Acute otitis media

Prevenar 20 addresses an additional seven serotypes of Streptococcus pneumoniae that give rise to invasive pneumococcal disease. Credits: create jobs 51/Shutterstock.com Following a US Food and Drug Administration (FDA) approval in April 2023, the European Commission (EC) has awarded marketing approval to Pfizer ’s Prevenar 20 (20-valent Pneumococcal Conjugate Vaccine) for the active immunisation and protection of infants and children against common pneumococcal diseases. The latest EU approval is based on data from four Phase III studies evaluating the safety and immunogenicity of Prevenar 20 in pediatric patients and is accompanied by a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The vaccine is marketed as Prevnar 20 in the US. Prevenar 20 is a 20-valent pneumococcal conjugate vaccine designed to stave off invasive pneumonia, and acute otitis media caused by 20 different serotypes of Streptococcus pneumoniae . While the vaccine is already approved for use in adults, the latest approval authorises its use in those between the ages of 6 weeks and 18 years. As per the 13 March press announcement, the latest version of the vaccine expands on Pfizer’s Prevenar 13 and includes protection against serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F, which are global causes of invasive pneumococcal disease. Marketing authorisation of Prevenar 20 addresses “the majority of currently circulating pneumococcal disease in the EU and globally,” Alexandre de Germay, executive VP of Pfizer said in the announcement. GlobalData’s consensus forecasts predict that Prevenar 20 will bring in $3.7bn in sales in 2028. GlobalData is the parent company of Pharmaceutical Technology . See Also: Biotheus and Hansoh Pharmaceutical expand ADC collaboration Bright Green invests $250m to expand facility in New Mexico Pfizer is not alone in the space to develop vaccines against streptococcal pneumonia. Hot on the pharma giant’s heels is MSD’s investigational 21-valent pneumococcal conjugate vaccine V116. The FDA is set to make a decision on the vaccine’s approval by the Prescription Drug User Fee Act (PDUFA) date of 17 June 2024. MSD’s biologics licence application (BLA) is partially supported by data from the Phase III STRIDE-3 study (NCT05425732), which compared the safety, tolerability, and immunogenicity of V116 and Pfizer’s pneumococcal vaccine in adults who have not received prior pneumococcal conjugate vaccination. As per the trial findings , V116 induced non-inferior immune responses in both cohorts of the study. Data from the Phase III STRIDE-4, STRIDE-5, and STRIDE-6 studies also supplement the BLA.

PREVENAR 20® (20-valent Pneumococcal Conjugate Vaccine) offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine to help protect infants and children from the 20 serotypes responsible for the majority of currently circulating pneumococcal disease in the EU and globally1,2,3,4,5,6,7,8 NEW YORK--(BUSINESS WIRE)-- 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. 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 175 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 . In addition, to learn more, please visit us on and follow us on X 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 March 13, 2024. 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/Prevenar 20, including its potential benefits, a marketing authorization granted by the European Commission 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 and applications pending in other jurisdictions, 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/Prevenar 20; 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 Prevnar 20/Prevenar 20 for any potential indications; whether and when any applications that may be pending or filed for Prevnar 20/Prevenar 20 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/Prevenar 20 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/Prevenar 20; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities regarding Prevnar 20/Prevenar 20 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, 2023, 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 and . 1 Active Bacterial Core (ABCs) surveillance. National Center for Immunization and Respiratory Diseases. Atlanta, GA. CDC. Published March 2020. Updated May 22, 2020. Accessed February 6, 2024. Available at: . 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 February 6, 2024. Available at: . 6 Invasive pneumococcal disease. In: ECDC. Annual epidemiological report for 2016. ECDC. Published August 8, 2018. Accessed February 6, 2024. Available at: . 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 February 6, 2024. Available at: . 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 February 6, 2024. Available at: . Category: Vaccines View source version on businesswire.com: Contacts Media Contact: EUPress@Pfizer.com +44 (0)1737 332 335 Investor Contact: IR@Pfizer.com +1 (212) 733-4848 Source: Pfizer Inc. View this news release online at:

Physician-scientists at UPMC and the University of Pittsburgh found a way to use AI to accurately diagnose ear infections. The AI-powered smartphone app that diagnoses acute otitis media (AOM) could help decrease unnecessary antibiotic use in young children. Researchers published their outcomes in JAMA Pediatrics. AOM commonly has antibiotics prescribed to treat it, but can prove difficult to discern from other ear conditions without intensive training. This AI tool makes a diagnosis by assessing a short video of the eardrum captured by an otoscope connected to a smartphone camera. The researchers say this offers a simple and effective solution with potentially more accuracy than trained clinicians’ diagnoses. “Acute otitis media is often incorrectly diagnosed,” said senior author Dr. Alejandro Hoberma, professor of pediatrics and director of the Division of General Academic Pediatrics at Pitt’s School of Medicine and president of UPMC Children’s Community Pediatrics. “Underdiagnosis results in inadequate care and overdiagnosis results in unnecessary antibiotic treatment, which can compromise the effectiveness of currently available antibiotics. Our tool helps get the correct diagnosis and guide the right treatment.” Hoberman says about 70% of children have an ear infection before their first birthday. Despite the common nature of the condition, accurate diagnosis requires a trained eye. To develop a practical tool that improves accuracy, Hoberman and his team began by building and annotating a training library of 1,151 videos of the tympanic membrane from 635 children who visited outpatient UPMC pediatric offices between 2018 and 2023. Two trained experts reviewed the videos and made a diagnosis. Using 921 videos from the training library, the team taught two different AI models to detect AOM by looking at the features of the tympanic membrane. Features include shape, position, color and translucency. The remaining 230 videos helped to test how the models performed. Both models proved highly accurate, with sensitivity and specificity values totaling greater than 93%. Hoberman says previous studies of clinician diagnoses demonstrated accuracy ranging from 30% to 84%, depending on type of health care provider, level of training and age of the children being examined. “These findings suggest that our tool is more accurate than many clinicians,” said Hoberman. “It could be a game-changer in primary health care settings to support clinicians in stringently diagnosing AOM and guiding treatment decisions. “Another benefit of our tool is that the videos we capture can be stored in a patient’s medical record and shared with other providers,” said Hoberman. “We can also show parents and trainees — medical students and residents — what we see and explain why we are or are not making a diagnosis of ear infection. It is important as a teaching tool and for reassuring parents that their child is receiving appropriate treatment.” Hoberman hopes that the technology could soon be implemented widely across healthcare provider offices to enhance accurate diagnosis of AOM and support treatment decisions.