New Study Aims To Offer More Solid Evidence of Vaccine Safety in Pregnancy
The Organization of Teratology Information Specialists (OTIS), a non-profit organization based at the University of California, San Diego with affiliates across North America, urges pregnant women to receive the influenza vaccine as soon as possible. The recommendation comes shortly after the American College of Obstetricians and Gynecologists Committee on Obstetric Practice issued new guidelines regarding the influenza vaccine during pregnancy.
OTIS aims to educate women about exposures during pregnancy and lactation through a toll-free hotline as well as observational research studies. The organization is looking for the help of pregnant women to collect information on exposures such as the flu vaccine in pregnancy, with a goal to enroll 1100 pregnant women across the U.S. in the study by March 2011.
“The newest opinion from experts is that pregnant women at any gestational age during the flu season should receive the influenza vaccine,” Christina Chambers, PhD, MPH, UCSD professor of pediatrics and an epidemiologist with a special focus in the area of birth defects prevention. Chambers also serves as program director of OTIS’ California affiliate and The California Teratogen Information Service (CTIS) Pregnancy Health Information Line.
“It’s preferable for a woman to receive the immunization early during the flu season since protection against the flu doesn’t begin to set in until about two weeks after the flu shot is administered,” Chambers added. The vaccine protection typically lasts six to eight months.
According to Chambers, fewer than half of pregnant women get the flu vaccine while they are pregnant, even though the recommendation is that all pregnant women receive the vaccine. She adds that pregnant women have an increased risk of having serious complications from the flu, such as severe breathing problems. Severe disease and even death from infection with the flu virus occurs more often in pregnant women than in women who are not pregnant.
The flu vaccine being administered during the 2010-2011 flu season provides protection against both the seasonal and H1N1 flu viruses. Unlike last season, this year a separate H1N1 flu shot is no longer needed. In addition to the flu shot, a nasal-spray influenza vaccine is also available. However, unlike the flu shot, the nasal-spray vaccine contains a live, but weakened virus, so is not recommended during pregnancy.
“We’ve received a number of calls from concerned women wondering if they should receive the flu shot,” said Sonia Alvarado, a counselor supervisor at CTIS Pregnancy Health Information Line. “Many worry that since the H1N1 protection is included in this year’s flu shot, the H1N1 portion may be dangerous, but that’s simply a misconception. The H1N1 vaccine has, in fact, been thoroughly studied in both pregnant and non-pregnant volunteers.”
“Since research has shown how important it is for pregnant women to receive the flu shot, it’s important that pregnant women feel reassured that the vaccine itself is safe to use in pregnancy,” said Diana Johnson, MS, study manager for OTIS Studies. In addition, a recent study published in the Archives of Pediatrics & Adolescent Medicine suggests that babies born to women who received a flu vaccine during pregnancy may themselves have some additional protection against the flu virus.
Johnson is one of dozens across the country helping to coordinate the Vaccines and Medications in Pregnancy Surveillance System (VAMPSS). VAMPSS is a North American effort to obtain and evaluate information on developing babies whose mothers receive H1N1 flu vaccines, seasonal flu vaccines, antiviral medications, and/or asthma medications during pregnancy.
“The VAMPSS surveillance system is more important now than ever before,” explained Johnson. “As new medications and vaccines become available, an established system for identifying the safety or risks of exposures that occur during pregnancy in a timely and comprehensive manner is critical in helping pregnant women and their health providers make informed decisions about treatment options,” she said.
Women who are currently pregnant may qualify to enroll in the VAMPSS study. Participation involves two to four phone interviews and release of medical records relating to the woman’s current pregnancy. More information is available at OTISPregnancy.org or by calling OTIS Studies at (877) 311-8972.
For more information or if you would like to schedule an interview, please contact Nicole Chavez at (619) 294-6262. Spanish-speaking interviews are also available.
The VAMPSS study of flu vaccines and antiviral medications is being supported by the U.S. Office of Biomedical Advanced Research and Development Authority (BARDA) and is a collaboration between OTIS, the American Academy of Allergy Asthma and Immunology and the Slone Epidemiology Center at Boston University.
If a woman is planning on becoming pregnant or is currently pregnant, she is encouraged to talk to her doctor about getting the influenza vaccine. Questions or concerns can also be directed to OTIS’ California affiliate, CTIS Pregnancy Health Information Line, at (800) 532-3749 or at CTISPregnancy.org. Outside of California, please call OTIS counselors at 866-626-6847.
OTIS is a North American non-profit dedicated to providing accurate and evidence-based clinical information to patients and health care professionals about exposures during pregnancy and lactation through its toll-free hotline and website, www.OTISPregnancy.org. Nearly 100,000 women seek information about birth defect prevention from OTIS every year. Its California affiliate is housed at the University of California, San Diego in the Department of Pediatrics.