A recent Danish study found that exposure to the influenza A(H1N1)pdm09 vaccine during pregnancy was not associated with a significantly increased risk of major birth defects or preterm births.
A recent Danish study found that exposure to the influenza A(H1N1)pdm09 vaccine during pregnancy was not associated with a significantly increased risk of major birth defects or preterm births.
The study, published in the July 11 issue of the Journal of the American Medical Association, was led by Björn Pasternak, MD, PhD, with the Department of Epidemiology Research at the Statens Serum Institut in Copenhagen, Denmark. This is the first study to directly compare outcomes from H1N1 vaccinations during pregnancy to unvaccinated pregnancies, according to the researchers.
After examining a national registry of 53,432 infants born between November 2009 and September 2010, the researchers found that 13.1% were exposed to the H1N1 vaccine during pregnancy. A major birth defect was diagnosed in 18 of 330 (5.5%) infants exposed to the vaccine in the first trimester, compared with 15 out of 330 (4.5%) unexposed infants. Preterm births occurred in 9.4% in infants exposed to the vaccine in the first trimester, compared to 7.3% who were not exposed.
“Taken together, these studies partially assuage concerns about safety of adjuvant pandemic influenza vaccines during pregnancy,” wrote Mark C. Steinhoff, MD, and Noni E. MacDonald, MD, MSc, in a JAMA editorial accompanying the study. “However, more studies are needed examining other types of vaccine adjuvants,” Drs Steinhoff and MacDonald added.
Dr Pasternak and the Danish researchers also agreed that further research is needed to address the risk of specific birth defects and the effectiveness of H1N1 during pregnancy.
Navitus to Offer Unbranded Stelara Biosimilar, Remove Stelara from Formulary
March 13th 2025Lumicera Health Services, Navitus’ specialty pharmacy, has made a deal with Teva to offer an unbranded biosimilar that they estimate will save $112,000 and $336,000 per patient per year. Navitus will remove Stelara from formulary on July 1, 2025.
Read More
FDA Approves Neffy 1 mg Nasal Spray for Pediatric Patients
March 6th 2025Neffy 1 mg is now approved by the FDA to treat pediatric patients who weigh 33 to 65 lbs. Neffy was first FDA-approved as a 2 mg dose in August 2024 for the emergency treatment of anaphylaxis in children and adults weighing at least 66 lbs.
Read More