December 4, 2022

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EU approves Pfizer next-generation pneumococcal conjugate vaccine Apexxnar (PCV20) for adults over 18 years old!

EU approves Pfizer next-generation pneEU approves Pfizer next-generation pneumococcal conjugate vaccine Apexxnar (PCV20) for adults over 18 years old!



 

EU approves Pfizer next-generation pneumococcal conjugate vaccine Apexxnar (PCV20) for adults over 18 years old!

Pfizer announced today that the European Medicines Agency (EMA) has approved the 20-valent pneumococcal conjugate vaccine (PCV20) for active immunization of adults 18 years of age and older against 20 Streptococcus pneumoniae serotypes in the vaccine. Invasive disease and pneumonia caused.

In the United States, the vaccine was approved in June 2021.

 

PCV20, a next-generation pneumococcal conjugate vaccine, will be marketed under the brand name Apexxnar in the European Union (EU) and Prevnar 20 in the United States .

With a single injection, PCV20 will provide robust and meaningful protection in the adult population from the serotypes responsible for the majority of prevalent pneumococcal disease globally.

Notably, this is the first approval of a conjugate vaccine that protects against most invasive pneumococcal disease and pneumonia caused by 20 serotypes.

Prevnar 20/Apexxnar will help prevent more serotypes of pneumococcal disease than any other conjugate vaccine currently on the market.

The approval is based on data from Pfizer’s adult clinical program, which includes Phase 1 and 2 trials, and three Phase 3 trials (NCT03760146, NCT03828617, NCT03835975) evaluating the safety and immunogenicity of Prevnar 20 sex.

The Phase 3 trial enrolled more than 6,000 adult subjects 18 years of age and older, including older adults 65 years of age and older, as well as pneumococcal vaccinated and pneumococcal vaccinated adults.

“The EMA’s approval of Apexxnar for the adult population continues Pfizer’s ongoing commitment to help prevent some potentially serious infectious respiratory diseases, including invasive pneumococcal disease and pneumonia,” said Dr. Nanette Cocero, global president of Pfizer Vaccines. “Apexxnar Helping to prevent 20 serotypes in the vaccine, today’s approval provides the adult population with the broadest serotype protection of any pneumococcal conjugate vaccine available in Europe in a single dose.”

The success of mRNA vaccines ushered in a new era of vaccinology

 

Prevnar 20/Apexxnar includes 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) and 7 serotypes contained in Prevnar 13 (Prevnar 13) New serotypes (8, 10A, 11A, 12F, 15BC, 22F and 33F).

The seven new serotypes are all global causes of invasive pneumococcal disease, of which six (8, 10A, 11A, 15BC, 22F, and 33F) are associated with high mortality and four are associated with antibiotic 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 and older. Altogether, the 20 serotypes contained in Prevnar 20/Apexxnar are responsible for most of the pneumococcal disease currently circulating globally.

 

 

 

Reference:

European Medicines Agency Approves Pfizer’s 20-Valent Pneumococcal Conjugate Vaccine Against Invasive Pneumococcal Disease and Pneumonia in Adults

EU approves Pfizer next-generation pneumococcal conjugate vaccine

(source:internet, reference only)


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