The first vaccine to protect babies from the respiratory virus RSV is a step closer to approval, after a panel of the Food and Drug Administration's outside vaccine advisers voted to back the safety and effectiveness of a new shot developed by Pfizer.
found 69.4% vaccine efficacy in lowering the risk of severe lower respiratory tract illness, through six months after birth. That was well above the minimum criteria to be licensed, the FDA said, though they noted protection against infection is expected to wane as babies age out of their most vulnerable months.
Both FDA and Pfizer concluded that the trial's safety results appeared largely favorable to both pregnant moms and their babies. But the FDA asked their advisers to wrestle with details of a potentially concerning, but too small to be statistically significant, increase"I'm troubled, as everybody is, by the prematurity issue. And I'm not sure running it through another, maybe season, is going to give us an answer," said committee member Dr. Arnold Monto.
Pfizer said they planned to continue to study the risk of premature births if the shots are approved, using data from databases of health insurance claims.
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