Vaccine Shortages : Possible Solutions, What's New With the Flu?

by Food and Drug Administration (FDA)

(Page 2 of 3)

Chickenpox (Varicella): Merck's manufacturing shutdowns also affected production of the chickenpox vaccine, VARIVAX. ACIP recommended that during the shortage, vaccine providers should delay vaccination of children until the age of 18 months or 2 years. Normally, the recommendation is one dose of varicella vaccine between 12 months and 18 months or at any age after 18 months if a child has not had chickenpox or the vaccine.

Vaccination was recommended for susceptible children ages 5 to12, especially those entering school, and adolescents age 11 or 12. People not vaccinated until age 13 or older should get two doses, four to eight weeks apart. This shortage is likely to improve soon, but it will still take time to build up the inventory of chickenpox vaccine.

Pneumococcal Conjugate: Wyeth Vaccines markets Prevnar, approved by the FDA in 2000 to prevent invasive pneumococcal diseases in infants and toddlers. A shortage has occurred because demand was unexpectedly high, exceeding supply. Infants normally receive a series of four shots, the first three given at two-month intervals beginning at 2 months and ending at 6 months, with the final shot in the series given at 12-15 months of age. During the shortage, ACIP temporarily changed recommendations so that infants receive the first three doses and will get the fourth dose when the supplies are sufficient. According to manufacturer projections, pneumococcal conjugate vaccine will remain in short supply through 2003.

Tetanus and Diphtheria Toxoids for adults (Td): Along with DTaP, the Td supply was affected when Wyeth Lederle decided to stop producing tetanus and diphtheria toxoids in 2001. In this case, only one major producer — Aventis Pasteur — remained. Production of the vaccine, from start to finish, takes about a year.

ACIP had recommended that routine Td boosters for adolescents and adults temporarily be deferred and that people return for shots once the supply was sufficient. Compared with distribution levels before the shortage, the amount of Td distributed nationally dropped 40 percent during 2001-2002. Now, the supply of adult Td in the United States has reached levels high enough that the routine Td schedule as recommended by ACIP can be resumed.

Possible Solutions

Prioritizing patients and adjusting the routine schedule of immunizations is clearly a short-term solution. Federal agencies, meantime, have been meeting to address long-term strategies to head off future shortages.

The FDA's Egan says some of the possible solutions being discussed include requiring manufacturers to give sufficient notice before interrupting or ending vaccine production so that other manufacturers can increase production. "We're also looking at what we can do at FDA to speed up lot release to get vaccines on the market sooner," he says.

Experts also are talking about ways to boost the vaccine stockpile. This isn't a big warehouse of extra vaccine, but rather refers to the CDC's Storage and Rotation Contracts with manufacturers. The contracts allow the CDC to buy vaccine beyond the national need so there is a supply to draw from in an emergency.

The CDC has the authority to stockpile six-month supplies of vaccines. It has been drawn on several times. Manufacturers borrow from the stockpile and usually replace it within a year. The CDC sets priorities for vaccine stockpiles, which typically contain vaccines that are routinely recommended and that have a single manufacturer. The MMR vaccine, for example, has been stockpiled since 1983.

What's New With the Flu?

Because of distribution delays with the flu vaccine over the last couple of years, the CDC's Advisory Committee on Immunization Practices (ACIP) is recommending that certain groups get their flu shots in October and earlier this year in anticipation of the 2002-2003 flu season.

The groups include people at high risk for complications from the flu (such as those age 65 and up and people of any age with certain chronic health conditions) and health-care workers. Children younger than 9 receiving the vaccine for the first time need a booster dose one month after the initial dose.

Everyone else should begin flu vaccination in November. The optimal months for vaccination are October and November, but ACIP encourages the use of vaccines even later than November because it's still likely to be beneficial. The number of influenza cases in the United States typically has not peaked until late December through early March.

About the Author

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