCE in all 27 member states of the European Union, as well as in Iceland, Norway, and Liechtenstein.

December 1, 2—Merck announced that the U.S. FDA has accepted for Priority Review a supplemental Biologics License Application for VAXNEUVANCE to prevent invasive pneumococcal disease in children six weeks through 17 years of age. Additionally, the FDA has set a target action date under the Prescription Drug User Fee Act of April 1, 2022.

October 20, 2021 - Merck announced the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) unanimously voted in favor of updates to pneumococcal vaccination recommendations for adults 65 years and older and adults ages 19 to 64 with certain underlying medical conditions (e.g., chronic conditions such as diabetes, chronic heart disease, chronic lung disease, or chronic liver disease, as well as HIV) or other disease risk factors (e.g., smoking, alcoholism). In both groups, the ACIP voted to provisionally recommend vaccination with either a sequential regimen of VAXNEUVANCE followed by PNEUMOVAX23 or a single dose of 20-valent pneumococcal conjugate vaccine. These updates would apply to adults who have not received a pneumococcal conjugate vaccine or whose previous pneumococcal vaccination history is unknown.

October 15, 2021 - Merck announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) had recommended the approval of VAXNEUVANCE™.

August 25, 2021 - Merck announced topline results from the pivotal PNEU-PED (V114-029) study evaluating the immunogenicity, safety, and tolerability of VAXNEUVANCE™ in 1,720 healthy infants enrolled between 42-90 days of age. In the PNEU-PED study, primary endpoints demonstrated that VAXNEUVANCE had a safety profile generally comparable to PCV13 following receipt of any vaccine dose. Secondary endpoints demonstrated statistically superior immune responses for VAXNEUVANCE compared to PCV13 for shared serotypes three and unique serotypes 22F and 33F, based on prespecified criteria. Additionally, VAXNEUVANCE showed non-inferior immune responses to antigens contained in several routinely used pediatric vaccines when administered concomitantly with VAXNEUVANCE or PCV13.

July 16, 2021 - Merck today announced the U.S. Food and Drug Administration approved VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older.

May 20, 2021 - Merck announced that V114, the company's investigational 15-valent pneumococcal conjugate vaccine, met its primary immunogenicity and safety endpoints in the V114 Phase 3 pediatric clinical program.

January 12, 2—Merck announced that the U.S. FDA accepted for priority review a Biologics License Application (BLA) for V114, Merck's investigational 15-valent pneumococcal conjugate vaccine, for the prevention of invasive pneumococcal disease in adults 18 years of age and older. Additionally, the FDA established a target action date under the Prescription Drug User Fee Act, as of July 18, 2021. The European Medicines Agency is also reviewing an application for licensure of V114 in adults.

October 20, 2020 - Merck announced Positive topline results from Two Additional Phase 3 Adult Studies Evaluating V114, Merck's Investigational 15-valent Pneumococcal Conjugate Vaccine. In the PNEU-PATH (V114-016) study, healthy adults 50 or older received V114 or PCV13, followed by PNEUMOVAX® 23 one year later. Following vaccination with PNEUMOVAX 23 (month 13), immune responses were comparable in vaccination groups for the 15 serotypes in V114. Results also showed that at 30 days post-vaccination with either V114 or PCV13 (day 30), immune responses were comparable for both groups across the 13 serotypes shared by the conjugate vaccines and higher in the V114 group for serotypes 22F and 33F, the two serotypes not included in PCV13.

January 30, 2019 - Merck announced that V114 received a Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) to prevent invasive IPD caused by the vaccine serotypes in pediatric patients six weeks to 18 years of age.

VAXNEUVANCE 15 Clinical Trials

Merck's V114 Pneumococcal Vaccine has undergone many clinical trials, and Merck continues to test the vaccine candidate under many scenarios. The registered 28 clinical trials can be accessed here.