GlaxoSmithKline (GSK) has received Chinese approval for its shingles vaccine Shingrix, but with demand already outstripping supply the firm must invest significantly in its production capabilities.
China’s National Medical Products Administration (NMPA) has approved Shingrix, a non-live, recombinant subunit vaccine for the prevention of shingles (herpes zoster) in adults aged over 50.
Shingrix underwent an expedited review after falling on a list of 48 ‘clinically urgently needed new medicines’ in China aimed at bringing critical new prevention and treatment options to the country. Thomas Breuer, chief medical officer of GSK Vaccines welcomed the expedited process and said the firm is looking “forward to working with the relevant agencies to bring the benefits of this vaccine to local communities.”
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Changing regulations and reforms have opened China up, and with the country having a fifth of the world’s population and a growing need for biological drugs and vaccines, the market is a major target for multinational pharma companies.
Production problems
To feed the Chinese demand for Shingrix, GSK told this publication it will introduce the vaccine in phases, beginning 2020, to ensure as little disruption on what is currently an overwhelmed global supply chain.
Shingrix received US Food and Drug Administration (FDA) in October 2017. It is also marketed in numerous over territories, including Europe and Japan, and in 2018 GSK reported global sales of around $1 billion.
However, sales have been stilted by a lack of global capacity. The vaccine remains on the US Centers for Disease Control and Prevention (CDC) website as being affected by delays and shortages, attributed to high levels of demand.
GSK is looking to address the capacity question, and in January an additional, existing facility in France was approved by the FDA to produce the vaccine. More recently, the firm pumped $100 million into its production site in Hamilton, Montana.
And while the firm would not give us details on further developments, we were told: “GSK expects to increase supply of Shingrix globally and is investing in significant capacity expansion,” over the next few years.
While there is no evidence that the two are related, last week WuXi Biologics announced plans to create a vaccine production joint venture – WuXi Vaccines – to help bring a multinational’s vaccine candidate to the Chinese market.