Researchers have been studying and working with mRNA vaccines for decades, and mRNA was one of
the
technologies used to rapidly develop and manufacture safe and effective COVID-19 vaccines. As
with
all licensed vaccines, mRNA vaccines undergo multiple clinical trials to generate safety data
for
FDA review prior to licensure.
Currently, H5N1 is circulating in
birds and in some dairy cows, and at this time, risk to human health is low and vaccination is
not
recommended for any segment of the population. If successfully developed, a licensed mRNA-based
pandemic influenza vaccine would further improve U.S. government response capabilities.
ASPR recently announced that we are labeling and filling H5 vaccine manufactured from a
well-matched candidate vaccine virus as part of preparedness efforts. This is a cell-based
vaccine,
another technology licensed for seasonal and pre-pandemic vaccines supported by ASPR. An
mRNA-based
licensed pandemic influenza vaccine could further improve response timelines. This capability
would
establish a fourth platform option to the already licensed egg-, cell-, and recombinant
protein-based approaches for influenza vaccine production.
The base award will
support
advanced development towards FDA approval of a vaccine for H5; however, this agreement was
structured such that it could readily support the development and procurement of a vaccine
targeting novel strains of influenza or other emerging infectious viruses.
As with all vaccine
development, timelines will be data driven. This vaccine is early in clinical development, with
ongoing Phase I clinical trial data expected later this year. Phase three trials are projected
to
start in 2025.
Under
Federal
Acquisition Regulations, federal agencies are prohibited from disclosing any information on
potential future contracts.
mRNA is a proven platform for accelerated development, and this partnership will help enable
access
to this capability.
