Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has granted marketing authorization for the company's 20-valent pneumococcal conjugate vaccine, marketed in the European Union under the brand name PREVENAR 20®, 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.
"The EC's authorization of PREVENAR 20 for infants and children represents a significant opportunity to improve public health by helping to protect against the 20 serotypes responsible for the majority of currently circulating pneumococcal disease in the EU," said Alexandre de Germay, Chief International Commercial Officer, Executive Vice President, Pfizer. "PREVENAR 20 builds on Pfizer's decades-long commitment to develop vaccines to help prevent potentially life-threatening infections, and we are proud to now provide the broadest serotype coverage of any pneumococcal conjugate vaccine for children in Europe."
Today's authorization follows the recent positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). The authorization is valid in all 27 EU member states plus Iceland, Lichtenstein and Norway. It also follows the approval of PREVNAR 20 for infants and children by the U.S. Food and Drug Administration (FDA) in April 2023, and approvals in several other countries including Canada, Australia and Brazil. Regulatory applications for PREVENAR 20 for the pediatric indication have been submitted to additional countries around the world.
The EC authorization of PREVENAR 20 is based on evidence from the Phase 3 clinical trial program comprised of four core pediatric studies (NCT04546425, NCT04382326, NCT04379713, NCT04642079), which helped to expand the data on the safety, tolerability, and immunogenicity of the vaccine. These studies collectively enrolled more than 4,700 infants and 800 toddlers and children of all ages.
About PREVENAR 20®
Pfizer's PREVENAR 20® 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 PREVENAR 20 - 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 PREVENAR 20 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® (20-valent Pneumococcal Conjugate Vaccine) 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. Pfizer is changing the tradename of APEXXNAR to PREVENAR 20 following the expansion of its indication to include individuals from 6 weeks of age and older.
In April 2023, the United States Food and Drug Administration (FDA) approved PREVNAR 20® (20v PnC) 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 20®
- 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.
- Active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.
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.
- 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.
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 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.
