Advisory Committee on Immunization Practices Recommends PREVNAR 20® (20-valent Pneumococcal Conjugate Vaccine) in Infants and Children

NEW YORK, N.Y., June 22, 2023 - Pfizer Inc. (NYSE: PFE) announced today that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) unanimously voted to recommend PREVNAR 20^® (20-valent Pneumococcal Conjugate Vaccine) for routine use to help protect infants and children from invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae serotypes covered by the vaccine and for the prevention of otitis media in infants six weeks through five years of age caused by the original seven serotypes contained in PREVNAR^®.

The committee’s recommendations for PREVNAR 20 included:

• Routine vaccination for all children under two years of age with a four-dose series at 2, 4, 6, and 12-15 months
• Vaccination for eligible children aged 2-18 years with certain underlying medical conditions that increase their risk for pneumococcal disease 
• A catch-up dose for children with an incomplete PCV vaccination status for:
  • healthy children aged 24-59 months 
  • children aged 24-71 months with certain underlying medical conditions that increase their risk for pneumococcal disease  

These provisional recommendations will be reviewed and finalized by the director of the CDC and the Department of Health and Human Services. Following this, Pfizer intends to work with appropriate organizations to help ensure PREVNAR 20 is widely available to help protect the pediatric population.

“We are thrilled with today’s ACIP decision as it recognizes the increased level of protection that PREVNAR 20 will provide to millions of infants and children against pneumococcal disease,” said  Luis Jodar, PhD, Chief Medical Affairs Officer, Vaccines/Antivirals and Evidence Generation, Pfizer. “This decision represents a significant step in improving public health and allows pediatricians and other clinicians to offer the broadest serotype pneumococcal conjugate vaccine available to help protect infants and their families from life threatening infections caused by the 20 serotypes covered by the vaccine.”

On June 22, ACIP also reviewed Evidence to Recommendations (EtR), including cost-effectiveness for Pfizer’s bivalent RSV prefusion vaccine candidate, RSVpreF or PF-06928316, when administered to pregnant women to help protect infants from RSV disease through maternal immunization. On June 23, ACIP will review Pfizer’s pentavalent meningococcal vaccine candidate (MenABCWY) when administered to individuals 10 through 25 years of age.

ABOUT PREVNAR 20 REGULATORY REVIEW
In April 2023, the FDA granted approval of PREVNAR 20 (20-valent Pneumococcal Conjugate Vaccine) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae (pneumococcal) serotypes covered by the vaccine in infants and children six weeks through 17 years of age, and for the prevention of otitis media in infants six weeks through five years of age caused by the original seven serotype conjugates contained in PREVNAR.

In August 2022, Pfizer announced positive top-line results from its pivotal Phase 3 study in U.S. infants (NCT04382326) and, in January 2023, the U.S. FDA accepted for priority review a supplemental Biologics License Application (sBLA) for PREVNAR 20 for the prevention of IPD for the pediatric indication.
Additional positive top-line results from Pfizer’s Phase 3 study (NCT04546425) in infants in the European Union were announced in September 2022. In November 2022, Pfizer submitted the 20-valent pneumococcal conjugate vaccine candidate pediatric indication to the European Medicines Agency (EMA).

INDICATIONS FOR PREVNAR 20
PREVNAR 20 is a vaccine approved 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.

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.
• 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.
• Ask your doctor about the risks and benefits of PREVNAR 20. Only a doctor can decide if PREVNAR 20 is right for your child.

View the full Prescribing Information.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

DISCLOSURE NOTICE:

The information contained in this release is as of June 22, 2023. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about PREVNAR 20®, including its potential benefits,  a vote by ACIP to recommend PREVNAR 20 for routine use to help protect infants and children from invasive pneumococcal disease caused by the 20 Streptococcus pneumoniae serotypes covered by the vaccine and for the prevention of otitis media in infants six weeks through five years of age caused by the original seven serotypes contained in PREVNAR®, and an application submitted to the EMA for a pediatric indication; and certain of Pfizer’s other vaccine candidates that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of PREVNAR 20 and Pfizer’s other vaccines; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any biologics license applications may be filed in any other jurisdictions for PREVNAR 20 for the prevention of invasive disease and pneumonia in infants and children six weeks through seventeen years of age and in any jurisdictions for any other potential indications or for any of Pfizer’s other vaccines or vaccine candidates; whether and when the application pending in the EU for the 20-valent pneumococcal conjugate vaccine candidate pediatric indication may be approved and whether and when any such other applications that may be pending or filed for PREVNAR 20 or any other vaccines or vaccine candidates may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether PREVNAR 20 or any such other vaccines will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of PREVNAR 20 or any such other vaccines; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities regarding PREVNAR 20 or any such other vaccines and uncertainties regarding the commercial impact of any such recommendations; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.
 

Media Contact: 
 
[email protected] 
+1 (212) 733-1226  

Investor Contact:

[email protected] 
+1 (212) 733-4848