Vaccines Schedules

Safety and Effectiveness, Pregnancy
by Food and Drug Administration (FDA)

(Page 4 of 4)

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

• No vaccine is 100 percent safe or 100 percent effective.
• There may be disease even in people who have been vaccinated. But in many cases, vaccination reduces the risk of disease complications.
• When it comes to vaccine safety, it's a matter of weighing the benefits and the risks.
• Routine vaccinations are generally safe, and the risks of the vaccines are much smaller than the risks of the diseases. Side effects from vaccines are usually mild. But vaccines can cause severe allergic reactions, including time-limited difficulty breathing, wheezing, hives, and rapid heartbeat. Consumers should talk with their physicians about the risks and benefits for them.
• The FDA evaluates vaccine safety before and after a vaccine gets on the market. Some adverse events become detectable only after a vaccine is used in the larger, general population.
• The FDA and the CDC jointly manage the Vaccine Adverse Event Reporting System (VAERS), a postmarketing safety surveillance program that collects information about side effects occurring after administration of licensed vaccines.

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.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.