Pfizer today announced positive top-line results from its pivotal E.U. Phase 3 study in infants (NCT04546425) evaluating its 20-valent pneumococcal conjugate vaccine candidate (20vPnC) for the prevention of invasive pneumococcal disease (IPD), pneumonia, and acute otitis media caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes contained in the vaccine for the pediatric population.
The study had three coprimary outcomes, associated with immunogenicity responses one month after the second and third doses of a three-dose vaccination series given at approximately 2, 4, and 11-12 months of age of 20vPnC compared to Prevenar 13®. For the non-inferiority (NI) co-primary objective of immunoglobulin G (IgG) geometric mean concentrations (GMCs) one month after Dose 3 at 11-12 months of age, 19 of the 20 serotypes met the NI criteria with only one serotype narrowly missing. For the NI co-primary objective of IgG GMCs one month after Dose 2, 16 of the 20 serotypes met NI. Finally, for the third NI co-primary objective of the percentage of participants with predefined serotype-specific IgG concentrations one month after Dose 2, nine of the 20 serotypes met the NI criteria. All 20 serotypes showed increased booster responses from post dose 2 to post dose 3 which are indicative of immunological memory and long-term protection. All 20 vaccine serotypes also showed strong functional antibody responses as measured by the opsonophagocytic assay (OPA) post-dose 2 and post dose 3 similar to Prevenar® and Prevenar 13®. The totality of data is therefore directionally consistent with prior clinical experience with Prevenar® and Prevenar 13® after 2 and 3 infant doses, both of which have demonstrated effectiveness in a three-dose schedule against the serotypes contained in the vaccine in post-licensure studies.
In summary, the totality of these positive 20vPnC data, combined with the experience with Prevenar 13® in this schedule, demonstrates that the 20vPnC candidate, if approved, is likely to help protect against all 20 vaccine serotypes in a three-dose vaccine series.
"Today marks another important milestone in the 20vPnC pediatric program, with these data demonstrating 20vPnC's potential to provide the most comprehensive pneumococcal serotype coverage of any available pneumococcal conjugate vaccine," said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. "Based on the totality of immunogenicity and safety data, we feel confident that 20vPnC is likely to be protective against all vaccine serotypes in a three-dose series. We are thankful to everyone who worked on or participated in this study, and we look forward to hopefully being able to provide infants with more robust and meaningful protection against more pneumococcal disease-causing serotypes in the near future."
The safety profile of 20vPnC was similar to Prevenar 13® in this schedule, and concomitant use with common pediatric vaccines were supported.
Pfizer plans to file these data by the end of this year with the European Medicines Agency (EMA). These positive data mark the conclusion of pivotal topline readouts for the 20vPnC pediatric program. Pfizer will also seek to present and publish outcomes from this clinical trial at a future date once safety and immunogenicity data have been fully analyzed.
About the 20vPnC Phase 3 Pediatric Program
In 2020, Pfizer initiated the Phase 3 clinical trial program for the pediatric indication for 20vPnC. Four core Phase 3 pediatric studies will help expand the data on the safety, tolerability, and immunogenicity of 20vPnC. These studies collectively enrolled approximately 4,700 infants and 800 toddlers and children of all ages including:
- 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, with Prevenar 13® serving as the control in infants vaccinated at 2, 4, 6, and 12-15 months of age in multiple countries. (NCT04379713)
- 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 in children 15 months through
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 are global causes of invasive pneumococcal disease (IPD), and are associated with high case-fatality rates, antibiotic resistance, and/or meningitis. Together, the 20 serotypes included in 20vPnC are responsible for the majority of currently circulating pneumococcal disease in the EU and globally.
On Feb 14, 2022, the European Commission Decision was adopted for APEXXNAR ® (20vPnC) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older.
INDICATIONS FOR PREVENAR 13®
- Active immunisation 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 immunisation 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.
IMPORTANT SAFETY INFORMATION
- Prevenar 13® should not be given to anyone with a history of severe allergic reaction to any component of Prevenar 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
- 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, vomiting, fever, chills, and rash
- 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
- Ask your healthcare provider about the risks and benefits of Prevenar 13®. Only a healthcare provider can decide if Prevenar 13® is right for you or your child
INDICATIONS FOR APEXXNAR®
- Active immunisation 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
