Isolation Strategies to Contain an Outbreak

Organizing Vaccination Operations

The Smallpox Vaccination Clinic Guide was released in the United States as part of the national Smallpox Response Plan. Its purpose is to prepare state and local public health for the logistics involved in conducting mass vaccination clinics after a case of smallpox has occurred. Given the complicated setup for mass immunizations, it’s important for public health officials to start planning before the event occurs. This guide discusses the logistics surrounding the facility, the personnel and the supplies needed for such a large undertaking.

Timeline of Vaccination in the United States

In the United States, routine vaccination ended in 1971. Since that time, only laboratory workers and researchers working with orthopoxviruses have been receiving the vaccine. In December of 2002, President Bush announced that vaccinations would resume. Members of the military would begin vaccination immediately. Those in the civilian sector who volunteered for response teams – to help in contact management and tracing – and healthcare teams – to help in the care of cases – began vaccination January of 2003.

Large-Scale Vaccination

The window to prevent smallpox through vaccination is limited. Strategies have to be determined to get the maximum protection in the smallest time possible. Some considerations when establishing a “time-frame” to meet vaccination goals are:

  1. Set Goals – How many & how fast?
  2. Balance PH and Socio-political “goals.”
  3. Trade-off allowances

While the ring vaccination strategy must continue in order to prevent the spread of known cases, the community will most likely demand vaccination to feel secure. Conducting mass vaccination clinics may take valuable resources and time away from other public health interventions, it is important to consider the disruption that could be caused by the demand and worries of the public.

The federal government running these clinics would be impractical. It lacks the direct care personnel to make it happen. Local communities know best how to work within their own infrastructure. A centrally run system is impractical because of the potential scope of program (nationwide?) and resource limitations.

Vaccine Deployment Goals – The First 75 Million Doses

The federal government maintains a supply of smallpox vaccine that can be deployed very quickly. In the event of a highly suspect case, CDC Smallpox Response Teams can be deployed and can bring an initial supply of vaccine with them. Most teams can be onsite within hours. Additional doses of vaccine can begin arriving within 12 hours. The CDC Teams can be on-site to begin vaccination as soon as smallpox is confirmed. Up to 150,000 doses can be deployed with a team

The Vaxicool system is a refrigerated shipping and storage unit that can maintain cool temperatures for hours without needing recharging. It is a self contained shipping/storage unit and has 150, 000 doses per Vaxicool (300 vials).

Using the National Pharmaceutical Stockpile, or NPS, large amounts of vaccine can be delivered throughout the US in less than two days. Vaccine stored at multiple locations throughout the US. Clinics will receive other ancillary supplies necessary to conduct vaccination, including needles and diluent needed for administration, as well as the forms necessary for IND vaccines. The Ancillary supplies to arrive with Vaxicools:

  1. Diluent.
  2. Transfer needles for vaccine reconstitution.
  3. Bifurcated needles for single use administration.
  4. CD-ROM: IND and information materials.

Remainder of Stockpile (after first 75 million doses)

Since the Vaxicool containers will need recharging, public health planners should consider the logistics involved with having electrical outlets ready for the units.

Shipping containers to accommodate 10,000; 15,000; or 150,000 doses/container. The NPS goal capacity once vaccine available is:

  1. Deployment of total 280 million doses within 5 days.
  2. Deployment to multiple locations that include cities of > 10,000 population.

Logistics for Mass Vaccination

Public health planners should pre-identify community sites based on their geography and the distribution of the population in the area. Those sites will need to have large floor space and be accessible. Sites to consider include, schools, auditoriums and large churches or temples. Planning for potential vaccination clinics should include consideration of:

  1. Facilities that meet needs for size/access/security
  2. Training and staffing resources
  3. Supplies (non-vaccine related)

Public communications are key to a successful vaccination program. Public communication should be established to explain:

  1. Who should receive the vaccine and why.
  2. Which clinic(s) to go to.
  3. When to go and how to get there.
  4. What to do before going and what to expect.
  5. Information hotlines.

Staff and supply sources will need to be identified beforehand. Planners should also consider developing their communication materials as part of the planning process to save time during a response.

Because the smallpox vaccine is not licensed in the United States, it will have to be administered under Investigational New Drug, or IND, protocols. This requires more extensive paperwork and explanations than with most vaccines so that patients will be able to make an informed decision.

Since the last time smallpox vaccine was used, there are more patients with immune system issues that could indicate contraindications to the vaccine. More thorough medical screening will need to take place to minimize the possibility of severe adverse events. These screenings will be:

  1. Used to determine High-risk conditions (contraindications).
  2. More extensive than for any other vaccine. As there are more questions to answer and there is a greater medical counseling requirement along with them.
  3. What to do with high-risk/low benefit individuals who want vaccine?

Logistics for Mass Vaccination – Tracking & Surveillance

Part of your planning should also take into account data needs. Staff will be needed to keep records so that policy makers can monitor progress and further refine their response, as necessary.

Close monitoring for Adverse Events will be critical since the vaccine hasn’t been used on a large scale for decades. This should be kept as up-to-date as possible so that unexpected risk factors can be quickly communicated to healthcare providers. Information will need to be collected on:

  1. Adverse Events - passive system, VIG and medical care and unexpected rates or reactions.
  2. Vaccine response rates – the expected % of “takes” and passive system/self-reporting.
  3. Daily number of vaccinations administered – to establish whether or not the vaccination strategy is currently on-target for vaccine administration goal and whether or not there is a need for additional clinics.

Because the vaccine is IND, there are strict regulatory requirements for informed consent that must be followed. The guide contains examples of the types of forms that must be completed by each patient to ensure they understand the risks and benefits of the vaccine. The most current forms will be supplied with the vaccine shipment. The additional paperwork [information materials & screening and consent forms] will take up more clinic time. Staffing and clinic flow should be modified accordingly to handle this. An IND vaccine requires:

  1. Regulatory requirement for informed consent.
  2. PI (or multiple co-Pis) must assume oversight for vaccine administration sites.
  3. FDA and IRB approval
  4. Formal safety monitoring mechanisms
  5. Paperwork

Other Logistics

Parking - Given the demand for the vaccine we would expect, the parking around the clinic could quickly fill. Planners should consider identifying off-site parking and making arrangements for busing patients into the clinic site.

Triage - There should be some sort of triage system set up to deal with those patients who appear to be ill so that they can be further evaluated and monitored by public health.

Waiting - Since there could be a wait to get into the clinic, consideration should be given as to how to protect patients from the elements while they wait.

Information Materials - When they enter, patients should be handed a packet with all the printed information materials and volunteers should guide them to the next portion of the clinic. A quiet area with tables and chairs should be set up for patients to sit and review the paper forms. Those who indicate they have contraindications or who have questions should be referred to medically-trained counselors who can help the patient decide whether or not it’s prudent to take the vaccine. These screeners will also instruct those who choose not to get vaccinated on what to watch for and who to contact if they have problems.

Contacts - Those patients who have been identified as contacts or household members of contacts to a case should be moved out of the mass vaccination clinic flow and taken to a unit that will manage the intervention portion of the response.

Non-Contacts - Those who are not contacts should be entered into the mass vaccination clinic flow. A video will be provided that explains the IND process and the risks and benefits of vaccination. Multiple sites to view the video should allow more people to move through.

The actual vaccination should be relatively fast, compared to the informed consent portion of the clinic. Before exiting the clinic, patients should be given one more chance to ask questions. Forms should be brought directly over to the data entry staff from here.

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