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Washington File

09 April 2003

U.S. Infectious Disease Experts Work to Find SARS Vaccine

(U.S. Senate Committee examines U.S. action against new viral disease)
(2000)
The National Institute of Allergy and Infectious Diseases (NIAID) has
been working to develop a vaccine to prevent infection from the virus
causing severe acute respiratory syndrome (SARS), according to NIAID
Director Dr. Anthony Fauci. Testifying before the Senate Committee on
Health, Education, Labor and Pension April 7, Fauci also said a
diagnostics test to confirm SARS cases is being researched.
SARS has caused deep worldwide concern as it has moved rapidly through
certain Asian populations since its first emergence in early March. It
is a "novel coronavirus," said Fauci. "Coronaviruses are best known as
one of the causes of the 'common cold.'"
Fauci said this previously unknown type of coronavirus is suspected to
have developed in an animal, and then crossed species to infect
humans. Certain vaccines are already in use to protect young livestock
animals from such viruses, Fauci said. "These models could prove
useful as we develop vaccines to protect humans."
Following is Fauci's testimony as prepared for delivery:
(begin text)
Testimony Before the Committee on Health, Education, Labor, and
Pensions
United States Senate
NIH's Promising Research on Severe Acute Respiratory Syndrome (SARS)
Statement of Anthony S. Fauci, M.D. 
Director 
National Institute of Allergy and Infectious Diseases 
National Institutes of Health
Department of Health and Human Services 
Monday, April 7, 2003 
Mr. Chairman and Members of the Committee, thank you for the
opportunity to discuss the research activities of the National
Institutes of Health (NIH) that promise to help us better understand
and counter the global outbreak of Severe Acute Respiratory Syndrome,
or SARS. I am pleased to share this table with Dr. Julie Gerberding,
the Director of our sister agency, the Centers for Disease Control and
Prevention (CDC), which has done such an extraordinary job in
responding to the evolving epidemic.
As Dr. Gerberding will discuss in some detail, SARS rapidly has moved
across the globe, becoming a worldwide health emergency that has
resulted in quarantines, travel warnings, and mounting economic
damage. The global tally of SARS cases has grown to more than 2,300
cases in only six weeks since the apparent emergence of the disease.
At this early stage of the epidemic, it is impossible to predict
whether SARS will become an ongoing, major global health threat, or if
the epidemic will spontaneously burn out or be contained by public
health measures. However, we must be prepared for the worst-case
scenario.
Dr. Gerberding and her CDC team, together with the World Health
Organization (WHO) and others, have done a magnificent job in
identifying and tracking this epidemic, illuminating the etiology and
clinical features of SARS, and providing the world with information
about the epidemic in real time. Complementing the efforts of the CDC
and WHO, the National Institute of Allergy and Infectious Diseases
(NIAID), a component of NIH, also has a significant role in the
efforts against SARS, notably by rapidly addressing the issues of
vaccine development, drug screening, and clinical research.
As with Lyme disease, Hepatitis C, HIV/AIDS, Ebola, West Nile virus
and a host of other "new" diseases, the SARS outbreak has reminded us
that the emergence or reemergence of infectious diseases is a constant
threat. As has been the case with other emerging diseases, we
anticipate that the strong NIAID research base in disciplines such as
microbiology, immunology and infectious diseases will facilitate the
development of interventions such as diagnostics, therapies, and
vaccines to help counter SARS.
As described by CDC and WHO, evidence is mounting, although not yet
definitive, that SARS is caused by a novel coronavirus that may have
crossed species from an animal to humans. This hypothesis is based on
the detection and isolation of coronaviruses from unrelated patients
from different countries, and on the finding that several SARS
patients have mounted an immunological response to coronavirus as they
proceeded from the acute illness to the recovery or convalescent
stage. While some questions remain -- for example, there is some
evidence that a second virus may contribute to the pathogenesis of
SARS -- the strong evidence for a causative role for a coronavirus
justifies the ongoing development of diagnostic tools, therapies and
vaccines that target coronaviruses.
Coronaviruses are best known as one of the causes of the "common cold"
which is generally a very benign condition, very rarely resulting in
life-threatening disease. The coronavirus that has been shown to be
associated with SARS is a new type of coronavirus that has not been
previously identified.
I would note that no evidence of genetic "tampering" of the virus
implicated in SARS has been detected, based on analyses of the
mounting genomic sequence data of the samples from SARS patients
examined so far. As even more extensive genomic sequence data become
available for the SARS virus, it will be possible to further
distinguish natural origin from the possibility that the SARS agent
was created in a laboratory or even as a bioweapon. Until then, we
will keep our minds open to these possibilities, however remote.
NIAID Research on SARS 
NIAID maintains a longstanding commitment to conducting and supporting
research on emerging infectious diseases, such as SARS, with the goal
of improving global health. In carrying out its global health research
mission, the Institute supports a myriad of activities, including
intramural and extramural research, and collaborations with
international agencies and organizations. Since the first SARS
reports, NIAID has worked rapidly to identify opportunities for
accelerating or expanding research to improve the diagnosis,
treatment, and prevention of SARS. These areas include:
Surveillance and epidemiology. NIAID supports a long-standing program
for surveillance of influenza viruses in Hong Kong, led by Dr. Robert
Webster of St. Jude's Children's Research Hospital in Memphis. Dr.
Webster and his team in Hong Kong have collaborated with WHO, CDC and
others in helping to illuminate the SARS outbreaks in Asia. In
addition, at the request of WHO, NIAID assigned a staff epidemiologist
to provide epidemiologic and logistical assistance during the early
stages of the epidemic.
Diagnostics. As discussed by Dr. Gerberding, significant progress has
been made by the CDC in developing a diagnostic test for SARS. As part
of these efforts, NIAID-sponsored researchers in Hong Kong also
devised a diagnostic test based on PCR technology as well as a
diagnostic tool using the immunofluorescence assay technique. In other
research, the NIAID-funded Respiratory Pathogens Research Unit (RPRU)
at Baylor College of Medicine has developed methods to detect known
human coronaviruses using cell culture and molecular diagnostic tools
and can also assess the host immune response to known coronavirus
infections. In 2003 NIAID will expand this capacity for research on
emerging acute viral respiratory diseases, including pandemic
influenza and SARS.
Vaccine Research. As the SARS epidemic continues, it will be necessary
to consider a broad spectrum of vaccine approaches, as well as
immunotherapy. NIAID is supporting the rapid development of vaccines
to prevent SARS through both our extramural and intramural programs,
including the NIAID Vaccine Research Center. Initially, these efforts
are focusing on the development of an inactivated (or killed) virus
vaccine. However, other approaches will soon follow, including novel
approaches such as vector-based and recombinant vaccines, DNA-based
vaccines and live attenuated vaccines, as more knowledge about the
cause of SARS and its etiology becomes available.
NIAID scientists have received samples of the SARS coronavirus from
CDC and have initiated efforts to develop a vaccine. Fortuitously,
vaccines against common veterinary coronaviruses are routinely used to
prevent serious diseases in young animals, such as a vaccine given to
pigs to prevent serious enteric coronavirus disease. These models
could prove useful as we develop vaccines to protect humans.
To further accelerate SARS vaccine research and development efforts,
NIAID is initiating contracts with companies, institutions and other
organizations who have relevant technologies, cell lines and
containment facilities; supporting the development of reagents needed
for vaccine development; and developing animal models such as mice and
relevant species of monkeys.
Therapeutics Research. As the nation began its focus on SARS, NIAID
responded rapidly to a request from CDC to evaluate candidate
antiviral therapeutic agents through a collaborative antiviral
drug-screening project at the U.S. Army Medical Research Institute of
Infectious Diseases (USAMRIID). NIAID also has initiated discussions
with the pharmaceutical industry about candidate antiviral drugs, and
is reviewing a proposal for a clinical trial of antiviral therapy to
be conducted by investigators of the NIAID Collaborative Antiviral
Study Group and the NIH Clinical Center.
Clinical Research. Clinicians treating SARS patients have not yet
identified treatment strategies that consistently improve prognosis,
beyond good intensive and supportive care. Antibiotics do not work, a
fact that is consistent with SARS being a viral disease. However, some
improvement has been noted in certain patients treated with a
combination of ribavirin and corticosteroids, which are given together
in an effort to simultaneously block viral replication and modify the
immune system reaction to the virus.
At the NIH Clinical Center in Bethesda, MD, and through the NIAID
Collaborative Antiviral Study Group, NIH is preparing to admit SARS
patients for evaluation and treatment, should this become necessary.
This will be an opportunity to evaluate the efficacy of antiviral and
immune-based therapies, including interferons, in patients with SARS.
We also plan to evaluate approaches to improve management of patients
with severe forms of the disease, including the passive transfer of
antibodies from SARS patients who have recovered from the disease.
In addition to ensuring state-of-the-art treatment of potential
patients, our clinical experts will be able to study the clinical
characteristics of patients with SARS. We are particularly interested
in answering key questions about the disease mechanisms of SARS. For
example, are acute respiratory distress and mortality entirely caused
by the presence of virus, or could it be that the response of the
immune system is causing the severe outcomes in some patients? This is
a central question to address because it may open up an avenue for
treatment in addition to antiviral drugs.
Basic Research. NIAID currently is supporting 18 grants on coronavirus
research. Also, the study of patients, as well as specimens in NIAID
laboratories, will facilitate studies of the natural history of the
SARS agent and its potential animal reservoir, and help to illuminate
the risk factors and epidemiology of SARS. NIAID will support and
conduct basic research studies on the pathogenesis of the disease and
viral replication mechanisms, in order to identify targets for
antiviral drugs, diagnostic tests and vaccines. Finally, the Institute
will support and conduct genomic sequencing, proteomics and
informatics of coronaviruses.
Of note, an existing NIAID animal model of a virus infection that
causes a disease in mice very similar to SARS has been identified. The
relevance of this animal model will be evaluated and may prove an
important tool for defining treatment approaches to SARS that involve
modulation of the immune system.
Infrastructure. A central concern when working with the SARS virus or
SARS patients is the availability of facilities with the required
safety level for the clinicians and staff, as well as for the
community. Our ongoing plans to develop high-level containment
facilities will facilitate SARS research, as well as planned studies
of potential bioterror agents and other emerging diseases.
Conclusion 
Mr. Chairman, thank you again for allowing me to discuss our efforts
to address SARS. Despite ongoing research efforts and early successes,
we still have much to learn about the disease. As you have heard,
NIAID-sponsored coronavirus research, studies of other viral diseases,
and clinical research already have provided results that are relevant
to our quest for tools to detect, treat and prevent SARS. In the weeks
and months ahead, NIH will continue to collaborate with our sister
agencies the CDC and the Food and Drug Administration, as well as
other relevant agencies to accelerate and expand our research aimed at
improving the diagnosis, prevention, and treatment of SARS.
I would be pleased to answer your questions.
(end text)
(Distributed by the Office of International Information Programs, U.S.
Department of State. Web site: http://usinfo.state.gov)



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