The site inspection and GMP inspection of the Company's EV71
vaccine production facility have been completed.
The III phase of the clinical trial for EV71
has been concluded by the firm.
nin (8) yaptiklari calismada EV71
susunun saptanmasi, temas oykusu, ates, kusma, ekstremitelerde dokuntuler gibi kesin ve erken bulgular ve periferik kanda notrofil orani ciddi seyirli EAAH ile iliskili bulunmustur.
The new inactivated EV71
vaccine, made by Beijing Vigoo Biological, was developed for use in the Asia-Pacific region, which accounts for most of the serious cases of the disease that can cause potentially fatal meningitis and encephalitis.
The results showed that it prevented 90 percent of cases of hand, foot and mouth disease caused by EV71
Herein, the activity of punicalagin against EV71
replication was evaluated in vitro and in vivo.
The Ministry of Health's record also showed that there was a higher circulation of the EV71
strain, which has been known to cause infections to the brain, heart and lungs.
The boy died in the southern province of Guangdong from a suspected case of the disease that was apparently caused by the enterovirus 71, or EV71
, health authorities said.
Antibodies that neutralize the EV71
virus were measured in individuals who received both doses of the vaccine.
Yin continued, "Additionally, we continue to move forward in the approval process for our EV71
The 5 most frequently observed genotypes during each phase were phase I: E6, E13, E9, polio Sabin strain, and CB2; phase II: CB5, E18, CB3, CB2, and E25; and phase III: EV71
, E30, E6, CA16, and CB5.
are the common cause of Hand, foot and mouth disease, and it typically occurs in small epidemics in nursery schools or kindergartens, usually during the summer and autumn months.
The Company is currently conducting two Phase 1 studies of DENVax, a vaccine to protect against dengue fever, as well as a Phase 1 trial of EV71
, a vaccine against hand, foot and mouth disease (HFMD).
NASDAQ:SVA), a leading provider of biopharmaceutical products in China, today announced that the Company received site inspection notification for the commercial production facilities of its EV71
vaccine candidate from the China Food and Drug Administration (CFDA).
The 4 CVA2 strains clustered with EV71
subgenotype B3 strain SAR/SHA66 in the P2 region but with CVA4 strain SZ/CHN/09 in the P3 region.