Published Data Show Why GSK Bailed on Its Maternal RSV Vaccine
GSK’s abandoned maternal respiratory syncytial virus (RSV) vaccine protected infants from severe RSV, final results of a phase III trial indicated, but those positive outcomes came at the expense of an unexplained higher risk for preterm birth. For newborns up to 6 months of age, efficacy with the RSV prefusion F protein-based vaccine (RSVPreF3-Mat) during […]
COVID Vax in Pregnancy Protects Young Infants Against Omicron
Maternal COVID vaccination in pregnancy protected young infants against Omicron-associated hospitalization, but few women actually receive the vaccine during pregnancy, according to new data from the CDC. At least one maternal vaccine dose had an effectiveness of 54% (95% CI 32-68) against COVID-related hospitalization among infants younger than 3 months of age, and an effectiveness […]
CDC Advisors Endorse Maternal RSV Vax to Protect Newborns
The CDC’s advisors on Friday recommended a maternal respiratory syncytial virus (RSV) vaccine to protect infants from serious infections. By an 11-1 vote, the Advisory Committee on Immunization Practices (ACIP) recommended that pregnant women receive a single dose of Pfizer’s prefusion F protein (RSVpreF) vaccine (Abrysvo) at 32 to 36 weeks’ gestation to prevent lower […]
Opinion | ‘This Medication Is Not the Panacea’: What We Heard This Week
“This medication is not the panacea to tackle the maternal mental health crisis.” — Judite Blanc, PhD, of the University of Miami Miller School of Medicine, on the recent FDA approval of the zuranolone (Zurzuvae), the first pill for postpartum depression. “I know that patients will have a difficult time knowing what the results mean, […]
This Leading Cause Of Death For New Moms May Surprise You
You may have heard about the distressing rise in maternal mortality in the U.S., which disproportionately affects Black women. In a study of 11 high-income countries, the U.S. had the highest rate of maternal mortality. “Pregnancy-related deaths are defined as the death of a woman while pregnant or within 1 year of the end of […]
FDA Panel Gives Strong Backing to RSV Vaccine for Protecting Infants
An FDA panel on Thursday gave a strong endorsement for what could become the first maternal respiratory syncytial virus (RSV) vaccine approved for protecting infants against the annual scourge. In a unanimous vote, all 14 members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) said that the available data support the efficacy of […]
Safety Data on Maternal RSV Vaccine ‘Favorable,’ FDA Staff Says
A maternal respiratory syncytial virus (RSV) vaccine candidate prevents infections in infants and comes with “generally favorable” safety data, said FDA staff in briefing documents released ahead of an advisory committee meeting this week, but the reviewers “noted potential uncertainty based on the numerical imbalance in premature deliveries.” On Thursday, members of the Vaccines and […]
Lupus During Pregnancy Carries Higher Maternal, Fetal Morbidity Risks
Women with systemic lupus erythematosus (SLE) had higher risks for maternal and fetal morbidity compared to those without the chronic autoimmune disorder, according to a nationwide analysis of U.S. data. The 10-year study showed that patients with SLE had higher intrauterine growth restriction versus people without SLE (8.0% vs 2.7%) and more frequent preterm delivery […]
Maternal Mortality Rose Significantly in 2021, CDC Says
Maternal mortality in the U.S. significantly increased in 2021 compared with the previous year, the CDC reported Thursday. A total of 1,205 women died of maternal causes in 2021, compared with 861 in 2020 and 754 in 2019, according to the report from Donna Hoyert, PhD, of the CDC’s National Center for Health Statistics. The […]
Funding, Policy Changes Needed to End Maternal Health Crisis, Federal Officials Say
WASHINGTON — Addressing the maternal mortality crisis requires a layered approach that includes extending Medicaid coverage for postpartum persons, expanding home visitation programs, and giving hospitals “gold stars,” government officials said. But without action from Congress and the states, they stressed during a stakeholder meeting here Tuesday, certain tools to reduce maternal illness and death […]