Pregnant Pause

Some say a vaccine could prevent the deadly bacterium GBS, but others remain concerned about inoculating mothers-to-be

May 21, 2007|By Frank D. Roylance | Frank D. Roylance,Sun Reporter

It sounds like some medieval baby-killer that must have disappeared when husbands first began boiling water as their wives went into labor.

But 25 percent of pregnant women in the United States carry a common, potentially deadly bacterium called group B streptococcus (or GBS) that can infect their babies during childbirth or soon after.

Although doctors frequently administer antibiotics during labor to prevent them, GBS infections kill or injure several thousand babies each year - within hours or weeks of their birth.

Advocates say vaccinating pregnant women could avert those tragedies - unfortunately, no vaccine for GBS exists. Nor is any drug company likely to develop one, they say, and most doctors probably wouldn't use one if it were available.

"Just forget it. It ain't gonna happen," said Dr. Carol J. Baker, a GBS expert and co-director of the Texas Children's Vaccine Center, who spoke recently to colleagues in Baltimore for the 10th annual Conference on Vaccine Research. "We could make these numbers 100 times worse in terms of the disease burden and death rates, and it ain't gonna happen. It's about lawyers."

The debate over vaccinating pregnant women goes well beyond GBS. On one hand, researchers say this may be the best time to protect mother and infant against a variety of diseases, from flu to whooping cough.

But drug companies are less than enthusiastic about developing vaccines with small markets that could open them to ruinous lawsuits if a baby suffers a birth defect or complication - for any reason. Many doctors feel the same way about prescribing vaccines to pregnant women - even safe ones. So newborn deaths and GBS brain injuries persist.

One such infection caught little Max Royka, who was 6 weeks old and thriving at home in Nashville, Tenn., when the group B strep bacteria suddenly overwhelmed his system.

His mother had tested negative for the bacteria, so he probably had not been infected at birth - but he began his life with no immunity to the bacteria and paid a terrible price.

"He was fine one minute, and literally a couple of minutes later he was pale and whimpering," his mother, Jill Royka, 36, recalls. Within hours he was in a coma. "He was completely consumed by this germ."

After 13 days in intensive care and seven weeks of hospital treatment for meningitis, Max was left permanently brain-injured.

Now 6, he is legally blind and unable to speak or walk normally. He must be fed and hydrated through a tube. He also takes seven different medicines for epilepsy, behavioral problems such as head-banging and hair-pulling, and for diabetes insipidus, which causes frequent urination.

"It is a daily struggle," Jill Royka said.

The same fear of litigation is making doctors wary of vaccinating pregnant women against whooping cough, or pertussis - a rapidly growing threat in the United States.

More than 25,000 Americans came down with whooping cough in 2004 - double the count in 2003. Between 1997 and 2000, some 62 Americans died from complications of whooping cough, according to the U.S. Centers for Disease Control and Prevention. Fifty-six of those were younger than 6 months.

Just as disturbing: Despite clear government approval for it, doctors vaccinate only 12 percent of pregnant women against influenza, an illness that causes high rates of complications during pregnancy.

"At most, about half of OB-GYNs will provide [flu] vaccine," said Dr. Kathryn M. Edwards, professor of pediatrics at the Vanderbilt University Medical Center in Nashville. Another 28 percent will refer their patients for vaccination elsewhere, while 24 percent make no referral at all. "This is a major issue."

The flu vaccine should not be a concern, experts say. "We have good data that the inactivated [flu] vaccine is safe in pregnancy. It's not associated with any risk of adverse outcomes," said Dr. Neal A. Halsey, director of the Institute for Vaccine Safety at the Johns Hopkins Bloomberg School of Public Health.

But some doctors note that it's easy for parents to look back and find something to blame for abnormalities, which occur once in 100 births and for myriad reasons unrelated to vaccinations.

"People tend to assume that anything bad that happens - all congenital abnormalities - might have been caused by something administered during pregnancy," Halsey said.

Vaccines have come under increasing suspicion since the late 1980s, when some parents and researchers began to associate childhood immunizations with an increase in autism diagnoses.

The CDC says there is insufficient evidence to support such a conclusion. But the number of autism-related claims against drugmakers through the National Vaccine Injury Compensation Program has nevertheless soared into the thousands.

For drugmakers, the issue goes beyond fear of litigation, according to Alan Goldhammer, deputy vice president of the Pharmaceutical Research and Manufacturers of America.

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