Vaccines and Preventable Diseases:

Questions and Answers on 2002 Vaccine Shortages
March 7, 2002

Shortages (General Questions)

1. What vaccines are in short supply? 2002

There are shortages of five vaccines that protect against eight of 11 vaccine-preventable childhood diseases (as of 2004 there are 12 VPDs). There are shortages of DTaP vaccine, which protects against diphtheria, tetanus and pertussis (whooping cough); MMR vaccine, which protects against measles mumps and measles; PCV7 (pneumococcal conjugate) vaccine, which protects against serious invasive pneumococcal disease in young children; and varicella vaccine, which protects against chicken pox. Currently we do not have shortages of Haemophilus influenzae type b (Hib), hepatitis B, hepatitis A or polio vaccines.

2. What caused the shortages? 2002

There is no single reason for the shortages. There are a combination of factors, including manufacturing issues and compliance problems, vaccine manufacturers leaving the market for business reasons, supply and demand issues, and the removal of thimerosal preservative from vaccines, which led to a lower yield of vaccine.

3. What is being done to ensure future supplies? 2002

Cases of vaccine-preventable diseases are at an all-time low because of record high childhood vaccine coverage levels. It is important that vaccine coverage rates remain high to prevent the return of disease. There isn't a single cause for the vaccine supply problems, nor is there a simple solution. However, CDC, the Advisory Committee on Immunization Practices (ACIP) and the National Vaccine Program Office, working with other federal agencies, local and state health departments, manufacturers, health care providers and partners, have taken a number of actions to help effectively manage the delays and shortages, and prevent future problems. They include:

• CDC is working with the ACIP to modify the immunization schedule.

• CDC continues to closely monitor vaccine orders placed through the CDC contract and is working with vaccine manufacturers and states to ensure vaccine supplied to the public sector is prioritized to those areas most in need of vaccine.

• The National Vaccine Advisory Committee (NVAC) sponsored a workshop on Strengthening the Supply of Routinely Recommended vaccines in the US, in Washington, DC, February 11 and 12, 2002. The conference goals were to: 
  
  (1) to define and describe the scope of problems with vaccine supply in the United States, including possible contributing causes, and 
  
  (2) to identify and review possible ways to strengthen the vaccine supply. Vaccine manufacturers and researchers, provider organizations, purchasers of vaccines, federal agencies, and consumers were invited to attend. Topics of discussion included:

• increasing financial incentives for research/development/production; streamlining the regulatory process; establishing government-directed programs; utilizing vaccine stockpiles; and increasing liability protections. A report from the conference will be issued in the next few months.

• The General Accounting Office (GAO) is also looking into the issues of vaccine supply and vaccine shortages. NIP has been cooperating with GAO in its study

• ACIP temporarily revised recommendations for the pneumococcal conjugate, DTaP, TD and Varicella vaccines in response to continued shortages of vaccines.

ACIP temporarily revised recommendations for PCV7 vaccine

2002

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.

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.

ACIP temporarily revised recommendations for DTaP vaccine

2002

In December 2000, the ACIP voted to continue prior CDC recommendations (published March 16, 2001) for providers who had insufficient quantities of 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 years.

ACIP temporarily revised recommendations for Tetanus vaccine

2002

Td is in short supply. However, vaccine is still be available for adolescents and adults who need it most. This includes people with injuries and puncture wounds. Most children who have received their routine vaccinations will be protected by DTaP. CDC recommends the following people be vaccinated:

1. People traveling to a country where the risk for diphtheria is high (tetanus and diphtheria vaccines are usually given together).

2. Persons requiring tetanus vaccine for prophylaxis in wound management

3. People who have not received at least three doses of tetanus vaccine in the past.

4. Pregnant women who have not received tetanus vaccine within the past 10 years.

To assure vaccine availability for these priority indications, all routine Td boosters in adolescents and adults should be delayed until late 2002. CDC recommends recording the names of patients whose booster doses are delayed during the shortage. When Td supplies are restored, these patients should be notified to return for vaccination.

ACIP temporarily revised recommendations for Varicella vaccine

2002

Until adequate supplies of varicella vaccine are available, ACIP recommends that all vaccine providers in the United States delay administration of the routine childhood varicella vaccine dose from age 12-18 months until 18-24 months. If the shortage persists after delaying the dose at 12-18 months and is of sufficient severity that further prioritization of vaccine use is needed, recommendations for use (highest to lowest priority) of Varivax for susceptible persons are:

1. Vaccination of healthcare workers, family contacts of immuocompromised persons, adolescents aged >13 years, adults and high-risk children (e.g., children infected with human immunodeficiency virus and children with asthma or eczema).

2. Vaccination of susceptible children aged 5-12 years, particularly children entering school and adolescents aged 11-12 years. States may elect to provide guidance on priority cohorts for vaccination.

3. Vaccination of children aged 2-4 years. Within this age group, states may elect to provide guidance on priorities (e.g., children attending child care centers) for vaccination.

ACIP temporarily revised recommendations for MMR vaccine

2002

1. Two doses of Measles, Mumps, and Rubella (MMR) vaccine, separated by at least a month and administered on or after the first birthday, are recommended for children, adolescents, and adults who lack adequate documentation of vaccination or other acceptable evidence of immunity. The first dose is recommended at age 12-15 months and the second dose at age 4-6 years.

2. If providers are unable to obtain sufficient amounts of MMR vaccine to implement fully ACIP recommendations for MMR vaccination, ACIP recommends that they defer the second MMR dose. Because of the severity of measles in young children, providers should not delay administration of the first dose of the MMR series.

3. Records should be maintained for children who experience a delay in administration of either varicella or MMR vaccines so they can be recalled when vaccine becomes available.

Questions related to shortages of MMR vaccine

2002

What is the supply situation with MMR Vaccine?

The national need for MMR vaccine is about 1.08 million doses per month. Excluding October and November, the average monthly production of MMR vaccine for January - September was 942,800 doses. October and December production was 61% lower than other months, an average of 586,000 doses per month. December supply was 1,186,000 doses. CDC contract need is about 60%, or 500 - 600,000 doses per month. CDC approved Merck's borrowing 700,000 doses from the CDC's vaccine reserve of 3.13 million doses to meet current demand. As of 1/21/02, all 700,000 doses have been shipped. Merck has requested approval to continue accessing the CDC MMR vaccine reserve until production capacity can meet national need.

What caused the delay?

The current shortages in vaccine production are due to two voluntary interruptions in Merck's manufacturing operations. One interruption was due to modifications Merck made voluntarily in response to issues raised by the FDA during a routine Good Manufacturing Practices inspection. The other was the result of scheduled modifications Merck made to their facility. The scheduled modifications took longer than expected to complete and significantly impacted production.

Questions related to shortages of Varicella vaccine

2002

What is the supply situation with varicella or chickenpox vaccine?

Varicella vaccine supply rapidly declined at the end of 2001. The annual need for varicella vaccine in the United States is about 6 to 7 million doses or 500,000 - 583,000 doses per month. There have been significant amounts of varicella on backorder through the CDC contract since the beginning of 2002. CDC purchases about 60% of the varicella supply. Merck & Co. estimates an average of 60 days to fill these orders. Shortages are expected nationwide.

How long will the varicella shortage last?

The duration of the varicella vaccine shortage is uncertain, although Merck & Co., Inc. predicts that the varicella vaccine shortage will be resolved by late spring or early summer 2002.Should we be concerned?
Prior to introduction of varicella vaccine in 1995, varicella was widespread in the United States, causing 4 million cases, 11,000 hospitalizations, and 100 deaths each year. In the first half of 2001, national coverage for varicella vaccine was 75% for children 19 - 35 months. Since implementation of the varicella vaccination program in the United States, data from Texas, Philadelphia and Los Angeles indicates a dramatic decline in varicella cases in all age groups and a decline in varicella hospitalizations. There is a danger that varicella disease will once again increase if vaccine coverage falls.

Are children in danger?

CDC will work closely with states and manufacturer to ensure equitable vaccine distribution and priority targeting of the vaccine to children and others with the highest risk of exposure and severe disease.

What caused the varicella shortage?

The current shortages in vaccine production resulted from two voluntary interruptions to manufacturing operations by Merck & Co., Inc., the only U.S. manufacturer of the varicella vaccine. One interruption was attributed to modifications Merck made voluntarily in response to issues raised by the U.S. Food and Drug Administration (FDA) during a routine current Good Manufacturing Practices (GMP) inspection. The other was the result of scheduled modifications made to the manufacturer's facility, which took longer than expected to be completed and substantially impacted production during September-October 2001.

Questions related to shortages of PCV-7 vaccine

2002

How severe is the shortage?

Both public and private sectors have experienced vaccine shortages, but supply is improving. However there maybe significant supply fluctuations through mid-year.

What caused the shortage?

Provider demand for PCV-7 has been much greater than anticipated. In addition, several manufacturing difficulties prevented the manufacturer from producing at full capacity for several months. How long will the shortage last?
Inventory build-up may not be sufficient to return to the routine schedule before mid-year.

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) revised recommendations to decrease pneumococcal conjugate vaccine use until supplies are adequate. CDC continues to monitor and allocate pneumococcal conjugate supplies purchased through the CDC contract in coordination with the manufacturer.

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.

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.

Questions related to shortages of DTaP vaccine

2002

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.

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)

What has been done to address the situation?

Aventis Pasteur is prioritizing the sell of their DTaP vaccine to private health care providers, limiting product sales to 80 doses or less, per order per practice each week with orders adjusted as necessary. Aventis Pasteur is expecting licensure approval from the FDA for a new DTaP in the near future, which should begin to alleviate the current shortage once production capacity is attained. A new CDC contract with Av P will be completed this week though the amounts to be made available for the public sector will be significantly restricted by Av P.Glaxo SmithKline (GSK) is attempting to meet the need for almost the entire public sector. The CDC is establishing a new contract with Glaxo SmithKline this week. While this contract will be much larger than the amounts committed by Av P, the total dose amounts from both companies will not be sufficient to meet the public sector need.NIP is closely monitoring all DTaP vaccine orders placed through the CDC contract and coordinating vaccine supply with GSK and AvP. Shipments are prioritized to grantees indicating the greatest need based on reported inventory, amount purchased to date and amount on backorderWhat 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.

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.The ACIP voted to continue prior CDC recommendations (published March 16, 2001) for providers who had insufficient quantities of 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 years.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.How long will the DTaP shortage last?
The shortage may last all of 2002.

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.

Should the government control vaccine distribution?

The General Accounting Office is currently studying 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.

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