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ACIP Votes to Recommend Routine Use of PREVNAR 20

  • One dose of PREVNAR 20 is recommended by ACIP for adults ages 65 and older and adults ages 19 to 64 with certain risk conditions.
  • New PREVNAR 20 one-dose guidance helps simplify long-standing adult pneumococcal recommendations.

Pfizer Inc. announced today that the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for routine use to help protect adults against invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine. Specifically, the ACIP voted to recommend the following:

Adults 65 years of age or older who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown should receive a pneumococcal conjugate vaccine (either PCV20 or PCV15). If PCV15 is used, this should be followed by a dose of PPSV23.
Adults aged 19 years of age or older with certain underlying medical conditions or other risk factors who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown should receive a pneumococcal conjugate vaccine (either PCV20 or PCV15). If PCV15 is used, this should be followed by a dose of PPSV23.
The recommendations will be forwarded to the director of the CDC and the U.S. Department of Health and Human Services for review and following approval, the recommendations are published in the Morbidity and Mortality Weekly Report. This will represent the first-time any pneumococcal conjugate vaccine has been routinely recommended for certain risk populations ages 19 to 64 years, such as people with diabetes and asthma.

“A single dose of PREVNAR 20 helps protect adults against vaccine-type pneumococcal pneumonia and invasive pneumococcal disease during a period where their risk is gradually increasing due to aging among other factors. Today’s vote acknowledges the important role of adult immunizations in helping protect eligible populations against certain potentially serious respiratory diseases during the current pandemic and beyond,” said Luis Jodar, Ph.D., Senior Vice President and Chief Medical Officer, Pfizer Vaccines. “The ACIP recommendation recognizes the significance as well of helping protect more populations under age 65 with co-morbid and immunocompromising conditions who are at increased risk of disease against these 20 disease-causing serotypes.”

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The seven additional serotypes in PREVNAR 20 represent 30 percent of overall of invasive pneumococcal disease burden in U.S. adults.2 Pneumococcal pneumonia results in more than 180,000 adult hospital admissions and more than 150,000 adult outpatient visits in the U.S. each year.

“The new simplified ACIP recommendation may offer the opportunity to improve immunization rates and therefore help prevent more disease,” said Nanette Cocero, Ph.D., Global President, Pfizer Vaccines. “We believe that as U.S. health care professionals start implementing this ACIP recommendation, once endorsed by the CDC Director, PREVNAR 20 recommended as a single dose has the potential to provide an important public health benefit for adults. Building on Pfizer’s more than 20-year legacy of developing and supplying pneumococcal conjugate vaccines, we remain committed to working with the healthcare and public health communities to raise awareness of the importance of adult immunization and encourage recommended individuals to get vaccinated.”

About PREVNAR 20
PREVNAR 20 is a next-generation pneumococcal conjugate vaccine that includes capsular polysaccharide conjugates for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) already included in Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM Protein]). The vaccine also contains capsular polysaccharide conjugates for seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F) that cause invasive pneumococcal disease (IPD), and have been associated with high case-fatality rates, antibiotic resistance, and/or meningitis. PREVNAR 20 contains the broadest serotype coverage of any conjugate vaccine available; and helps protect against more strains of the bacteria that cause pneumococcal pneumonia than any conjugate vaccine available.

On June 8, 2021, Pfizer announced the U.S. Food and Drug Administration (FDA) approved PREVNAR 20 for the prevention of invasive disease and pneumonia in adults age 18 years or older. On February 26, 2021, the European Medicines Agency (EMA) accepted for review Pfizer’s Marketing Authorization Application (MAA) for the 20-valent pneumococcal conjugate vaccine candidate, as submitted for the prevention of invasive disease and pneumonia caused by S. pneumoniae serotypes in the vaccine in adults ages 18 years and older. The formal review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP) currently is ongoing.

INDICATIONS FOR PREVNAR 20

  • PREVNAR 20 is a vaccine indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and older
  • This indication for the prevention of pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA) assay. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

U.S. IMPORTANT SAFETY INFORMATION

  • PREVNAR 20 should not be given to anyone with a history of severe allergic reaction to any component of PREVNAR 20 or any diphtheria toxoid–containing vaccine
  • Some adults with weakened immune systems may have a lower response to PREVNAR 20. Safety data are not available for these groups. Your healthcare provider can tell you if PREVNAR 20 is right for you
  • In adults 18 years of age and older, the most common side effects were pain at the injection site, muscle pain, fatigue, and headache
  • Ask your healthcare provider about the risks and benefits of PREVNAR 20. Only a healthcare provider can decide if PREVNAR 20 is right for you

Source: Pfizer
Date: Oct 20, 2021


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