Richard H. Hughes, IV, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in AIS Health, in “Coverage, Supply Issues Dampen Promise of New RSV Immunizations,” by Leslie Small. (Read the full version – subscription required.)
Following is an excerpt:
After years of having just one, limited option available to combat respiratory syncytial virus (RSV) in at-risk populations, the U.S. market this year has suddenly become rich with new products. Yet insurance coverage limitations and supply issues are frustrating efforts to keep elderly adults and very young babies from contracting what can be a life-threatening illness.
This May, the FDA approved both GSK’s Arexvy and Pfizer Inc.’s Abrysvo for people who are 60 and older, and in August, federal regulators approved Abrysvo for use in people who have been pregnant for 32 to 36 weeks, with the goal of protecting their infants after birth. Additionally, in July, the FDA approved Sanofi/AstraZeneca’s Beyfortus (nirsevimab-alip), a monocolonal antibody injection indicated for preventing RSV in newborns and infants born during or entering their first RSV season, and for children up to 24 months old who remain vulnerable to severe disease throughout their second RSV season. …
“No one would have expected this level of demand for a new infant immunization for RSV, because we would expect immunization to occur on more of a rolling basis as babies are born and over the course of well child visits in pediatric offices,” says Richard Hughes IV, who is member of the law firm Epstein Becker Green and who advises health care clients on coverage, payment and policy issues related to vaccines. “Part of the constraint is likely due [to] the fact that some states ordered vaccines through CDC much earlier than others and so the availability may be a bit lopsided geographically.”
But he says there is an upside to the situation, since the high demand for Beyfortus means that “kids are getting immunized amid a serious seasonal threat that was never addressable before this year.” …
