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 A vaccine to protect against the respiratory syncytial virus, or
RSV, has long eluded developers as deficits in the understanding of
the virus' molecular structure and multiple trial failures have come
in the way.
An RSV vaccine represents a $1 billion opportunity in the United
States and potentially double that worldwide, Wedbush analyst
Heather Behanna estimated.
For most older healthy children and adults, the seasonal infection
causes little more than a common cold, but in high-risk groups -
including those with weak immune systems, young infants and the
elderly - it can lead to more serious lung and airway infections.
Novavax's vaccine was similar to or better than a number of
respiratory vaccines tested in the elderly, data presented on Monday
showed.
Armed with this data, Novavax hopes to begin a late-stage
8,000-10,000 patient study in the elderly later this year,
coinciding with the RSV season in the United States.
Meanwhile, Novavax is also immunizing pregnant women in a separate
mid-stage trial in an attempt to jumpstart infant immunity. 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.
Even though vaccine developers have been frustrated since the virus'
identification nearly 60 years ago, MedImmune, now part of
AstraZeneca Plc, developed a drug that prevents lung infections
caused by RSV, but not the RSV infection itself.
"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," Novavax's senior vice
president of R&D, Gregory Glenn, told Reuters.
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According to researcher Dr. Pedro Piedra of the Baylor College of
Medicine, who also serves on Novavax's scientific advisory board,
RSV kills fewer people than influenza.
Piedra said between 10,000 and 15,000 elderly Americans a year on
average die from RSV, while 20,000-50,000 older adults succumb to
the flu.
For the flu we know how antibodies relate to stopping the infection,
for RSV we haven't drawn those correlations yet, Behanna said.
"Part of what Novavax is doing for the first time is getting us data
to help understand that relationship."
(Story refiles to correct spelling of 'principle' in paragraph 10)
(Reporting by Natalie Grover in Bengaluru; Editing by Saumyadeb
Chakrabarty)
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