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Pfizer Corporation Hong Kong Limited Receives Approval for Prevenar 13* in Hong Kong for the Prevention of Pneumococcal Disease in Infants and Young Children

-Prevenar 13 to provide the broadest coverage of any pneumococcal conjugate vaccine for infants and young children-

[Hong Kong, 28 May 2010] – The Department of Health (DH) has granted Pfizer Corporation Hong Kong Limited approval for its pneumococcal conjugate vaccine, Prevenar 13* (Pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]). Prevenar 13 is indicated for active immunisation for the prevention of invasive disease, pneumonia, and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks to 5 years of age.³ The vaccine provides coverage against 13 specific pneumococcal serotypes.

Prevenar 13, built on the scientific foundation of Prevenar* (Pneumococcal Saccharide Conjugated Vaccine, Adsorbed), includes the seven serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) in Prevenar – the standard in pneumococcal disease prevention in infants and young children – plus six additional serotypes (1, 3, 5, 6A, 7F, and 19A). Together, these serotypes represent the most prevalent invasive disease-causing strains in young children worldwide.^1,2 Prevenar 13 is the only pneumococcal conjugate vaccine to include serotypes 3, 6A, and 19A. Both Prevenar and Prevenar 13 use CRM197 – a carrier protein that has been used in various approved pediatric conjugate vaccines for more than 20 years.^3,4

"The approval of Prevenar 13 will give the infants and young children of Hong Kong the broadest coverage of any pneumococcal conjugate vaccine, including against serotype 19A, which is emerging as a significant public health threat in many parts of the world, including Australia, Taiwan, US and UK and is often associated with antibiotic resistance.^{5-8, 13-16}" says Dr. Selwyn Fung, Medical Director of Pfizer Corporation Hong Kong Limited. "By providing this broad coverage, Prevenar 13 is poised to help reduce this risk and the economic burden associated with pneumococcal disease in infants and young children."

In Hong Kong, the schedule recommended for Prevenar 13 consists of four doses, three primary doses followed by a booster dose between 11 and 15 months of age. Alternatively, when Prevenar 13 is given as part of a routine infant immunization program, Prevenar 13 may be administered as a three-dose series, two primary doses followed by a booster dose. Infants and children who have begun immunization with Prevenar may switch to Prevenar 13 at any point in their dosing schedule. It is also recommended that children up to 5 years of age who have completed vaccination with Prevenar should be offered coverage against the six additional serotypes included in Prevenar 13. As with any vaccine, Prevenar 13 may not protect all individuals receiving the vaccine from pneumococcal disease. It is recommended that infants who receive a first dose of Prevenar 13 complete the vaccination course with Prevenar 13.3 The immunization schedules for Prevenar 13 should be based on official recommendations. The company expects Prevenar 13 will be available in Hong Kong by July 2010.

To date, Prevenar 13 has been approved for use in infants and young children in 56 places, including 30 European nations, United States, United Kingdom, Canada and Mexico. Other pediatric regulatory filings for Prevenar 13 are in advanced stages of review in countries spanning six continents. Prevenar 13 is also being studied in global Phase 3 clinical trials in adults, with regulatory submissions expected in 2010.

Pneumococcal Disease

According to a World Health Organization (WHO) 2002 estimate, pneumococcal disease is a leading cause of vaccine-preventable death worldwide in children younger than 5 years.^9-11 Pneumococcal disease is complex and describes a group of illnesses caused by the bacterium Streptococcus pneumoniae.¹² It affects both children and adults¹² and includes invasive infections such as bacteremia/sepsis and meningitis, as well as non-invasive disease including pneumonia and acute otitis media.

Indication for Prevenar 13

Prevenar 13 is indicated for the prevention of invasive disease, pneumonia, and otitis media caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in infants and children from 6 weeks to 5 years of age.

Important Safety Information for Prevenar 13

The use of Prevenar 13 should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as the variability of serotype epidemiology in different geographical areas.

In clinical studies, the most commonly reported adverse reactions were injection-site reactions, fever, irritability, decreased appetite, and increased and/or decreased sleep.

Risks are associated with all vaccines, including Prevenar 13. Hypersensitivity to any component, including diphtheria toxoid, is a contraindication to its use. As with other vaccines, the administration of Prevenar 13 should be postponed in subjects suffering from acute, severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination. Prevenar 13 does not provide 100% protection against vaccine serotypes or protect against non-vaccine serotypes.

Pfizer Inc: Working together for a healthier world™

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer 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 the world’s leading biopharmaceutical company, we also 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, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at www.pfizer.com.

DISCLOSURE NOTICE: The information contained in this release is as of [28 May 2010]. 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 that involves substantial risks and uncertainties regarding a potential indication for Prevenar 13 for use in infants and young children in the various countries in which the Company’s regulatory applications are pending; the anticipated submission of regulatory applications in various countries in 2010 for a potential indication for Prevenar 13 for use in adults; and the potential benefits of Prevenar 13. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; whether and when regulatory applications will be submitted in various countries for a potential indication for Prevenar 13 for use in adults; whether and when regulatory authorities in other jurisdictions will approve applications that have been or may be submitted for these potential indications and their decisions regarding labeling and other matters that could affect the availability or commercial potential of these indications; 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, 2008, and in its reports on Form 10-Q and Form 8-K.

Reference

1.	PCV13-ISS, 2009. Pfizer Inc. Data on File.
2.	Pneumococcal Global Serotype Project. Summary report of stage1/version 1 analysis. Available at: http://www.preventpneumo.org/pdf/GSP%20Summary%20for%20SAGE%20Nov6-8%202007_Oct%2019-07.pdf. Accessed January 20, 2009.
3.	Prevenar 13 Summary of Product Characteristics.
4.	Centers for Disease Control and Prevention. Update: Haemophilus influenza type B vaccine. 1989;38:14.
5.	Centers for Disease Control and Prevention. Invasive pneumococcal disease in children 5 years after conjugate vaccine introduction-eight states,1998-2005. MMWR. 2008;57:144-148.
6.	Choi EH, Kim SH, Eun BW, et al. Streptococcus pneumoniae serotype 19A in children, South Korea. Emerg Infect Dis. 2008;14:275-281.
7.	Shouval, Dror S. MD,; David Greenberg, MD, et al. Serotype Coverage of Invasive and Mucosal Pneumococcal Disease in Israeli Children Younger Than 3 Years by Various Pneumococcal Conjugate Vaccines. Ped Infect Disease J. 2009;28:1-6.
8.	Kyaw MH, Lynfield R, Schaffner W, et al. Effect of introduction of the pneumococcal conjugate vaccine on drug-resistant Streptococcus pneumoniae. N Engl J Med. 2006;354:1455-1463.
9.	Centers for Disease Control and Prevention. Vaccine preventable deaths and the global immunization vision and strategy, 2006-2015. Morb Mortal Wkly Rep. 2006;55:511-514.
10.	World Health Organization. Pneumococcal conjugate vaccine for childhood immunization, March 2007 – WHO position paper. Wkly Epidemiol Record. 2007; 12.93-104.
11.	World Health Organization. 2004 Global Immunization Data. 2004.1-3.
12.	Centers for Disease Control and Prevention. Pneumococcal Disease. CDC Pink Book. 2008;15:217-230.
13.	US: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5909a1.htm
14.	Taiwan: Hsieh YC, Lin PY, Chiu CH et al (2009) National survey of invasive pneumococcal diseases in Taiwan under partial PCV7 vaccination in 2007: emergence of serotype 19A with high invasive potential. Vaccine 27:5513–5518
15.	Australia: Giele CM, Keil AD, Lehmann D, Van Buynder PG. Invasive pneumococcal disease in Western Australia: emergence of serotype 19A.Med J Aust. 2009 Feb 2;190(3):166.
16.	UK: Isaacman DJ, McIntosh ED, Reinert RR. Burden of invasive pneumococcal disease and serotype distribution among Streptococcus pneumoniae isolates in young children in Europe: impact of the 7-valent pneumococcal conjugate vaccine and considerations for future conjugate vaccines. Int J Infect Dis. 2010;14:e197–209.