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GMP Dalteparin Sodium
2021-08-20 15:49:09

July 27, 2021/Bio Valley BIOON/ - GlaxoSmithKline (GSK) recently announced that the U.S. Food and Drug Administration (FDA) has approved Shingrix (recombinant shingles vaccine, Chinese trade name: Xin'an Lishi) ), used for immunocompromised adults 18 years and older to prevent shingles. The vaccine is specifically applicable to adults aged 18 and over who are at or will have an increased risk of shingles due to immunodeficiency, or immunosuppression caused by known diseases or treatments.

In the European Union, Shingrix was approved in August 2020 for use in adults 18 years of age or older with an increased risk of shingles to prevent shingles and post-herpetic neuralgia (PHN).

Shingrix is a recombinant subunit adjuvant vaccine that is injected intramuscularly in two doses. This product was approved by the US FDA in 2017 for the prevention of shingles in adults aged 50 and above. Shingrix is not suitable for the prevention of primary varicella infections. The approval for immune-compromised people aged 18 years and older expands the number of people who can prevent shingles through Shingrix.

It is worth mentioning that Shingrix is the first shingles vaccine approved for immunocompromised people. Individuals with low immune function are at greater risk of developing shingles and related complications than individuals with normal immune function. In terms of vaccination, Shingrix is divided into 2 doses for adults with normal immune function, with an interval of 2-6 months. However, for immunocompromised adults and adults who will benefit from a shorter vaccination regimen, the second dose can be given within 1-2 months after the first dose.

In China, Shingrix was approved in June 2020 for the prevention of shingles in adults aged 50 and above. It is worth mentioning that Shingrix is one of the country’s first batch of 48 "clinically urgently needed new drugs" that have been marketed overseas quickly introduced by the country, and it is also the first domestically marketed recombinant shingles vaccine, which effectively fills in the prevention of herpes zoster disease in China. The gap in the field has further expanded my country's vaccine prevention system.

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