China greenlights first self-developed 13-valent pneumonia vaccine
The National Medical Products Administration (NMPA) has given the go-ahead for the launch of China's first self-developed 13-valent pneumonia vaccine to better protect babies from a leading cause of death.
The pneumococcal polysaccharide conjugate vaccine, the second of its kind in the world, is produced by Yunnan-based Walvax Biotechnology Co., Ltd. and is designed to protect children who are six weeks or above but have not yet reached their sixth birthday from the invasive pneumococcal disease caused by 13 serotypes.
The only 13-valent pneumonia vaccine available in today's global market is manufactured by U.S. biopharmaceutical company Pfizer. In 2016, the product won approval to enter the Chinese market.
With over 15 million newborns in 2018, China has a huge clinical demand for the 13-valent pneumonia vaccine, which is recommended by the World Health Organization to shield children from the infectious disease, a major killer of children under five.
According to data from the United Nations International Children's Emergency Fund, pneumonia kills more children than any other infectious disease, claiming the lives of over 800,000 children under five every year worldwide, or around 2,200 every day.
While speeding up the approval of imported new drugs to meet urgent clinical needs, the NMPA is supporting domestic enterprises in terms of research and development applications, full-cycle guidance and streamlined procedures to fast-track the launch of home-developed vaccines.