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P.T. Jyothi Datta

Mumbai, July 13 Multinational drug-major Merck Sharp & Dohme will revise the labelling on its cervical cancer vaccine Gardasil, after it informs the Indian drug regulatory authority later this month.

The revised label will inform patients and advise doctors on adverse events including fainting and seizure-like activity seen in some vaccination cases. Last month, the United States Food and Drug Administration (FDA) had approved additional labelling on Gardasil warning healthcare providers of such adverse events that could cause falling and traumatic injuries.

“In case of a global update to label; the due process to update the label information locally is to notify the DCGI (Drug controller General of India) with an updated local package insert along with supporting documents. These documents normally include US/EU pack insert which has been updated and approved by respective regulatory authorities. This update in case of Gardasil is planned for submission to DCGI by mid-July 2009,” said MSD Pharmaceuticals’ Medical Director, Dr Swashraya Shah, responding to Business Line queries.

MSD is a wholly-owned subsidiary of US-based Merck & Co.

The company will undertake the labelling revision after informing the DCGI later this month, the official added.

Cervical cancer is caused by the human papilloma virus. And while Merck’s Gardasil targets strains 16, 18, 6 and 11, GlaxoSmithKline’s (GSK) bivalent vaccine Cervarix targets strains 16 and 18. Gardasil is for children and women between nine and 27 years, while GSK targets the 10 to 45 age group.

In India, cervical cancer vaccines are being actively promoted by both MSD and GSK Pharmaceuticals. MSD launched Gardasil in India, late 2008 and GSK launched Cervarix locally in early 2009.

Regulatory authorities often take note of observations made in different countries. Giving details on the local fall-out of the USFDA caution, a GSK spokesperson told Business Line: “As of date, GSK India has not received any communication related to labelling changes for Cervarix from the DCGI’s office.”

But then again, GSK’s Cervarix does not come under the FDA purview, because it has not yet got regulatory clearance to sell in the US, observed an industry representative.

So as Cervarix and Gardasil cover more ground here, the onus will be on the DCGI to watch for adverse events, if they are reported locally.

Significantly, the FDA said, syncope (fainting) had been reported after other adolescent and adult vaccines were given and so was not unique to Gardasil or even vaccines. The falls and injuries, after taking Gardasil, were preventable if people remained seated or lay down for 15 minutes following the vaccination, the FDA noted.

Based on ongoing assessments of vaccine safety, the FDA said it found that Gardasil was safe and effective and “its benefits continue to outweigh its risks”. However, as part of its ongoing surveillance of vaccine safety, the “FDA is evaluating whether changes to the labeling concerning syncope are needed for other adolescent and adult vaccines,” the US regulator observed.

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