From the Editor

Vaccine shortages: how to cope

Guidelines are available on how to use the four vaccines that are in short supply.

by Philip A. Brunell, MD
Chief Medical Editor

 

May 2002

Philip A. Brunell, MD---Philip A. Brunell, MD

We are now experiencing shortages of several childhood vaccines. The CDC Web site contains valuable information and updates on the status of the shortages, recommendations on how to use the existing supplies of vaccines, why there are shortages and who to contact for help (To find out more about the shortages, I urge you to read our special report in the March issue. "Physicians and public health officials..." and "Proposed strategies...)

National Vaccine Supply Shortages
Vaccine Shortage Expected Duration Temporary Change from Rountine Recommendation
Hepatitis B No* *    
Diphtheria, Tetanus & Pertussis (DTaP) Yes through end of 2002 Yes
www.cdc.gov/mmwr/preview/
mmwrhtml/mm5051a3.htm
Tetanus toxoid (Td) Yes through end of 2002 Yes
www.cdc.gov/mmwr/preview/
mmwrhtml/mm5020a8.htm
Haemophilus influenzae type b (Hib) No* * *    
Inactivated polio (IPV) No    
Measles, Mumps & Rubella (MMR) Yes early summer 2002 Yes
www.cdc.gov/mmwr/preview/
mmwrhtml/mm5109a6.htm
Varicella Yes summer 2002 Yes
www.cdc.gov/mmwr/preview/
mmwrhtml/mm5109a6.htm
Pneumococcal Conjugate (PCV) Yes fall 2002 or beyond Yes
www.cdc.gov/mmwr/preview/
mmwrhtml/mm5050a4.htm
Hepatitis A No    

Note: Only those vaccines included on the recommended childhood immunization schedule are included in this update.
**Some providers may be experiencing delays in receiving Merck vaccine.
***Some providers may be experiencing delays in receiving Merck and Wyeth vaccines.

Source: NIP/CDC

Shortages of varicella vaccine are expected to continue until the late spring or early summer of 2002. Until there are again ample supplies, it is recommended that immunization of children age 12-18 months be delayed until 18-24 months. Others for whom the vaccine is recommended, eg, certain adults and adolescents, should continue to receive vaccine. If the shortage becomes more severe, vaccination of the latter should be reserved for susceptibles at increased risk, eg,. adults, adolescents or certain patients with HIV, or those likely to expose individuals at increased risk, eg, certain health care workers. They should receive the vaccine in preference to children ages 5-12, 11-12 and 2-4 years, although those in these age groups who are about to leave home care and enter school should receive special consideration.

MMR shortages should end by early summer. If there is insufficient vaccine available, the preschool dose should be deferred. Otherwise, a routine two-dose schedule should be maintained.

The most complex recommendation during this period is that for pneumococcal conjugate vaccine shortages of which are expected to exist until at least late summer. Unless shortages are very severe, it is recommended that the first three doses be given as recommended but that the fourth booster dose be deferred. High-risk children younger than 5 years should continue to receive the currently recommended doses, but those older than 24 months should be deferred. If supplies are severely limited, a reduction in doses for those younger than 2 years who were not immunized during the first six months of life would be necessary. In the event of severe shortages, a routine two-dose schedule starting at age 2 months might be needed. These recommendations are presented in table 2.

There also is a shortage of acellular pertussis combination vaccines, which is expected to continue until the end of 2002. It is recommended that until sufficient supplies are available, the fourth dose be delayed. If supplies are in very short supply, consideration would be given to delaying the preschool booster.

Shortages of adult diphtheria tetanus booster are expected to continue until the end of 2002. All routine Td boosters in adolescents and adults should be delayed until 2003. Td use should follow existing recommendations for all other indications, which include people traveling to a country where the risk for diphtheria is high; people requiring tetanus vaccination for prophylaxis in wound management; people who have received fewer than three doses of any vaccine containing tetanus and diphtheria toxoids; and pregnant women who have not been vaccinated with Td during the preceding 10 years.

These shortages will impose an increased burden on pediatric offices, as patients whose immunizations have been deferred will have to be recalled when vaccine is again available. There will undoubtedly be increased phone calls to parents to schedule nonroutine visits and from parents wanting to know when vaccine will be available. In addition, one will need to be aware of the schedule to use based on the available supply in your office and nationally. It may result in some parents incurring additional out of pocket costs to obtain vaccine from the private sector rather through the Vaccines for Children program when the latter is not available.

Pneumococcal Conjugate Vaccine Use Among Healthy Children During Shortages
Updated recommendations for moderate and severe shortages from the Advisory Committee on Immunization Practices, 2001
Age at first vaccination No shortage* Moderate shortage Severe shortage
< 6 months 2, 4, 6 and 12-15 months 2, 4 and 6 months
(defer 4th dose)
2 doses at 2-month interval in first 6 months of life
(defer 3rd and 4th doses)
7-11 months 2 doses at 2-month interval;
12-15 month dose
2 doses at 2-month interval
12-15 month dose
2 doses at 2-month interval (defer 3rd dose)
12-23 months 2 doses at 2-month interval 2 doses at 2-month interval 1 dose (defer 2nd dose)
>24 months 1 dose should be considered No vaccination No vaccination
Reduction in vaccine doses used   21% 46%

*The vaccine schedule for no shortage is included as a reference. Providers should not use the no shortage schedule regardless of their vaccine supply until the national shortage is resolved.

†Assumes that approximately 85% of vaccine is administered to healthy infants beginning at age < 7 months; approximately 5% is administered to high-risk infants beginning at age < 7 months; and approximately 10% is administered to healthy children beginning at age 7 to 24 months. Actual vaccine savings will depend on a provider’s vaccine use.

Source: MMWR. 2001;50(50):1140-2.

There are many reasons why this has happened, but there is an expression in Hollywood that when a conversation starts with “it’s not about the money,” you can be sure it’s about money. Vaccines are undervalued. There are few things in medicine, which can compare with immunization for cost effectiveness. They generally are less profitable that the billion dollar blockbusters for which pharmaceutical companies strive. In the 1980s, when some manufacturers left the vaccine business and others considered doing so, I was told by one of their officers that their company makes just as much from selling underarm deodorant and they do not get sued for the latter. At that time the possibility of converting Fort Detrick to a government facility for the manufacture of vaccines was considered and found to be impracticable. One of the current proposals has been to give the government the responsibility for producing the less profitable vaccines.

Discontinuing the manufacture of vaccine products, which we have experienced recently, is a trend that has continued through the years. In 1967, when there were far fewer vaccines, there were 26 manufacturers; now there are 12. A variety of reasons have been offered for the shortage, the FDA (a handy culprit for whatever), unanticipated demand, production glitches, elimination of thimerosal from vaccines, inadequate stockpiles, etc. However, it still comes down to the bottom line.


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