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:
- Set Goals – How
many & how fast?
- Balance PH
and Socio-political “goals.”
- 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:
- Diluent.
- Transfer
needles for vaccine reconstitution.
- Bifurcated
needles for single use administration.
- 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:
- Deployment
of total 280 million doses within 5 days.
- 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:
- Facilities
that meet needs for size/access/security
- Training
and staffing resources
- Supplies
(non-vaccine related)
Public communications
are key to a successful vaccination program. Public communication
should be established to explain:
- Who should
receive the vaccine and why.
- Which clinic(s)
to go to.
- When to go
and how to get there.
- What to do
before going and what to expect.
- 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:
- Used to determine
High-risk conditions (contraindications).
- 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.
- 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:
- Adverse
Events - passive system, VIG and medical care and unexpected
rates or reactions.
- Vaccine
response rates – the expected % of “takes” and
passive system/self-reporting.
- 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:
- Regulatory
requirement for informed consent.
- PI (or multiple
co-Pis) must assume oversight for vaccine administration sites.
- FDA and IRB
approval
- Formal safety
monitoring mechanisms
- 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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