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China approves GSK's shingles vaccine Shingrix

Published on 24/05/19 at 10:42am

GSK’s shingles vaccine has secured approval in China, the company said, after the National Medical Products Administration (NMPA) authorised the therapy for the prevention of herpes zoster in adult patients over the age of 50.

In 2018, Shingrix was included as one the 48 “clinically urgently needed new medicines” in China, and was thus put through an accelerated review process. The vaccine will be first introduced in 2020, and will be phased in gradually to ensure a consistent supply. GSK also confirmed it plans to increase its investment to expand its global supply of Shingrix over the next few years

The vaccine therapy is already approved in the US, EU, Canada, Japan and Australia, based on data showing an efficacy of more than 90% in all age groups which was sustained over a four-year follow-up period.

“Today’s approval of Shingrix in China is recognition of the significant scientific advance this vaccine represents,” commented Dr Thomas Breuer, Senior Vice President and Chief Medical Officer of GSK Vaccines. “In the pivotal studies the vaccine has shown over 90% efficacy across all age groups in the prevention of shingles, a disease that affects one in three people across the Asia-Pacific region. It can result in lasting pain and other complications which can severely impact the quality of people’s lives.

“We welcome the Chinese government’s progress to enable faster entry of new products into China and we look forward to working with the relevant agencies to bring the benefits of this vaccine to local communities,” he added.

Matt Fellows

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