Pfizer's Prevenar 13® receives approval for use in infants and children in China

PfizerPfizer China announced today that it has received approval from the Chinese Food and Drug Administration (CFDA) to market its pneumococcal 13-valent conjugate vaccine, Prevenar 13®, in China for active immunization for the prevention of invasive diseases (including bacteremic pneumonia, meningitis, septicemia, and bacteremia) caused by Streptococcus pneumoniae (S. Pneumoniae) serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in infants and children aged 6 weeks to 15 months. S. pneumoniae is the most common cause of invasive disease as well as pneumonia and upper respiratory tract infections.

Pneumococcal disease is a leading cause of vaccine-preventable deaths globally in children under five years old(1). In China alone, approximately 30 thousand children in this age group die due to pneumococcal diseases every year(2).

"We applaud the efforts of CFDA and other relevant Chinese government agencies to bring new medicines and vaccines to the Chinese healthcare system," said Dr. Xiaobin Wu, President of Pfizer China. "Pfizer is committed to working closely with the CFDA in these efforts, and also looks forward to partnering with the Chinese government to help improve the lives of patients and people of all ages in China."

In China, the recommended Prevenar 13® immunization series is a primary series administered at 2, 4 and 6 months of age with a fourth (booster) dose administered at approximately 12~15 months of age.

About Streptococcus Pneumoniae
Pneumococcus (also known as Streptococcus pneumoniae) is widely colonized in the human nasopharynx, with a carrier rate of 27% - 85%; infants and young children are the main carrier and transmission group(3). Pneumococcus can be spread through respiratory droplets. Vaccination in children is critical as their immune systems are still developing during the first years of life, leaving them more susceptible to infectious diseases(4). Serious sequelae such as deafness, developmental delay and even death can be associated with invasive pneumococcal disease(5). Due to the increasingly serious problem of multi-drug resistance to pneumococcus, the clinical treatment of pneumococcus related diseases has also become more difficult(6).

Pneumococcal disease is a leading cause of vaccine-preventable deaths in children under 5 years old globally and in China(7). In view of the large public health problem caused by pneumococcal disease, the World Health Organization (WHO) has prioritized vaccination against this disease worldwide(8).

About Prevenar 13®
Prevenar 13® is the most widely used pneumococcal conjugate vaccine in the world, and is included in the pediatric National Immunization Programs of numerous countries in the Asia Pacific region such as Australia, Hong Kong, Japan, and Taiwan(9,10) Prevenar 13® will only protect against Streptococcus pneumoniae serotypes included in the vaccine, and will not protect against serotypes not present in the vaccine or other microorganisms that cause invasive disease, pneumonia, or otitis media.

Prevnar 13® is the trade name in the United States, Canada, and Taiwan.

Pfizer Inc.: Working together for a healthier worldTM
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. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. 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 more than 150 years, we have worked to make a difference for all who rely on us.

1. WHO Centers for Disease Control and Prevention. Pneumococcal disease. In: Atkinson W, Wolfe S, Hamborsky J, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 12th ed. Washington, DC: Public Health Foundation; 2011:233-248. Available at: http://www.cdc.gov/vaccines/pubs/pinkbook/pneumo.html. Accessed January 28, 2015.
2. O'Brien KL, et al. Burden of disease caused by Streptococcus pneumoniae in children younger than 5 years: global estimates. Lancet. 2009; 374(9693): 893-902.
3. Lynch JP 3rd,et al. Semin Respir Crit Care Med. 2009;30(2): 189-209.
4. Offit P, Quarles J, Gerber M, et al. Addressing Parents’ Concerns: Do Multiple Vaccines Overwhelm or Weaken the Infant’s Immune System? Pediatrics. 2002;109:124-129.
5. Pneumococcal Disease - Symptoms and Complications, Centers for Disease Control and Prevention. http://www.cdc.gov/pneumococcal/about/symptoms-complications.html
6. Chin J. Epidemiol. November 2012, Vol 33, No. 11.
7. Levine OS, Liu G, Garman RL, Dowell SF, Yu S, Yang YH. Haemophilus influenzae type b and Streptococcus pneumoniae as causes of pneumonia among children in Beijing, China. Emerg Infect Dis. 2000. 6(2): 165-70
8. WHO. Meeting of the immunization Strategic Advisory Group of Experts, November 2007 - conclusions and Recommendations. Wkly Epidemiol Rec, 2008;83:1-16.
9. GlaxoSmithKline. GSK’s Synflorix™ receives CHMP positive opinion for major label extension. July 27, 2015. http://www.gsk.com/en-gb/media/press-releases/2015/gsk-s-synflorix-receives-chmp-positive-opinion-for-major-label-extension/. Accessed July 7, 2016.
10. Data on file. Pfizer Inc, New York, NY. [Total Prevenar 13V Doses Through May 2016]

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