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CFDA granted Pfizer China approval for the company’s Prevenar 13 vaccine.
On Nov. 2, 2016, Pfizer China announced that the company received approval from the China Food and Drug Administration (CFDA) to market its pneumococcal 13-valent conjugate vaccine, Prevenar 13 in China. The vaccine is approved 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, Pfizer noted in a press release.
This approval comes after Pfizer was forced to shut down its vaccine business in China in 2015, Reuters reports. According to the publication, Pfizer closed its business after a license for Prevenar was not renewed in 2015. In third-quarter financial results, Pfizer stated Prevnar/Prevenar 13 revenues were down 2% operationally, but international revenues for the vaccine grew 1% operationally.
Source: Pfizer China