July 2 (Reuters) - The U.S. government has awarded $176
million to Moderna ( MRNA ) to advance development of its bird
flu vaccine, the company said on Tuesday, as concerns rise over
a multi-state outbreak of H5N1 virus in dairy cows and
infections of three dairy workers since March.
Funds from the U.S. Biomedical Advanced Research and
Development Authority will be used to complete late-stage
development and testing of a pre-pandemic mRNA-based vaccine
against H5N1 avian influenza.
U.S. officials said on a press call that late-stage testing
would begin in 2025, pending results expected in the coming
weeks of Moderna's ( MRNA ) phase 1 trial. The late-stage trial would
likely focus on safety and immune response.
The contract includes options to accelerate the development
timeline if needed, based on an increase in human cases, the
severity of cases or human-to-human transmission of the virus.
It is too early to tell how many doses Moderna ( MRNA ) will be able
to manufacture, said Robert Johnson, director of the medical
countermeasures program at HHS, on the call.
In March, U.S. officials reported the first outbreak of the
H5N1 virus in dairy cattle, which has since infected more than
130 herds in 12 states.
Scientists are concerned that exposure to the virus in
poultry and dairy operations could increase the risk that the
virus will mutate and gain the ability to spread easily among
people, touching off a pandemic.
The risk to the general public from bird flu remains low,
and vaccination is not currently recommended for any segment of
the population, Dawn O'Connell, assistant secretary for
preparedness and response at the U.S. Department of Health and
Human Services, said on a call with reporters.
However, "robust discussions" are occurring within
government agencies about whether vaccinating farm workers would
be helpful, said Nirav Shah, principal deputy director of the
U.S. Centers for Disease Control and Prevention, adding that no
final decisions have been made.
The government expects to have more announcements on H5N1
vaccines in the near future, O'Connell said. In a previous
briefing, O'Connell said her agency was also negotiating with
Pfizer ( PFE ) for an mRNA vaccine against H5N1.
Both the Moderna ( MRNA ) and Pfizer ( PFE ) vaccines use messenger RNA, the
technology used in their COVID-19 vaccines.
"mRNA vaccine technology offers advantages in efficacy,
speed of development and production, scalability, and
reliability in addressing infectious disease outbreaks, as
demonstrated during the COVID-19 pandemic," Moderna ( MRNA ) CEO Stephane
Bancel said in a statement.
Manufacturing of conventional flu vaccines using cell or
egg-based technology can take four to six months.
U.S. officials previously announced they were moving bulk
vaccine from CSL Seqirus that closely matches the
current virus into finished shots that could provide 4.8 million
doses if needed.
Some of those doses could be available as early as this
month, O'Connell said. Those shots could potentially be used to
inoculate farm workers and others at risk of exposure to the
virus.
Lab experiments from the U.S. Food and Drug Administration
continue to confirm that pasteurization inactivates the bird flu
virus in dairy products, said Don Prater, director of the
agency's Center for Food Safety and Applied Nutrition.
The FDA is conducting ongoing tests of retail dairy products
for traces of avian flu and has cautioned against consuming raw
milk.