(CercleFinance.com) – GSK announced today that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has agreed to review the regulatory application of Shingrix (recombinant shingles vaccine or RZV) for the prevention of shingles in adults aged 18 years and older at increased risk.
Recombinant herpes zoster vaccine (RZV) is a non-live, recombinant subunit vaccine administered intramuscularly in two doses. It was initially approved in 2019 by the NMPA to prevent shingles in adults ages 50 and older.
Globally, shingles will affect up to 1 in 3 people in their lifetime. Various factors can increase the risk of developing shingles, including older age and immunodeficiency.
It is estimated that there are around 6 million cases of shingles in China each year.
The NMPA application is based on six clinical trials conducted on patients aged 18 and over who have recently undergone a hematopoietic cell (stem cell) transplant, a kidney transplant or suffering from blood cancer, a solid tumor or HIV.
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