FDA authorizes Pfizer RSV vaccine for utilization during pregnancy in order to safeguard infants.
Abrysvo, the maternal RSV vaccine for respiratory syncytial virus, stands as the singular and pioneering solution to shield infants from this virus.
The FDA has granted approval to Pfizer’s bivalent vaccine for respiratory syncytial virus (RSV), known as Abrysvo, to be administered during pregnancy. This approval is aimed at preventing lower respiratory tract disease (LRTD) as well as severe LRTD caused by RSV in infants from birth up to 6 months of age, as stated in an official press release. This landmark approval positions Abrysvo as the inaugural and sole maternal RSV vaccine established to safeguard infants from this virus.
RSV, an exceedingly transmissible virus responsible for respiratory infections, can affect individuals of all age groups; however, it predominantly affects children. It holds the distinction of being the primary cause behind respiratory-linked hospitalizations in infants on a global scale, constituting the major cause of hospitalizations within the first year of life. Although its symptoms are often akin to those of a common cold, the virus can also trigger pneumonia and bronchiolitis.
“RSV is a prevalent source of childhood illness, and among those most vulnerable to severe consequences, infants stand out, facing the potential for hospitalization,” remarked Peter Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation and Research, in an official statement. “This endorsement furnishes healthcare providers and expectant individuals with a means to safeguard infants from this potentially life-threatening ailment.”
The validation of Abrysvo was grounded in the effectiveness findings of the MATISSE phase 3 clinical trial (NCT04424316). The study encompassed 3682 expectant mothers who were administered the vaccine and 3676 who were given a placebo between the 24th and 36th weeks of gestation. The subsequent evaluation included 3570 infants from the Abrysvo group and 3558 from the placebo group. The outcomes showcased Abrysvo’s capability to diminish the risk of severe lower respiratory tract disease (LRTD) by 81.8% within the initial 90 days after birth, and by 69.4% within the initial 180 days following birth.
Abrysvo’s safety was assessed through two separate investigations. The initial study encompassed 3,600 pregnant individuals who were administered a solitary dose of the vaccine, while another 3,600 pregnant individuals were given a placebo. In the subsequent study, 100 individuals received Abrysvo, and another 100 were provided with a placebo. The frequently noted adverse effects comprised discomfort at the injection site, headaches, muscle pain, and nausea. Furthermore, a reported 1.8% of participants experienced pre-eclampsia.
“Neonates and early-stage infants, whose immune systems are still in the process of maturation and lack the strength to effectively combat infections, can now potentially acquire RSV protection right from birth through maternal immunization,” stated Eric A.F. Simões, MD, as conveyed in an official statement. “The endorsement of Pfizer’s ABRYSVO represents a significant achievement, as it guarantees the immediate availability of potential RSV safeguarding during the initial and most delicate six months of an infant’s life. This offers healthcare providers a fresh avenue to contribute to the prevention of severe RSV cases.”
Abrysvo carries a boxed warning indicating the presence of a numerical discrepancy in the occurrence of preterm births among recipients when compared to those who were administered a placebo. Presently, the available data is inadequate to definitively determine or rule out a causal association. The FDA has emphasized its directive for Pfizer to initiate postmarketing investigations to evaluate the potential indication of a serious risk related to preterm birth and hypertensive disorders during pregnancy, which includes pre-eclampsia.
