CDC Recommends Routine Use of Pfizer’s PREVNAR 20™ in Adults for Broad Protection Against Pneumococcal Disease
Oct 21, 2021 15:34
CST Updated
15:34
Pfizer
Pharmaceutical R&D Developer
October 21, 2021 /BioonBIOON/ ---Pfizer(Pfizer) recently announced that the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) votedPrevnar 20 (20-valent pneumococcal conjugate vaccine, 20vPnC) is recommended for routine use to protect the adult population from invasive disease and pneumonia caused by the 20 pneumococcal serotypes contained in the vaccine.
Specifically, the ACIP voting recommendations are as follows: (1) Adults aged 65 years or older who have not previously received a pneumococcal conjugate vaccine or whose vaccination history is unknown should receive a pneumococcal conjugate vaccine (PCV20 or PCV15). If PCV15 is used, it should be followed by one dose of PPSV23.(2) Adults aged 19 years or older with certain underlying medical conditions or other risk factors who have not previously received a pneumococcal conjugate vaccine or whose vaccination history is unknown should receive a pneumococcal conjugate vaccine (PCV20 or PCV15). If PCV15 is used, it should be followed by a dose of PPSV23.
These recommendations will be submitted to the Director of the CDC and the U.S. Department of Health and Human Services for review, and upon approval, will be published in the *Morbidity and Mortality Weekly Report*. Notably,This will be the first time a pneumococcal conjugate vaccine is routinely recommended for specific at-risk populations aged 19 to 64 years, such asDiabetesand# AsthmaPatient.
In June this year, Prevnar 20 received U.S.FDAApproved for use in adults 18 years of age and older for the prevention of invasive disease and pneumonia caused by the pneumococcal serotypes contained in the vaccine.Through a single dose, Prevnar 20 will provide the adult population with robust and meaningful protection against the serotypes responsible for the majority of prevalent pneumococcal diseases worldwide.
Prevnar 20 was approved through the Priority Review program. In September 2018, the U.S. FDA granted Breakthrough Therapy Designation (BTD) to 20vPnC for the prevention of invasive disease and pneumonia in adults aged 18 years and older. In September 2017 and May 2019,FDAFast Track Designation (FTD) was granted for 20vPnC for adult and pediatric indications, respectively.
Notably,This marks the first approval of a conjugate vaccine that can prevent most invasive pneumococcal disease and pneumonia caused by 20 serotypes, seven of which account for 40% of pneumococcal disease cases and deaths in the United States. Compared with other conjugate vaccines currently on the market, Prevnar 20 will help prevent pneumococcal disease caused by more serotypes.
Streptococcus pneumoniae (S. pneumoniae, image source: paramedicsworld.com)
FDAThe approval of Prevnar 20 was based on data from Pfizer’s adult clinical program, which included Phase 1 and Phase 2 trials, as well as three Phase 3 trials (NCT03760146, NCT03828617, NCT03835975) evaluating the safety and immunogenicity of Prevnar 20. The Phase 3 trials enrolled more than 6,000 adult subjects aged 18 years and older, including adults aged 65 years and older, as well as both pneumococcal vaccine-experienced and pneumococcal vaccine-naïve adults.
Prevnar 20 includes the 13 serotypes contained in Prevnar 13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as well as 7 additional serotypes (8, 10A, 11A, 12F, 15BC, 22F, and 33F).
These seven new serotypes are all global causes of invasive pneumococcal disease, among which six (8, 10A, 11A, 15BC, 22F, and 33F) are associated with high case fatality rates, and four are associated withAntibioticsAssociated 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 among adults aged 70 years and older. In summary, the 20 serotypes contained in 20vPnC collectively account for the majority of pneumococcal diseases currently circulating in the United States and worldwide.
Prevnar 13 (Peier 13) is a blockbuster pneumococcal vaccine launched by Pfizer. In 2020, global sales of the vaccine reached $5.85 billion, remaining flat year-on-year.
Prevnar 13 (Pei'er 13) has been approved: (1) for adults aged ≥18 years, for the prevention of pneumococcal disease and invasive disease caused by 13 serotypes of Streptococcus pneumoniae; (2) for children aged 6 weeks through 17 years (prior to the 18th birthday), for the prevention of invasive disease caused by 13 serotypes of Streptococcus pneumoniae; (3) for children aged 6 weeks through 5 years (prior to the 6th birthday), for the prevention of ear infections caused by 7 of the 13 serotypes of Streptococcus pneumoniae.Prevnar 13 is not 100% effective and can only help prevent the 13 serotypes covered by the vaccine. (Bioon.com)