On October 26 2015, Sinovac Dalian, a subsidiary of Sinovac Biotech Ltd. received the approval to conduct human clinical trials (Phase I) using their vaccine candidate from the China Food and Drug Administration (CFDA).
The candidate in question is a live attentuated virus derived from a human cell line, which the company expects to be commercialised by 2019. Sinovac hopes to be able to release a MMRV combination vaccine in the future and has began its preparations by setting up its commercial vaccine production plant which will be able to produce up to 5 million vaccine doses annually.
This is especially important as some less developed areas in China may not have access to these vaccines and thus the people there may not have been immunised. Infants and the elderly are especially susceptible due to their weakened immune systems, and in the rural areas the people may not be able to afford to see medical help as they simply do not have the money to pay antiviral drugs like aciclovir for their conditions. Mass produced vaccines would be more affordable and can help prevent outbreaks.
The following is an excerpt from the CDC Pinkbook about Varicella, on the Epidemiology and Prevention of Vaccine-Preventable Diseases:
“In the prevaccine era, approximately 11,000 persons with varicella required hospitalization each year. Hospitalization rates were approximately 2 to 3 per 1,000 cases among healthy children and 8 per 1,000 cases among adults. Death occurred in approximately 1 in 60,000 cases. From 1990 through 1996, an average of 103 deaths from varicella were reported each year. Most deaths occur in immunocompetent children and adults. Since 1996, hospitalizations and deaths from varicella have declined more than 70% and 88% respectively.”
This is why vaccination is so important–it reduces the morbidity and mortality rate of diseases that can be prevented.
Clinical Trial Stages Picture:
Information on Clinical Trial stages: