Pfizer announced that the U.S. Food and Drug Administration (FDA) has approved its respiratory syncytial virus vaccine, the company’s bivalent RSV pre-fusion F protein vaccine (RSVpreF), for the prevention of LRTD and severe LRTD caused by RSV in infants from birth to six months of age through active immunization of pregnant women at 32 to 36 weeks of gestation. The vaccine, which contains no adjuvant and consists of two preF proteins selected to optimize protection against RSV A and B strains, was shown to be safe and effective.
“This approval as the first and only maternal vaccine protecting newborns from RSV from birth through six months represents an important step for the scientific community and for public health,” said Daniel Bustos, Pfizer Mexico’s chief medical officer.
“We are incredibly grateful to clinical trial participants and clinical research teams around the world, as well as to our colleagues for their efforts to make this vaccine available. Today we have achieved a goal we have long pursued: to bring a vaccine to mothers that will help protect babies from birth to six months of age or less, when they are most at risk from the serious consequences of this virus are.”
The FDA’s decision is supported by data from the pivotal Phase 3 clinical trial of the Maternal Immunization Study to Evaluate Safety and Efficacy, a randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the efficacy, safety and immunogenicity of vaccines against LRTD and severe RSV-LRTD in infants of healthy individuals vaccinated during pregnancy. The medical journal The New England Journal of Medicine published these results in April 2023.
“Newborns and young children — whose immune systems are still developing and lack the ability to defend themselves against infection — can now be protected from RSV from birth through maternal vaccination,” said Dr. Eric AF Simões, MD, Clinical Professor of Pediatric Infectious Diseases at the University of Colorado School of Medicine and at the Children’s Hospital Colorado campus in Aurora.
“The approval of the vaccine is an important victory as it helps ensure potential protection against RSV is not delayed in the baby’s first six months – the months most at risk – and gives healthcare providers a new way to prevent it of severe RSV.” he added.
RSV is a contagious virus and one of the most common causes of respiratory disease worldwide. The virus can infect the lungs and airways of an infected person, causing serious illness or death.
The burden of RSV disease in young children is alarming, as virtually all children acquire RSV infection before the age of two. In the United States, approximately 500,000 to 600,000 babies are diagnosed with RSV LRTD each year, and it is one of the leading causes of hospitalization for children under one year old.
About consent
On March 2, 2022, Pfizer announced that the FDA had granted Breakthrough Therapy designation to its RSV vaccine for the prevention of RSV-associated lower respiratory tract disease in infants from birth through six months of age by actively immunizing pregnant women . Subsequently, in February 2023, the FDA accepted the vaccine’s Biological Product License (BLA) application by priority review as it is a decision affecting babies.
Pfizer is currently the only company with an RSV vaccine that helps protect both older adults and infants, the latter through maternal vaccination. In May 2023, the FDA approved the vaccine to prevent RSV LRTD in people age 60 and older. Following that approval, in June, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices issued an official recommendation for the vaccine for use in adults 60 and older.
In July 2023, the company announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion recommending that the RSV vaccine candidate be granted marketing authorization to protect older adults and adults Contribute to babies through maternal immunization against RSV. This positive CHMP opinion is currently being evaluated by the European Commission (EC) for each indication. The EC will decide whether to authorize marketing in the European Union.
In February 2023, Pfizer Japan announced that it had submitted an application to the Ministry of Health, Labor and Welfare for the vaccine as a maternal immunization method to protect infants from RSV. In April 2023, Pfizer Canada announced that Health Canada had accepted that the vaccine would protect infants from RSV.
The company has started two more clinical trials to evaluate its vaccine. A study is currently underway in children aged 2 to <18 years who are at increased risk of developing RSV disease. A second study examines adults aged 18 to 60 who are at increased risk of RSV due to underlying diseases such as asthma, diabetes and COPD, and immunocompromised adults aged 18 and over who are at high risk of RSV. RSV. It is also proposed to conduct studies and post-marketing surveillance programs to further determine the safety of the vaccine.
