This section highlights FDA-related milestones and regulatory updates for drugs developed by Sinovac Biotech (SVA).
Over the past two years, Sinovac Biotech has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Coxsackievirus and Enterovirus. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Coxsackievirus 16 - FDA Regulatory Timeline and Events
Coxsackievirus 16 is a drug developed by Sinovac Biotech for the following indication: Bivalent Vaccine Against Hand Foot and Mouth Disease (HFMD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Coxsackievirus 16
- Announced Date:
- December 16, 2024
- Indication:
- Bivalent Vaccine Against Hand Foot and Mouth Disease (HFMD)
Announcement
Sinovac Biotech Ltd. today kicked off the enrollment for a Phase III clinical trial on a vaccine candidate to prevent HFMD caused by both Enterovirus 71 (EV71) and Coxsackievirus 16 (CA16).
AI Summary
Sinovac Biotech Ltd. has started enrolling infants and young children, ages 6 to 71 months, in a Phase III clinical trial for a new HFMD vaccine candidate. This vaccine is designed to prevent hand-foot-mouth disease caused by both Enterovirus 71 (EV71) and Coxsackievirus 16 (CA16). The trial is a multicenter, randomized, double-blind, controlled study focused on assessing the vaccine’s efficacy, safety, and ability to induce an immune response in its target group.
This step follows positive results from earlier Phase I/II trials, which showed that the vaccine candidate was both safe and effective in producing the desired immune response. Notably, this multivalent HFMD vaccine would be the first of its kind approved for market use worldwide, marking a significant advancement in protecting young children from the disease.
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Enterovirus 71 - FDA Regulatory Timeline and Events
Enterovirus 71 is a drug developed by Sinovac Biotech for the following indication: Bivalent Vaccine Against Hand Foot and Mouth Disease (HFMD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Enterovirus 71
- Announced Date:
- December 16, 2024
- Indication:
- Bivalent Vaccine Against Hand Foot and Mouth Disease (HFMD)
Announcement
Sinovac Biotech Ltd. today kicked off the enrollment for a Phase III clinical trial on a vaccine candidate to prevent HFMD caused by both Enterovirus 71 (EV71) and Coxsackievirus 16 (CA16).
AI Summary
Sinovac Biotech Ltd. has recently begun enrolling participants for a Phase III clinical trial of its vaccine candidate aimed at preventing hand-foot-mouth disease (HFMD) caused by Enterovirus 71 (EV71) and Coxsackievirus 16 (CA16). This development marks the first global Phase III trial for a multivalent HFMD vaccine, targeting infants and young children aged 6 to 71 months.
The study is designed as a multicenter, randomized, double-blind, controlled trial to assess the vaccine's effectiveness, safety, and ability to provoke an immune response. Previous Phase I/II trials demonstrated promising safety and immunogenicity results. By advancing this clinical trial, Sinovac is taking a significant step towards offering better protection for children at risk of HFMD, a disease that commonly affects those under the age of five.
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