Pfizer Broadens Portfolio of Respiratory Vaccines Recommended by CDC Advisory Committee with ABRYSVO™ for RSV

Pfizer Inc. (NYSE: PFE) shared today it has broadened its portfolio of respiratory vaccines recommended by the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) following a favorable vote for ABRYSVO™ [Respiratory Syncytial Virus Vaccine], the company’s bivalent RSV prefusion F (RSVpreF) vaccine, as a maternal immunization. This is the first-ever fall in which eligible individuals can receive Pfizer vaccines to help protect against RSV, COVID-19, and pneumococcal pneumonia.

“This fall marks the start of the annual respiratory infection season in the Northern Hemisphere, and we are prepared with vaccines against multiple infectious diseases and — for the first time in history — an available RSV vaccine to help prevent disease in two at-risk populations,” said Luis Jodar, PhD, Chief Medical Affairs Officer, Vaccines/Antivirals and Evidence Generation, Pfizer. “Today’s ACIP recommendation for maternal immunization with ABRYSVO reinforces the wide-ranging impact vaccines can have, including helping protect infants immediately at birth from the potentially severe and life-threatening complications that can develop from RSV. Approximately 75 percent of RSV-related hospitalizations in newborns and infants occur in the first six months of life.”

Today, ACIP recommended:

  • Maternal RSV vaccine for pregnant people during 32 through 36 weeks gestation, using seasonal administration, to prevent RSV lower respiratory tract infection in infants

This provisional recommendation will be official once it is reviewed and adopted by the director of the CDC. The ACIP recommendation follows the U.S. Food and Drug Administration’s (FDA) approval of ABRYSVO in August as the first and only maternal vaccine for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age.

The action today by ACIP comes on the heels of recent and previous recommendations from the CDC.

  • After FDA authorization and approval of our Pfizer-BioNTech COVID-19 Vaccine 2023-2024 Formula earlier this month, ACIP recommended everyone 6 months and older get an updated COVID-19 vaccine to protect against COVID-19 illness this fall and winter.
  • ABRYSVO is currently available and recommended using shared clinical decision making for adults 60 years of age and older to help protect against RSV disease. With more than 77 million individuals aged 60 and older in the U.S.1, the recommended use of this vaccine can help prevent the potentially serious consequences associated with RSV, which leads to the hospitalization of more than 60,000 of these adults each year.2
  • PREVNAR 20® has been recommended by the CDC since October 2021 to help prevent pneumococcal disease among adults aged 65 years or older and adults 19-64 years old with certain medical conditions, such as asthma, diabetes or other risk factors. Pneumococcal pneumonia results in more than 180,000 adult hospital admissions and more than 150,000 adult outpatient visits in the U.S. each year.3

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