Pfizer's Prevenar 13 Gains Approval for Use in Infants and Children in China

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 old. In China alone, approximately 30 thousand children in this age group die due to pneumococcal diseases every year.

“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.