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MERIEUX INSTITUTE LOWER DOSE/LOWER COST IMOVAX I.D. RABIES VACCINE

Executive Summary

MERIEUX INSTITUTE LOWER DOSE/LOWER COST IMOVAX I.D. RABIES VACCINE will be available in January. Price to the trade for a three-dose regimen of the .1 ml intradermal vaccine will be approximately $75 compared to $165 for three doses of the currently marketed 1 ml intramuscular vaccine, the company says. The new vaccine is supplied in pre-filled syringes designed to deliver a .1 ml dose. FDA emphasized the lower cost of the new dose vaccine in a Dec. 15 press release. Citing the June approval of the vaccine, the agency said that "because it is one-tenth the currently used one milliliter dose, the vaccine will be much less expensive." FDA noted that the lower cost may promote "wider use by people visiting or camping in areas where there are many rabid animals." The release adds that the vaccine may also be "used to protect people traveling abroad to rabies endemic areas, such as parts of Africa, India, and Latin America." The low dose vaccine is indicated only for people who have not been bitten by a rabid animal. The 1 ml dose, however, is used in the treatment of people bitten by rabid animals as well as in the prevention of rabies. Merieux said the 1 ml dose will continue to be available for the preventative indication. The Rhone-Poulenc subsidiary explained that as a preventative vaccine, the higher dose vaccine is more appropriate than the .1 ml vaccine for certain people at risk of rabies. For example, the company noted that higher dose vaccine should be used in travelers who will also be receiving the antimalarial chloroquine and in people who may be exposed to rabies less than 30 days after vaccination. Approval for the low dose vaccine was obtained through an amendment to the firm's license application for the 1 ml vaccine. Merieux Institute said it submitted the amendment to FDA in 1982. The firm suggested that approval may have been delayed due to results of a Centers for Disease Control study in Peace Corps volunteers that found decreased titers with concommitant chloroquine vaccinations.
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