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▎Pfizer, the editor of WuXi AppTec's content team, recently announced that the US FDA has approved the listing of Prevnar 20 (pneumococcal 20-valent conjugate vaccine) for the prevention of 20 pneumococcal serotypes in the vaccine in adults 18 years and older Caused by aggressive disease and pneumonia
.
In the United States, more than half of invasive pneumococcal disease (IPD) cases (including bacteremia and meningitis) in adults over 65 are caused by the 20 serotypes in Prevnar 20
.
They are estimated to cause as many as 250,000 cases of IPD and community-acquired pneumonia and more than 10,000 deaths among adults 18 years of age or older
.
The seven new serotypes in the Prevnar 20 vaccine cause 40% of pneumococcal disease cases and deaths in the United States
.
The US FDA's decision is based on evidence from Pfizer's clinical programs in adults, including phase 1 and phase 2 clinical trials, and 3 phase 3 clinical trials evaluating the safety and immunogenicity of the vaccine
.
More than 6000 adult subjects 18 years and older participated in three phase 3 trials, including adults 65 years and older, unvaccinated adults, and adults who had previously been vaccinated against pneumococcal vaccine
.
Previously, in September 2017, the U.
S.
FDA granted Prevnar 20 fast track designation; in September 2018, the U.
S.
FDA granted Prevnar 20 breakthrough therapy designation for the prevention of aggressive diseases and pneumonia in adults 18 years of age or older
.
Dr.
Kathrin U.
Jansen, Pfizer’s senior vice president and head of vaccine development, said that the approval of Prevnar 20 marks an important step forward for the company in helping to solve the burden of pneumococcal disease.
.
With a single injection, Prevnar 20 provides adults with strong protection against the serotype that causes most of the world's epidemic pneumococcal diseases
.
Image source: 123RFPrevnar 20 contains 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and The capsular polysaccharide conjugate of 23F) also contains capsular polysaccharide conjugates of the other 7 serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F) that cause IPD, which are associated with high mortality and antibiotic resistance Sexual and/or meningitis related
.
Important safety information: People with a history of severe allergic reactions to any component of Prevnar 20 or diphtheria toxoids should not give Prevnar 20; adults with weakened immune systems may have a lower response to Prevnar 20; adults 18 years and older Among them, the most common side effects are pain at the injection site, muscle pain, fatigue, headache, and joint pain.
In addition, swelling at the injection site is also common in adults aged 18-59
.
References: [1] US FDA Approves PREVNAR 20™, Pfizer's Pneumococcal 20-valent Conjugate Vaccine for Adults Ages 18 Years or Older.
Retrieved 2021-06-09, from https:// 20210608006149/en Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation
.
If you need guidance on the treatment plan, please go to a regular hospital for treatment
.