GlaxoSmithKline (GSK) will conduct clinical trials in Korea of its Rotavirus vaccine “Rotarix,” with the exclusion of PCV (Porcine circovirus).

The Ministry of Food and Drug Safety (MFDS) _{식품의약품안전처} has approved the 3a clinical trial plan of Rotarix Pre-filled Syringe Injection, which excluded PCV.

Rotavirus vaccine 'Rotarix’ of GSK

The clinical trials will test clinical consistency among three lot productions after giving the liquid drug devoid of PCV two times to healthy infants six- to 12-week-old and compare their immunogenicity, antigen, and safety with the frozen tablet of Heart Rate Variability(HRV) vaccine that has already won the approval.

The clinical trials will exclude the controversial PCV. In 2010, the U.S. Food and Drug Administration (FDA) recommended GSK to stop selling the Rotarix vaccine temporarily after it detected the animal-carrying virus PCV-1. The PCV-1 virus is in pigs and mostly detected in processed food and pork meat, but isn’t harmful to animals or people.

At that time, the ministry also halted its sale temporarily in Korea. But the FDA said there wasn’t a safety problem related to PCV-1 two months after the controversy and Korea allowed the resumption of its use.

Even though the PCV controversy was solved, the U.S. agency asked the company to check safety and effectiveness of Rotarix without PCV, and GSK has decided to perform clinical trials in various countries.

"There isn’t a problem with PCV, but we decided to do clinical trials without PCV. It isn’t clear when we got the recommendation from FDA, but we included Korea because they should be multinational trials. PCV is harmless to people, but we want to dispel any suspicion," a GSK official said.

Meanwhile, MSD Rotatec_로타텍 is also distributing the vaccine without PCV by changing manufacturing processes. "MSD Rotatec also found PCV virus in its drug, and the FDA has recommended us to change production process," said an official at MDS Korea_한국MSD.

lhs@docdocdoc.co.kr

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