Baltimore Sun Examines Debate Over Providing Pregnant Women With Vaccines Against Various Diseases

Main Category: Pregnancy / Obstetrics
Also Included In: Immune System / Vaccines
Article Date: 23 May 2007 - 4:00 PDT

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The Baltimore Sun on Friday examined the debate over developing and providing pregnant women with vaccines against various diseases, including influenza, group B streptococcus and whooping cough. According to some researchers, providing women with vaccines during pregnancy might be the best time to protect them and their infants against various diseases. However, some pharmaceutical companies are "less than enthusiastic" about developing vaccines for diseases, such as GBS, that have small markets and that could "open them to ruinous lawsuits" if birth defects or complications arise, the Sun reports.

According to the Sun, 25% of pregnant women in the U.S. carry GBS, which can infect infants during or immediately after birth. Of the 3,000 infants who contract GBS annually, 95% become sick within the first 24 hours of life, Carol Baker, co-director of the Texas Children's Vaccine Center, said. She added that 50% of these infants develop neurological symptoms, including meningitis. At least 200 infants die annually from complications associated with the disease, Baker said. The American College of Obstetricians and Gynecologists recommends that all women who test positive for GBS after 35 weeks' gestation receive intravenous antibiotics during labor to reduce the risk of transmitting the disease to their infants, the Sun reports.

Alan Goldhammer, deputy vice president of the Pharmaceutical Research and Manufacturers of America, said the issue of developing vaccines for diseases like GBS goes beyond the fear of litigation for drug companies. He added that ethical concerns make it "extremely unlikely" that FDA would approve clinical trials among pregnant women, and university ethical review boards likely would not endorse the research. There also is a "real concern on the part of pharmaceutical companies as to whether there would be a sufficient return on investment to engage in the considerable amount of work required to develop a vaccine," Goldhammer said.

According to the Sun, concerns about litigation also are making some physicians more cautious about providing pregnant women with vaccines. For example, although the government has approved influenza vaccinations, 12% of pregnant women in the U.S. receive the vaccines. "At most, about half of ob-gyns will provide (flu) vaccines," Kathryn Edwards, professor of pediatrics at the Vanderbilt University Medical Center, said, adding that 28% will refer their patients to be vaccinated elsewhere and that 24% make no referral at all. "This is a major issue," Edwards said.

According to Neal Halsey, director of the Institute for Vaccine Safety at the Johns Hopkins University's Bloomberg School of Public Health, there are "good data that the inactivated (flu) vaccine is safe in pregnancy" and is "not associated with any risk of adverse outcomes." However, he added that people "tend to assume that anything bad that happens -- all congenital abnormalities -- might have been caused by something administered during pregnancy" (Roylance, Baltimore Sun, 5/18).

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