Volume 40 Issue 3, Fall 2013, pp. 303-309

ABSTRACT

In 2008, the US experienced a disruption in human rabies vaccine supplies, leading public health authorities to prioritize vaccine release for post-exposure prophylaxis (PEP) and limit vaccine supplies for pre-exposure prophylaxis (PreEP) in high-risk groups. In 2008, the Association of American Veterinary Medical Colleges (AAVMC) surveyed its member institutions on rabies vaccination policies and practices. Senior administrators at Colleges of Veterinary Medicine (CVMs) and departments of veterinary science and comparative medicine were asked to identify the person most knowledgeable about their institution's student rabies vaccination program. Respondents were asked to describe their policies and procedures for administering PreEP to veterinary medical students and staff and to estimate the annual demand for student and staff PreEP vaccine. Twenty-one CVMs responded. Twenty (95%) reported requiring PreEP of veterinary medical students and 16 (80%) of those 20 required vaccination upon matriculation. An estimated 7,309 doses of vaccine were required for PreEP of an estimated 2,436 first-year US veterinary medical students. Seventy-two percent of respondents administered PreEP in August, September, and October, coinciding with the highest public demand for PEP. CVMs should consider altering the timing of rabies vaccine administration to veterinary medical students and staff to other months, thereby helping to ensure that PEP rabies vaccine will be available to people with validated rabies exposures and to ensure that supplies will be available for PreEP of students and staff. AAVMC may wish to identify and support a point of coordination to facilitate the purchase and distribution of human rabies vaccine among its US member CVMs.

Veterinary medicine has played a major role in the prevention and control of rabies in human and domestic animal populations in the United States. Many factors have contributed to substantial decreases in the number of reported rabies cases in human and domestic animal populations. These factors include state regulations and local ordinances that make rabies vaccination a prerequisite for licensing dogs and cats; animal-shelter spay and neuter policies that reduce the number of rabies-susceptible stray animals; the ready availability of safe, effective vaccines for pre-exposure prophylaxis (PreEP) of people at high risk for exposure to rabid animals and post-exposure prophaylaxis (PEP) of people following exposure to rabid animals; and the education of veterinary medical and other health professionals and the public about rabies risks and prevention.1,2 In 1946, 8,394 cases of rabies were reported in dogs and 69 in humans; in 2010, 69 cases of rabies were reported in dogs and two in humans, representing declines of 99.2% and 93.9% respectively.3,4

The success of rabies prevention and control efforts in the US stands in marked contrast to the situation in many low and middle income countries where prevention and control efforts are limited and canine-variant rabies is common.5,6 Nonetheless, in spite of the success of prevention efforts in the US, transmission of rabies from wildlife reservoirs remains an ever-present threat to human health.7,8 For example, from January 1 to May 31, 2010, 114 cases of rabies in raccoons were reported in Central Park, Manhattan,9 a site that receives an estimated 37 to 38 million visits by 8 to 9 million people annually.10 Furthermore, of the 6,154 rabid animals reported by 48 states and Puerto Rico to the Centers for Disease Control and Prevention (CDC) in 2010, approximately 92% were wildlife species, with bats constituting 23.2% of these cases.4 The number of laboratory-confirmed rabid bats in the US has increased steadily from fewer than a hundred cases in 1960 to more than a thousand in 2010.11 For the period 1995–2011, 68.9% of the 45 cases of rabies diagnosed in humans and determined to be not attributable to transplanted organs and tissue were found to be of bat origin.12

In the US, veterinarians, including students, faculty, and staff at Colleges of Veterinary Medicine (CVMs), are among the people at highest risk for exposure to rabid animals.1315 The clinical teaching mission of CVMs increases the likelihood of multiple human exposures to a single rabid animal. This is particularly worrisome for veterinary medical students who are usually the first individuals to examine animal patients but who lack the clinical experience of staff veterinarians. They must learn how to recognize and handle animals suspected of having rabies and animals that have been exposed to rabies suspects. They must also learn to communicate appropriate and timely information about rabies to clients and other members of the public. The surest means of protecting students from rabies is to teach them proper personal precautions to minimize their risk of exposure. However, due to the possibility of unrecognized exposures that could result from frequent contact with animal patients during veterinary students' education, the vaccination of veterinary medical students before they begin hands-on experience with animals (i.e., PreEP) has been recommended for decades.1315

In 2008, rabies vaccines approved for use in people in the US were produced by two manufacturers—Sanofi Pasteur and Novartis—in their European facilities. In 2007, Sanofi Pasteur began renovations to its production facilities, leading to a delay in 2008 of its production of rabies vaccine and resulting in a disruption in the supply of human rabies vaccine destined for the US that year. The manufacturer announced the disruption in supply in May 2008, preceding the typical CVM preparations for administering PreEP vaccine to matriculating students and others in need of primary or booster vaccinations. In August 2012, Sanofi Pasteur again notified health care professionals in the US that, due to a manufacturing delay that coincided with a significant increase in demand during the summer months, rabies vaccine supplies would be limited and the vaccine would be available for PEP use only. This announcement occurred at the time of year when classes begin in most US CVMs. In addition, the CVMs were well into their plans to vaccinate matriculating students and others in need of vaccine at their institutions. In both 2008 and 2012, the CDC posted health alerts noting that supplies of human rabies vaccine would be prioritized for PEP in persons having documented exposures to rabies and that vaccine for PreEP would be temporarily limited.16,17

Because administration of PreEP primary rabies vaccination series for veterinarians typically occurs during veterinary medical school, the Association of American Veterinary Medical Colleges (AAVMC), upon learning of the human rabies vaccine supply disruptions in 2008, anticipated that vaccine for PreEP of students, staff, and faculty at CVMs would be in short supply that year. Furthermore, CVMs expressed concerns that the shortage could well recur in subsequent years, thereby threatening the ability of AAVMC member institutions to meet Advisory Committee on Immunization Practices (ACIP) guidelines on rabies PreEP.

In light of these concerns, AAVMC asked its Public Health Committee, whose members represent most CVMs, to assess the overall situation with respect to rabies vaccine supplies. In turn, the Committee sought to determine (1) the number of doses of human rabies vaccine used annually for PreEP by all of its institutional members and (2) the policies and procedures in place for rabies vaccine administration during a typical year. This information would be used to establish a baseline for the annual need for rabies vaccine among AAVMC member institutions, thereby enabling more efficient use and timing of PreEP vaccine administration to ensure PreEP vaccination of students, faculty, and staff in the event of future disruptions in human rabies vaccine supplies. Accordingly, in 2008 the AAVMC Public Health Committee conducted a survey of the rabies vaccine needs of its member institutions. This article summarizes and discusses the findings of that survey.

In June 2008, the Public Health Committee of the AAVMC developed a survey for distribution to all AAVMC members at that time, including CVMs from the US (N=28), Canada (N=5), and Europe (N=9), and Departments of Comparative Medicine (N=8) and Veterinary Science (N=9) at US academic institutions. Prior to distribution, plans for the survey were approved by the AAVMC Executive Directors Survey Committee. Institutional Review Board approval was not sought as the survey asked for institutional responses on routine procedures and policies already in place at their member institutions, with results to be used by those providing information. The following questions were asked of all AAVMC member institutions about rabies PreEP vaccination of veterinary medical students:

  • Is your college or its outposts in a rabies endemic area? (yes, no, or not sure)

  • Does your college or organization have a requirement for rabies vaccination for all students upon admission? (yes or no); before entry into clinics? (yes or no); other? (yes or no); no mandatory requirement? (yes or no)

  • Who is responsible for scheduling rabies vaccinations at your school? (college administration [Dean or Associate Dean or college administration], professional staff, zoonotic consultants or public health faculty, or other)

  • Do you vaccinate students in mass clinics? (yes, no, or other)

  • [For schools that vaccinate students in mass clinics] When is your student vaccination clinic held? (August through October, November through January, February through April, or May through July)

  • Why is the clinic scheduled for the above time? (The time is logistically easier, the time provides protection closest to clinical experience, or other)

  • Who administers the rabies vaccine to students? (University Health Center [UHC] physician, UHC nurse, or other)

  • Vaccines are administered by intramuscular (IM) injection (yes or no)

  • Vaccines are administered by intradermal (ID) injection (yes or no)

  • Who pays for student rabies vaccinations? (students, university health plan, the CVM, public health department, or other)

  • If vaccine is in short supply, would your institution, including the UHC, approve the use of ID injection for pre-exposure rabies vaccination of students? (yes, no, or other)

  • What is the average annual need for number of doses delivered for rabies PreEP vaccination of your students?

  • How many veterinary medical students are vaccinated in a typical cycle?

The survey was formatted using FormSite.com (http://www.formsite.com) and distributed electronically to Deans of the CVMs, Deans of Academic Affairs, and Health Officers of all AAVMC member institutions. Recipients of the survey were asked to identify the person most knowledgeable about the details of the vaccination program at their institution and have that person respond on behalf of that institution.

To obtain the best possible estimate of the number of doses required annually among responding institutions, we used institutional responses to the questionnaire when answers were in close agreement with published reports of the number of matriculating students at each institution (AAVMC collects this information annually). When information provided by an institution was missing or was judged to be substantially different from published reports, we consulted published reports on the number of students admitted to these institutions in 2008 and multiplied this number by the three doses required for PreEP (days 0, 7, and 21 or 28).

Because it was only the US that experienced a vaccine disruption in 2008, we restricted the analysis to US institutions. In addition, responses from Departments of Comparative Medicine and Veterinary Science at US academic institutions were excluded from the analysis because the few that did respond either did not have students who handled live animals or their vaccine requirements were extremely small and varied significantly from year to year. Thus, the analysis only included responses from the 28 US CVMs.

Twenty-eight responses were received from 21 of the 28 US CVMs (Table 1). Of the 21 responding CVMs, 15 submitted a single response. However, despite requests for a response coordinated and submitted by a single source for each institution, five CVMs each submitted responses from two individuals responding for the same institution, and one CVM submitted responses from three individuals responding for the same institution. Multiple responses from the same CVM that matched exactly were treated as a single response. Multiple responses from a single CVM that did not match are described in more detail in the presentation of results just below.

Table

Table 1 Rabies pre-exposure prophylaxis policies and procedures among veterinary medical students at 21 US CVMs, 2008

Table 1 Rabies pre-exposure prophylaxis policies and procedures among veterinary medical students at 21 US CVMs, 2008

Question Responses
CVM in a rabies-endemic area? n=21
Yes=14
No=5
Not sure=2
PreEP vaccine is required n=20
Upon admission=16
Prior to entering clinics=3
CVMs with >1 response=1
Vaccines scheduled by… n=21
Professional or academic administrators=14
Zoonotic or public health consultants=2
Physician=1
Other=1
CVMs with >1 response=3
Vaccine administered in mass clinics? n=21
Yes=17
No=4
Vaccine administered during… n=17
August, September, October=15
February, March, April=2
Reason for timing of vaccine administration n=17
Logistics=7
Entry into clinics=4
As soon as possible after matriculation=3
CVMs with >1 response=3
Health care personnel who administer vaccine n=20
UHC MD=2
UHC nurse=15
CVMs with >1 response=3

CVM=Colleges of Veterinary Medicine; PreEP=pre-exposure prophylaxis; UHC=University Health Center; MD=medical doctor

Of the 21 responding CVMs, 14 (67%) reported that they were located in a rabies-endemic area; five (24%) reported that they were not, and two (10%) were not sure.

Among the 21 responding CVMs, only one reported not requiring rabies PreEP of its students. Among the 20 CVMs that reported requiring PreEP, 16 (80%) reported requiring it upon the student's admission, and three (15%) reported requiring it before students enter clinics. The one CVM with three respondents sent conflicting information about the timing of vaccination (two respondents stated that vaccination was required upon admission and one stated that it was required before entering clinics).

Professional or academic administrators were reported to be responsible for scheduling rabies vaccinations at 14 (67%) CVMs, zoonotic consultants or public health faculty at two (10%) CVMs, and a physician member of the faculty at one (5%) CVM. One CVM reported that faculty were responsible for scheduling vaccinations but did not specify which faculty, and three CVMs responded with conflicting answers (administration, student health services, and faculty; administration and student health services; an academic department and students themselves).

Seventeen of 21 CVMs (81%) reported vaccinating students in mass clinics, while four (19%) reported that they did not do so. Likewise, 17 (81%) of 21 CVMs reported timing the scheduling of their student vaccinations. Fifteen (88%) of those 17 CVMs reported scheduling student vaccinations in August, September, or October and two (12%) reported scheduling them in February, March, or April. Seventeen CVMs reported at least one reason for choosing the timing of their student vaccinations. Seven reported that the sole reason for scheduling vaccinations in the months they reported was because it was easier logistically for them at that time, while four reported that vaccinations were timed to coincide with students' entry into clinics. Three CVMs reported scheduling them as soon as possible after matriculation, and the remaining three CVMs cited multiple reasons for the timing of vaccine administration.

Twenty CVMs reported which health care personnel was responsible for administering vaccine. Of these, a UHC nurse administered vaccine in 15 (75%) CVMs, a UHC physician in two (10%), a UHC nurse and physician in two (10%), and both types of medical professionals as well as students' own physicians administered vaccine in one CVM (5%).

Of the 20 CVMs that responded to the question about the route of rabies vaccine administration, 19 (95%), reported administering vaccine by the IM route and one (5%) reported administering vaccine by the ID route. Six CVMs reported that they would consider ID administration of vaccine if the disruption in supply of rabies vaccine were to continue, two reported that they would not, and three did not know. Three CVMs reported that other individuals, including staff members of the student health service, would make this decision. One CVM reported that ID administration of vaccine would be considered if it were approved by the Food and Drug Administration (FDA) and no longer considered investigational, one reported that it was unlikely that their CVM would use ID administration because “titers were low” and this route was not approved by the FDA, and four CVMs with more than one respondent gave conflicting answers to this question.

Students in 16 CVMs were reported to be solely responsible for paying the estimated $600 to $800 cost of the three inoculations that comprise a complete PreEP regime. Students in three CVMs were reported to share this expense with others (the CVM and American Veterinary Medical Association insurance). Two CVMs reported that the CVM's development office or the CVM alone bore the cost of student vaccinations.

Respondents were asked to estimate the annual number of doses of vaccine their CVM required for student PreEP. Answers to this question were inconsistent. Some respondents gave the number of students in the matriculating class and others the number of students in the matriculating class multiplied by three doses of vaccine. Some respondents estimated the annual number of doses at less than three times the number of matriculating students, presumably allowing for students who had already been vaccinated before matriculation, and yet others estimated the number of doses at greater than three times the number of matriculating students, perhaps allowing for students whose earlier inoculations had not resulted in sufficiently high antibody titers or for faculty and staff vaccinations. When more than one response was received for a CVM, estimated numbers of doses did not always agree.

We calculated the annual number of doses of rabies vaccine required to administer PreEP to an estimated 1,827 veterinary medical students across the 21 responding CVMs to be 5,482 doses, for an average of 261 doses per CVM. Extrapolating this figure to the seven CVMS that did not respond to the survey, we estimate that 7,309 doses of vaccine would be required each year to provide PreEP to 2,436 first-year veterinary medical students, all considered at high risk for rabies exposure.

The initial motivation for this study was to assess the hypothetical impact that the 2008 rabies vaccine supply disruption would have had on CVM's capability of meeting ACIP rabies vaccine recommendations for protecting their students, faculty, and staff should unanticipated exposure to rabies occur. Our determination—that 7,309 vaccine doses are needed to provide PreEP to 2,436 veterinary medical students in one year—is similar to findings from other studies.18 This same amount of vaccine would also be sufficient to deliver the ACIP-recommended four-dose PEP regimen to 1,827 members of the public who had documented rabies exposures.19 Thus, the timing of vaccination programs by CVMs should be carefully considered by these institutions.

CVMs have an opportunity to contribute to public health in two ways. First, CVMs should redouble educational efforts aimed at preventing rabies exposure among veterinary medical students, faculty, and staff, clients who seek care for their animals, and members of the public. Second, CVMs should tailor the timing of PreEP vaccination clinics for their students, faculty, and staff to avoid the peak periods of public need for PEP. Because the peak for public PEP demand generally occurs from the middle of the summer through the autumn,2022 there may be reluctance on the part of local and national health authorities to release rabies vaccine at that time for lower-priority PreEP. At least 15 CVMs report scheduling rabies PreEP for incoming students in August, September, and October of each year, coinciding with the peak of public demand for PEP. CVMs may thus find themselves in competition for scarce vaccine supplies at this time of year. By altering the timing of vaccination clinics, CVMs can help to ensure that rabies vaccine will be provided to individuals with validated rabies exposures.

Results of this study raised concerns that lines of responsibility at some CVMs for implementing PreEP of veterinary medical students, faculty, and staff may lack clarity and coordination. That multiple responses from six CVMs were received, occasionally with conflicting information, was troubling. Of equal concern was that although rabies is considered enzootic in the contiguous 48 states,4 respondents at two CVMs did not know if their institutions were located in rabies-endemic areas and five responded that their CVM was not located in a rabies-endemic area, possibly indicating that responses to the survey were not provided by the individual most knowledgeable and responsible for the PreEP program. To ensure that rabies PreEP and PEP are administered according to ACIP recommendations, each CVM should identify at least one person who can speak with authority regarding vaccination of veterinary medical students, and everyone, students included, should know where that authority resides. Individuals with authority in rabies PreEP and PEP must be fully informed and remain up-to-date about rabies epidemiology in the geographic area surrounding the CVM. In addition, these individuals should identify appropriate public health authorities to assist in assessing risks regarding the need for rabies prophylaxis.

All but one responding CVM reported requiring PreEP vaccination of veterinary medical students. This practice has become far more widespread since 1986 when only eight of the then 27 US CVMs required pre-exposure vaccination.23 The increase in the number of CVMs requiring vaccination may be driven by several factors that include the development and availability of safe and efficacious human diploid cell rabies vaccines, growing concerns for student safety, changes in the epidemiology of rabies in wildlife populations, increased student participation in clinical and research activities outside the US, and increasing concerns about litigation. In the absence of a requirement for PreEP vaccination by one CVM and considering the high cost of the vaccine, students who are expected to bear at least some of the cost burden may choose to remain unvaccinated and unprotected. Accordingly, we believe that CVMs should consider instituting routine review of their rabies vaccination policies and procedures to keep pace with changes in local rabies epidemiology, risks of exposure, health insurance policies, and health care costs.

ID administration of rabies vaccine has been shown to be effective for PreEP.2427 At present, neither of the two vaccines currently available for rabies PreEP and PEP in the US is approved by the FDA for administration by any method other than IM. Of the 20 CVMs reporting route of administration, 19 reported IM administration and one reported ID administration, but the latter report was not verified. There were considerable differences of opinion among CVMs as to whether ID administration would be considered for use in the event of another rabies vaccine supply disruption and who might be involved in making this decision. Human rabies vaccine supply has been constrained three times in the period 2004–2012.1618,28 The total volume of vaccine recommended for pre-exposure administration by the IM route is 3.0 ml, but there is evidence that a total volume of 0.6 ml delivered by the ID route may be as effective and therefore more cost-effective than the present regimen.27 Therefore, it may behoove CVMs to develop contingency plans that consider ID administration as an off-label use that could be employed to stretch available supplies when necessary; CVMs should discuss and prepare for this situation in advance. Physicians willing to take responsibility for the ID decision-making process should be identified beforehand and included in these discussions.

In 2012, the US again experienced a disruption in the supply of rabies vaccine, raising fears that the significant vaccine restrictions that occurred in 2008 were going to occur again. In light of the continuing threat of vaccine supply disruptions and lack of coordination detected in US CVMs, AAVMC, as the only organization with all US CVMs as members, should help to identify a point of coordination for ensuring that annual PreEP vaccine needs among CVMs are met. The benefits of efficient coordination could be severalfold. First, the coordinating body or unit might act as a clearing house for bulk vaccine purchase, which may decrease the total cost of vaccine, estimated to be between $1,461,600 and $1,948,800. Savings at individual levels could be passed on to price-sensitive students, perhaps decreasing any monetary barriers to vaccination. Second, more efficient coordination in vaccine purchases could result in a simpler and clearer process, rather than the current one that appears to involve much duplication of effort. Third, improved coordination would lead to a higher likelihood that CVMs would avoid holding their vaccination programs in competition with national public health needs, particularly if vaccine supplies are constrained in the future. At the same time, individual CVMs could take steps to modify curricula so that students would not be faced with risk of exposure in the first semester. This could be accomplished by implementing schedule changes and by emphasizing strict biosecurity measures, including hand washing, personnel hygiene, scrupulous first aid for all bites and scratches, and the reporting of suspected exposures to public health authorities. Finally, we suggest that AAVMC consider advocating the prioritization of vaccine supplies to CVMs immediately following supply disruptions when supplies are more readily available.

In light of events described here and the potential future volatility of rabies vaccine supply if no changes occur to current production and distribution practices, disruption of rabies vaccine supply should be anticipated in the future. Results from this survey may also be used by vaccine companies to plan for future demands and by CVMs for contingency planning in the event that a supply disruption recurs in future years.

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