Bioterrorism Preparedness Program

Smallpox Information for the Public

Questions and Answers on Rhode Island's Smallpox Vaccination Plans

April 14, 2003

1. What is the Federal Smallpox Vaccination Program and how does Rhode Island plan to participate?

The Federal Smallpox Vaccination Program is part of a national initiative to protect the public. The federal government provides smallpox vaccine and asks the States to administer it to US residents. The voluntary program will occur in at least three phases starting with (1) a small number of health and safety workers ("strategic reserve"), possibly expanding to (2) all health care workers and finally, if necessary, (3) the entire population. All states, including Rhode Island, are cooperating with the voluntary program. Rhode Island began the first phase of vaccinations on March 13, 2003. The results of the first phase will be used in determining how to respond to subsequent phases in Rhode Island.

2. How did Rhode Island respond to the federal recommendations for smallpox vaccinations?

HEALTH filed a statewide plan for the first phase of smallpox vaccinations for up to 1200 volunteers in essential health and public safety positions. The federal government approved Rhode Island’s plan. Implementation began on March 13, 2003.

3. What will it take for Rhode Island to implement this recommendation?

The RI Department of Health (HEALTH) secured the cooperation of key organizations, especially Rhode Island’s acute care hospitals, the RI Department of Mental Health, Retardation and Hospitals (MHRH) and the RI Emergency Management Agency (RIEMA) to implement the first phase of our plan.Financially, we slowed down some other bioterrorism preparedness projects (communications equipment, travel, consultants, etc.) to pay for this phase of the federal recommendations. The direct cost of vaccinating 1200 volunteers is about $250,000-$300,000. Hospitals will pay the salaries of vaccine volunteers and may incur some costs for substitute workers if volunteers require time off.

4. How will Rhode Island arrange for medical nursing and support staff to implement this recommendation?

Current HEALTH bioterrorism preparedness staff will provide supervision and support for the smallpox vaccine program. HEALTH also contracted for medical services with the Center for Biodefense and Emerging Pathogens (CBEP) at Memorial Hospital and with Maxim Healthcare Services, Inc., for emergency public health nursing services.

5. Now that a federal program has been announced, how will Rhode Island implement the policy? What are the first or next steps for Rhode Island?

Rhode Island’s pre-event plan is posted on the website: www.health.ri.gov. Briefly, employers are offering vaccine to volunteers (mainly from acute care hospitals, emergency medical transport systems, the National Guard and the State Police) who may be asked to fill certain emergency roles if a case of smallpox occurs in Rhode Island. All will receive trainings about what to expect from the vaccine. Most volunteers will be vaccinated at a central clinic. HEALTH is training physicians, nurse practitioners and nurses at each hospital how to evaluate vaccinees for adverse effects and how to check vaccinees every day until the vaccination scab falls off.

6. Who is responsible for implementing the federal vaccination plan in Rhode Island?

The Director of the RI Department of Health is the responsible official and will lead implementation of the program, in partnership with other state agencies and private organizations.

7. Which Rhode Island non-government agencies are involved?

The state's acute care hospitals are the main non-government agencies involved. The hospitals are informing, recruiting and training most of the volunteer vaccinees in close coordination with the Department of Health.

8. How do people get chosen for smallpox vaccination?

Rhode Island is offering vaccine to volunteers at each of the acute care hospitals, including:

• "arm checkers" or 1-2 nurses from each hospital who will monitor the vaccinations of other hospital staff during this program,a number of hospital health care response teams (up to 5 persons each) who will vaccinate others if mass vaccination should become necessary,sufficient emergency room staff so that vaccinated persons are available at all times to isolate and care for any smallpox victims, and
• various other healthcare professionals and support staff to operate a 100-bed smallpox hospital if necessary.

The state also is offering vaccine to a small number of state police and emergency medical transport volunteers, National Guard, and public health staff (e.g. epidemiologists, Medical Examiners, and laboratory personnel).

9. Who is giving the vaccinations in Rhode Island?

HEALTH operates the vaccine program through contracts with the Center for Biodefense and Emerging Pathogens (CBEP) at Memorial Hospital and Maxim Healthcare Services, Inc.

10. Who determined which hospitals and medical facilities will have Health Care Response Teams?

We expect that all acute care hospitals in Rhode Island will have some staff vaccinated to care for potential cases of smallpox.

11. How many people do you think will be vaccinated in Rhode Island as a result of the Federal policy?

Rhode Island expects to vaccinate up to 1200 people during the first phase of this federal program.

12. When will the first people in Rhode Island be vaccinated as part of the state program? Who are these people likely to be?

The core medical team (CBEP) and the "arm checkers" have already been vaccinated. The remaining vaccinations will occur over a three-month period at a statewide smallpox vaccine clinic located at the Eleanor Slater Hospital in Cranston, RI. Because those vaccinated may feel unwell during the second post-vaccination week, the vaccinations for any one employer will be spaced out over the full period.

13. How does Rhode Island plan to monitor and deal with smallpox safety?

Safety is the primary concern. Some people should not get vaccinated at the present time due to health conditions or living circumstances that increase the risk of a bad reaction for themselves or others. People most likely to have side effects are those with certain skin conditions, weakened immune systems (from transplants, HIV or cancer treatment), pregnant or breastfeeding women or children under age 18.

The Rhode Island plan for safety and monitoring includes:

• All potential volunteers receive training and an information package. Those who choose to continue in the process receive additional training and are tested for HIV. Women of childbearing age are screened for pregnancy.All potential volunteers are screened for diagnosed heart disease and factors indicating a potential for heart disease.All remaining volunteers receive rigorous screening to minimize potential for adverse side affects for themselves, family members and others.Post-vaccination, the staff check the vaccination daily and replace dressings when needed.
• There is a 24/7 medical hot line if a vaccinee should become ill at other times.

14. What are some of the adverse effects of smallpox vaccination?

Most people experience normal, usually mild reactions that include a sore arm, fever and body aches. About 1000 out of every million experience reactions that, while not life-threatening, are serious—including an allergic reaction at the vaccination site or spread of the vaccinia virus to other parts of the body. Rarely (less than 50 times per million vaccinations), people have very bad or potentially life-threatening reactions to the vaccine, such as a generalized spread of the vaccinia virus to other parts of the body or encephalitis. Between 1 and 2 out of every million people vaccinated die as a result of life-threatening reactions to smallpox vaccine.

15. What about cardiac (heart) problems?

On March 26, 2003, CDC issued a health advisory recommending as a precautionary measure that persons with known cardiac disease not be vaccinated as response team members in the pre-event smallpox vaccination program at this time. The Advisory Committee on Immunization Practices recommends that persons be excluded from the pre-event smallpox vaccination program who have known underlying heart disease, with or without symptoms, or who have three or more known major cardiac risk factors (i.e., hypertension, diabetes, hypercholesterolemia, heart disease at age 50 in a first-degree relative, and smoking). Rhode Island is following these guidelines.Persons receiving smallpox vaccine will be informed that myopericarditis is a potential complication of smallpox vaccination and that they should seek medical attention if they develop chest pain, shortness of breath, or other symptoms of cardiac disease within 2 weeks after vaccination.

16. How will smallpox vaccination adverse events be handled?

All vaccinations are checked daily until the scab falls off and the scar heals. A team of infectious disease specialists evaluate and manage any potential adverse effects among RI volunteers.

17. Are Rhode Island hospitals prepared for recognizing and treating vaccination adverse affects?

Each hospital will have a team to monitor vaccinees for three-four weeks following their vaccination. HEALTH. The infectious disease specialists (CBEP) have trained these teams.

18. What will Rhode Island do if there is a confirmed serious adverse reaction, or death, from the vaccine?

We intend to avoid serious complications through careful screening and monitoring, but some may occur. Our reaction will be determined by a complete, expert analysis of the circumstances. We will publicly report any suspected and/or confirmed adverse reactions requiring hospitalization without disclosing any identifying information about the person involved.

19. How should the public weight the risks vs. benefits of vaccine?

The federal government does not recommend smallpox vaccine for the general public. Prior to the existence of a single case of smallpox anywhere in the world, the risk of adverse consequences from the vaccine may outweigh the benefits—at least for some people. This is why the Rhode Island Pre-Event Vaccination Plan has so many safety controls for volunteers who could be asked to provide immediate response in a smallpox emergency.Rhode Island’s ability to respond to a case of smallpox does not rise or fall solely on the number of volunteers vaccinated at this phase. The state smallpox prevention and control plan includes measures such as post-exposure vaccination, ring vaccination and a smallpox hospital, which will protect the population from smallpox. However, pre-event vaccination for a small number of health care workers provides an added measure of safety.

20. Will Rhode Island need additional funds to implement this policy?

HEALTH does not expect to need additional funds to carry out vaccination of the "strategic reserve" during Phase I of the federal program. The implementation of future phases in RI will require substantial additional resources.

21. What costs will Rhode Island have to assume as a result of the federal smallpox program?

HEALTH expects to pay the entire direct cost of the Phase I Vaccination Program out of federal Bioterrorism Preparedness funds. Hospitals and other participating agencies will contribute costs related to recruiting volunteers, time off and other related expenses.

22. Why can't members of the public get smallpox vaccine right now? Why do they have to wait?

The Federal government has not released vaccine for the general public and does not recommend mass vaccination of the public at large. Protecting health care workers is an essential precondition to any larger vaccination program, should it become necessary.

23. How great or real a threat is smallpox to Rhode Island?

We don’t know for sure. Smallpox was proposed as a biological weapon in the 1980s. Some of the virus may have gotten into the hands of those who are willing to use it. The last naturally occurring human case of smallpox was reported in 1977 in Somalia. The last US case occurred in 1949.

24. When was the last person in Rhode Island vaccinated for smallpox?

Smallpox vaccinations for the general public stopped about 1972. Some health care workers, researchers and military personnel have been vaccinated since then.

25. Is anyone in Rhode Island trained to administer smallpox vaccine?

Yes, the CBEP Team, under contract to HEALTH, was trained to administer smallpox vaccine. They will train others to administer vaccine, monitor vaccinees and identify and treat adverse conditions.

26. Is this an indefinite program or does it have a stopping point? How long do you expect to continue a smallpox vaccination program?

Current activities related only to vaccinating a strategic reserve of volunteers on a pre-outbreak (no smallpox cases) basis. Rhode Island’s post-event response plan would be activated if an actual case of smallpox occurs.

27. In general, how prepared is Rhode Island for a smallpox case or outbreak?

Preparation is a process, not a single event. We have plans, based on past experiences, that could be implemented to respond to actual cases of smallpox. We continue to exercise and refine those plans.

Rhode Island’s ability to respond to a case of smallpox does not rise or fall solely on the number of volunteers vaccinated at this phase. The state smallpox prevention and control plan includes measures such as post-exposure vaccination, ring vaccination and a smallpox hospital, which will protect the population from smallpox. However, pre-event vaccination for health care and public safety workers provides an added measure of safety.

28. Why did Rhode Island hold off starting the smallpox vaccination program?

Rhode Island planned to implement the vaccination program in late February. The Station nightclub fire of February 20^th introduced scores of severely burned patients into Rhode Island’s acute care hospitals. The presence of newly-vaccinated health care workers in institutions with many severely burned patients presented an unacceptable risk of involuntary vaccinia virus transmission and other adverse consequences of vaccination. Vaccination commenced in Rhode Island on March 13, 2003. For more information consult www.health.ri.gov or www.CDC.gov