News > Shortages
Decreased
Availability of Pneumococcal Conjugate Vaccine
(PCV-7)
During
2001 and 2002
The
2002 availability of PCV-7 can be accessed
at:
http://www.cdc.gov/nip/news/shortages/
Questions
about the 2002 shortage of PCV-7 are answered
at:
http://www.cdc.gov/nip/news/shortages/faqs_shortages_3-7-02.htm
Information
below this line was current on December 19, 2001
Deliveries of Prevnar, the new
Pneumococcal Conjugate Vaccine (PCV-7), marketed by Wyeth Lederle Vaccines,
have been delayed resulting in shortages for some providers and health
departments. State immunization programs, private providers and local health
departments have reported to NIP difficulty in obtaining enough PCV-7 to
immunize all children for whom the vaccine is recommended. On August 28,
2001, NIP estimated that 34 State immunization programs had less than a one
month inventory of PCV-7. NIP recommends that a minimum of one month
inventory is necessary at the State level in order to avoid shortages among
providers.
Until supplies are replenished, the CDC
recommends that all providers defer the vaccination of children older than 2
years except those 2-5 years old who are at increased risk of pneumococcal
disease (e.g., children with sickle cell disease or anatomic asplenia,
chronic illness, or who are immunosuppressed including those with human
immunodeficiency virus infection). Providers with insufficient vaccine to
vaccinate all these children should give highest priority to vaccinating all
infants less than 12 months and children 1-5 years at increased risk. Catch
up vaccinations for healthy children 1-2 years and booster doses for healthy
children who have completed the primary series may be deferred. Records
should be kept so that the deferred vaccinations can be given when vaccine
becomes available.
Click
to view MMWR
December 21, 2001
/ 50(50); 1140-2
Click
to view MMWR
September
14, 2001
/ 50(36);783-4
December 19, 2001
Questions and links to the
answers:
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Is there a shortage of PCV-7?
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What caused the shortage?
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Which children should receive the available
doses?
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How long will the shortage last?
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What's being done to address the situation?
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Why are some locations experiencing
shortages and other locations are not?
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Should the manufacture have anticipated the
demand?
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What if my child has only received one dose
of the vaccine -- is he protected or will he have to start over?
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What diseases dos the PCV-7 protect
against?
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Can we anticipate an increase in disease
in those areas where shortages exist?
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Is
there a shortage of PCV-7?
There are spot shortages
of PCV-7 being reported to the Centers for Disease Control and
Prevention’s National Immunization Program (NIP). State immunization
programs, private providers and local health departments have reported
to NIP difficulty in obtaining enough PCV-7 to immunize all children for
whom the vaccine is recommended. Over one half of all childhood vaccine
is purchased through CDC contracts and distributed to providers through
state immunization programs. On August 28, 2001, NIP estimated that 34
State immunization programs had less than a one month inventory of
PCV-7. NIP recommends that a minimum of one month inventory is necessary
at the State level in order to avoid shortages among providers.
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What
caused the shortage?
Provider demand for PCV-7 has been much greater
than anticipated. The manufacturer, Wyeth Lederle, feels that they have adequate
production capacity to meet U.S. demand for the vaccine. However, several
temporary manufacturing difficulties have prevented Wyeth Lederle from producing
at full capacity for the past several months.
Top
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Which
children should receive the available doses?
Until supplies are
replenished, the CDC recommends that all providers defer the vaccination
of children older than 2 years except those 2-5 years old who are at
increased risk of pneumococcal disease (e.g., children with sickle cell
disease or anatomic asplenia, chronic illness, or who are
immunosuppressed including those with human immunodeficiency virus
infection). Providers with insufficient vaccine to vaccinate all
children <2 years and those at increased risk of pneumococcal disease
should give highest priority to vaccinating all infants less than 12
months and children 1-5 years at increased risk. Catch up vaccinations
for healthy children 1-2 years and booster doses for healthy children
who have completed the primary series may be deferred. Records should be
kept so that the deferred vaccinations can be given when vaccine becomes
available.
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How
long will the shortage last?
The duration of the shortage is uncertain, but it
is expected the shortage will last at least through December, 2001. NIP
calculates that the national need for PCV is about 2 million doses per month.
The manufacturer may be able to ship on average about 1.7 million doses each
month for the remainder of 2001. When supply catches up to demand, there will
still be an interim period when inventories will need to be restored before the
supply shortage can be declared officially over.
Top
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What's
being done to address the situation?
Prioritizing the available
vaccine as described above should decrease demand and eventually end the
spot shortages. Once the spot shortages are alleviated and the supply
inventories are increased to adequate levels, the current
"routine" recommendations should be restored. In the meantime,
prioritizing the use of PCV-7 should help assure that those children at
highest risk of disease receive the vaccine.
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Why
are some locations experiencing shortages and other locations are not?
PCV-7 shortages among providers (and States)
reflect the inventory amounts that were in provider offices or storage depots at
the time the manufacturer began having problems in meeting the supply demands.
Those with a greater amount of inventory have up until now been able to meet the
demands of their practices, while those with smaller inventories and unfilled
orders began reporting shortages.
Top
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Should
the manufacture have anticipated the demand?
Anticipated demand may not
correlate with anticipated production. In this instance, unanticipated
problems with the production process are reasons cited for the supply
shortage.
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What
if my child has only received one dose of the vaccine -- is he protected
or will he have to start over?
Although prelicensure trials have shown efficacy
of a partial vaccination series, the duration of protection and whether
protection occurs for all serotypes included in the vaccine is not clear. If a
child has missed one or more dose of the primary series, they should resume
vaccination where they left off when more vaccine is available. There are no
safety or efficacy implications in doing so. Completing the primary series is a
higher priority than delivering the 12-15 month booster dose on schedule and the
latter should be deferred before the former.
Top
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What
diseases does the PCV-7 protect against?
The vaccine is highly
effective in preventing invasive pneumococcal disease in young children.
Prior to the introduction of PCV-7, pneumococcal infections caused
approximately 700 cases of meningitis, 17,000 cases of bacteremia –
blood stream infections – and 200 deaths each year in children under
age five. Meningitis is the most severe type of pneumococcal disease.
About five percent of children under 5 years old with pneumococcal meningitis will die of their infections.
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Can we
anticipate an increase in disease in those areas where shortages exist?
Because vaccine is
available to immunize those at highest risk and because deferral of
vaccine for others is likely to be short, we don't anticipate an increase in disease or outbreaks of disease.
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