Cer­vi­cal can­cer vac­cine ap­proved by Chi­nese au­thor­i­ties

BioSpectrum (Asia) - - Regulatory News -

Ini­tial ship­ments of Cer­varix, the first vac­cine for cer­vi­cal can­cer to be ap­proved for use on the Chi­nese main­land, has passed in­spec­tion by Chi­nese qual­ity au­thor­i­ties and is head­ing to health clin­ics across the coun­try. Cer­varix, de­vel­oped by GSK, was ap­proved by the China Food and Drug Ad­min­is­tra­tion in July last year. Cer­varix has been reg­is­tered in 132 coun­tries and re­gions, and more than 69 mil­lion doses have been ad­min­is­tered world­wide, ac­cord­ing to GSK. A clin­i­cal trial in China, backed by CFDA and cov­er­ing more than 6,000 fe­males be­tween 18 and 25 from 2008 to 2015, showed the vac­cine gen­er­ally to be more than 90 per­cent ef­fec­tive.

Be­cause of its high cost, the vac­cine may not be in­cluded in China’s na­tional im­mu­niza­tion plan. The three doses re­quired for the vac­ci­na­tion may cost more than 1,700 yuan ($253) in China. Some Chi­nese com­pa­nies are also re­search­ing vac­cines for cer­vi­cal can­cer, and some are al­ready the sub­ject of clin­i­cal tri­als. It is ex­pected that do­mes­ti­cally made vac­cines will be avail­able at lower prices in the next few years, and even­tu­ally they may be in­cluded in the na­tional vac­cine pro­gram.

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