European Medicines Agency Approves Pfizer’s 20-Valent Pneumococcal Conjugate Vaccine Apexxnar (PCV20) for Adults Aged 18 and Older
Feb 16, 2022 01:52
CST Updated
01:52
Pfizer
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European Medicines Agency
The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.
Streptococcus pneumoniae (S. pneumoniae, image sourced from paramedicsworld.com)
News on February 15, 2022 /BioValleyBIOON/ --Pfizer(Pfizer) recently announced that the European Medicines Agency (EMA) has approved the 20-valent pneumococcal conjugate vaccine (PCV20): for active immunization in individuals aged 18 years and older to prevent invasive diseases and pneumonia caused by the 20 pneumococcal serotypes included in the vaccine. In the United States, this vaccine was approved in June 2021.
PCV20 is the next-generation pneumococcal conjugate vaccine, which will be marketed under the brand name Apexxnar in the European Union (EU) and Prevnar 20 in the United States.PCV20, with a single injection, will provide adults with strong and meaningful protection against the serotypes responsible for the majority of pneumococcal disease epidemics globally.
It is worth mentioning that,This is the first approval of a combination vaccine that can prevent most invasive pneumococcal diseases and pneumonia caused by 20 serotypes.Compared with other conjugate vaccines currently on the market, Prevnar 20/Apexxnar will help prevent more serotypes of pneumococcal disease.
This approval is based on data from Pfizer's adult clinical program, which includes Phase 1 and Phase 2 trials, as well as three Phase 3 trials (NCT03760146, NCT03828617, NCT03835975). These trials evaluated the safety and immunogenicity of Prevnar 20. The Phase 3 trials enrolled more than 6,000 adult participants aged 18 years and older, including elderly individuals aged 65 years and above, adults who had previously received a pneumococcal vaccine, and those who had not.
Dr. Nanette Cocero, Global President of Pfizer Vaccines, stated: "The EMA's approval of Apexxnar for adult populations continues Pfizer's commitment to helping prevent certain potentially serious infectious respiratory diseases, including invasive pneumococcal disease and pneumonia. Apexxnar helps protect against 20 serotypes in the vaccine, and today’s approval provides adults with the broadest serotype coverage available in a single dose among all pneumococcal conjugate vaccines currently accessible in Europe."
Prevnar 20/Apexxnar includes the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in Prevnar 13, as well as seven new serotypes (8, 10A, 11A, 12F, 15B/C, 22F, and 33F).
These seven new serotypes are all global causes of invasive pneumococcal disease, six of which (8, 10A, 11A, 15BC, 22F, and 33F) are associated with high mortality rates, and four are...AntibioticsAssociated with drug resistance (11A, 15BC, 22F, and 33F) and/or meningitis (10A, 15BC, 22F, and 33F).
Globally, pneumococcal pneumonia is estimated to cause approximately 500,000 deaths and 30 million infections annually in people aged 70 years and older. Overall, the 20 serotypes included in Prevnar 20/Apexxnar collectively account for the majority of pneumococcal disease currently prevalent worldwide. (Bioon.com)