Sinovac Reports PhIII Trial Results For HFMD Vaccine Candidate

Chinese vaccine provider Sinovac Biotech Ltd. has completed a Phase III clinical trial on its Enterovirus 71 vaccine against hand, foot, and mouth disease.

AsianScientist (Mar. 25, 2013) – Chinese vaccine provider Sinovac Biotech Ltd. (SVA) announced this week that its Enterovirus 71 (EV71) vaccine against hand, foot, and mouth disease (HFMD) was not only safe, but shows significant efficacy in subjects.

The primary objective of the Phase III trial was to evaluate the efficacy of the EV71 vaccine in the prevention of HFMD caused by EV71 in infants of 6 to 35 months old. According to Sinovac, the preliminary Phase III data showed that its EV71 vaccine was 95.4 percent (95% CI: 87.5%, 98.3%) efficacious against HFMD caused by EV71.

Sinovac said that the Phase III trial showed good immunogenicity and safety for its EV71 vaccine. The overall incidence of serious adverse events in this trial was 2.2 percent among the EV71 candidate vaccine recipients and 2.6 percent among those receiving a control vaccine during the fourteen months observation period.

The double-blinded, randomized, placebo controlled Phase III clinical trial was conducted at three sites across China’s Jiangsu province. Approximately 10,000 healthy infants completed the two dose vaccination schedule (at 0 and 28 days) in the first quarter of 2012, prior to the HFMD epidemic season in China, followed by active monitoring period.

In parallel, Sinovac conducted another clinical study that was comprised of 1,400 volunteers and designed to evaluate the consistency of three consecutive lots of EV71 vaccine manufactured by the Company. The study results showed consistent immune response for all three lots and a good safety profile, it said.

In March 2008, an EV71 outbreak in Fuyang City of China’s Anhui Province caused 23 fatalities, and attracted significant attention from the government and medical communities. In May 2008, the PRC Ministry of Health identified EV71 as a Class C infectious disease according to prevention and control regulations. EV71 outbreaks have increased over the last five years, with over one million cases identified and 500 to 900 reported fatalities each year.

“Hand, foot, and mouth disease continues to represent a significant unmet public health need and economic burden in China, as well as several other Asian countries. Our EV71 vaccine is poised to provide an effective solution to prevent hand, food and mouth disease caused by EV71,” said Dr. Weidong Yin, Chairman, President and CEO of Sinovac.

The Company’s next step is to finalize the clinical report, which will become an important part of documents to be filed with the PRC State Food and Drug Administration (SFDA) for the application of new drug certificate, GMP certification, and the production license in order to commence the commercial production of the vaccine. In parallel, Sinovac’s dedicated EV71 vaccine manufacturing facility has been completed and is ready for the GMP inspection by SFDA.

Sinovac obtained clinical research approval for its proprietary EV71 vaccine candidate from the SFDA in December 2010, and completed Phase I and II clinical trials in 2011.

——

Source: Sinovac.
Disclaimer: This article does not necessarily reflect the views of AsianScientist or its staff.

Asian Scientist Magazine is an award-winning science and technology magazine that highlights R&D news stories from Asia to a global audience. The magazine is published by Singapore-headquartered Wildtype Media Group.

Related Stories from Asian Scientist