PATH welcomes maternal RSV vaccine WHO prequalification
The milestone marks the first-ever prequalification of an RSV vaccine and paves the way for improving respiratory disease prevention for infants around the world.
PATH applauds the announcement that the World Health Organization (WHO) has prequalified a respiratory syncytial virus (RSV) maternal vaccine (Abrysvo®, Pfizer, Inc.). The groundbreaking step is an important advancement on the pathway toward broadening access to prevention against the top cause of severe respiratory infections and hospitalizations in infants and young children worldwide.
WHO recently recommended the maternal RSV vaccine for global use to prevent RSV disease in young infants. WHO prequalification allows the vaccine to be procured by United Nations agencies and is a precursor to Gavi, the Vaccine Alliance support for RSV vaccine use in low- and middle-income countries, where the RSV disease burden is greatest but access to the vaccine has, so far, been out of reach. To date, use of the vaccine has been mainly in high- and some upper-middle income markets.
“WHO prequalification is critical and exciting progress in the larger effort to ensure that maternal RSV vaccine can begin saving young lives on a global scale,” says Dr. Clint Pecenka, director of PATH’s RSV vaccine program. “In addition to improving infant health and survival, RSV prevention can also reduce substantial strain on health systems and households. With a vaccine prequalified, now is an opportunity to focus on preparations for introduction and addressing remaining barriers to access and implementation.”
RSV causes more than 30 million severe respiratory infections, 3.5 million hospitalizations, and 100,000 deaths among children less than five years of age worldwide each year. Nearly half of RSV deaths occur before 6 months of age. Almost all RSV deaths are in low- and middle-income countries where many children die never making it to the hospital—underscoring the urgency of preventing severe RSV disease before it starts and ensuring that prevention measures are within reach in these contexts.
Given in pregnancy, the maternal RSV vaccine enhances a pregnant woman’s immunity and increases natural antibody transfer to the baby for protection in the first months of life after birth. It confers passive immunity whereby the infant is given protective antibodies rather than making them through his or her own immune system—a powerful way to protect infants in early life.