VAXNEUVANCE 15 Pneumococcal Vaccine (V114) Description
VAXNEUVANCE (V114) is Merck's 15-valent pneumococcal conjugate vaccine. The U.S. Food and Drug Administration (FDA) approved VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) 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 on July 16, 2021.
VAXNEUVANCE (V114) consists of pneumococcal polysaccharides from 15 serotypes conjugated to a CRM197 carrier protein and includes serotypes 22F and 33F, commonly associated with invasive pneumococcal disease (IPD) worldwide.
On September 9, 2020, Merck announced the pivotal PNEU-AGE (V114-019) phase 3 study demonstrated that V114 is non-inferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for the 13 serotypes targeted by both vaccines and superior for serotypes 22F and 33F, the two serotypes targeted by V114 but not PCV13. These results are based on opsonophagocytic activity (OPA) responses, measuring vaccine-induced functional antibodies. In addition, the PNEU-AGE study also met the key secondary immunogenicity objective, demonstrating the superiority of V114 compared to PCV13 for serotype 3, a leading cause of invasive pneumococcal disease globally.
In another Phase 3 study, PNEU-TRUE (V114-020), in healthy adults 50 years of age or older, V114 met its primary immunogenicity objective demonstrating equivalent immune response across all 15 serotypes for three different lots of V114. In both studies, V114 was generally well tolerated, with a safety profile comparable to PCV13 and consistent with that observed for V114 in previously reported studies. On August 25, 2021, Merck announced VAXNEUVANCE Also Met Key Safety Objectives in the Phase 3 PNEU-LINK (V114-031) Study in Infants.
"By nature, pneumococcal disease is constantly evolving. Strains of the disease associated with invasiveness cause significant disease burden in children, calling for innovation to help protect this vulnerable population worldwide," stated Dr. Roy Baynes, SVP and head of global clinical development, chief medical officer, Merck Research Laboratories, on August 25, 2021. "At Merck, our goal is to design pneumococcal vaccines that target strains causing the greatest proportion of disease while maintaining a strong immune response to these serotypes. With the inclusion of serotypes 22F and 33F, VAXNEUVANCE has the potential to play an important role in the prevention of invasive pneumococcal disease in children."
The U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices is expected to meet in October 2021 to discuss and recommend using VAXNEUVANCE in adults in the USA.
For more VAXNEUVANCE vaccine information, visit www.merck.com. Or visit this Merck webpage. The brand is trademarked in Canada. STN: 125741.
VAXNEUVANCE 15 Pneumococcal Vaccine (V114) Indication
VAXNEUVANCE is indicated for active immunization to prevent invasive disease caused by the S. pneumoniae serotypes contained in the vaccine. There are more than 90 different types of pneumococcal bacteria, which can affect adults differently than children, says the U.S. FDA disclosure.
Pneumococcal serotypes not in the currently licensed conjugate vaccine, such as 22F and 33F, are commonly associated with the invasive pneumococcal disease worldwide. For example, serotypes 22F and 33F currently cause 13 percent of the invasive pneumococcal disease seen among adults aged 65 and older in the U.S. and seven to 12% of the adult cases in Europe.
Additionally, serotype 3 remains one of the top causes of invasive pneumococcal disease in adults and children despite being included in the currently available pneumococcal vaccines. In the U.S., 15% of invasive pneumococcal disease among adults aged 65 and older continues to be caused by serotype 3, says the U.S. CDC. And this ranges from 12 to 18% of cases in adults across European countries.
However, do not administer VAXNEUVANCE to individuals with a severe allergic reaction to any component of VAXNEUVANCE or diphtheria toxoid. In addition, some individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to VAXNEUVANCE, says Merck.
VAXNEUVANCE 15 Pneumococcal Vaccine (V114) Dosage
Merck's VAXNEUVANCE (V114 vaccine) is administered as an intramuscular injection.
VAXNEUVANCE 15 Pneumococcal Vaccine (V114) Side Effects
Do not administer VAXNEUVANCE to individuals with a severe allergic reaction to any component of VAXNEUVANCE or diphtheria toxoid. Some 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 to a vaccine. However, anyone can submit a report to VAERS, including parents and patients. Furthermore, healthcare providers are required by law to report to VAERS. People are also encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1–800–FDA–1088.
VAXNEUVANCE 15 Pneumococcal Vaccine (V114) Updates
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 for 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 either with a sequential regimen of VAXNEUVANCE followed by PNEUMOVAX23 or with a single dose of 20-valent pneumococcal conjugate vaccine. These updates would apply to adults who have not previously 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™ for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. The European Commission will now review the CHMP recommendation for marketing authorization in the European Union, and a final decision is expected by the end of 2021.
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 VAXNEUVANCE had a safety profile generally comparable to PCV13 following receipt of any vaccine dose. Secondary endpoints showed statistically superior immune responses for VAXNEUVANCE compared to PCV13 for shared serotype three and unique serotypes 22F and 33F based on prespecified criteria and non-inferior immune responses to antigens contained in several routinely used pediatric vaccines when administered concomitantly with VAXNEUVANCE or PCV13.
July 19, 2021 - Ligand Pharmaceuticals Incorporated announced that its partner Merck had received approval from the U.S. FDA for VAXNEUVANCE, also known as V114, 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.
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 today announced V114, the company's investigational 15-valent pneumococcal conjugate vaccine, met its primary immunogenicity and safety endpoints in two trials of the V114 Phase 3 pediatric clinical program. These data support the potential use of V114 in healthy infants who may have previously started a pneumococcal vaccination series with the currently available 13-valent pneumococcal conjugate vaccine (PCV13) (PNEU-DIRECTION) and in a catch-up setting for healthy children who were either pneumococcal vaccine-naïve or who previously received a full or partial regimen with lower valency pediatric pneumococcal conjugate vaccines (PCV) (PNEU-PLAN).
January 12, 2021 - Merck announced 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. The FDA set a Prescription Drug User Fee Act, or target action date, of July 18, 2021. The European Medicines Agency is also reviewing an application for licensure of V114 in adults.
November 23, 2020 - Merck announced the company had submitted applications to the U.S. FDA and European Medicines Agency (EMA) for licensure of V114, Merck's investigational 15-valent pneumococcal conjugate vaccine for use in adults 18 years of age and older. The company awaits acceptance of the U.S. and European regulatory authorities' submissions. The regulatory applications for licensure of V114 include results from Phase 2 and Phase 3 clinical studies in various adult populations, including healthy adults and those at increased risk, such as adults with chronic medical conditions, adults with HIV, and those 65 years of age and older.
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 years of age 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.
September 12, 2020 - The V114 pneumococcal vaccine candidate, which includes 15 serotypes, is non-inferior to the 13-valent vaccine currently on the market for adults.
September 9, 2020 - Merck announced that two Phase 3 studies evaluating the safety, tolerability, and immunogenicity of V114, the investigational 15-valent pneumococcal conjugate vaccine, met their primary immunogenicity objectives. These findings and additional Phase 3 data from Merck's clinical program will be presented at a scientific congress in the future. In addition, they will form the basis of global regulatory licensure applications, beginning with the U.S. FDA before the end of 2020.
January 30, 2019 - Merch 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.
June 22, 2020 - Merck announced results from two initial Phase 3 studies evaluating the safety, tolerability, and immunogenicity of V114, the company's investigational 15-valent pneumococcal conjugate vaccine. The PNEU-WAY (V114-018) study in adults 18 years of age or older living with Human Immunodeficiency Virus (HIV) showed that V114 elicited immune response all 15 serotypes included in the vaccine, including serotypes 22F and 33F.
May 8, 2019 - Merch announced V114 Met Primary Endpoint by Demonstrating Noninferiority to PCV13 for all Shared Serotypes and an Immune Response for Two Additional Serotypes.
VAXNEUVANCE 15 Pneumococcal Vaccine Clinical Trials
Merck's V114 Pneumococcal Vaccine has undergone many clinical trials, and Merck continues to test the vaccine candidate under many different scenarios. The registered 28 clinical trials can be accessed here.