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Pfizer Receives Authorization from Health Authority for Its 20-valent Pneumococcal Conjugate Vaccine for Infants and Children

2024-12-04 Pfizer HaiPress

In Hong Kong,the 20-valent Pneumococcal Conjugate Vaccine (PCV20) that offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine – helping to fight against 20 serotypes leading to most of the invasive pneumococcal diseases and pneumonia[i],[ii] – is now approved for infants,children and adolescents from 6 weeks to less than 18 years of age and has been approved by Hong Kong Department of Health in April 2023 for adults aged 18 years and older[iii]

PCV20 builds on PCV13 and includes seven additional serotypes shown to be associated with antibiotic resistance,heightened disease severity,invasive potential,and prevalence in pediatric pneumococcal cases[iv]

The vaccine further advances Pfizer's pediatric pneumococcal vaccine portfolio and builds on more than 20 years of Pfizer leadership,legacy and innovation in developing pneumococcal conjugate vaccines

HONG KONG,Dec. 3,2024 -- Pfizer announced today that the Hong Kong Department of Health (DoH) has approved the company's 20-valent Pneumococcal Conjugate Vaccine (PCV20) for active immunization for the prevention of invasive disease,pneumonia,and acute otitis media caused by the streptococcus pneumoniae in infants,children and adolescents from 6 weeks to less than 18 years of age,on top of its approval for adults aged 18 years and older.[iii]

"The updated approval of PCV20,now offers parents an additional choice to help their children fight against 20 pneumococcal serotypes in circulation,"said Krishnamoorthy Sundaresan,General Manager,Pfizer Hong Kong,and Macau. "This important approval highlights Pfizer's leadership in developing pneumococcal conjugate vaccines to support infants and their families fight against life-threatening infections."

According to the Department of Health,pneumonia is the second leading cause of deaths[v],responsible for 31 deaths per day on average in 2023[vi],and one of the most common causes for hospitalization in Hong Kong[vii]. Specifically among the pediatric population,pneumonia accounts for 14% of all deaths of children under 5 years old globally,killing 740,180 children in 2019,and streptococcus pneumoniae is the most common cause of bacterial pneumonia in children.[viii]

PCV20 builds on the previously approved PCV13,and includes seven additional serotypes (8,10A,11A,12F,15B,22F and 33F) shown to be associated with antibiotic resistance,and prevalence in pediatric pneumococcal cases.[iv]

For more information about the pneumococcal conjugate vaccine and its new indication,please go to your local healthcare providers.

About PCV20

PCV20 is Pfizer's next-generation pneumococcal conjugate vaccine that includes capsular polysaccharide conjugates for the 13 serotypes (1,3,4,5,6A,6B,7F,9V,14,18C,19A,19F and 23F) already included in Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]. The vaccine also contains capsular polysaccharide conjugates for seven additional serotypes (8,22F and 33F) that cause invasive pneumococcal disease (IPD),and have been associated with high case-fatality rates,antibiotic resistance,and/or meningitis. PCV20 contains the broadest serotype coverage of any available pneumococcal conjugate vaccine and helps combat against the 20 Streptococcus pneumoniae serotypes in the vaccine.

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. To learn more,please visit us on www.pfizer.com.hkand like us on YouTube at www.youtube.com/c/pfizerhongkong.

[i]Cannon,K.,Elder,C.,Young,M.,Scott,D. A.,Scully,I. L.,Baugher,G.,Peng,Y.,Jansen,K. U.,Gruber,W. C.,& Watson,W. (2021). Vaccine,39(51),7494–7502.

[ii]Essink,B.,Sabharwal,Cannon,Frenck,R.,Lal,H.,Xu,X.,Sundaraiyer,V.,Moyer,L.,Pride,M. W.,W. (2022). Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,75(3),390–398.

[iii]PCV20 (Pneumococcal polysaccharide conjugate,20-valent adsorbed) Prescribing Information. Pfizer Corporation Hong Kong Limited. Version: July 2024

[iv]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. Retrieved March 3,2023,fromhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8443440/

[v]Department of Health. Leading Cause of all Deaths. https://www.healthyhk.gov.hk/phisweb/en/chart_detail/22/. Accessed Nov 29,2024

[vi]Centre for Health Protection. Number of Deaths by Leading Causes of Death. https://www.chp.gov.hk/en/statistics/data/10/27/380.html. Accessed Nov 29,2024

[vii]Department of Health. Tables on Health Status and Health Services 2022 https://www.dh.gov.hk/english/pub_rec/pub_rec_ar/pdf/2223/supplementary_table2022.pdf. Accessed Nov 29,2024

[viii]World Health Organization. Pneumonia in Children. https://www.who.int/news-room/fact-sheets/detail/pneumonia. Accessed Nov 29. 2024

[PP-PNR-HKG-0441]

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