Novavax Inc has developed a vaccine that has shown to prevent a common respiratory viral infection in a mid-stage study. This vaccine takes a step closer to becoming the first vaccine for the virus that affects almost all American children.
Developers are baffled in trying to understand the respiratory syncytial virus's or RSV's molecular structure and thus posing a challenge to them to create a vaccine against the virus. Multiple failures in trials have come in the way.
Wedbush analyst Heather Behanna estimated that an RSV vaccine represents a $1 billion opportunity in the United States and potentially double that worldwide.
The seasonal infection for most older healthy children and adults causes little more than a common cold but for high risk groups, such as those with weak immune system, young infants and the elderly, can lead to more serious results like lung and airway infections.
The vaccine developed by Novavax was similar to or better than a number of respiratory vaccines tested in the elderly. With this data, the company hopes to begin a late-stage 8,000-10,000 patient study in the elderly this year which coincides with the RSV season in the United States.
In a separate mid-stage trial in an attempt to jumpstart infant immunity, Novavax is also immunizing pregnant women. Data from this trial is expected later this quarter. The biotech is aiming for the regulator's fast-track and/or breakthrough therapy pathway, potentially shortening its path towards approval.
MedImmune, now part of AstraZeneca Plc, developed a drug that prevents lung infections caused by RSV but not the RSV infection itself, though the virus was identified 60 years ago.
"If you look at the principle involved in this monoclonal antibody working, you knew if you could replicate that, your vaccine should work ... that's been our big breakthrough," told Novavax's senior vice president of R&D, Gregory Glenn.
Dr. Pedro Piedra of the Baylor College of Medicine, who also serves on Novavax's scientific advisory board says RSV kills fewer people than influenza. On an average, between 10,000 and 15,000 elderly Americans die from RSV, while 20,000-50,000 older adults succumb to the flu.
Behanna said for the flu we know how antibodies relate to stopping the infection but for RSV we haven't drawn those correlations yet. "Part of what Novavax is doing for the first time is getting us data to help understand that relationship."