CHICKENPOX VACCINE NEARS APPROVAL IN USA

6 December 1993

An advisory committee to the US Food and Drug Administration is now writing what is expected to be its recommendation for approval of Merck & Co's Varivax chickenpox vaccine, and it is looking increasingly like the agency will grant final approval by the coming spring, reports the Marketletter's US correspondent.

One sign that approval will be forthcoming is the proposed guidelines that a Centers for Disease Control advisory committee has drafted, recommending that Varivax should be given to infants at age one. If approved, the vaccine would eventually be incorporated into the measles-mumps-rubella (MMR) vaccine now given, according to Stuart Katz of Duke University, who heads the CDC panel. While the vaccine has not been around long enough to know if it offers lifelong protection, Dr Katz said that if needed, adults can always get a booster. Importantly, the vaccine may also offer protection against shingles.

It has been predicted that the vaccine could cut chickenpox cases to 240,000 annually, with only four deaths, from the present level of 3.9 million cases and 90 deaths. About 9,000 people in the USA each year develop complications from chickenpox infection, ranging from blood infections to brain damage. A study sponsored by the CDC has found that Varivax would cost $157 million a year to incorporate into the national vaccination program, but would in turn save almost $700 million annually in medical bills and workdays lost by the parents of sick children. A version of the vaccine has been successfully used in Japan and Europe since the mid-1980s.

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