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PREVENAR 20® (20-valent pneumococcal conjugate vaccine) offers the widest serotype coverage of any paediatric pneumococcal conjugate vaccine to help babies and children, as opposed to the 20 serotypes responsible for most pneumococcal diseases that are circulating lately in the EU and worldwide1,2,3. ,4,5,6,7,8
NEW YORK, March 13, 2024–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has granted marketing authorization for its 20-valent pneumococcal conjugate vaccine, announced in European countries. under the logo called PREVENAR 20®, for active immunization for the prevention of invasive diseases, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, young people and adolescents from 6 weeks to less than 18 years of age.
“The CE authorisation of PREVENAR 20 for infants and children represents a significant opportunity for public health by helping to protect against the 20 serotypes responsible for the majority of pneumococcal diseases circulating in the EU lately,” said Alexandre de Germay, International Commercial Director. , executive vice president of Pfizer. ” PREVENAR 20 builds on Pfizer’s decades-long commitment to developing vaccines that help prevent life-threatening infections, and we are proud to now offer the most comprehensive serotyping policy of any pneumococcal conjugate vaccine for children in Europe. “.
Today’s authorisation follows a recent positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The authorisation is valid in all 27 EU Member States, as well as Iceland, Liechtenstein and Norway. This also follows the approval of PREVNAR 20 for infants and youth through the U. S. Food and Drug Administration. It was approved by the U. S. Food and Drug Administration (FDA) in April 2023, and approvals in several other countries, including Canada, Australia, and Brazil. Regulatory programs have been submitted for PREVENAR 20 for pediatric indication in other countries around the world. world.
The CE approval of PREVENAR 20 is based on evidence from the Phase 3 clinical trial program consisting of 4 major pediatric studies (NCT04546425, NCT04382326, NCT04379713, NCT04642079), which contributed to expanding knowledge about the safety, tolerability and immunogenicity of the vaccine. The studies collectively included more than 4,700 infants and 800 toddlers and young adults of all ages.
About PREVENAR 20®
Pfizer’s PREVENAR 20® includes thirteen serotypes already included in PREVENAR thirteen®: 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 linked to high case fatality rates, antibiotic resistance and/or meningitis. 9 Together, the 20 serotypes included in PREVENAR 20 are responsible for the majority of pneumococcal diseases recently circulating in the EU and globally. 1, 2,3,4,5,6,7,8
In February 2022, it followed the European Commission’s resolution on APEXXNAR® (20-valent pneumococcal conjugate vaccine) for the prevention of invasive diseases and pneumonias caused by the 20 S serotypes. Pneumoniae (pneumococcus) provided in the vaccine in adults 18 years of age and older. Pfizer is converting the industry’s call for APEXXNAR to PREVENAR 20 following the expansion of its indication to reach Americans 6 weeks of age and older.
In April 2023, the U. S. Food and Drug Administration issued a report on the U. S. Food and Drug Administration. The U. S. Food and Drug Administration (FDA) approved PREVNAR 20® (20v PnC) for the prevention of invasive pneumococcal disease (IPD) in all 20 S serotypes. Pneumococcal pneumonia (pneumococcus) in infants and young adults aged six weeks to 17 years. and for the prevention of otitis media in infants aged six weeks to five years through the seven original serotypes contained in PREVNAR. ®
EU INDICATION FOR PREVENTION 20®
Active immunization for the prevention of invasive diseases, pneumonia, and acute otitis media caused by Streptococcus pneumoniae in infants, children, and adolescents 6 weeks to less than 18 years of age.
Active immunization for the prevention of invasive disease and Streptococcus pneumoniae pneumonia in Americans 18 years of age and older.
INDICATIONS FOR PREVNAR 20® IN THE U. S.
PREVNAR 20® is a vaccine for:
prevention of invasive disease through 20 strains of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F) in Americans 6 weeks of age and older.
Prevention of otitis media (middle ear infection) through 7 of 20 strains in Americans 6 weeks to five years of age.
Active immunization for the prevention of pneumonia using 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 Americans 18 years 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 a vaccine containing diphtheria toxoid.
People with weakened immune systems may have a weaker immune response. Such groups should not be security-savvy.
A transient pause in breathing after receiving the vaccine has been observed in some babies born prematurely. For premature infants, tell your doctor about the baby’s physical condition before deciding to be vaccinated with PREVNAR 20.
In Americans 2, 4, 6, and 12 to 15 months of age vaccinated in a 4-dose series, the maximum adverse reactions reported at a rate > 10% were irritability, pain at the injection site, drowsiness, decreased appetite, and redness at the injection site. injection site, swelling at the injection site, and fever.
In Americans aged 15 months to 17 years vaccinated with a single dose, the most common side effects reported at a rate > 10% were irritability, pain at the injection site, drowsiness, fatigue and muscle aches, decreased appetite, and swelling at the injection site. Injection site and redness at the injection site, headache, and fever.
In people 18 years of age and older, the most common side effects reported in > 10% were pain at the injection site, muscle aches, fatigue, headache, and joint pain. In addition, swelling at the injection site is not unusual in other seniors ages 18 to 59.
Talk to your doctor about the dangers and benefits of PREVNAR 20. Only a doctor can do this if PREVNAR 20 is right for your child.
See full prescribing information.
EU INDICATION FOR APEXXNAR®
Active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in Americans 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 a severe allergic reaction to any part of APEXXNAR or diphtheria toxoid.
Adults with weakened immune systems may have a weaker reaction to APEXXNAR. Such groups do not need to have security knowledge. 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 aches, fatigue, headache, and joint pain. In addition, swelling at the injection site is also not unusual in adults ages 18 to 49.
Talk to your health care provider about the dangers and benefits of APEXXNAR. Only a healthcare professional can do this if APEXXNAR is right for you.
About Pfizer: Breakthroughs That Transform Patients’ Lives
At Pfizer, we apply science and our global resources to provide solutions for others that improve and enhance their lives. We try to make a difference in quality, protection and price in the discovery, progression and production of medical devices, adding state-of-the-art medicines and vaccines. Every day, Pfizer colleagues work in evolved and emerging markets to advance wellness, prevention, treatments and cures that combat the most feared diseases of our time. In line with our duty as one of the world’s leading cutting-edge biopharmaceutical companies, we collaborate with healthcare providers, governments, and local communities to help and expand access to reliable and affordable healthcare around the world. For 175 years, we’ve worked to make a difference for everyone who counts on us. We publish data that would potentially be vital for investors on our online page in www. Pfizer. com. Also, to receive more information, visit www. Pfizer. com and follow us on X on @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook. com/Pfizer.
DISCLOSURE NOTICE:
The data contained in this press release is as of March 13, 2024. Pfizer assumes no legal responsibility to update the forward-looking statements contained in this press release as a result of new data or long-term developments or events.
This release includes prospective data on Prevnar 20/Prevenar 20, adding its potential benefits, a marketing authorization granted through the European Commission for active immunization for the prevention of invasive diseases, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and kids. . and adolescents aged 6 weeks to less than 18 years and completion programs in other jurisdictions, which involve significant threats and uncertainties that may also cause actual effects to differ materially from those expressed or implied by those statements. Risks and uncertainties include, but are not limited to, uncertainties related to the advertising success of Prevnar 20/Prevenar 20; the uncertainties inherent to the studies and development, including the ability to achieve the expected clinical endpoints, the start and/or completion dates of our clinical trials, the regulatory submission dates, the regulatory approval dates and/or the dates launch, as well as the option of more adverse clinical developments. extra knowledge and studies of existing clinical knowledge; the risk that clinical trial data will be subject to divergent interpretations and testing by the regulatory government; whether the regulatory government will be satisfied with the design and effects of our clinical studies; whether and when biologics licensing programs could be filed in specific jurisdictions for Prevnar 20/Prevenar 20 for any potential indications; Whether and when completed or submitted programs for Prevnar 20/Prevenar 20 may be approved by the regulatory government will depend on a multitude of factors, in addition to determining whether the benefits of the product outweigh its known threats and determining the benefits of the product. effectiveness and, if approved, whether Prevnar 20/Prevenar 20 will be advertising successful; decisions through regulatory governance have an effect on labeling, production processes, protection and/or other issues that would possibly affect the potential utilization or advertising of Prevnar 20/Prevenar 20; uncertainties related to the ability to download recommendations from vaccine technical or advisory committees and other public health governments related to Prevnar 20/Prevenar 20 and uncertainties related to advertising affecting such recommendations; uncertainties related to the effect of COVID-19 on our business, operations and financial effects; and competitive developments.
A more detailed description of the dangers and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the year ended December 31, 2023, as well as in its upcoming reports on Form 10-Q, by adding in the sections titled “Risk Factors. “and “Forward-Looking Information and Factors That May Affect Future Results,” as well as in its forthcoming reports on Form 8-K, all of which are filed with the U. S. Securities and Exchange Commission. They are available in the U. S. and can be obtained in www. sec. gov and www. pfizer. com.
1 Monitoring of the active bacterial nucleus (ABC). National Center for Vaccination and Respiratory Diseases. Atlanta Georgia. CENTERS FOR THE CONTROL AND PREVENTION OF DISEASES. Published March 2020. Updated May 22, 2020. Accessed February 6, 2024. Available at: https://www. cdc. gov/abcs/reports-findings/survreports/spneu18. pdf. 2 Ladhani, SN, Collins S, Djennad A et al. Rapid accumulation of non-vaccine serotypes of invasive pneumococcal disease in England and Wales, 2000-17: a prospective national observational cohort study [published correction appears in Lancet Infect Dis. February 6, 2018; :]. InfectDis Lancet. 2018;18(4):441-451. doi:10. 1016/S1473-3099(18)30052-53 Menéndez R, España PP, Pérez-Trallero E, et al. PCV13 serotype burden in hospitalized pneumococcal pneumonia in Spain: a novel urinary antigen detection test. Examine CAPA. Vaccine. 2017;35(39):5264-5270. doi:10. 1016/j. vaccine. 2017. 08. 0074 Azzari C, Cortimiglia M, Nieddu F et al. Distribution of pneumococcus serotypes in adults with invasive disease and in carrier children in Italy: do we deserve to expect collective coverage of adults through childhood vaccination? Hum vaccine immunother. 2016;12(2):344-350. doi:10. 1080/21645515. 2015. 11028115 Pivlishi T. Impact of PCV13 on the burden of invasive pneumococcal disease (IPD) and serotype distribution in the US CDC ACIP. Published October 24, 2018. Accessed February 6, 2024. Available at: https://stacks. cdc. gov/view/cdc/61449. 6 Invasive pneumococcal disease. In: ECDC. Annual epidemiological report 2016. ECDC. Published on August 8, 2018. Accessed on February 6, 2024. Available at: https://www. ecdc. europa. eu/sites/default/files/documents/AER_for_2016-solving-pneumococcal-disease_0. pdf. 7 Beall B, Chochua S, Gertz RE Jr, et al. A population-based descriptive atlas of invasive pneumococcus strains recovered in the United States in 2015-2016. Published November 2018. Accessed February 6, 2024. Available at: https://pubmed. ncbi. nlm. nih. gov/30524382/. 8 Grant L, Suaya J, Pugh S, et. Alabama. Coverage of the 20-Valent conjugate vaccine against invasive pneumococcal disease by age 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 Journal of Pediatric Infectious Diseases. Published September 13, 2021. Accessed February 6, 2024. Available at: https://www. ncbi. nlm. nih. gov/pmc/articles/PMC8443440/.
Category: Vaccines
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