Silver Spring, MD—Pharmacists likely will have an additional vaccine to administer this fall to older adults.

Earlier this month, the FDA approved Arexvy, the first RSV vaccine approved for use in the United States. Arexvy is used for the prevention of lower respiratory tract disease caused by RSV in adults aged 60 years or older and underwent priority review.

GlaxoSmithKline (GSK) Biologicals advised that in June 2023, the Advisory Committee on Immunization Practices will make recommendations on the appropriate use of the vaccine in the United States. It is expected to be available for older adults before the 2023/24 RSV season, which usually begins prior to the winter months.

“Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States.”

In the study that led to the FDA approval, the vaccine was shown to significantly reduce the risk of developing RSV-associated lower respiratory tract disease (LRTD) by 82.6% and reduced the risk of developing severe RSV-associated LRTD by 94.1%.

An FDA advisory panel recently recommended that Arexvy and another candidate from Pfizer be approved to protect against RSV in older adults.

The randomized, placebo-controlled clinical study on Arexvy was conducted in the U.S. and internationally in participants aged 60 years and older and is ongoing. The study will continue with the same group through three RSV seasons to assess the duration of effectiveness and the safety and effectiveness of repeat vaccination. Data for a single dose of Arexvy from the first RSV season of the study were available for the FDA’s analysis.

In another study, in which Arexvy was concomitantly received with an FDA-approved influenza vaccine, two participants developed acute disseminated encephalomyelitis (ADEM), a rare type of inflammation that affects the brain and spinal cord, 7 and 22 days, respectively, after receiving Arexvy. One of the participants who developed ADEM died. In a third study, one participant developed Guillain-Barré syndrome 9 days after receiving Arexvy.

The FDA is requiring the company to conduct a postmarketing study to assess the signals of serious risks for Guillain-Barré syndrome and ADEM. Although not an FDA requirement, GSK also has committed to assessing atrial fibrillation in the postmarketing study.

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

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