World’s First Maternal Vaccine Approved by FDA!

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World’s First Maternal Vaccine Approved by FDA! Pfizer’s RSV Vaccine Granted Clearance for Pregnant Women at 32-36 Weeks to Prevent Fetal RSV Infections

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World’s First Maternal Vaccine Approved by FDA! Pfizer’s RSV Vaccine Granted Clearance for Pregnant Women at 32-36 Weeks to Prevent Fetal RSV Infections.

On August 21, 2023, Pfizer, Inc. announced that the United States Food and Drug Administration (FDA) has granted approval for ABRYSVO™ (Respiratory Syncytial Virus Vaccine) for active immunization of pregnant women at gestational weeks 32 to 36.

This groundbreaking approval aims to prevent lower respiratory tract diseases (LRTD) and severe LRTD caused by RSV in fetuses born up to six months old.

This marks the first and only maternal vaccine ever approved by the FDA!

ABRYSVO is a non-adjuvanted bivalent vaccine incorporating the RSV preF fusion protein. It had previously received FDA clearance on May 31, 2023, for the prevention of RSV-related acute respiratory diseases and lower respiratory diseases in adults aged 60 and above.

The approved administration strategy involves a single-dose intramuscular injection for pregnant individuals during weeks 32 to 36 of gestation.

The FDA’s decision was based on critical Phase 3 clinical trial data (NCT04424316) involving over 14,000 pregnant women and neonatal subjects.

The data revealed a protection rate of 81.8% against severe lower respiratory symptoms within 90 days of birth and a 57.1% protection rate against lower respiratory symptoms.

Safety data indicated only mild adverse reactions rated at Grade 3 or below.

In clinical trials comparing ABRYSVO with a placebo, the most common side effects (≥10%) included injection site pain, headache, muscle pain, and nausea.

The incidences of low birth weight (ABRYSVO 5.1% vs. placebo 4.4%) and jaundice (ABRYSVO 7.2% vs. placebo 6.7%) in infants born to vaccinated mothers were comparable to the control group, demonstrating that the vaccine’s use in pregnant women at 32-36 weeks does not significantly increase safety risks.

However, due to an imbalance in adverse event rates, important safety information underscores the need to administer ABRYSVO between gestational weeks 32 to 36 to avoid potential risks of preterm birth.

Dr. Annaliesa Anderson, Senior Vice President and Chief Scientific Officer of Vaccine Research and Development at Pfizer, commented, “The approval of ABRYSVO as the first and only vaccine for maternal immunization is a significant milestone for science and public health, helping protect RSV newborns from birth to six months.”

Dr. Eric A.F. Simões, Clinical Professor of Pediatric Infectious Diseases at Children’s Hospital Colorado, added, “Pfizer’s ABRYSVO approval is a major victory as it contributes to ensuring potential RSV protection in the most vulnerable first six months of life and provides healthcare institutions with a new opportunity to prevent severe RSV.”

It’s worth noting that the FDA’s approval also requires Pfizer to conduct post-marketing research to assess the risks of severe preterm birth and hypertensive disorders of pregnancy, including preeclampsia.

Reference:

[Pfizer Press Release] 

World’s First Maternal Vaccine Approved by FDA!

(source:internet, reference only)

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