Rabies Vaccine Recall and "Lots" of Strain

Abstract & Commentary

Synopsis: On April 5, 2004, Aventis Pasteur contacted all recipients of IMOVAX Rabies Vaccine to inform them of an urgent recall of their manufactured lots: X0067-2, X0067-3, W1419-2, and W1419-3.

Source: Decker MD. Urgent vaccine recall, letter; instructions for complying with recall; medical opinion from Aventis Pasteur regarding management of patients. Aventis Pasteur Inc. Discovery Drive, Swiftwater Pennsylvania.

Quality-care measurement indicators are taking increasing priority in the current US health care environment. An Institute of Medicine report in 1998 revealed that numerous medical errors occur each year among hospitalized patients. A surge in documentation of quality care has taken place, and the public both demands and deserves safe care with assurance of good quality. Quality preventive care is also of great importance to the traveling public, who seek such services under the assumption that the prevention can be provided with little or no risks.

Recently quality assurance testing of IMOVAXâ Rabies Vaccine revealed one product lot that contained non-inactivated live vaccine virus, albeit the attenuated Pitman-Moore virus. Although this rabies vaccine lot was not ever distributed for use, Aventis Pasteur chose to recall those other vaccine lots that had been produced during the same time period as the affected lot, for "further testing." Thus, the 4 vaccine lots listed above, which were distributed between 9/23/03 and 4/2/04, were called back for confirmatory testing even though they had each "passed all release testing prior to distribution" including tests to confirm the absence of any live virus. No unusual adverse events were noted in any vaccine recipients. Persons who had vaccine from any of the above named lots were advised to undergo additional post-exposure prophylaxis. In some instances, the word of this recommendation caused as much fury and concern in some persons and their family members as though they had actually been bitten by a rabid animal!

Comment by Maria D. Mileno, MD

While Aventis graciously offered to provide the additional safe vaccine doses free of charge, this was not always practical. We had direct experience with such issues in our own clinic. Some individuals received this information while they were still overseas. In Mongolia, some of our patients felt obliged to seek vaccination immediately, placing themselves at possible risk for blood-borne pathogens via needle exposure. For others extensive reassurance was first required to even begin to implement the suggestions. For persons who received the recalled vaccine within 7 days, rabies immune globulin was obtained and administered, not without significant time and expense, to a number of travel medicine practitioners and their patients. Those who had completed the full 3 dose pre-exposure rabies series required only 2 additional vaccine doses. A number of individuals requested a refund for their original vaccine series administered, given the angst they experienced due to this ordeal. Needless to say, quality assurance should be implemented in a more peaceful manner.

On the other hand, some excellent questions arose from this exercise. "What is the real benefit of this incredibly expensive pre-exposure rabies vaccine?" Most practitioners point out that worldwide there is limited availability of rabies immune globulin, the life-saving component of treatment; thus, the pre-exposure series essentially buys time and requires only 2 additional rabies vaccine doses to complete treatment. "Won’t I still have the possibility of acquiring yet another disease via the needles used to give the rabies treatment?" We answer, "yes, but remotely so." "How long does one have after a rabies-infected dog bite to complete the 2 additional vaccine doses, if one has already had the 3 dose pre-exposure series?" I have yet to receive a clear and definitive answer to this question, yet the reality is that it probably takes between 1 day and 1 week at the least to find and access health care that provides post-exposure rabies treatment. No rabies deaths have been reported in persons who have taken the pre-exposure series and then completed the vaccine course as indicated. I guess this information should assure us and allow everybody to sleep at night, right? For patient management or to report adverse events call 1-800-835 3587.

Maria D. Mileno, MD, Director, Travel Medicine, The Miriam Hospital, Assistant Professor of Medicine, Brown University, Providence, RI, is Assistant Editor of Travel Medicine Advisor.