Clinical Trials

Tetravalent Norovirus Vaccine Study Launched in China

Norovirus vaccines could prevent 50% of acute gastroenteritis
lab testing
(Precision Vaccinations News)

China’s National Medical Products Administration (NMPA) has approved a clinical trial for the world's first tetravalent vaccine candidate against norovirus on May 30, 2019. 

This vaccine’s developer is the Institut Pasteur of Shanghai (IPS), which is under the Chinese Academy of Sciences. 

The vaccine candidate, after four years of development, can theoretically prevent 80 to 90 percent of norovirus infections," said Huang Zhong, who leads the project at IPS, and reported by Xinhuanet.

‘The norovirus has long eluded the world's vaccine development, as traditional strategies of inactivation and attenuation fail on the virus that cannot be cultured in vitro on a large scale. 

"This was further complicated by the virus' many genotypes, regional variations and its propensity to mutate,’ according to Huang. 

This clinical trial is expected to last for 5 years before the vaccine can apply for new drug registration, which will benefit norovirus prevention in both China and abroad, said Tang Hong, a researcher with the IPS. 

This norovirus vaccine candidate was jointly developed by the IPS and Anhui Zhifei Longcom Biopharmaceutical Co. Ltd. 

Data from the US Centers for Disease Control and Prevention (CDC) suggest that noroviruses are the leading cause of acute gastroenteritis across all age groups seeking medical care in emergency departments, outpatient clinics, and community health centers. 

Recent reviews of the literature on outpatient and hospital-based studies in developing and developed countries report that norovirus gastroenteritis account for 10–15 percent of severe cases in children less than 5 years of age. 

Each year, noroviruses cause 19–21 million illnesses and results in 56,000–71,000 hospitalizations and 570–800 deaths. 

Noroviruses are single-stranded RNA viruses of the family Caliciviridae and thus undergo genetic drift due to an error-prone RNA polymerase, as well as the ability to undergo recombination, says the CDC.   

Polyvalent vaccines including multiple norovirus genotypes and/or other viruses acquired by the enteric route have been developed. One vaccine candidate has reached phase II clinical trials and several others are in pre-clinical stages of development.

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