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Pfizer Receives Positive CHMP Opinion for its 20-Valent Pneumococcal Conjugate Vaccine (20vPnC) Candidate for Infants and Children

Friday, January 26, 2024 - 08:30am
  • 20vPnC offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine (PCV), helping to protect infants and children against all 20 serotypes contained in the vaccine
  • Together, the 20 serotypes included in 20vPnC are responsible for the majority of currently circulating pneumococcal disease in the EU and globally 1,2,3,4,5,6,7,8 
  • The vaccine candidate builds on PREVENAR 13® and includes seven additional serotypes that are global causes of invasive pneumococcal disease (IPD) and are associated with high case-fatality rates, antibiotic resistance and meningitis 9

NEW YORK, January 26, 2024 – Pfizer Inc. (NYSE: PFE) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for its 20-valent pneumococcal conjugate vaccine candidate (20vPnC) for active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age.

“Pfizer has a longstanding history of developing groundbreaking pneumococcal conjugate vaccines to help protect infants and their families from life-threatening infections,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. “Today’s CHMP positive opinion represents a significant step forward in our continued efforts and, if approved, 20vPnC has the potential to cover more disease burden than any other available pediatric pneumococcal conjugate vaccine in the EU.”

The CHMP’s positive opinion will now be reviewed by the European Commission (EC) to decide whether to approve the vaccine. This decision is expected in the coming weeks and will apply to all 27 EU member states plus Iceland, Liechtenstein, and Norway.

The CHMP issued its positive opinion based on evidence from Pfizer’s Phase 3 clinical trial program for the pediatric indication for 20vPnC.

About the 20vPnC Phase 3 Pediatric Program

In 2020, Pfizer initiated a Phase 3 clinical trial program for the pediatric indication for 20vPnC, comprised of four core Phase 3 pediatric studies which helped expand the data on the safety, tolerability, and immunogenicity of 20vPnC. These studies, which collectively enrolled approximately 4,700 infants and 800 toddlers and children of all ages, included:

  • A Phase 3 study describing the tolerability and safety and comparing immunogenicity of 20vPnC to PREVENAR 13® in infant vaccination at approximately 2, 4, and 11-12 months of age in Europe and Australia (NCT04546425)
  • A Phase 3 study describing the tolerability and safety and comparing immunogenicity of 20vPnC to PREVENAR 13 in infants vaccinated at 2, 4, 6, and 12-15 months of age in the U.S. (NCT04382326)
    A Phase 3 study describing the tolerability and safety of 20vPnC compared with PREVENAR 13® in infants vaccinated at 2, 4, 6, and 12-15 months of age in multiple countries. (NCT04379713)
  • A Phase 3 study in children 15 months through <18 years of age receiving a single dose of 20vPnC in the U.S. (NCT04642079).

About 20vPnC

Pfizer’s 20vPnC pediatric vaccine candidate includes 13 serotypes already included in PREVENAR 13® – 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. The seven new serotypes included in 20vPnC – 8, 10A, 11A, 12F, 15B, 22F, and 33F – are global causes of invasive pneumococcal disease (IPD), and are associated with high case-fatality rates, antibiotic resistance, and/or meningitis.9 Together, the 20 serotypes included in 20vPnC are responsible for the majority of currently circulating pneumococcal disease in the EU and globally.1,2,3,4,5,6,7,8

In February 2022, the European Commission Decision was adopted for APEXXNAR® (20vPnC) for the prevention of invasive disease and pneumonia caused by the 20 S. pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older.

In April 2023, the United States Food and Drug Administration (FDA) approved PREVNAR 20® (20-valent Pneumococcal Conjugate Vaccine) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 S. pneumoniae (pneumococcal) serotypes contained in 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 serotypes contained in PREVNAR®. 

EU INDICATION FOR PREVENAR 13®

  • Active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to 17 years of age.
  • Active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in adults ≥18 years of age and the elderly.
  • The use of PREVENAR 13® should be determined on the basis of official recommendations taking into consideration the risk of invasive disease and pneumonia in different age groups, underlying comorbidities as well as the variability of serotype epidemiology in different geographical areas.

US INDICATION FOR PREVNAR 13®

  • PREVNAR 13® is a vaccine approved for children 6 weeks through 17 years of age for the prevention of invasive disease caused by 13 Streptococcus pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), and for children 6 weeks through 5 years for the prevention of otitis media caused by 7 of the 13 strains.
  • PREVNAR 13 is not 100% effective and will only help protect against the 13 strains included in the vaccine.

IMPORTANT SAFETY INFORMATION FOR PREVNAR 13®

  • PREVENAR 13®/PREVNAR 13® should not be given to anyone with a history of severe allergic reaction to any component of PREVENAR 13/PREVNAR 13 or any diphtheria toxoid–containing vaccine
    Children and adults with weakened immune systems (e.g., HIV infection, leukemia) may have a reduced immune response
  • A temporary pause of breathing following vaccination has been observed in some infants born prematurely
  • The most commonly reported serious adverse events in infants and toddlers were bronchiolitis (an infection of the lungs) (0.9%), gastroenteritis (inflammation of the stomach and small intestine) (0.9%), and pneumonia (0.9%)
  • In children 6 weeks through 17 years, the most common side effects were tenderness, redness, or swelling at the injection site, irritability, decreased appetite, decreased or increased sleep, and fever. Most commonly reported side effects in children 5 years through 17 years also included hives
  • In adults, the most common side effects were pain, redness, and swelling at the injection site, limitation of arm movement, fatigue, headache, muscle pain, joint pain, decreased appetite, chills or rash
  • Ask your healthcare provider about the risks and benefits of PREVENAR 13/PREVNAR 13. Only a healthcare provider can decide if PREVENAR 13/PREVNAR 13 is right for you or your child

US 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-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.
  • 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.

EU INDICATION FOR APEXXNAR®

  • Active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. APEXXNAR® should be used in accordance with official recommendations.

IMPORTANT SAFETY INFORMATION

  • APEXXNAR® should not be given to anyone with a history of severe allergic reaction to any component of APEXXNAR or to diphtheria toxoid
  • Adults with weakened immune systems may have a lower response to APEXXNAR. Safety data are not available for these groups. Your healthcare provider can tell you if APEXXNAR 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, headache, and joint pain. Additionally, injection site swelling was also common in adults 18 through 49 years of age
  • Ask your healthcare provider about the risks and benefits of APEXXNAR. Only a healthcare provider can decide if APEXXNAR is right for you

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 January 25, 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 Pfizer’s 20-valent Pneumococcal Conjugate Vaccine including its potential benefits, and an application pending with the European Commission for a pediatric indication, 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 Pfizer’s 20-valent Pneumococcal Conjugate Vaccine; 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 particular jurisdictions for Pfizer’s 20-valent Pneumococcal Conjugate Vaccine for any potential indications; whether and when the application pending in the EU may be approved and whether and when any such other applications that may be pending or filed 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 Pfizer’s 20-valent Pneumococcal Conjugate Vaccine 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 Pfizer’s 20-valent Pneumococcal Conjugate Vaccine; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities regarding Pfizer’s 20-valent Pneumococcal Conjugate Vaccine and uncertainties regarding the commercial impact of any such recommendations; uncertainties regarding the impact of COVID-19 on our 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.

 

References

1Active Bacterial Core (ABCs) surveillance. National Center for Immunization and Respiratory Diseases. Atlanta, GA. CDC. Published March 2020. Updated May 22, 2020. Accessed January 19, 2024. Available at: https://www.cdc.gov/abcs/reports-findings/survreports/spneu18.pdf.
2 Ladhani, SN, Collins S, Djennad A, et al. Rapid increase in non-vaccine serotypes causing invasive pneumococcal disease in England and Wales, 2000-17: a prospective national observational cohort study [published correction appears in Lancet Infect Dis. 2018 Feb 6;:]. Lancet Infect Dis. 2018;18(4):441-451. doi:10.1016/S1473-3099(18)30052-5
3 Menéndez R, España PP, Pérez-Trallero E, et al. The burden of PCV13 serotypes in hospitalized pneumococcal pneumonia in Spain using a novel urinary antigen detection test. CAPA study. Vaccine. 2017;35(39):5264-5270. doi:10.1016/j.vaccine.2017.08.007
4 Azzari C, Cortimiglia M, Nieddu F, et al. Pneumococcal serotype distribution in adults with invasive disease and in carrier children in Italy: Should we expect herd protection of adults through infants’ vaccination?. Hum Vaccin Immunother. 2016;12(2):344-350. doi:10.1080/21645515.2015.1102811 
5 Pivlishi T. Impact of PCV13 on invasive pneumococcal disease (IPD) burden and the serotype distribution in the U.S. CDC. ACIP. Published October 24, 2018. Accessed January 19, 2024. Available at: https://stacks.cdc.gov/view/cdc/61449.
6 Invasive pneumococcal disease. In: ECDC. Annual epidemiological report for 2016. ECDC. Published August 8, 2018. Accessed January 19, 2024. Available at: https://www.ecdc.europa.eu/sites/default/files/documents/AER_for_2016-invasive-pneumococcal-disease_0.pdf.
7 Beall B, Chochua S, Gertz RE Jr, et al. A population-based descriptive atlas of invasive pneumococcal strains recovered within the US during 2015-2016. Published November 2018. Accessed January 19, 2024. Available at: https://pubmed.ncbi.nlm.nih.gov/30524382/.&nbsp;
8 Grant L, Suaya J, Pugh S, et. al. Coverage of the 20-Valent Conjugate Vaccine Against Invasive Pneumococcal Disease By Age Group in the United States, 2017. Abstract No. ISP20-237. 
9 Senders, S., et al. (2021, October 1). Safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in healthy infants in the United States. The Pediatric Infectious Disease Journal. Published September 13, 2021. Accessed January 19, 2024. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8443440/.

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