The primary section III medical trial of a multivalent HFMD vaccine on this planet
BEIJING–(BUSINESS WIRE)–Sinovac Biotech Ltd. (SINOVAC or the Firm) (NASDAQ: SVA), a number one biopharmaceutical provider in China, at present initiated recruitment for a Section III medical trial of a vaccine candidate geared toward stopping HFMD brought on by enterovirus 71 (EV71) and Coxsackievirus 16 (CA16). Notably, no multivalent HFMD vaccine has but been accredited for advertising worldwide.
The Section III medical trial is designed as a multicenter, randomized, double-blind, managed trial to guage the efficacy, security, and immunogenicity of this vaccine candidate in infants and younger kids aged 6 to 71 month.
SINOVAC has launched a section I/II medical trial of its bivalent vaccine in China since September 2023. The outcomes of the section I/II medical trial demonstrated that the vaccine candidate has favorable security and immunogenicity.
HFMD may be brought on by a number of enteroviruses, which regularly exhibit low cross-immunogenicity, resulting in inadequate safety. HFMD primarily impacts kids beneath 5 years of age, accounting for no less than 90% of complete HFMD sufferers. To enhance the safety of youngsters, SINOVAC is dedicated to researching and growing multivalent vaccines that present safety towards a broader vary of dominant virus varieties. Primarily based on these efforts, the Firm additionally developed the world’s first tetravalent enterovirus inactivated vaccine, which was not too long ago accredited for medical trials in December. This vaccine goals to stop HFMD brought on by EV71, CA16, CA10 and CA6.
Devoted to offering complete safety for kids, SINOVAC will collaborate with companions to advance medical analysis on inactivated bivalent and tetravalent enterovirus vaccines, with the aim of constructing these vaccines commercially out there as quickly as attainable.
About SINOVAC
Sinovac Biotech Ltd. (SINOVAC) is a China-based biopharmaceutical firm centered on the R&D, manufacturing and commercialization of biomedical merchandise that shield towards human infectious ailments.
SINOVAC’s product portfolio contains vaccines for COVID-19, enterovirus 71 (EV71)-infected hand, foot and mouth illness (HFMD), hepatitis A, chickenpox, influenza, polio, pneumococcal illness, mumps, and so forth.
The COVID-19 vaccine, CoronaVac ®, has been accredited to be used in additional than 60 international locations and areas world wide. Hepatitis A vaccine, Healive ®, met WHO prequalification necessities in 2017. EV71 vaccine, Inlive ®, is an revolutionary vaccine falling beneath class 1 of preventive organic merchandise and marketed in China in 2016 In 2022, SINOVAC’s Sabin pressure inactivated polio vaccine (sIPV) and chickenpox vaccine have been prequalified by. the WHO.
SINOVAC was the primary firm to acquire approval for its H1N1 influenza vaccine Panflu.1 ®, which supplied the Chinese language authorities’s vaccination marketing campaign and stockpiling program. The Firm can be the only provider of the H5N1 pandemic influenza vaccine, Panflu ®, to the Chinese language authorities’s stockpile program.
SINOVAC is repeatedly devoted to the event of pipelines, together with however not restricted to new applied sciences, new vaccines in addition to different biomedical merchandise. We’ll continuously discover international alternatives for strategic growth.
For extra info, please go to the Firm’s web site at www.sinovac.com.
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Sinovac Biotech Ltd.
Helene Yang
Tel: +86-10-8279 9720
E mail: ir@sinovac.com
Supply: Sinovac Biotech Ltd.
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