Combo Vaccine Approved

Federal regulators have approved a new vaccine against five major diseases that will significantly cut the number of shots in an infant’s first six months, reducing the pain and hassle involved in this childhood rite of passage.

The new vaccine, Pediarix, cuts from nine to three the number of shots required to protect against tetanus, diphtheria, pertussis, polio and hepatitis B. The shot would be administered at 2 months, 4 months and 6 months of age.

Pediatricians in the Southland welcomed the news, saying it will increase vaccination rates and will lessen the anxiety that children and parents suffer during each encounter with the dreaded needle.

“I think this is a godsend,” said Dr. Marie Kelley, a pediatrician in Pasadena. “I think the parents will be appreciative and the babies too.”

But some parents expressed concern about whether so many vaccines combined in one shot would harm their children.

“If a child is being vaccinated for one bug, their system has an easier time fighting that off,” said Eli Ramirez of Studio City, who has a 6-month-old daughter. If you have more, “the immune system has a lot to deal with at that point.”

The U.S. Food and Drug Administration says the side effects caused by Pediarix -- pain, redness, swelling, fever and fussiness -- are not much different from the effects caused by the current vaccines for the same diseases. But fevers are more common with Pediarix, according to the agency, which approved the drug late Friday.

The vaccine, manufactured by GlaxoSmithKline, is expected to be available in doctors’ offices next month and will cost about the same as the existing vaccines combined. Previously, the five diseases were covered by three separate vaccines: diphtheria-tetanus-pertussis, polio and hepatitis B.

“This vaccine allows protection against more diseases in one vaccine than any other that we currently have in the U.S.,” said Dr. Karen Midthun, director of the Office of Vaccines Research and Review at the FDA’s Center for Biologics.

The new vaccine does not provide protection against a number of other childhood diseases. Children younger than 2 years will still need shots against measles, mumps, rubella, chickenpox, pneumococcal disease, haemophilus influenza type B, hepatitis A and influenza.

But sparing children six shots in the first six months is a major advance because it will likely improve vaccination rates, doctors say. Research has shown that the more times parents have to take children to the doctor, the less likely they are to return.

As new vaccines have been added to the childhood regimen, doctors and parents have struggled to keep up with the recommended schedule. The percentage of children who received most of the needed vaccines by age 2 was about 73.7% nationally last year. For Los Angeles, the comparable rate was 71.6%.

Combining the vaccines should help improve those numbers, medical experts said.

“This vaccine and combination vaccines like it that other companies have in the development pipeline represent a real advance in our ability to immunize children,” said Dr. John Modlin, chairman of the Advisory Committee on Immunization Practices, which advises the federal government on the topic.

Much of the research on the new vaccine was conducted in Southern California at the UCLA Center for Vaccine Research and at Kaiser Permanente.

Dr. Joel Ward, director of the UCLA center, said many physicians require infants to come in for multiple visits because they don’t feel comfortable giving them so many shots at once. “By combining them all in a single vaccine, it makes it much more ... easy to administer,” he said.

In addition, the new vaccine should reduce the time and trouble it takes to prepare and administer different shots, said Dr. Steven Feig, a Los Angeles pediatrician. It will also cut down on medical errors, others said.

Some insurance companies, including Kaiser and PacifiCare Health Systems, are still studying the new vaccine and haven’t decided whether to cover it. Others, like WellPoint Health Networks, say they will pay for it.

Parents said they would value convenience and fewer shots but only if the vaccine was as safe and effective as existing inoculations.

“Will it be as effective?” asked Karissa Coakley, 23, of Lancaster, who brought her 4-month-old son, Kadyn Joshua Griffith, to a doctor’s office Monday for several vaccines. “One more shot wouldn’t hurt if [the new vaccine is] not as effective as it’s supposed to be. I would want him to get the full effect of it.”

Her doctor, Dr. Pejman Salimpour of Sherman Oaks, expressed confidence in the new vaccine, adding that in his experience, parents don’t want to see their children wail any more than they have to.

“When they cry, you feel it with them,” he said. “Every time that mother, that father, that family member brings a child to the pediatrician’s office, he or she has to see them cry in pain.”

Cheryl Randolph, a PacifiCare spokeswoman, said her employer is still weighing the costs and benefits of the vaccine, but she favors it personally -- as a parent of a 20-month-old daughter.

“It’s just awful, especially when they’re infants, because they’re just looking at you like, ‘What are you doing to me?’ ”