Vaccines and Immunization Schedules

by Food and Drug Administration (FDA)

Deborah Dohne, 42, a college professor in Syracuse, N.Y., didn't think much of it when she developed a mild fever and sore throat in mid-May 2006. "I thought maybe I had a cold and kept going about my business," she says. But two weeks later, she wasn't getting any better. By the third week, she started vomiting and her throat became so swollen she could barely swallow.

She went to the emergency room where physicians suspected strep throat and performed a throat culture. The test came back negative, but they said there was still a chance she could have strep throat and they gave her an antibiotic.

Four weeks into her illness, Dohne felt even worse. She developed a loss of appetite, sinus congestion, chest tightness, fatigue, and a relentless cough. "I took cough medicines, but nothing helped," she says. "When I talked or laughed, it made me cough even more." Physicians suggested that her symptoms could be caused by an infectious disease, such as mononucleosis, or allergies.

After the cough persisted for three more weeks, Dohne's primary care physician performed a blood test to check for whooping cough (pertussis). That test came back positive, and Dohne began seeing an infectious disease specialist.

Whooping cough is a bacterial respiratory illness characterized by severe spasms of coughing that can last for weeks or even months. Because of her illness, Dohne took an entire semester off from teaching. "In addition to the cough, fatigue has been an incapacitating problem," she says. Dohne suspects that she contracted whooping cough from a student who may have been ill, but she isn't sure. The disease is spread by close contact with respiratory tract droplets that are released when a person coughs or sneezes.

"Vaccines aren't only for young children," says Norman Baylor, Ph.D., director of the Office of Vaccine Research and Review in the FDA's Center for Biologics Evaluation and Research (CBER). "We want to get children off to a healthy start by giving them the recommended series of vaccinations, and adolescents and adults should also know that they need certain vaccinations to remain protected throughout their lifetime. Serious illness and deaths from many infectious diseases have declined because of vaccination. But if we stopped vaccinations, we would see disease epidemics again."

Here's a look at vaccines that have been recently licensed by the FDA, along with the latest recommendations from the CDC's Advisory Committee on Immunization Practices (ACIP) for young children, adolescents, and adults.

The ACIP provides practice of medicine recommendations based on different criteria from those which the FDA must use for vaccine approvals and licensure, so some recommendations on the CDC's Web site may differ from a vaccine's label.

For Young Children

By ages 4 years to 6 years, children should have received vaccinations that protect them from a string of diseases, including influenza, diphtheria, tetanus, whooping cough, chickenpox (varicella), hepatitis A and B, polio, pneumococcal diseases, measles, mumps, German measles (rubella), diseases due to Haemophilus influenzae, and rotavirus. Recent changes affecting young children include:

Vaccine against rotavirus. In February 2006, the FDA licensed RotaTeq, a live virus vaccine and the only vaccine approved in the United States that can help protect against rotavirus, a viral infection that causes diarrhea, vomiting, and fever, which may lead to serious dehydration. According to the RotaTeq label, the vaccination series consists of three doses given by mouth starting at 6 weeks to 12 weeks of age, with subsequent doses given at four- to 10-week intervals. The ACIP recommends that rotavirus vaccine be given at 2 months, 4 months, and 6 months of age. The vaccine can be given with most other childhood vaccines.

In one of the largest vaccine safety studies ever conducted, more than 30,000 healthy infants were given rotavirus vaccine in the United States and other countries. Of these infants, almost 7,000 from the United States and Finland were studied for effectiveness of the vaccine. RotaTeq prevented 74 percent of all rotavirus gastroenteritis cases and 98 percent of the severe cases. The most common side effects of the vaccine have been mild, short-lived episodes of diarrhea and vomiting.

The large study did not show an increased risk of intussusception associated with RotaTeq. Intussusception is a rare, life-threatening type of blockage or twisting of the intestine. This condition was associated with a previously licensed version of rotavirus vaccine called RotaShield, which was withdrawn from the market in 1999. Safety of the new vaccine will be closely monitored.

Before giving RotaTeq, health care providers should determine the infant's current health status and previous vaccination history, including whether there has been a reaction to a previous dose of RotaTeq or other rotavirus vaccine.

RotaTeq is manufactured by Merck & Co. Inc. of Whitehouse Station, N.J.

About the Author

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