First RSV vaccine to protect infants wins backing of FDA panel
CBSN
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 Thursday to back the safety and effectiveness of a new shot developed by Pfizer, branded as Abrysvo.
If ultimately approved by the FDA, Abrysvo could be the first vaccine to protect infants from a respiratory disease that ranks as the leading cause of hospitalization in this youngest age group. Pfizer says the FDA is expected to issue its final decision by August.
The FDA's Vaccines and Related Biological Products Advisory Committee voted specifically on two questions, weighing whether there was adequate data from clinical trials studying Abrysvo's safety and effectiveness, following a daylong meeting of the panel.