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FDA priority review: 15-valent pneumonia vaccine V114 for adults 18 years and older
FDA priority review: 15-valent pneumonia vaccine V114. This vaccine is used in adults aged 18 and over to prevent invasive pneumococcal disease.
Merck & Co recently announced that the U.S. Food and Drug Administration (FDA) has accepted the 15-valent pneumococcal conjugate vaccine V114 (15-valent) biological product license application (BLA) and granted priority review, the vaccine is used for 18 For adults aged and above, prevent invasive pneumococcal disease.
The FDA has designated the Prescription Drug User Fees Act (PDUFA) target date as July 18, 2021.
In November 2020, Merck simultaneously submitted a V114 regulatory application to the US FDA and the European Medicines Agency (EMA). Currently, EMA is also reviewing the V114 license application.
V114 is a 15-valent vaccine under development. It is composed of pneumococcal polysaccharides from 15 serotypes combined with CRM197 carrier protein, including 22F and 33F serotypes. These two serotypes are usually associated with invasive pneumococcal bacteria worldwide. The disease is related, but not included in the pneumococcal conjugate vaccine currently approved for use in adults.
Currently, V114 is in phase III clinical development for the prevention of pneumococcal disease in adults and children. In January 2019, the U.S. FDA has granted V114 Breakthrough Drug Designation (BTD) for the prevention of invasive pneumococcal disease (IPD) caused by vaccine serotypes in infants and adolescents from 6 weeks to 18 years old.
The V114 regulatory application documents include the results of phase 2 and phase 3 clinical studies conducted on various adult groups, including healthy adults and high-risk groups, such as adults with chronic diseases, HIV-infected people, and people over 65 years of age. crowd. In these studies, V114 reached the main immunogenicity goal, and produced a strong immune response to all 15 serotypes covered by the vaccine (including the unique 22F and 33F serotypes of V114). Other studies included in the BLA support the potential applications of V114 in a variety of actual clinical settings, including combined application with quadrivalent influenza vaccines and as part of sequential applications with PNEUMOVAX 23, and have demonstrated that V114 has comparable performance in consecutive batches.
There are more than 90 different types of pneumococcal bacteria, and their effects on adults are different from children. Pneumococcal serotypes (such as 22F and 33F) that are not included in the currently marketed conjugate vaccines are usually associated with invasive pneumococcal diseases worldwide. At present, 13% of invasive pneumococcal diseases in adults aged 65 and over in the United States are caused by serotypes 22F and 33F. In Europe, adult pneumococcal diseases caused by these two serotypes account for 7%-12%.
In addition, serotype 3 remains one of the main causes of invasive pneumococcal disease in adults and children, although it has been included in currently available pneumococcal vaccines. In the United States, 15% of invasive pneumococcal disease among adults aged 65 years and older is still caused by serotype 3; this proportion accounts for 12%-18% of adults in European countries.
The Phase III clinical development project of V114 consists of 16 clinical trials, which studied the safety of V1114 in different groups of people (including healthy elderly people, healthy children, people with impaired immune function, and people with certain chronic diseases). Tolerability and immunogenicity.
(source:internet, reference only)