China's Sinovac Biotech has presented positive top-line late-stage data on its investigational vaccine for hand, foot and mouth disease.
HFMD is a viral infection that can affect young children. The two most common types of viruses that can cause the condition are the coxsackievirus A16 and enterovirus 71; the latter carries a higher risk of causing serious complications.
The Sinovac study evaluated the vaccine in the prevention of HFMD caused by EV71 in infants of six to 35 months old. The preliminary Phase III data showed that it was 95.4% efficacious against the disease caused by EV71.
The trial was conducted at three sites across China's Jiangsu province and 10,000 healthy infants completed the two-dose vaccination schedule. Sinovac also noted that the overall incidence of serious adverse events in this trial was just 2.2% among the EV71 candidate vaccine recipients and 2.6% among those receiving a control vaccine during the fourteen months observation period.
The Beijing-based firm, which is listed on the Nasdaq in the USA, said it will finalise the clinical report ahead of filing the vaccine with China's State Food and Drug Administration. It added that a dedicated EV71 vaccine manufacturing facility has been completed and is ready for inspection by the SFDA.
Chief executive Weidong Yin said the conclusion of this trial marks "an important milestone" in the development of the vaccine. He added that HFMD "continues to represent a significant unmet public health need and economic burden in China, as well as several other Asian countries".
Shares of Sinovac climbed 17.9% to close at $3.76, having risen earlier in the day to over $5.
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