FDA advisers recommend approval of monoclonal antibody to protect newborns and young children from RSV
STAT (6/8)
Last week, a US Food and Drug Administration (FDA) advisory committee voted to recommend a monoclonal antibody product to protect children one year and under, as well as high-risk children between one and two years old, from respiratory syncytial virus, or RSV. Nirsevimab, which will be marketed as Beyfortus, was developed by AstraZeneca and will be marketed in the United States by Sanofi. The product is intended to be administered to babies via a single injection during RSV season or at birth depending on birth timing. RSV is a major challenge in children, particularly in very young children, causing up to 80,000 hospitalizations and 300 deaths a year in the United States. Pfizer’s RSV vaccine for pregnant people, which is also aimed at protecting babies, is currently being considered by regulators as well.
Moderna to test mpox vaccine in humans this summer
Fierce Biotech (6/7)
Moderna will launch a phase 1/2 trial of their mpox vaccine this summer with the goal of generating data to inform dose selection and eventually licensure. The company announced the start of preclinical work on an mpox vaccine back in May of last year, with the vaccine being swiftly developed using the company’s mRNA platform. After the immediate mpox outbreak waned in the United States, the vaccine was deprioritized by Moderna, but ahead of this summer, when mpox is expected to re-emerge, Moderna has announced the trial and has been meeting with the US mpox response team.
Scientists set AI to work on finding vaccines to combat the next Disease X
The Telegraph (6/6), features the Coalition for Epidemic Preparedness Innovations (CEPI)
The Coalition for Epidemic Preparedness Innovations (CEPI) last week announced £1.5 million in funding for Germany’s Leipzig University, where researchers have created artificial intelligence technology that will be used to build a vaccine library aimed at streamlining the development of a new generation of vaccines against a future pathogen with pandemic potential, or Disease X. The technology will analyze the genetic structures of pathogens from ten high-risk viral families, starting with those families that include Nipah and Lassa viruses; model protein sites in the viruses that are crucial targets for generating immune responses in human; and then use those viral protein targets to develop vaccine blueprints. Future scientists will hopefully be able use the library to develop vaccine candidates within 100 days of identifying a pathogen with pandemic potential.
