> Vaccine Shortages
(Prevnar®) Shortages and
Suspension of the Recommendation
for the 3rd & 4th
new action is being taken?
Effective immediately, the Centers for Disease
Control and Prevention, (CDC) in consultation
with the American Academy of Family Physicians
(AAFP), the American Academy of Pediatrics
(AAP), and the Advisory Committee on Immunization
Practices (ACIP), recommends that all
health-care providers temporarily suspend routine
use of both the third and fourth doses of PCV7.
Children at increased risk of severe disease
should continue to receive the routine, 4-dose
action was taken to minimize shortages of the
vaccine until the manufacturer can reach full
production. Limiting healthy children to two
doses of PCV7 will conserve vaccine and permit
more children to get at least two doses. As
a result of this action, there should be enough
vaccine for all children to get a least two
whose 3rd and 4th doses are delayed should
receive the missed doses on their first visit
to a healthcare provider after supplies return
to normal. Healthcare providers should keep
track of children who miss vaccinations and
recall those patients when they receive adequate
supplies of vaccine.
February 13, 2004, CDC recommended that health-care
providers temporarily suspend routine use of
the fourth dose of 7-valent pneumococcal conjugate
vaccine (PCV7) when immunizing healthy children.
Since that recommendation was issued, PCV7
production has been much less than had been
expected and shipments have been further delayed,
resulting in shortages of vaccine. Widespread
shortages may now continue beyond this summer.
Vaccines, the sole manufacturer in the United
States, markets PCV7 under the trade name Prevnar®.
Why is this new action necessary?
CDC recognizes the concern that suspending
the third and fourth doses of PCV7 may cause
but we are taking this action because the potential
for widespread and serious shortages of PCV7
could occur if the third and fourth doses are
not delayed. By delaying the third and fourth
doses, we expect to save a large amount of
vaccine so that all children will be protected
with at least two doses of vaccine.
United States needs approximately 1.3 million
doses of PCV7 each month to provide every infant
the full, 4-dose, vaccination series. For the
period January – April, 2004, total shipments
are estimated to be no more than 55% of the
4-dose need. The production shortfall is markedly
worse than was anticipated on February 13 and
results from continuing problems with the PCV7
vial-filling production line. This recommendation
being taken to minimize shortages until the
manufacturer can reach full production capacity.
It reflects current CDC’s assessment
of the existing national PCV7 supply and may
be changed if the supply changes.
are the health implications of delaying the
third and 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.
Children who have had two doses should also
have some protection, but the exact level is
unknown. Delaying the third and fourth doses
of PCV7 is not ideal. However, this step will
help ensure that all children receive at least
two doses of the vaccine.
is CDC doing?
Besides recommending delaying the third and
fourth dose of vaccine, CDC will continue to
work closely with the manufacturer and our
partners to monitor the vaccine supply. We
will continue to update healthcare providers
and the public on the status of vaccine supplies
as long as the shortages persist. In addition,
we are developing a fact sheet for parents
that explains the current situation.
is the usual recommended schedule for vaccination
The vaccine is recommended for young children
in a four-dose schedule: one dose at 2 months,
at 4 months, and at 6 months, and one dose
between 12 and 15 months. This recommendation
suspends the third and fourth doses usually
administered at 6 months and between 12 and
15 months for healthy children. PCV7 is not
routinely recommended for children 2 years
of age or older.
What does the vaccine
The vaccine can help prevent serious pneumococcal
diseases, such as meningitis and blood infections.
It can also prevent some ear infections. But
ear infections have many causes, and the vaccine
is only effective against some of them. 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.
should physicians do?
Children whose 3rd and 4th doses are delayed
should receive the missed doses on their first
visit to a healthcare provider after supplies
return to normal. Healthcare providers should
keep track of children who miss vaccinations
and recall those patients when they receive
adequate supplies of vaccine.
should parents do?
Immunizations are one of the most important
ways parents can protect their children against
serious diseases. Parents should monitor their
child’s immunization record and talk
with their healthcare provider about their
child’s immunization status. Parents
should schedule a catch-up appointment with
their healthcare provider if their child misses
either the third or fourth dose of PCV7.