Vaccine Irony: COVID Complicates Review, Uptake Of New RSV Vaccines
COVID vaccines saved the world and then became a liability. US FDA vaccine advisors cited COVID experience as they urge agency to slow down on approval of new RSV vaccines, due to worries of declining public vaccine confidence and coadministration complications.
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Pfizer’s Maternal RSV Vaccine Quest May Hinge On FDA Advisors’ Views of Preterm Birth Data
A numerical – but not statistically significant – imbalance in preterm births was seen in two Pfizer studies of its RSV vaccine when given to pregnant people with the aim of protecting newborns.
GSK’s RSV Vaccine Prospects In Youngest Pediatric Patients Looks Unlikely Per US FDA Label
Arexvy is the first vaccine approved for the respiratory virus, but GSK's RSV program may lose out on a key population due to safety concerns for individuals younger than two. For Arexvy, CDC’s advisory committee could limit recommendation to 65 and up at June meeting.
Moderna And The All-American Drug Pricing Hearing
Moderna’s time in the hot seat of the US drug pricing debate went about as well as it could for the company. The firm astutely set a tone of an All-American success story – but the hearing also showcased other ‘only in America’ themes.