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News
> Vaccine Shortages
PCV7
(Prevnar®) Shortages and
Reinstatement of the 3rd
Dose in PCV7 Recommendation
July
8 , 2004
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What
is CDC recommending?
Production problems that caused shortages of the pneumococcal conjugate
vaccine (PCV7, marketed as Prevnar™) appear to have been resolved
and supplies are now adequate to allow healthcare providers to routinely
administer three doses of the vaccine to their young patients. Effective
immediately, the CDC, in consultation with the Advisory Committee
on Immunization Practices (ACIP), American Academy of Family Physicians
(AAFP), and the American Academy of Pediatrics (AAP), recommends
that providers administer three doses of PCV7. The fourth dose should
still be deferred for healthy children until further production
and supply data demonstrate convincingly that a 4-dose schedule
can be sustained. The full, 4-dose, series should continue to be
given to children at increased risk for pneumococcal disease because
of certain chronic conditions (e.g., sickle cell disease, anatomic
asplenia, chronic heart or lung disease, diabetes, cerebrospinal
fluid leak, cochlear implant, or an immunocompromising condition).
Alaska
Native children and American Indian children living in Alaska, Arizona,
or New Mexico and Navajo children in Utah and Colorado currently
have a risk of invasive pneumococcal disease more than twice the
national average. These groups of children should receive the standard
4-dose PCV7 series despite the shortage.
Why
is CDC taking this action?
In February 2004, production of Prevnar™, a 7-valent pneumococcal
conjugate vaccine manufactured by Wyeth Vaccines (Collegeville,
PA), failed to meet demand, resulting in shortages. To conserve
the limited supply, CDC recommended that the fourth dose be withheld
from healthy children. In March, when it became clear that production
would be curtailed for several months, CDC recommended that the
third dose also be withheld. Production problems appear now to have
been resolved and deliveries are projected to be adequate to permit
every child to receive at least three doses.
This recommendation reflects CDC's assessment of the existing national
PCV7 supply and will be changed if the supply changes. Updated information
about the national PCV7 supply is available from CDC at http://www.cdc.gov/nip/news/shortages/default.htm.
What
are the health implications of delaying the fourth dose?
Four doses of PCV7 provide the best protection, but children who
have received three doses should also have a very high level of
protection. PCV is a highly effective vaccine. In 2003, the incidence
of invasive pneumococcal disease among children less than two years
of age was 69 percent lower than it was during 1998–99, before
universal recommendation for the vaccine. There is evidence of high,
short-term effectiveness of the 3-dose primary series of the PCV7
administered at 2, 4, and 6 months. Preliminary data from CDC’s
Active Bacterial Core Surveillance program indicate that effectiveness,
at least for the short term, is not greatly compromised by delaying
administration of the fourth dose in healthy children.
What does the vaccine protect against?
The vaccine can help prevent serious pneumococcal diseases, such
as meningitis and blood infections. Pneumococcal infection can cause
serious illness and even death. Invasive pneumococcal disease is
the leading cause of bacterial meningitis in the United States.
Children under two years of age are at highest risk. Before a vaccine
was available, each year pneumococcal infection caused more than
700 cases of meningitis, 13,000 blood infections and about 5 million
ear infections.
What
should those parents do whose children missed a dose of the vaccine?
Parents should contact their healthcare provider if their child
missed a dose of PCV7.
What should providers do?
The highest priority for catch-up vaccination is to ensure that
children less than 5 years of age at high risk for invasive pneumococcal
disease are fully immunized. Second priorities include vaccination
of healthy children aged less than 24 months who have not received
any doses of pneumococcal conjugate vaccine and healthy children
aged less than 12 months who have not yet received 3 doses.
Because of the frequency of health-care provider visits for children
during their first 18 months, catch-up vaccination might occur at
regularly scheduled visits for most children who receive vaccines
from their primary-care provider. Programs that provide vaccinations
but do not see children routinely for other reasons should consider
a notification process to contact undervaccinated children.
Recommended
Regimens While the PCV7 Shortage Exists
| Age
at examination (months) |
Previous
pneumococcal conjugate vaccination history |
Recommended
regimen* |
| 2-6
|
0
doses |
3
doses 2 months apart |
| |
1
dose |
2
doses 2 months apart |
| |
2
doses |
1
dose |
| 7-11 |
0
doses |
2
doses 2 months apart, 3rd dose at 12-15 months |
| |
1
dose before age 7 months |
1
dose at 7-11 months, with another dose at 12-15 months (>=
2 months later) |
| |
2
doses before age 7 months |
1
dose at 7-11 months |
| 12-23
months |
0
doses |
2
doses >= 2 months apart |
| |
1
dose before age 12 months |
2
doses >= 2 months apart |
| |
1
dose at >= 12 months |
1
dose >= 2 months after the most recent dose |
| |
2
doses before age 12 months |
1
dose >= 2 months after the most recent dose |
| 24-59,
Healthy children |
|
Not
routinely recommended † |
| 24-59,
High risk‡ |
Any
incomplete schedule comprising <3 doses |
1
dose >= 2 months after the most recent dose, and another
dose >= 2 months later |
| 24-59,
High risk‡ |
Any
incomplete schedule comprising 3 doses |
1
dose >= 2 months after the most recent dose |
Notes
for Recommended Regimen
| Note* |
For
children vaccinated at age <1 year, the minimum interval
between doses is 4 weeks. Doses given at >= 12 months should
be at least 8 weeks apart.
|
| Note† |
When the shortage is completely resolved, providers should
consider administering a single dose to unvaccinated, healthy
children 24-59 months old with priority to children 24-35
months old, children of African-American descent, children
of American-Indian descent but not otherwise identified as
high risk‡, and children who attend group day care centers.
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| Note‡ |
Children
with sickle cell disease, asplenia, chronic heart or lung
disease, diabetes, cerebrospinal fluid leak, cochlear implant,
HIV infection or another immunocompromising condition and
children of Alaska Native or American Indian descent in areas
with a demonstrated risk of invasive pneumococcal disease
more than twice the national average (Alaska, Arizona, New
Mexico and Navajo populations in Utah and Colorado).
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