Sinovac updates public on pipeline vaccines
The main updates concern the vaccine for EV71, which causes hand, foot and mouth disease (HFMD). In 2014, there 2.78 million HFMD cases in China, with 508 of those cases ending in death.
In January, Sinovac submitted documentation for its EV71 vaccine to China's Food and Drug Administration (CFDA). As the CFDA reviews the documentation, Sinovac has kept in regular contact with the various CFDA departments. This enables Sinovac to remain prepared for the on-site inspection that will occur. There will also be sample testing and lot and production releases when EV71 is commercialized.
After the inspection and sample testing are finished, Sinovac will be granted a new drug certificate and licenses for good manufacturing practices and production to begin.
In other vaccine news, the company’s Pneumococcal 23-valent polysaccharide vaccine (PPV) should begin trials by the end of June; the varicella vaccine should be approved for its clinical trial license this year; the Pneumococcal 13-valent conjugate vaccine (PCV) will begin trials within the next three years; the Sabin-inactivated polio vaccine is currently being reviewed by the CDE; the rubella vaccine is awaiting the approval of its clinical trial application from the CFDA; and the company’s hepatitis B vaccine and novel hepatitis A & B vaccines are continuing to progress as well.