Federal authorities are contemplating distributing a vaccine meant to safeguard infants against Respiratory Syncytial Virus (RSV)

Federal authorities are contemplating distributing a vaccine meant to safeguard infants against Respiratory Syncytial Virus (RSV)

**Introduction**

A new vaccine, Abrysvo (RSVpreF), has been approved in the United States for the prevention of severe respiratory syncytial virus (RSV) disease in infants. The vaccine, developed by Pfizer, is a significant advancement in protecting newborns against severe RSV, particularly during the first 90 days of life, a period of highest vulnerability for infants.

**Approval and Indication**

Pfizer’s Abrysvo is the only maternal vaccine currently approved in the United States for this purpose. The U.S. FDA has authorised its use in pregnant individuals between 32 and 36 weeks of gestation, with the aim of minimising the risk of preterm birth.

**Effectiveness**

Clinical studies and real-world data suggest that maternal vaccination with Abrysvo provides substantial protection to newborns against severe RSV. The vaccine has demonstrated 82.4% effectiveness in reducing the risk of severe RSV during the first 90 days of life.

**Durability of Protection**

As of now, there is no published real-world effectiveness data for the second year following vaccination in infants. However, the high initial effectiveness during the first three months of life addresses the period of highest need, as most severe RSV cases in infants occur during this time.

**Safety**

Clinical trials found that serious adverse events (SAEs) in both vaccinated pregnant individuals and their infants were balanced between the vaccine and placebo groups. There was a non-significant increase in preterm births, leading the FDA to restrict use to 32–36 weeks of gestation. There was also a non-significant increase in hypertensive disorders of pregnancy, but causality remains unclear.

Post-licensure safety monitoring supports these findings: preliminary data from the first season of use indicate that vaccination at 32–36 weeks’ gestation is not associated with increased risk of preterm birth or babies being small for gestational age (SGA). Ongoing studies aim to further clarify risks of hypertension and other maternal outcomes.

**Expert Perspective**

Abrysvo is a significant advance in preventing severe RSV disease in infants, with strong protection during the highest-risk period immediately after birth. Safety monitoring is ongoing, but current data support its use in the recommended gestational window for eligible pregnant individuals. Continued real-world surveillance will further clarify long-term effectiveness and rare safety signals.

**Implications for Low- and Middle-Income Countries**

RSV is a major cause of illness and death in children under five, especially in the first six months of life, in low- and middle-income countries. The new RSV vaccine is particularly significant for these regions, where RSV is a major cause of illness and death in young children.

**Availability**

The South African Health Products Regulatory Authority approved Abrysvo in December 2024, and it became available in the private sector in 2025.

**Conclusion**

Abrysvo is a promising tool in the fight against severe RSV disease in infants. Its effectiveness in reducing the risk of severe RSV illness continues to be monitored, and its availability in low- and middle-income countries could have a significant impact on child health outcomes.

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