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It's now the second treatment approved by the FDA to prevent RSV in infants and the first vaccine. It uses maternal immunization, which refers to vaccinating pregnant mothers so they can pass protective antibodies to their fetuses. "When you think globally, this vaccine could potentially have a huge public health impact," Gurtman told CNBC. The FDA in mid-July approved an RSV monoclonal antibody from Sanofi and AstraZeneca that is directly administered to infants. The shot would help the U.S. combat the upcoming RSV season as it comes off an unusually severe year.
Persons: It's, Alejandra Gurtman, Gurtman, Dr, Peter Marks Organizations: Drug Administration, Pfizer, FDA, Centers for Disease Control, Prevention, CNBC, Sanofi, AstraZeneca, CDC Locations: U.S
The vote followed concerns at the FDA and among advisory committee members about two cases of Guillain-Barre syndrome among about 20,000 vaccine recipients. The FDA has asked Pfizer to conduct a safety study on Guillain-Barre syndrome, which the company has agreed to do. There currently is no approved RSV vaccine for the elderly. Pfizer's vaccine contains both strains of RSV, which circulate at the same time during fall and winter. Dr. David Kaslow, a senior official in the FDA's vaccine division, said safety monitoring will be "critically important" if Pfizer's RSV vaccine is approved.
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