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New Combo Vaccine STORY BY

Sonora Hudson

As every parent knows, taking babies in for their first shots can be a "wail" of an experience – an ordeal to be relived by both of you each time you approach the doctor's door.

Cry-proof it isn't, but a new vaccine will cut short that river of tears. This year, a new combination vaccine, Pediarix, to prevent diphtheria, tetanus, pertussis (whooping cough), hepatitis B and polio, is now available.

Produced by GlaxoSmithKline, it was approved by the US Food and Drug Administration in December 2002 and included in the federal government's "Vaccines for Children" program last February.

Babies will receive a whopping 6 fewer injections, which is expected to result in as many as 24 million fewer injections for infants per year in the United States.

"I think it's terrific," says Kimberly C. Smith, MD, MPH, associate professor of pediatrics at The University of Texas Medical School at Houston. "These are all vaccines we've been using for years. They are all known, safe vaccines that have just been combined into one shot. It's hard to give a child five shots at one visit. We're hoping for more combined shots in the future."

The new vaccine is intended for babies at 2, 4 and 6 months. Since most babies are now given a hepatitis B injection before leaving the hospital, Smith suggests that parents might want to consider holding off on that until the 2-month visit. (The exception would be mothers who are contagious with hepatitis B; their babies should receive a hepatitis B shot (but not the combined shot) before going home.)

New Polio Portion, Safer

Another plus with the new vaccine is that its polio portion is made from a killed virus, which means that it is impossible for anyone to actually contract the disease from taking the shot. The previous oral polio vaccine was made from live virus, resulting in about 10 cases of polio in the United States per year. There are no live viruses in the new combination, so it is impossible to get diseases from any portion of this vaccine.

Adverse Effects: They Still Cry

Adverse effects include injection-site reactions (pain, redness or swelling), fever and fussiness. Its administration was associated with higher rates of fever compared with separately administered vaccines. It should not be given to infants with known hypersensitivity to any component of the vaccine, including yeast, neomycin and polymyxin-B. During clinical testing, 20,739 injections were given to 7,028 infants.

Combination vaccines have been available and used for more than half a century. In fact, the use of combination vaccines is preferred by the Advisory Committee on Immunization Practices, the American Academy of Pediatrics and the American Academy of Family Physicians. These groups believe that combined vaccines are a practical way to overcome the constraints of multiple injections and that they may help reduce costs for parents.

"Vaccines are the safest and most cost-effective way to get rid of disease, and worldwide they have made an enormous difference," Smith says.

On the Horizon

She also says that there are some new changes underway: an effort to immunize babies from 6 months to 2 years with influenza vaccine; a vaccine for Rotavirus, which causes diarrhea, now being tested; and the probable development of vaccines for certain ear infections.

"There will be many promising developments in the future, and we know a lot more now about the safety and effectiveness of vaccines," Smith says.

UPDATED: 8-17-2004