Smallpox Vaccine for Monkeypox Outbreak
On June 11, 2003, the CDC issued recommendations and interim guidance for the use of Dryvax smallpox vaccine in the prevention and treatment of the recent outbreak of monkeypox infections. The use of the vaccine for this purpose is part of an Investigational New Drug program. Pursuant to this program, persons being vaccinated are required to assume all of the risks and any unknown adverse reactions that may result from the use of the vaccine. The CDC guidelines recommend use of the vaccine for persons in four basic categories, and set further conditions and recommendations for those vaccinations. The Indiana State Department of Health (ISDH) has reviewed those guidelines and, subject to the reservations herein, will implement them for Indiana as follows:
- The ISDH will offer the smallpox vaccine to persons in the following categories:
- Health care workers and other persons who have or are expected to care for someone with suspected monkeypox disease
- Persons who are above one year of age and (a) who have been exposed to recently acquired ill, involved small mammals from implicated dealers, or (b) who have been exposed to confirmed animal cases of monkeypox disease.
- Persons who have had the exposures set forth above but who are under one year of age will be evaluated by the ISDH on a case by case basis for the nature of the exposure and the risks/benefits of receiving the vaccination. Due to the risks of secondary contact of the vaccine virus, the ISDH recommends that any child receiving the vaccination as part of this program should avoid contact with other children and not participate in school or day-care programs until the scab from the vaccination site has fallen off on its own.
Persons investigating suspected human and animal cases, including public health investigators, involved veterinary and animal control personnel.
The CDC guidance provides for the use of the vaccine for persons considered close or intimate contacts of suspected and/or confirmed human and animal cases of monkeypox. Close contact for this purpose is defined under the guidelines as more than three hours of direct exposure within six feet. Intimate contact for this purpose refers to contact resulting in exposure to body fluids or lesions of affected persons. The ISDH is not currently offering or recommending use of the vaccine for persons in this group. The ISDH is currently studying data regarding the likelihood of person to person transmission, and the recommendations for persons in this group, and especially children. The ISDH is also consulting with CDC and infectious disease experts, and will make further recommendations for the use of the vaccine for persons in this group as appropriate.
Persons falling within one of the eligible categories must have been last exposed to the monkeypox disease within four days and no more than fourteen (14) days prior to the vaccination. While the CDC guidelines provide that vaccinations should be “considered” for persons up to fourteen (14) days after last exposure, the ISDH strongly encourages that persons who were last exposed between four and fourteen days prior to vaccination consult with their health care provider regarding the risks and benefits of vaccination. Since there is no current scientific data on the efficacy of the post-exposure use of the vaccine, the risk of the vaccination more than four days after exposure may outweigh the benefits.
Further, the vaccine is contra-indicated for persons who are significantly immuno-compromised (e.g., persons with diseases or conditions that weaken the immune system, such as HIV/AIDS, leukemia, lymphoma, cancer, agammaglobulinemia, or who are receiving treatment with alkylating agents, antimetabolites, radiation, large doses of corticosteroids, or other immunosuppressive medicines). These persons should not be vaccinated.
- A person falling within one of the eligible categories who wishes to be vaccinated will be required to obtain an order from their physician or other qualified health provider. A physician evaluating whether a person fits within one of the eligible criteria shall be responsible for contacting the ISDH or their local health department for guidance and assistance in authenticating the exposure. The ISDH can be contacted at 317-233-1325 at any time 24 hours a day. The ISDH will also maintain a list of vaccination clinic locations, dates and times.
- Vaccinations shall be voluntary.
- The vaccine will be offered at hospitals and through local health departments where suspect/confirmed cases have been identified and/or treated, and to other hospitals and local health departments throughout the state as needed. Vaccinators and vaccination locations or clinics should take reasonable steps to secure the vaccination locations or clinics and to protect the privacy of the vaccinators and persons being vaccinated. Vaccination locations or clinics must follow the ISDH guidance for operating a smallpox vaccination clinic.
- Vaccinations should be made from existing stockpiles of vaccine present in each of the state’s ten (10) bioterrorism districts, whenever possible. Vaccine may be transported between local health departments and vaccination locations or clinics. ISDH personnel will assist with the transportation and transfer of the vaccine as needed.
- The vaccine will be administered by vaccinated, trained members of established smallpox vaccination teams and pursuant to established smallpox vaccination protocols. Trained vaccinators, not already vaccinated, will be offered the smallpox vaccination.
- The vaccinations shall be carried out in accordance with these guidelines and within the confines of the CDC Interim Guidance.
- Each person receiving the vaccination as part of this Investigational New Drug program shall be provided with a copy of the CDC “Participant Consent Form for Dryvax Smallpox Vaccine for Monkeypox Outbreak,” and shall be required to review and sign that form before the person or, if applicable, the person’s minor child shall be vaccinated.
- Persons receiving the vaccine should be instructed on the proper care of the vaccination site. Careful site care is needed to prevent the transmission of the vaccine virus.
- Vaccinations shall be conducted in the same manner as they have been conducted as part of Phase I Pre-Event Vaccination. This includes using the same patient intake form and assigning CDC provided Pre-Event Vaccination Numbers (PVN) to each person.
- Adverse reactions to the vaccinations shall be recorded and reported to both the local health department and to the ISDH through the main ISDH contact number, 317-233-1325.