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Recently, the FDA gave the green light to Pfizer's PREVNAR 20™, a pneumococcal 20-valent conjugate vaccine, and approved it for the prevention and treatment of invasive diseases and pneumonia caused by 20 pneumococcal serotypes in adults 18 years and older
.
Pfizer said in a recently approved statement that it is expected that the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practice (ACIP) will meet sometime in October to update the appropriate and safe use of PREVNAR 20 in adults.
Recommendations for cocci vaccines
.
In the United States, more than half of cases of invasive pneumococcal disease are caused by the 20 serotypes in PREVNAR 20 in adults 65 years of age or older
.
Nationwide, these serotypes have caused an estimated 250,000 cases of invasive pneumococcal disease and community-acquired pneumonia, and more than 10,000 deaths in people over 18 years of age
.
The other seven serotypes in the recently approved Pfizer vaccine also account for 40% of pneumococcal disease cases and deaths in the United States
.
The FDA’s new approval is based on data from Pfizer’s Phase I and Phase II trials and three Phase III research trials (NCT03760146, NCT03828617, and NCT03835975)
.
These early and late trials demonstrated the safety and immunogenicity of the vaccine in adult participants
.
Three phase III trials included more than 6,000 adults 18 years and older
.
Participants include people 65 years of age and older, adults who have not received similar vaccines, and adults who have previously received pneumococcal vaccines
.
"Today's approval of PREVNAR 20 marks an important step forward in our ongoing struggle to help address the burden of pneumococcal disease, including adult pneumonia, and expands the number of pathogenic serotypes globally compared to any other pneumococcal conjugate vaccine.
Protection,” said Dr.
Kathrin U.
Jansen, Pfizer’s senior vice president and head of vaccine development, in a statement
.
.
Pfizer said in a recently approved statement that it is expected that the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practice (ACIP) will meet sometime in October to update the appropriate and safe use of PREVNAR 20 in adults.
Recommendations for cocci vaccines
.
In the United States, more than half of cases of invasive pneumococcal disease are caused by the 20 serotypes in PREVNAR 20 in adults 65 years of age or older
.
Nationwide, these serotypes have caused an estimated 250,000 cases of invasive pneumococcal disease and community-acquired pneumonia, and more than 10,000 deaths in people over 18 years of age
.
The other seven serotypes in the recently approved Pfizer vaccine also account for 40% of pneumococcal disease cases and deaths in the United States
.
The FDA’s new approval is based on data from Pfizer’s Phase I and Phase II trials and three Phase III research trials (NCT03760146, NCT03828617, and NCT03835975)
.
These early and late trials demonstrated the safety and immunogenicity of the vaccine in adult participants
.
Three phase III trials included more than 6,000 adults 18 years and older
.
Participants include people 65 years of age and older, adults who have not received similar vaccines, and adults who have previously received pneumococcal vaccines
.
"Today's approval of PREVNAR 20 marks an important step forward in our ongoing struggle to help address the burden of pneumococcal disease, including adult pneumonia, and expands the number of pathogenic serotypes globally compared to any other pneumococcal conjugate vaccine.
Protection,” said Dr.
Kathrin U.
Jansen, Pfizer’s senior vice president and head of vaccine development, in a statement
.
