The first China-made pneumococcal 13-valent conjugate vaccine has been approved for market use, according to the National Medical Products Administration.
Pneumococcal disease is a leading cause of illness and death in children under the age of 5. The approved pneumococcal polysaccharide conjugate vaccine is the first of its kind independently developed and produced in China and the second in the world. The new drug will break the monopoly Pfizer has held in the market.
Pneumococcus is the main cause of invasive disease, pneumonia and upper respiratory tract infection. Severe pneumococcal diseases can also lead to deafness, paralysis, intellectual disability and other serious sequelae.
The World Health Organization (WHO) estimates that about 1.6 million people die from pneumococcal infections globally each year, of which 700,000 to one million are children under the age of five. WHO lists pneumococcal disease in children as a high priority for vaccination and recommends pneumococcal 13-valent conjugate vaccines.
The China-made pneumococcal 13-valent conjugate vaccine was produced by Walvax Biotechnology Co., Ltd. Currently, only New York-based Pfizer Inc. produces pneumococcal conjugate vaccines, and the company has dominated the market unchallenged since its approval in 2010. Pfizer's 13-valent pneumococcal vaccines generated 5.8 billion U.S. dollars in global sales in 2018. The vaccine was approved for the Chinese market in October 2016, and was officially used in March 2017. In 2018, Pfizer provided 3.848 million doses of 13-valent pneumococcal vaccines in China, with a total value of 2.686 billion yuan.
Pfizer's 13-valent pneumococcal vaccine is approved in China for infants between 6 weeks to 5 months of age. Infants over 6 months cannot be vaccinated. The approved China-made pneumococcal 13-valent conjugate vaccine has a wider age range and can be administrated for children from 6 weeks to 5 years old.
China-made vaccines also have a price advantage. At some vaccination sites, the price of the vaccine is nearly 3,000 yuan (420 U.S. dollars) for all four doses. Walvax officials said the new products will not cost more than Pfizer's.