FDA approves first RSV vaccine developed by GlaxoSmithKline

Amid fierce competition, GSK’s Arexvy has become the world’s first vaccine approved to prevent RSV in older adults.

The FDA approved GSK’s Arexvy for the first time as a respiratory syncytial virus (RSV) vaccine for people age 60 and older after a winter of hospitalizations due to RSV. This vaccine specifically protects against RSV-associated lower respiratory tract disease (LRTD).

The approval comes after the FDA’s Vaccines and Related Biology Advisory Committee (VRBPAC) voted unanimously in favor of Arexvy’s efficacy and safety. In addition, the European Medicines Agency’s Committee on Medicines for Human Use (CHMP) gave a positive opinion in favor of the approval of the vaccine in April 2023. FDA based on positive data from a phase III study. AreSVi-006. Study results showed a statistically significant and clinically relevant overall efficacy rate of 82.6% for RSV-LRTD in adults 60 years of age and older. In addition, the ability to reduce the risk of LRTD associated with severe RSV 94,

Arexvy consists of a combination of recombinant subunits fused with the RSV F glycoprotein antigen (RSVPreF3) and the GSK adjuvant AS01E. The GSK vaccine is one of a series of RSV vaccines entering its final phase this year. Pfizer’s RSV vaccine faces regulatory decisions in the United States due to the Prescription Drug Use Charges Act (PDUFA) passed in late May. Moderna and Bavarian Nordic are also conducting phase III trials. for RSV vaccine candidates.

In June, the Advisory Committee on Immunization Practices (ACIP) will issue guidelines for appropriate vaccine use in the United States. In a press release, GSK also announced that the vaccine for the elderly will be available until the RSV 2023/24 season. RSV season typically begins in the fall and peaks in winter in the Northern Hemisphere.

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Dr about this in a press release on May 3. Peter Marks, director of the FDA’s Center for Biological Evaluation and Research: “Today’s approval of the first RSV vaccine is an important public health achievement in the prevention of life-threatening disease. and reflects FDA’s commitment to developing an RSV vaccine in the United States that is safe and effective.”