GlaxoSmithKline announced Thursday that China's National Medical Products Administration has approved Shingrix following an expedited review for the prevention of shingles in adults aged 50 years or older. Thomas Breuer, chief medical officer of GlaxoSmithKline's vaccines unit, said "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."
The drugmaker noted that introduction of the vaccine into China will be phased, beginning next year, "to ensure consistent and reliable supply of the vaccine to all countries in which [it] has been launched." The company added that supply of the vaccine will be increased globally "over the next several years," with investments being made to significantly expand manufacturing capacity.
Approval of the vaccine was backed by data from a Phase III programme involving more than 38 000 people. In a pooled analysis of the ZOE-50 and ZOE-70 trials, Shingrix was found to be more than 90-percent effective against shingles across all age groups studied, and also demonstrated sustained efficacy over four years of follow-up.
Shingrix was approved in the US and Canada in 2017, with clearance in Europe and Japan following the next year. Meanwhile, a US Centers for Disease Control and Prevention advisory panel has also recommended use of Shingrix for preventing herpes zoster over Merck & Co.'s Zostavax.
Sales of the vaccine in the first quarter more than tripled year-on-year to 357 million pounds ($452 million).
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