Pfizer Inc. (NYSE: PFE) announced today that the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practice (ACIP) voted to expand its recommendation for the use of certain pneumococcal vaccines, including PREVNAR 20 ® (20-valent Pneumococcal Conjugate Vaccine) for all adults aged 50 and older. This recommendation is pending final approval by the director of the CDC and the Department of Health and Human Services. With respect to PREVNAR 20, ACIP recommended:
- Vaccination is recommended for all adults aged ≥50 years and for adults aged 19-49 years with certain underlying conditions or risk factors who have not received a PCV or whose vaccination history is unknown.
"ACIP's vote to expand adult pneumococcal vaccination to now include all adults aged 50 and older marks an important milestone in Pfizer's long-standing commitment to reducing the burden of this life-threatening disease," said Luis Jodar, PhD, Senior Vice President, Vaccines and Anti-Infectives Chief Medical Affairs Officers, Pfizer. "PREVNAR 20 offers protection against the serotypes responsible for the majority of invasive pneumococcal disease cases in this age group. Expanding its use also provides an opportunity to limit the re-emergence of disease-causing strains like serotype 4, which has recently affected certain U.S. adult populations and is covered by the vaccine."
In the U.S., the 20 serotypes contained in PREVNAR 20 are estimated to cause over 2,000 deaths and more than 65,000 cases of invasive pneumococcal disease (IPD), including bacteremia and meningitis, and community-acquired pneumonia annually in adults aged 50 to 64. 2 Between 2018 and 2022, more than half of IPD cases in people aged 50 to 64 were caused by these 20 serotypes. 3 Vaccination with PREVNAR 20 helps prevent serotype 4 disease, which incidence has been rising in certain populations in the western U.S. 4
About PREVNAR 20 ®
PREVNAR 20 ® is Pfizer's 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 CRM197 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), 5,6,7,8,9 and have been associated with high case-fatality rates, 10,11,12,13 antibiotic resistance, 14,15,16 and/or meningitis. 17,18 PREVNAR 20 helps protect against disease caused by the 20 Streptococcus pneumoniae serotypes in the vaccine.
On June 8, 2021, Pfizer announced the U.S. Food and Drug Administration (FDA) approved PREVNAR 20 for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults aged 18 years or older. On September 30, 2022, the FDA approved the addition of information in the PREVNAR 20 prescribing information regarding coadministration with an influenza vaccine, adjuvanted (Fluad Quadrivalent 19 ), in adults aged 65 years or older.
INDICATIONS FOR PREVNAR 20
PREVNAR 20 ® is a vaccine indicated for:
- the prevention of invasive disease caused by 20 Streptococcus pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F) in individuals 6 weeks and older.
- the prevention of otitis media (middle ear infection) caused by 7 of the 20 strains in individuals 6 weeks through 5 years.
- active immunization for the prevention of pneumonia caused by Streptococcus pneumoniae strains 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 18 years of age and older.
- The indication of PREVNAR 20 for the prevention of pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F in individuals 18 years of age and older is approved based on immune responses. Continued approval may depend on a supportive study
IMPORTANT SAFETY INFORMATION FOR PREVNAR 20
- PREVNAR 20 ® should not be given to anyone who has had a severe allergic reaction to any component of PREVNAR 20 or to diphtheria-toxoid-containing vaccine.
- Individuals with weakened immune systems may have a lower immune response. Safety data are not available for these groups.
- A temporary pause in breathing after getting the vaccine has been observed in some infants who were born prematurely. For premature infants, talk to your doctor about the infant's medical status when deciding to get vaccinated with PREVNAR 20.
- In individuals 2, 4, 6, and 12 through 15 months of age vaccinated with a 4-dose schedule, the most common side effects reported at a rate of >10% were irritability, pain at the injection site, drowsiness, decreased appetite and injection site redness, injection site swelling, and fever.
- In individuals 15 months through 17 years of age vaccinated with a single dose, the most common side effects reported at a rate of >10% were irritability, pain at the injection site, drowsiness, fatigue and muscle pain, decreased appetite, injection site swelling and injection site redness, headache, and fever.
- In individuals 18 years and older, the most common side effects reported at a rate of >10% were pain at the injection site, muscle pain, fatigue, headache, and joint pain. Also, injection site swelling was common in individuals 18 years through 59 years of age.
- Ask your doctor about the risks and benefits of PREVNAR 20. Only a doctor can decide if PREVNAR 20 is right for you or your child.
View the full Prescribing Information.
