Beijing Sinovac to produce EV71 vaccine against HFMD

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Recently, Beijing-based Sinovac Biotech announced that the China Food and Drug Administration (FDA) has issued the Good Manufacturing Practices certificate for the company’s Enterovirus 71 vaccine. The vaccine is made from inactivated enterovirus 71.

Yang Guang, Sinovac investor relations director said that preclinical and clinical studies showed that the EV71 vaccine is effective and safe. This vaccine targets children that are aged 6 months to 3 years old. 

The company intends to start the manufacture of the vaccine at the end of January this year. 

Source: http://www.biopharma-reporter.com/Markets-Regulations/Beijing-Sinovac-to-produce-vaccine-against-hand-foot-and-mouth-disease (27 January 2016)

 

Two-year efficacy and immunogenicity of Sinovac Enterovirus 71 vaccine against HFMD in children

This research was done to evaluate the efficacy and immunogenicity of Sinovac Enterovirus 71 vaccine for up to two years. 

10,077 participants were randomised to receive EV71 vaccine or placebo in a 1:1 ratio, and followed for 14 months. Extended follow-up was done for 12 months and the primary endpoint pf the study was EV71-associated HFMD. 

The EV71 vaccine showed an efficacy of 95.1% against EV71-associated HFMD in the extended follow-up, and showed an overall efficacy of 94.7% for two years. The vaccine induced a high level of neutralising antibodies in the patients, with no serious side effects observed. 

Therefore, it shows that the vaccine is able to provide a high protection against EV71-associated HFMD for up to 2 years. 

Source: http://www.ncbi.nlm.nih.gov/pubmed/26460695

More HFMD cases recently, but ‘no cause for alarm’

More HFMD cases are being reported in Singapore this year as compared to the same period last year, according to weekly figures published by the Ministry of Health. 

There were 568 HFMD cases from 6 December to 12 December 2015, compared with 302 cases during the same period in 2014. For this period from 2010 to 2014, the median number for HFMD cases was also 302. 

Source: http://www.channelnewsasia.com/news/singapore/more-hfmd-cases-recently/2371202.html (23 December 2015)