China-based pharmaceutical products developer Sinovac Biotech Ltd. today announced it has submitted the application to commence clinical trials for its 13-valent pneumococcal conjugate vaccine (PCV) to China’s State Food and Drug Administration (SFDA). PCV is a vaccine used to protect infants and young children from Streptococcus pneumonia.
Sinovac initiated its PCV research program in 2008; the vaccine is designed to target China’s population of infants under two years old, estimated at approximately 34 million. There is currently only one internationally produced 7-valent pneumococcal conjugate vaccine with a three-dose basic vaccination schedule – no domestic manufacture has been granted a license to manufacture PCV.
“The clinical trial application for PCV marks the significant progress we have made in advancing the research and development of a pneumococcal conjugate vaccine. During the pre-clinical studies, we made significant technical breakthroughs including establishing a seeds bank, developing the production process and testing methods, completing the production and quality control testing of vaccine doses for the clinical trials application and completing the safety evaluation in animals, which demonstrated the good safety and immunogenicity profile in animals,” Dr. Weidong Yin, chairman and CEO of Sinovac stated in the press release.
According to the World Health Organization’s (WHO) as of November 2010, more than 50 countries have included PCV into their national immunization programs, including the United States, United Kingdom, Australia, Canada and Mexico. The high price of the PCV vaccines currently on the market cuts the incorporation of this vaccine into China’s immunization program.
In March 2011, WHO declared that China’s State Food and Drug Administration (SFDA) complies with international standards for vaccine regulation based on a December 2010 assessment. The standing could open the door for vaccines produced in China to be supplied through United Nations agencies to developing countries.
“PCV is one of the vaccine products recommended by WHO to be purchased by United Nation agencies to supply to the developing countries and it is on the list of WHO prequalified vaccines. And we are happy to see that China SFDA passed WHO the evaluation on its vaccine regulatory system, which will enable Chinese vaccine products to be prequalified by the WHO and speed up the process of our vaccine products entering into the international market,” Dr. Yin stated. “With both PCV and PPV under development, Sinovac is poised to provide broader protection against pneumonia to all age groups both in China and around the globe as we further implement our mission to supply vaccines to eliminate human diseases.”
For more information visit www.sinovac.com