News > Shortages
Votes to Temporarily Revise Recommendations
Pneumococcal Conjugate Vaccine (PCV-7) and
Votes to Continue Previously Issued Diphtheria,
Tetanus, and Pertussis (DTaP) Recommendations
status of PCV-7 and DTaP shortages and recommendations:
Archived information below
Information on this page was written December 7, 2001
Conjugate Vaccine Vote
Advisory Committee on Immunization Practices
(ACIP) voted on December 7, 2001 to temporarily
revise recommendations for the pneumococcal
conjugate vaccine due to continued shortages
of the vaccine. The ACIP had previously revised
recommendations for the vaccine on September
14, 2001, for shortages which at the time were
anticipated to be brief. However, according
to manufacturer estimates, about 1.2 million
doses of vaccine will be distributed per month
through March 2002, less than the 1.5 million
doses per month needed, based on current demand.
The shortage of the vaccine is due to a
rapid increase in demand and manufacturing problems that have prevented the
manufacturer from producing at full capacity. The shortage is expected to
continue until mid-2002, depending on adherence with the revised
The ACIP is making revised recommendations
to limit pneumococcal conjugate vaccine use until supplies are adequate. Two
key principles underlie the revised recommendations. First, providers should
conserve vaccine supply by decreasing the number of doses administered to
healthy infants, rather than leaving some children in the group recommended
for vaccination completely unprotected. Second, changes in pneumococcal
conjugate vaccine use and ordering should be made by all providers,
regardless of the current vaccine supply in their own practice.
The ACIP revised recommendations are as
- High risk children less than 5 years of
age should continue to be vaccinated as recommended by the ACIP in
- Healthy infants and children less than
24 months old should receive a decreased number of pneumococcal
conjugate doses based on the age at which vaccination is initiated and
the provider’s estimate of vaccine supply in their practice. All
providers should defer the 4th dose for infants who are
vaccinated beginning at less than 6 months of age. Additional
recommendations to decrease vaccine use are included in the specific
recommendations adopted by the Committee. (Guidelines will be given when
the recommendations are published in CDC’s Morbidity and Mortality
- Further studies should be done to
evaluate the immune response to a pneumococcal polysaccharide vaccine
booster dose among children 12-15 months of age. Polysaccharide vaccine
is recommended for children more than 2 years old who are at increased
risk of invasive pneumococcal infection. It is not licensed for use in
children less than 2 years old.
- Providers should maintain a list of
children for whom PCV-7 has been deferred so that it can be administered
when the supply situation improves.
ACIP voted on December 7, 2001 to continue
prior CDC recommendations (published March
16, 2001) for providers who had insufficient
quantities of Diphtheria, Tetanus, and Pertussis
(DTaP) vaccine due to spot shortages of the
vaccine. The recommendation applies only to
providers with insufficient quantities of DTaP
vaccine and recommends that they prioritize
vaccinating infants with the initial three
DTaP doses, and if necessary, to defer the
fourth DTaP dose. The ACIP also added that
if deferring the fourth DTaP dose still does
not provide enough vaccine to vaccinate infants
with three DTaP doses, then the fifth DTaP
dose can be deferred. When adequate DTaP vaccine
becomes available, steps should be taken to
recall all children who did not receive a DTaP
dose for remedial immunization. Children should
be vaccinated in accordance with existing ACIP
recommendations to assure immunity to pertussis,
diphtheria and tetanus during the elementary
December 7, 2001
Questions and links to the
their PCV-7 recommendations in September 2001 because of a shortage. Why are they being changed again?
How long will
the shortage last?
What is being
done to address the situation?
What is ACIP
asking health care providers to do?
should receive the available doses?
does the PCV-7 protect against?
changed the recommendations for PCV-7 in September 2001 because of a
shortage of the vaccine. Why are the recommendations being changed
At the time the
recommendations were published the shortage was anticipated to be less
severe and of shorter duration. Vaccine distribution in September and
October, however, was less than half that needed to meet demand, and a
survey of providers suggested that many were experiencing more severe
shortages than was addressed by the September recommendations.
caused the shortage?
Provider demand for PCV-7
has been much greater than anticipated. In addition, several manufacturing
difficulties have prevented the manufacturer from producing at full
capacity for the past several months.
long will the shortage last?
The duration of the shortage
is uncertain. Current projections for vaccine distribution by the
manufacturer are about 1.2 million doses per month from November 2001
through March 2002, and approximately 2 millions per month from April 2002
through mid-year 2002. If providers adopt ACIP recommendations to decrease
the number of vaccine doses needed, vaccine supply would be adequate by
mid-2002. If vaccine use does not change, the shortage will be more long
is being done to address the situation?
Because of the critical
supply situation, the need to meet ongoing demand, and the importance of
replenishing stocks at state health departments, the Advisory Committee on
Immunization Practices (ACIP) is making revised recommendations to
decrease pneumococcal conjugate vaccine use until supplies are adequate.
is ACIP asking health care providers to do?
Two key principles underlie
these recommendations. First, providers should conserve vaccine supply by
decreasing the number of doses administered to healthy infants, rather
than leaving some children in the group recommended for vaccine completely
unprotected. Second, ACIP is asking all health care providers to make
changes in their pneumococcal conjugate vaccine use and ordering
practices, regardless of their current vaccine supply. This will assure
that vaccine is available as widely as possible for all children.
children should receive the available doses?
1) High risk children less
than 5 years of age should continue to be vaccinated as recommended by
ACIP in October 2000.
Healthy infants and children less than 24 months old should receive a
decreased number of PCV-7 vaccine doses, based on the age at which
vaccination is initiated and the provider’s estimate of vaccine supply
in their practice. For infants, a schedule of 3 or 2 doses is recommended
while supply is limited.
Providers should maintain a list of children for whom conjugate vaccine
has been deferred so that it can be administered when the supply situation
recommends that additional studies be done to evaluate the immune response
to a pneumococcal polysaccharide vaccine booster dose among children 12-15
months of age. Polysaccharide vaccine is recommended for children greater
more than 2 years old who are at increased risk of invasive pneumococcal
infection. It is not licensed for use in children less than 2 years old.
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.
December 7, 2001
Questions and links to the
What is the current
situation concerning the shortage of DTaP vaccine?
What caused the shortage?
What has been done to
address the situation?
What diseases does DTaP
What are the recommended
doses for DtaP?
What are the current
Are these recommendations
How long will the shortage
What is the ACIP?
What vaccines are currently
in short supply?
Why are so many vaccines in
short supply and/or experiencing delays?
What is CDC doing to
ameliorate problems associated with the shortages?
Should the government
control vaccine distribution?
What is the current
situation concerning the shortage of DTaP vaccine?
Spot shortages are now
occurring among many health care providers and those shortages will
continue mid-2002. It appears that DTaP vaccine shortages may be more
acute among providers depending on the public sector for vaccine supply
than for those providers who purchased vaccine through the private sector.
caused the shortage? In early 2001, Wyeth Lederle announced it had
stopped production of tetanus toxoid-containing products. Although a
small amount of Td is produced by the University of Massachusetts for
local distribution, Aventis Pasteur is now the sole nationwide
distributor of Td and TT. In addition to Wyeth Lederle discontinuing
production of its tetanus and diphtheria toxoids and acellular pertussis
vaccine, Baxter Hyland Immuno Vaccines (formerly North American Vaccine,
Inc.) is not producing its DTaP vaccine. Aventis Pasteur and Glaxo
SmithKline are the remaining suppliers of DtaP. Additionally, the
problem has been compounded by vaccine production issues related to the
removal of thimerosal (mercury) from vaccines following a Joint
Statement issued by AAP and the PHS in July 1999, establishing the goal
of removing the vaccine preservative from vaccines routinely recommended
for infants. (Thimerosal is a derivative of ethylmercury which has been
used as an additive to vaccines since the 1930s because it is effective
in killing bacteria and in preventing bacterial contamination,
particularly in opened multi-dose containers).
has been done to address the situation?
Aventis Pasteur is selling
DTaP vaccine to private health care providers, limiting product sales to
150-200 doses per provider per month, with greater amounts supplied based
on justification. Glaxo SmithKline (GSK) is attempting to meet the need
for almost the entire public sector. The total DTaP vaccine doses on
backorder through GSK appears to be diminishing, down from 800,000 doses
in October to 426,000 doses in late November. NIP is closely monitoring
all DTaP vaccine orders placed through the CDC contract and coordinating
vaccine supply with GSK. Shipments are primarily prioritized to grantees
reporting 0 dose inventories or inventories of less than 16 days.
diseases does DTaP protect against?
The vaccine protects against
Diphtheria, Tetanus, and Pertussis or whooping cough. Diphtheria, tetanus,
and pertussis are serious diseases caused by bacteria. Diphtheria and
pertussis are spread from person to person. Tetanus enters the body
through cuts or wounds.
the recommended doses for DtaP?
Prior to the shortage,
DTaP vaccine was recommended as a five-dose series: three doses given to
infants at ages 2, 4, and 6 months, followed by two doses – a dose at
age 15--18 months and a dose at age 4--6 years.
are the current recommendations?
On March 16, 2001,
recommendations from the Advisory Committee on Immunization Practices were
published in the MMWR advising providers that if they have insufficient
quantities of DTaP, priorities should be given to vaccinating infants with
the initial three DTaP doses and, if necessary, to defer the fourth DTaP
dose. When adequate DTaP supplies become available, providers should
recall for vaccination all children who did not receive the fourth dose of
DTaP. Children should be vaccinated in accordance with existing ACIP
recommendations to assure immunity to pertussis, diphtheria, and tetanus
during the elementary school years. The ACIP will meet on Friday, December
7, 2001 to review these recommendations.
these recommendations adequate?
Data from the European
clinical trials of various DTaP vaccines suggest 3 doses may provide
protection against tetanus and pertussis; immunogenicity data support the
need for booster doses at age 12-18 months and 4-6 years to protect
against diphtheria. However in the United States, the risk of exposure to
diphtheria is low.
long will the shortage last?
The shortage is expected to
continue at least until the 2nd quarter 2002.
is the ACIP?
The Advisory Committee on Immunization Practice
consists of 15 experts in fields associated with immunization who have
been selected by the Secretary of the U. S. Department of Health and
Human Services to provide advice and guidance to the Secretary, the
Assistant Secretary for Health, and the Centers for Disease Control and
Prevention (CDC) on the most effective means to prevent
What vaccines are currently in short
We are experiencing shortages of vaccines against four of the
eleven diseases preventable through routine vaccination of children:
diphtheria, tetanus, pertussis, and pneumococcal disease, and delays in
vaccine availability for influenza vaccine which is recommended for many
adults and children.
Why are so many vaccines in short supply and/or
Today’s supply problems are
complex and vary from vaccine to vaccine and manufacturer to manufacturer.
This issues now include manufacturer withdrawal from the market, difficulty
in complying with Good Manufacturing Practices established by FDA, and
insufficient stockpiles of vaccines to be used to mitigate the impact of any
transient supply disruptions.
What is CDC doing to ameliorate problems
associated with the shortages?
CDC has taken a number of steps to deal
with the problems associated with the shortages, including:
vaccination schedules to reduce the number of doses from optimal protection
to what can be managed given limited vaccine supplies
2) monitoring the
manufacturers’ production and release of vaccines through voluntary
3) managing as best as possible the purchase, ordering,
and distribution of vaccines purchased by states through the federal
contracts to facilitate equitable distribution of the limited supplies. For
the longer term, we are working closely with the National Vaccine Advisory
Committee to evaluate the reasons for the current supply problems and
recommend solutions to prevent vaccine shortages. Since 1983, CDC has been
operating stockpiles of certain vaccines.
Should the government control
The General Accounting Office is currently study
the issue of vaccine shortages to better understand the problems and
identify solutions. CDC is cooperating with the GAO and look forward to