Novavax Shares Tank On Second Phase III RSV Vaccine Study Failure

Novavax stock plummeted 65 percent in pre-market activity late this week, now trading hands at just north of $2 per share.  The tank is definitely the result of investors losing patience for a company who has not been able to fulfill promises in their new RSV vaccine.  

This was for the product they call ResVax. It is an aluminum adjuvanted respiratory syncytial virus (RSV) fusion (F) protein recombinant nanoparticle vaccine.  

You may recall that Novavax was in the middle of Phase III testing for its latest RSV vaccine back in late 2016, when testing crashed and the company was left to pine over how they could recover.  When they found the Gates Foundation backed a program which tested the drug and determined it could be a “significant commercial opportunity” for infants, they shifted focus. With a Bill & Melinda Gates Foundation grant worth more than $89 million they moved forward to testing with infants.  

But unfortunately, the infant trial seems to have suffered the very same fate, and also in late testing stages as well. 

Apparently ResVax failed is primary endpoint for maternal immunization of infants.  The four-year study examined the effects of the vaccine on 4,600 pregnant women, with administrations of the vaccine in the third trimester. The goal, of course, was to see if the immunity properties could be passed from mother to child after birth and could be carried on through at least the first 90 days of life. The vaccine turned out to be quite well-tolerated but was only effective in 39 percent of cases against the primary study objective—preventing medically significant RSV-related lower respiratory tract infections. 

This study—and medication—is important because RSV is actually the leading cause of infant hospitalizations in the United States. It is also the second leading cause of infant deaths, globally, after malaria.  

At the end of the day, Keith Klugman, who is the director of the Gates Foundation pneumonia program, remains optimistic. In a statement, he said, “We are very encouraged that the Novavax maternal RSV vaccine reduced severe RSV hypoxemia by 60 percent in the first months of life and believe this vaccine has great potential for reducing RSV-associated deaths in young babies.”