In a groundbreaking step toward infant health protection, the World Health Organization (WHO) has prequalified the first-ever vaccine to shield newborns from Respiratory Syncytial Virus (RSV)—a virus that hospitalizes an estimated 3 million children under five every year and causes around 100,000 deaths globally.
The vaccine, Abrysvo, developed by Pfizer, is administered to pregnant individuals and offers protection to their babies in the earliest and most vulnerable months of life. This maternal vaccination strategy is a major public health innovation and is expected to significantly reduce the global RSV burden.
What Is RSV and Why Is It Dangerous?
RSV is a highly contagious virus that infects the respiratory tract. While it typically causes mild, cold-like symptoms in older children and adults, it can lead to serious complications such as bronchiolitis and pneumonia in infants, especially those younger than six months.
According to WHO, RSV is one of the top three causes of death from lower respiratory infections in infants. It’s also a leading reason for pediatric hospitalizations during the winter season in many countries.
How Abrysvo Works
Pfizer’s Abrysvo is administered as a single dose to pregnant women between 32 and 36 weeks of gestation. The vaccine triggers an immune response in the mother, producing RSV-neutralizing antibodies that cross the placenta to the fetus. This passive immunity helps protect the baby during the first six months of life, when they are too young to receive most vaccines.
This vaccine doesn’t replace other RSV prevention tools—it complements them. Together with monoclonal antibodies like nirsevimab (Beyfortus), Abrysvo offers a layered strategy against RSV infection.
Efficacy and Safety Data
- In clinical trials involving over 7,000 participants, Abrysvo showed:
- 57% reduction in severe RSV-related illnesses in infants
- Over 80% protection against medically attended RSV cases within the first 90 days of life
- The vaccine was found to be safe, with no significant safety concerns for either the mother or baby.
- Side effects were mild and similar to those of other pregnancy-administered vaccines, including fatigue, injection site pain, and headache.
The vaccine was already approved by regulatory bodies such as the U.S. FDA in 2023, and WHO’s recent prequalification now allows global procurement and distribution, especially in low- and middle-income countries.
A Game-Changer for Global Health
WHO’s prequalification status means Abrysvo can now be included in United Nations procurement lists, making it accessible through global vaccine alliances like Gavi, which support immunization programs in over 70 low-income countries.
This development is particularly important for countries with high RSV-related infant mortality rates and under-resourced health systems. By preventing severe illness, the vaccine could reduce pressure on hospitals and save lives where medical access is limited.
What About the Cost?
Pfizer has announced plans to work with Gavi and other partners to make the vaccine affordable and widely available. While the final pricing for low- and middle-income countries is still under negotiation, the prequalification by WHO is a major step toward equitable access.
In high-income countries like the U.S., the vaccine has been priced at around $295 per dose, but insurance coverage is expected to reduce the out-of-pocket costs for most families.
Expert Opinions
“This is a breakthrough moment in infant health,” said Dr. Soumya Swaminathan, former WHO Chief Scientist. “Maternal immunization against RSV has the potential to save thousands of newborn lives every year, particularly in settings where hospital care is hard to reach.”
“Preventing RSV through maternal vaccination is not just a scientific win—it’s a public health triumph,” added Dr. Kate O’Brien, Director of WHO’s Immunization Department.
👶 What Should Parents Do Now?
If you’re expecting a baby or planning to, here’s what you need to know:
- Talk to Your Doctor Early: Ask your healthcare provider about the RSV maternal vaccine, especially if your third trimester will coincide with RSV season (typically fall to winter).
- Plan Around Timing: The vaccine must be given between 32–36 weeks of pregnancy to be effective.
- Stay Informed: If you miss the vaccine window, nirsevimab is another excellent option for infant RSV prevention.
- Don’t Panic: RSV is serious, but these new tools drastically improve protection and peace of mind.
Final Thought
The launch of the maternal RSV vaccine is more than just a medical milestone—it’s a shift in how we think about protecting our youngest citizens. For parents and healthcare systems alike, this vaccine represents hope, science, and a proactive step toward healthier beginnings.
As rollout efforts continue globally, WHO’s endorsement will help ensure that every baby—regardless of where they are born—has a better shot at a healthy start.
