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FDA Consumer magazine

January-February 2007


Keeping Up With Vaccines

By Michelle Meadows

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."

Immunization Schedules

Complete schedule of recommended childhood vaccines

Complete schedule of recommended adult vaccines

Centers for Disease Control and Prevention

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.

Recommendations reinstated for pneumococcal conjugate vaccine (PCV7). Prevnar, marketed by Wyeth Vaccines of Sanford, N.C., had production problems that resulted in shortages in 2001 which changed the recommendations for the vaccine from four doses to two doses for healthy children. These shortages were resolved, and in September 2004, the ACIP recommended that health care providers resume the full four-dose vaccination schedule for young children for PCV7: one dose each at 2 months, 4 months, and 6 months of age, and one dose at 12 months to 15 months of age. According to Prevnar's label, the fourth dose should be given at least two months after the third dose. This vaccine can help prevent serious invasive pneumococcal diseases, such as meningitis, pneumonia, and blood infections, all of which can be fatal.

Second dose of chickenpox vaccine. The FDA licensed Varivax (varicella virus vaccine live), the first vaccine for chickenpox, in 1995. Varivax, which is manufactured by Merck & Co., is indicated for people 1 year of age and older.

In June 2006, the ACIP voted to recommend a second dose of chickenpox vaccine for children 4 years to 6 years old to further improve protection against the disease. The first dose of chickenpox vaccine is recommended at ages 12 months to 15 months. Parents should talk with physicians about the best way to catch up. The ACIP also recommended that adolescents and adults who previously received one dose receive a second dose of chickenpox-containing vaccine.

Availability of measles, mumps, rubella, and varicella (MMRV) vaccine. In September 2005, the FDA licensed ProQuad, a combined live, attenuated MMRV vaccine. It is indicated for the simultaneous vaccination against measles, mumps, German measles, and chickenpox among children ages 12 months to 12 years. Manufactured by Merck & Co., the vaccine presents a more convenient way to give MMR and varicella vaccines at the same time.

Expanded hepatitis A vaccination. Hepatitis A is a liver disease caused by the hepatitis A virus. Previous ACIP recommendations called for vaccinations only in states with the highest rates of hepatitis A. The ACIP now recommends that all children in the United States receive hepatitis A vaccine. Children should get the first dose of a two-dose series at ages 1 year to 2 years.

Expanded age range for flu vaccination. Previously, the ACIP recommended that children ages 6 months to 23 months receive an annual flu shot. The latest ACIP recommendations expand this age range and call for children ages 6 months to 5 years to receive the flu vaccine annually. Research has shown that children ages 2 years to 5 years are nearly as likely to require visits to health care providers and emergency rooms for flu as are children 6 months to 23 months. In February 2006, the ACIP also recommended expansion of routine flu vaccination for household contacts, caregivers, and anyone else who spends a significant amount of time with children from birth to 5 years.

 For Adolescents 

Adolescents 11 to 18 years of age also need to be sure that they are up-to-date with their immunizations. The checkup that takes place near age 11 years is a good time to check on what they need, says Robert Frenck, M.D., professor of pediatrics in the Division of Infectious Diseases at Children's Hospital in Cincinnati.

"At this time, parents should make sure that adolescents have had two doses of the MMR vaccine," Frenck says. "There's also a recommendation to receive a booster dose of Tdap after the eleventh birthday if it's been five years since the last Td dose. And if an adolescent has never had chickenpox and missed the chickenpox vaccine, this would be the time to get it."

Parents should discuss any concerns about booster vaccines with their children's physicians. For example, if a child had a serious reaction to a previous dose of vaccine as a young child, a booster dose in adolescence may not be recommended. Some adolescents with certain health risks may need other vaccines, such as the annual flu vaccine, hepatitis vaccine, or pneumococcal vaccine.

The following vaccines were recently licensed by the FDA and include adolescents in the targeted population.

Approval of a vaccine for human papillomavirus (HPV). In June 2006, the FDA licensed Gardasil to help prevent HPV, the most common sexually transmitted infection in the United States. The vaccine is highly effective against four types of the HPV virus, including two that cause about 70 percent of the cases of cervical cancer in the United States. Manufactured by Merck & Co., Gardasil was licensed in six months under the FDA's priority review process. This vaccine is indicated in girls and women who are ages 9 years to 26 years.

According to the ACIP, three doses of the new vaccine should be routinely given over a six-month period to girls when they are 11 years or 12 years old. But the vaccine can be given to girls as young as 9 years old at the discretion of a health provider, and can be given to women up to age 26.

Approval of vaccines for whooping cough. In May 2005, the FDA licensed two new combination vaccines to prevent tetanus, diphtheria, and whooping cough. One preparation of Tdap, Boostrix, is licensed for use for people 10 years to 18 years of age.  The other preparation, Adacel, is licensed for people ages 11 years to 64 years.

In June 2005, the ACIP recommended that adolescents ages 11 years to 18 years be given a single shot of Tdap in place of the tetanus–diphtheria (Td) booster typically given to adolescents. Those who already received a Td booster should get the Tdap five years after having received the Td vaccine. If they live in an area where pertussis is epidemic, the Tdap vaccine can be given two years after having received a Td vaccine.

Approval of vaccine for meningococcal disease. In January 2005, the FDA licensed Menactra (MCV4) for people ages 11 years to 55 years. MCV4 is a meningococcal vaccine manufactured by Sanofi Pasteur of Swiftwater, Pa. The vaccine is not indicated for the treatment of meningococcal infections.

Meningococcal disease strikes up to 3,000 Americans, killing 300 people every year. The infection can present as meningitis or an overwhelming bloodstream infection. The disease often begins with symptoms that can be mistaken for flu or other common illnesses. But it progresses rapidly and can kill within hours. People at elevated risk include first-year college students living in dorms, military recruits, and travelers to areas with high meningococcal disease.

In May 2006, the ACIP recommended routine meningococcal vaccine for adolescents at 11 to 12 years of age. For those who have not previously received MCV4, the ACIP recommends vaccination at high school entry, for entering college students who plan to live in dorms, and for people at high risk for meningococcal disease.

MCV4 is given as a single injection, and the most common reaction is a sore arm.

In September 2005, the FDA and the CDC issued an alert on MCV4 and Guillain–Barré Syndrome (GBS), a serious neurological disorder that can occur either spontaneously or after certain infections. The disorder typically involves increasing weakness in the legs and arms that can be severe and that can require hospitalization.

As of October 2006, 15 cases of GBS were reported in people ages 11 years to 19 years with onset within 6 weeks of vaccination with MCV4, according to the CDC. So far, the data suggest that there is no definitive link between the MCV4 vaccine and GBS, and there hadn't been any changes in vaccination recommendations as of October 2006. The FDA and the CDC continue to evaluate the cases. The ACIP has recommended that people with a history of GBS should not be vaccinated with MCV4.

For Adults

Adults ages 19 years and older should talk with their physicians about what vaccines they might need, says Larry Pickering, M.D., senior advisor to the director of the CDC's National Center for Immunization and Respiratory Disease.

"Many young adults entering college are more susceptible to some infectious diseases because they live in dorms, which makes it easier for illness to spread," Pickering says. The CDC, the FDA, and state and local health departments investigated a mumps outbreak that began in Iowa in December 2005 and involved at least 10 other states. The first cases were detected on a college campus in eastern Iowa. In 2006, cases continued to be reported from college campuses. As a result of these outbreaks, a two-dose mumps vaccine regimen has been recommended.

"Adults should talk with their physicians about their risks for vaccine-preventable diseases, and the elderly population should be especially encouraged to get the flu-vaccine and pneumococcal vaccine," Pickering says. Some adults may need revaccination with the pneumococcal vaccine, which should be discussed with their physicians. Influenza, pneumococcus, tetanus, and shingles can be especially serious diseases for adults ages 65 years and older.

Most hospitalizations and deaths from the flu occur in people ages 65 years and older. Adults 65 years and older should get the pneumococcal polysaccharide vaccine, which protects against blood-borne pneumococcal disease. This illness can lead to serious infections of the lungs, the blood, and the covering of the brain.

All adults should receive the Td booster every 10 years throughout life to protect against these infections. Some adults should get the MMR vaccine and have all of their recommended vaccines reviewed regularly. According to the CDC, generally any persons born after 1956 should get at least one dose of MMR vaccine unless they can show that they have had either the vaccine or each of the three diseases.

"Adults also are at greater risk of complications from chickenpox than young children," Pickering says. "People without a reliable history of having the disease or a vaccine should get two doses of varicella vaccine."

If you have no idea of your vaccination record, your physician can help evaluate your vaccination status. In some cases, a blood test can indicate whether you have immunity to particular diseases. New vaccine developments for adults include:  

More flu vaccines available. During an influenza vaccine shortage in the 2004–2005 flu season, the ACIP recommended that the vaccine be reserved for people in high- priority groups, including people ages 65 years and older. This year, it is estimated that 110 million to 115 million doses of flu vaccine will be available in the United States, which should be sufficient to meet the demand.

To further the availability of flu vaccine, the FDA recently licensed two more manufacturers to market flu vaccines in the United States. Fluarix, manufactured by a subsidiary of GlaxoSmithKline (GSK) Biologicals, protects people ages 18 years and older against influenza types A and B. FluLaval, another vaccine manufactured by ID Biomedical, also a subsidiary of GSK, is for people ages 18 years and older. Both vaccines contain inactivated or killed virus, and were approved using the FDA's accelerated approval pathway, which allows the agency to approve products for serious or life-threatening diseases based on early evidence of a product's effectiveness.

Household contacts of children younger than 6 years of age, especially children younger than 6 months of age, should be vaccinated against the flu.

Approval of a booster for tetanus, diphtheria, and whooping cough. The FDA approved Adacel, for people ages 11 years to 64 years, in June 2005. In November 2005, the ACIP announced its decision to recommend that adults ages 19 years to 64 years be vaccinated with the newly licensed adult Tdap booster vaccine. The ACIP recommended that adults receive a booster dose of Tdap if they haven't received a Td booster dose in five or more years.

Tdap should also be given to adults who have close contact with infants younger than 12 months of age, ideally at least one month before beginning close contact. In infants, the disease can be more severe and even fatal. And Tdap should be given to health care professionals because there have been whooping cough outbreaks in hospitals.

Approval of a vaccine for human papillomavirus (HPV). The FDA has also approved Gardasil to help prevent HPV in adults. For additional details, see the information on HPV in the "For Adolescents" section of this article.

Approval of a vaccine for meningococcal disease. The FDA has licensed Menactra (MCV4) for people ages 11 years to 55 years. MCV4 is a meningococcal vaccine manufactured by Sanofi Pasteur of Swiftwater, Pa. For additional details on this vaccine and its use, refer to the "For Adolescents" section of this article.

Approval of a vaccine for shingles (herpes zoster). The FDA licensed Zostavax in May 2006 to reduce the risk of shingles in people ages 60 years and older. Shingles is caused by the varicella-zoster virus, the same virus that causes chickenpox. After an attack of chickenpox, the virus lies dormant in certain nerve tissue. As we age, the virus can reappear in the form of shingles. It's characterized by clusters of blisters that can cause severe pain that may last for weeks, months, or years.

Zostavax is a live virus vaccine that's given as a single injection under the skin, preferably in the upper arm. The most common side effects in people who received Zostavax were redness, pain and tenderness, swelling at the site of the injection, itching, and headaches.

Vaccine Safety and Effectiveness

Vaccines in Pregnancy

Jon Temte, M.D., Ph.D., associate professor of family medicine at the University of Wisconsin, says it's ideal if women can check their vaccination status before pregnancy.

For example, the tetanus, diphtheria, and pertussis (Tdap) vaccine, which should not be administered during pregnancy, would be good to get in pre-pregnancy to provide protection from these diseases for the newborn.

"Women who are pregnant shouldn't get live viral vaccines," Temte says. "Even when there is no data of adverse effects, it's to protect against any possible transmission to the fetus."

A pregnant woman can and should get inactivated flu vaccine if she will be pregnant during flu season. FluMist, a live virus influenza vaccine, should not be given to pregnant women. "Pregnant women also should not get the measles, mumps, and rubella (MMR) vaccine or chickenpox (varicella) vaccine, both of which contain weakened live viruses," Temte says. Other vaccines that pregnant women shouldn't get are Gardasil for the human papillomavirus (HPV), Menactra (MCV4) for meningococcal disease, and Zostavax for shingles. 

Temte says that other vaccines for pneumococcal disease, tetanus, meningitis, and hepatitis A or B would be given in pregnancy only if there was some medical reason to do so.

For More Information

Vaccine information from the FDA's CBER

Vaccines for travelers
Centers for Disease Control and Prevention

National Immunization Program
Centers for Disease Control and Prevention

Vaccine Adverse Event Reporting System
Department of Health and Human Services

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