News > Shortages
ACIP Votes to Temporarily Revise Recommendations
For Pneumococcal Conjugate Vaccine (PCV-7) and Votes to Continue Previously Issued Diphtheria, Tetanus, and Pertussis (DTaP) Recommendations

2002 status of PCV-7 and DTaP shortages and recommendations: http://www.cdc.gov/nip/news/shortages

Archived information below
Information on this page was written December 7, 2001

• Pneumococcal Conjugate Vaccine Vote  (Dec. 7, 2001)

• DTaP Vote  (Dec. 7, 2001)

• Press Release  (Dec. 7, 2001)

• Questions and answers about PCV-7  (Dec. 7, 2001)

• Questions and answers about DTaP  (Dec. 7, 2001)

Pneumococcal Conjugate Vaccine Vote
2001
The 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 recommendations.

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 follows:

1. High risk children less than 5 years of age should continue to be vaccinated as recommended by the ACIP in October 2000.
2. 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 4^th 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 Weekly Report).
3. 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.
4. 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.

DTaP Vote
2001
The 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 school year.

 PCV-7

December 7, 2001 
Questions and links to the answers:

1. CDC changed their PCV-7 recommendations in September 2001 because of a shortage. Why are they being changed again?

2. What caused the shortage?

3. How long will the shortage last?

4. What is being done to address the situation? 

5. What is ACIP asking health care providers to do?

6. Which children should receive the available doses?

7. What diseases does the PCV-7 protect against? 

1. CDC changed the recommendations for PCV-7 in September 2001 because of a shortage of the vaccine. Why are the recommendations being changed again?

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.

2. What 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.

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3. How 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 lasting.

4. What 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.

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5. What 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.

6. Which 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.

2) 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.

3) Providers should maintain a list of children for whom conjugate vaccine has been deferred so that it can be administered when the supply situation improves.

4) ACIP 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.

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7. 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.

 DTaP

December 7, 2001 
Questions and links to the answers:

1. What is the current situation concerning the shortage of DTaP vaccine?

2. What caused the shortage?

3. What has been done to address the situation?

4. What diseases does DTaP protect against?

5. What are the recommended doses for DtaP?

6. What are the current recommendations?

7. Are these recommendations adequate?

8. How long will the shortage last?

9. What is the ACIP?

10. What vaccines are currently in short supply?

11. Why are so many vaccines in short supply and/or experiencing delays?

12. What is CDC doing to ameliorate problems associated with the shortages?

13. Should the government control vaccine distribution?

1. 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.

2. What 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).

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3. What 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.

4. What 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.

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5. What are 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.

6. What 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.

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7. Are 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.

8. How long will the shortage last? 

The shortage is expected to continue at least until the 2^nd quarter 2002.

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9. What 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 vaccine-preventable diseases.

10. What vaccines are currently in short supply?

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.

11. Why are so many vaccines in short supply and/or experiencing delays?

Today’s supply problems are multifactorial, 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.

12. 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:

1) changing 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 communications

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.

13. Should the government control vaccine distribution?

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 their report.

This page last modified on March 7, 2002