Sinovac PPV23 Pneumococcal Vaccine Description
Sinovac's PPV23 Vaccine consists of 23 pneumococcal serotypes that are most frequently found in China. It was authorized in China in January 2021.
The new PPV23 vaccine is immunologically non-inferior to the control commercial vaccine and well-tolerated in a healthy Chinese population aged ≥ 2 years.
Sinovac started to research and develop the 23-valent pneumococcal polysaccharide vaccine in 2009, completed pre-clinical studies in 2011, and was approved to conduct human clinical trials in May 2014. A phase III non-inferiority study conducted in 2015 demonstrated a good safety and immunogenicity profile, and non-inferiority of immunogenicity of all 23 serotypes was observed, which was published in the Human Vaccines and Immunotherapeutics medical journal.
Mr. Weidong Yin, Chairman, President, and CEO of Sinovac issued a comment on January 9, 2021, “The approval of our pneumococcal vaccine allows us to provide another high-quality product to address unmet medical needs for the Chinese population. This is our first bacterial vaccine product approved so far, broadening the potential of the company’s product portfolio.”
Streptococcus pneumoniae (S. pneumoniae) is a major cause of illness and death in children and adults worldwide, causing invasive pneumococcal diseases (IPDs) including bacteremic pneumonia, meningitis, and septicemia; or noninvasive diseases including non-bacteremic pneumonia, otitis media, and sinusitis. 91 distinct pneumococcal serotypes have been identified, and infection or vaccination with S. pneumoniae can induce specific protective antibodies that exhibit cross-protection against certain serotypes, says the U.S. CDC.
As of 2019, 152 countries have fully or partially introduced routine PCV immunization of infants, while 42 countries have not yet introduced PCV, stated the WHO.
Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacturing, and commercialization of vaccines that protect against human infectious diseases.
Sinovac PPV23 Pneumococcal Vaccine Indication
Sinovac's 23-Valent Pneumococcal Polysaccharide (“PPV”) Vaccine is indicated to prevent the infection by streptococcus pneumonia in adults and children ages 2 years old and above.
There are at least 94 serologically distinct pneumococcal serotypes that have been identified. The distribution of these serotypes varies significantly between countries and populations. In Europe, the most frequent serotypes are 1, 3, 7F, 14 and 19A,4,5 while in China, 19F, 23F, 19A, 6B, 14, 6A and 15B are most frequent.
Sinovac PPV23 Pneumococcal Vaccine News
January 9, 2021 - Sinovac announced that the China National Medical Products Administration has approved and issued a Product license for the Company’s 23-Valent Pneumococcal Polysaccharide Vaccine to prevent the infection by streptococcus pneumonia in adults and children ages 2 years old and above.
December 9, 2020 - Sinovac Announces Product License for 23-Valent Pneumococcal Polysaccharide Vaccine. Mr. Weidong Yin, Chairman, President, and CEO of Sinovac, commented, “The approval of our pneumococcal vaccine allows us to provide another high-quality product to address unmet medical needs for the Chinese population. This is our first bacterial vaccine product approved so far, broadening the potential of the company’s product portfolio.”
September 21, 2018 - Research paper: A phase III clinical trial to evaluate the safety and immunogenicity of 23-valent pneumococcal polysaccharide vaccine (PPV23) in healthy children, adults, and elderly. The newly Sinovac PPV23 is immunologically non-inferior to the control commercial vaccine and well-tolerated in a healthy Chinese population aged ≥ 2 years. Antibody persistence and efficacy studies are needed to guide the vaccine application further.
April 30, 2018 - Sinovac Biotech Ltd. announced it had been forced to destroy the bacterial seeds intended for use in the production of its 23-valent pneumococcal polysaccharide vaccine, or PPV, and to suspend all preparations for and ultimately postpone the China Food and Drug Administration inspection of the manufacturing site necessary for 23-valent PPV production approval.
September 16, 2015 - Immunogenicity and safety of a 23-valent pneumococcal polysaccharide vaccine in Chinese healthy population aged >2 years: A randomized, double-blinded, active control, phase III trial.
March 3, 2011 - Sinovac announced it applied to commence clinical trials for its 13-valent pneumococcal conjugate vaccine to China's State Food and Drug Administration on March 3, 2011. Sinovac initiated its PCV research program in 2008. The vaccine targets infants under two years old in China and is estimated at 34 million.
Sinovac PPV23 Pneumococcal Vaccine Clinical Trials
Clinical Trial NCT02451969: Safety and Immunogenicity Study of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Children, Adults, and Elderly - Last Update Posted: May 3, 2017.
This phase 3 study is a randomized, double-blind, single-center, controlled clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of an investigational 23-valent pneumococcal polysaccharide vaccine (PPV) manufactured by Sinovac Biotech Co., Ltd.
This study's primary objective is to demonstrate that the investigational vaccine's immunogenicity is non-inferior to that of a commercialized 23-valent PPV manufactured by Chengdu Institute of Biological Products Co., Ltd; the secondary objective is to assess the safety of the investigational and control vaccines.
Participants will be grouped into three cohorts by age: child cohort (2 - 17 years old), adult cohort (18 - 60 years old), and elderly cohort (≥ 61 years old). In each cohort, the participants will be randomly assigned to the experimental group or control group in the ratio of 1:1.
Human Vaccines and Immunotherapeutics published the results on September 21, 2018.
The newly Sinovac PPV23 is immunologically non-inferior to the control commercial vaccine and well-tolerated in a healthy Chinese population aged ≥ 2 years. The antibody persistence and efficacy studies are needed to further provide guidance for the vaccine application.