With an eye on an "emergent global health concern," GeneOne Life Science teamed up with the Walter Reed Army Institute of Research this week to usher its vaccine for Middle East respiratory syndrome (MERS) into a first-in-human trial at the institute.
Barely a month after reporting promising Phase II results for its respiratory syncytial virus (RSV) jab and netting an $89 million Gates Foundation grant, Gaithersburg, MD-based Novavax is going full steam ahead, initiating a Phase III trial for its RSV candidate.
Novavax reported on Tuesday that topline results from a Phase II trial in pregnant women showed that its respiratory syncytial virus vaccine protected infants via maternal immunization. It also announced that it won a potential $89 million grant from the Bill & Melinda Gates Foundation to get its candidate through Phase III.
Immunizing pregnant women with an RSV vaccine charged up levels of antibodies that should be able to protect infants during the first few months of their lives, Novavax reported Tuesday morning, adding that the Bill & Melinda Gates Foundation followed up with an $89 million grant to fund a pivotal study.
There is no vaccine for respiratory syncytial virus (RSV), which causes 177,000 hospitalizations and 14,000 deaths each year in adults older than 65. But early data from Novavax's Phase II trial of its RSV candidate show its promise in protecting older adults.
Novavax shares surged today on the news that its vaccine for respiratory syncytial virus (RSV) proved effective in a large midstage study that company officials billed as a "historic" achievement.
Novavax is making waves in the influenza space, reporting positive Phase II results for its quadrivalent seasonal flu vaccine on Thursday.
Back in February, Novavax took its Ebola candidate to Australia for a Phase I trial. The company reported positive top-line results from the 230-person trial on Tuesday.
Novavax announced on Thursday that it would take its Ebola candidate to Australia for a Phase I trial involving 230 healthy adults. It is the fourth company to bring an Ebola vaccine to human trials, but Novavax says it has a better vaccine.
Right now, the U.S. government is in search of an H7N9 vaccine that can reach the market to help prevent against a potential pandemic. And a new FDA fast-track designation for Novavax's candidate might help it get there a little sooner.