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China refuses to release safety record of HPV vaccine ahead of national launch
About the author: 
Bryan Hubbard

China’s drug regulator is refusing to release the safety reports on the Cervarix HPV vaccine ahead of the drug’s national launch next year.

The vaccine, manufactured by GlaxoSmithKline (GSK), is to be made available to all girls in China aged from nine years in 2017. It is designed to prevent cervical cancer.

Ahead of the launch, it was tested on 6,000 Chinese girls—but authorities are refusing to release the toxicology reports and clinical trial data that would reveal any side effects and adverse reactions suffered by the girls.

Activists in Beijing requested China’s drug regulator, the Chinese State Bureau of Food & Drug Supervisory Administration, to release the data last July, but the bureau has refused to do so, on the grounds that it “involves enterprise commercial secrets”—in other words, because the results are a trade secret.

One reason for the secrecy could be because the trial wasn’t properly constructed, and the vaccine was never tested against an inert placebo. As a result, adverse reactions could be experienced by those given the vaccine or the placebo, so reducing the risk profile of the vaccine itself.

The decision is unprecedented in developed countries, where safety takes precedence over trade secrecy. It also goes against the policies of the Healthy China initiative, set out by China’s chairman Xi Jin-ping, says researcher Cen I-wan.

China’s drug regulator has also received a request from pathologist Dr Sin Hang Lee to rethink its decision to grant its approval for Cervarix’s launch. Dr Lee, who studied in China but now lives in the US, says the HPV vaccines haven’t prevented even one case of cervical cancer, and yet had been associated with tens of thousands of reports of adverse reactions in young girls, ranging from nervous disorders, chronic disabilities and even death.


References

(Source: SaneVax Inc)

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