The rate of smallpox vaccine-associated adverse events in the
United States, and smallpox preparedness activities by the Netherlands, Germany,
and WHO
The Centers for Disease Control and Prevention (CDC) and
state health departments in the United States are conducting ongoing
surveillance for adverse effects due to smallpox vaccine during the civilian
smallpox vaccination programme (1). Out of 4213 civilian healthcare workers
vaccinated between 24 January and 14 February 2003, no potentially life
threatening or moderate to severe adverse events have been reported. Seven
vaccine recipients were reported to have non-serious adverse events. The most
common signs and symptoms were fever (n=two), rash (n=two), malaise (n=two),
pruritis (n=two), hypertension (n=two), and pharyngitis (n=two) (Table).
Table: Number of cases* of adverse events after smallpox vaccination among
civilians, by type - United States, 24 January - 18 February 2003. (Source:
CDC)
|
|
No. cases
|
|
Adverse events |
Suspected |
Probable |
Potentially life threatening events
|
|
Eczema vaccinatum |
-† |
- |
|
Erythema multiforme
major (Stevens-Johnson syndrome) |
- |
- |
|
Foetal vaccinia |
- |
- |
|
Post-vaccinial
encephalitis or encephalomyelitis |
- |
- |
|
Progressive vaccinia |
- |
- |
Moderate to severe events
|
|
Generalised vaccinia |
- |
- |
|
Inadvertent
inoculation, non-ocular |
- |
- |
|
Ocular vaccinia |
- |
- |
|
Pyogenic infection
of vaccination site |
- |
- |
|
|
No. cases
|
Other events of concern
|
|
|
Other serious
adverse events§ |
- |
|
Other non-serious
adverse events¶ |
7 |
|
Vaccinia
immunoglobulin release |
- |
|
Vaccinia
transmission to contacts |
- |
* Under investigation or completed as of February 18, 2002; numbers and
classifications of adverse events will be updated regularly in MMWR as more
information becomes available.
† No cases reported.
§ Events that result in hospitalisation, permanent disability, life
threatening illness, or death; these events are associated temporally with
smallpox vaccination but have not been documented to be associated causally
with vaccination.
¶ Include expected self-limited responses to smallpox vaccination (eg
fatigue, headache, pruritis, local reaction at vaccination site, regional
lymphadenopathy, lymphangitis, fever, myalgia and chills, and nausea);
additional events are associated temporally with smallpox vaccination but have
not been documented to be associated causally with vaccination.
In the first stage of the vaccination programme active surveillance is
being conducted for potentially life threatening, moderate to severe, and
other serious adverse events and for vaccinia transmission to contacts of
vaccine recipients. Non-serious events are expected to be under-reported as
these are being ascertained through passive surveillance.
In the Netherlands, the ministry of health has written to all local health
services asking them to complete contingency plans by April for the mass
vaccination against smallpox of the Dutch population of 16 million (2). The
Dutch institute of Public Health and the Environment (RIVM) has manufactured
20 million vaccine doses. Supplies of vaccinia specific immunoglobulin from
blood donated by vaccinated volunteers are being built up. The mass
vaccination option is one part of plans to counter bioterrorism prepared by
the National Coordination Centre for Communicable Disease Control (www.infectieziekten.info).
Mass vaccination is not the first option, but the Dutch government began
preparing for every option after the 11 September attacks in the United
States. Ring vaccination remains the starting point for containing an
outbreak. If ring vaccination fails or if there are many overlapping rings
then mass vaccination could follow.
Plans by the German government to vaccinate selected medical staff against
smallpox as a precautionary measure have been objected to by some infectious
diseases physicians (3). There is general agreement that vaccination of the
entire population should follow within a few days if a smallpox case occurred
in Germany. But plans developed by the Robert Koch-Institut (www.rki.de) and
government health officials involving vaccination of key medical personnel,
health care workers, and other critical personnel before a bioterrorist attack
have been criticised, because it is argued that the vaccine is currently
unlicenced in Germany and the level of threat does not justify the risks of
serious side effects from smallpox vaccination.
It is World Health Organization (WHO) policy that countries should devise
and implement plans for the immunisation of key workers to allow a rapid
response to a smallpox outbreak (4). WHO advocates investment in public health
infrastructure to strengthen outbreak intelligence and verification, support
the response to an outbreak, maintain an emergency vaccine reserve, and
provide public health information. WHO has been working to provide members
states with guidance and help, improving preparedness for epidemics of natural
or intentional origin. The organisation's global alert and response programme
detects rumours of outbreaks, verifies or refutes such rumours with the
affected countries, and rapidly offers technical and operational support
through the global outbreak alert and response network (5). Since 2000,
investigations by WHO have refuted 13 smallpox rumours (4).