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FDA approves Pfizer’s RSV vaccine

The United States Food and Drug Administration announced Wednesday that it has approved Pfizer’s respiratory syncytial virus or RSV vaccine for adults 60 years or older, according to the New York Times.

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Pfizer’s vaccine is called “ABRYSVO,” according to a news release from the FDA.

RSV is one of the most common causes of respiratory illnesses around the world and affects the lungs and breathing passages. It can also cause severe illness or death. How severe RSV is depends on age and other factors such as chronic obstructive pulmonary disease, asthma, and congestive heart failure.

“A vaccine to help prevent RSV had been an elusive public health goal for more than half a century. Today’s approval is a monumental step forward in delivering on Pfizer’s commitment to help alleviate the significant burden of RSV in higher-risk populations, which includes older adults,” Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer, said in the news release.

“ABRYSVO will address a need to help protect older adults against the potentially serious consequences of RSV disease. We are extremely grateful to the clinical trial participants, study investigator teams and our dedicated Pfizer colleagues for their roles in making this vaccine available.”

The decision to approve the RSV vaccine was based on data from a Phase 3 clinical trial called RENOIR.

“RENOIR is a global, randomized, double-blind, placebo-controlled study designed to assess the efficacy, immunogenicity, and safety of a single dose of the vaccine in adults 60 years of age and older,” according to the news release.

The Centers for Disease Control and Prevention is expected to go over recommendations for healthcare providers about the shots in a meeting next month, the Times reported.

RSV usually causes cold-like symptoms that are normally mild but can become serious in older adults and infants, according to the CDC. Most people are better within a week or two.

Symptoms of RSV include:

  • Runny nose.
  • Decreased appetite.
  • Coughing.
  • Sneezing.
  • Fever.
  • Wheezing.

The symptoms, according to the CDC, develop in stages.

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