FDA Approves Pfizer's Respiratory Syncytial Virus Vaccine for Pregnant Women

The U.S. Food and Drug Administration (FDA) has approved the use of Pfizer's respiratory syncytial virus (RSV) vaccine for pregnant women, to be administered during the middle of the third trimester to protect their infants. The company stated that the approval allows the vaccine to be given to women between 32 and 36 weeks of pregnancy to prevent lower respiratory tract infection or severe illness symptoms in infants until they reach six months of age. An FDA advisory committee of external experts endorsed the safety and efficacy of the Pfizer RSV vaccine for women during the second and third trimesters of pregnancy. A Pfizer spokesperson could not comment on the reason for the shorter time frame for receiving the vaccine but expressed confidence that the vaccine will have a positive impact on public health and RSV infection rates. RSV is a common virus that typically causes mild cold-like symptoms but can lead to severe illness and hospitalization. The vaccine, marketed under the brand name Abrysvo, has already been approved for individuals aged 60 and older to prevent a disease that claims an estimated 160,000 lives worldwide annually. However, infants are the most vulnerable to severe symptoms from RSV. Government data indicate that between 58,000 to 80,000 children under five are hospitalized each year in the United States due to RSV. The new use of the vaccine still requires approval from the Centers for Disease Control and Prevention (CDC) to become the first widely available vaccine in the U.S. for mothers to receive to prevent RSV. Approval is expected soon following the FDA's green light issued on Monday.