Pfizer (PFE) Receives CFDA Approval of Prevenar 13 for Invasive Diseases

November 2, 2016 6:47 AM EDT

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Pfizer China announced 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 old1. In China alone, approximately 30 thousand children in this age group die due to pneumococcal diseases every year2.

"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 group3. 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 diseases4. Serious sequelae such as deafness, developmental delay and even death can be associated with invasive pneumococcal disease5. Due to the increasingly serious problem of multi-drug resistance to pneumococcus, the clinical treatment of pneumococcus related diseases has also become more difficult6.

Pneumococcal disease is a leading cause of vaccine-preventable deaths in children under 5 years old globally and in China7. In view of the large public health problem caused by pneumococcal disease, the World Health Organization (WHO) has prioritized vaccination against this disease worldwide8.

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