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09 May 2003

Reliable SARS Test, Vaccine May Be Available Within a Few Years

(May 7 remarks by Anthony Fauci of NIH before House panel) (2770)

A reliable test and possibly even a vaccine for the deadly Severe
Acute Respiratory Syndrome (SARS) may be available within the next
three to four years, predicts Anthony S. Fauci, the director of the
National Institute of Allergy and Infectious Diseases (NIAID) at the
National Institutes of Health, U.S. Department of Health and Human
Service.

In prepared remarks delivered May 7 to the House Subcommittee on
Oversight and Investigations of the Committee on Energy and Commerce,
Fauci said: "It is anticipated that a sensitive and specific
diagnostic test for SARS may be available within six to 12 months.
Within one to three years, it may be possible to develop a rapid,
accessible easy-to-use test for SARS that could be widely deployed in
diverse healthcare settings."

NIAID, he said, is pushing for the rapid development of vaccines to
prevent SARS.

"Within the next six to 12 months, NIAID anticipates that it will be
possible to demonstrate whether an inactivated vaccine against SARS is
a workable concept, e.g., to show that we can protect a monkey against
the SARS virus," he said. "If so, Phase I trials of such a candidate
vaccine can be accelerated. If research and development proceed on
schedule and if animal testing is successful, a first-generation
inactivated SARS vaccine could become available within several years."

Treatment for current victims of SARS is still ambiguous, he said.

"Clinicians treating SARS patients have not yet identified treatment
strategies that consistently improve prognosis, beyond good supportive
and intensive care," Fauci said. "Conventional antibiotics do not
work, a fact that is consistent with SARS being a viral disease. NIAID
is pursuing several strategies to determine whether any existing drugs
or combinations of treatments can simultaneously block viral
replication and boost the immune response to the virus."

At the National Institutes of Health (NIH) Clinical Center in
Bethesda, Maryland, and through the NIAID Collaborative Antiviral
Study Group, NIH is developing protocols to admit SARS patients for
evaluation and treatment, should this become necessary, Fauci said.

"This will be an opportunity to evaluate the pathogenesis of the
illness and the efficacy of antiviral and immune-based therapies in
patients with SARS," he said. "We also plan to evaluate approaches to
improve management of patients with severe forms of the disease, such
as the passive transfer of antibodies from SARS patients who have
recovered from the disease."

Following is the text of Fauci's remarks, as prepared for delivery:

(begin text)

Testimony
Before the Subcommittee on Oversight and
Investigations
Committee on Energy and Commerce
United States House of Representative

NIH's Response to the Global
Outbreak of 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

Mr. Chairman and Members of the Committee, thank you for the
opportunity to discuss how the National Institutes of Health (NIH) is
responding to the global outbreak of Severe Acute Respiratory
Syndrome, or SARS. I am pleased to appear today with my colleagues
from our sister agencies, within the Department of Health and Human
Services. As of April 29, 2003, 5462 cases of SARS have been reported
across the globe, with 54 probable cases identified in the United
States; there have been no deaths from SARS thus far reported in the
United States. The relatively low number of probable cases reported in
the United States is likely the result of early diagnoses and
effective public health measures put in place by the CDC and state and
local health authorities to contain the imported SARS cases and
prevent secondary transmissions.

While travel alerts and advisories and recommended infection control
measures can help slow the progression of the SARS epidemic, these
alone are not long-term solutions to this new and unpredictable
disease. Instead, we must develop safe and effective treatments and
vaccines that can protect the American people. The SARS epidemic is
still evolving and it is unclear whether the incidence of the diseases
will decline, plateau or accelerate. Therefore we must be prepared for
any eventuality.

Like HIV/AIDS, Ebola and West Nile virus, SARS reminds us that
emerging and reemerging infectious diseases are constant threats to
national and international public health. Dr. Gerberding and her CDC
team, together with the World Health Organization (WHO) and others,
have done an outstanding job in identifying and tracking the SARS
epidemic, illuminating the clinical features and etiology of the
disease, 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, has a
significant role in the efforts against SARS, notably in diagnostics,
therapeutics and vaccine development, drug screening, and clinical
research. As has been the case with other emerging infectious
diseases, we anticipate that the strong NIAID research base in
disciplines such as microbiology, immunology and infectious diseases
will facilitate the development of new interventions to help counter
SARS.

The CDC and WHO have accumulated evidence, which we now believe is
close to definitive, that SARS is caused by a novel coronavirus that
may have crossed species from an animal to humans, although this
latter point has certainly not been proven. This hypothesis is based
on the detection and isolation of coronaviruses from unrelated SARS
patients from different countries and on the finding that SARS
patients mount an immunological response to coronavirus as they
proceed from the acute illness to the recovery or convalescent stage.
Furthermore, data from the Netherlands show that non-human primates
infected with this coronavirus develop a SARS-like disease, suggesting
that this virus is the cause of SARS. Although some questions remain,
the strong evidence for a causative role for a coronavirus has
prompted 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,
a benign condition that very rarely results in life-threatening
disease. The coronavirus associated with SARS is a type of
coronavirus, possibly of animal origin, that has not been previously
identified.

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 earliest indications that we were dealing with a new
disease, very likely caused by a newly recognized virus, the NIAID has
marshaled its resources to rapidly initiate the development of
diagnostics, therapeutics, and vaccines against SARS. NIAID has
assembled a multi-disciplinary working group to develop a broad-based
program that addresses the research needed to combat SARS. Key
intramural laboratories have begun to pursue a range of research
strategies to develop a SARS vaccine as well as therapeutics,
including immune-based therapies, and our extramural programs are
poised to help as well. We also have initiated and expanded
collaborations with our colleagues in other federal agencies,
academia, and private industry. In addition, NIAID recently released
three "Sources Sought" announcements, a special mechanism to rapidly
identify contractors who can develop treatment strategies, vaccines,
and antibody preparations to address SARS.

Surveillance and Epidemiology

NIAID supports a long-standing program for the 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. At the request of
WHO, NIAID assigned a staff epidemiologist to provide technical
assistance during the early stages of the epidemic. In addition to
global surveillance activities, NIAID will support epidemiological
studies of populations at potentially greater risk for SARS, including
individuals with HIV/AIDS.

Diagnostics Research

As Dr, Gerberding has indicated, the CDC already has made significant
progress in developing diagnostic tests for SARS. As part of these
efforts, NIAID-sponsored researchers in Hong Kong also devised a
diagnostic test based on polymerase chain reaction (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. During this calendar year,
NIAID will expand this capacity for research on emerging acute viral
respiratory diseases. Also, NIAID is using existing funding
mechanisms, such as the contract with St. Jude's Hospital, to help
support the development of other sophisticated diagnostic tools.

It is anticipated that a sensitive and specific diagnostic test for
SARS may be available within six to 12 months. Within one to three
years, it may be possible to develop a rapid, accessible easy-to-use
test for SARS that could be widely deployed in diverse healthcare
settings.

Vaccine Research

As the SARS epidemic continues, it will be necessary to consider a
broad spectrum of vaccine approaches. NIAID is supporting the rapid
development of vaccines to prevent SARS through both our extramural
and intramural programs, including the NIAID Vaccine Research Center
on the NIH campus. NIAID scientists have received samples of the SARS
coronavirus from CDC and have already successfully grown the virus in
cell culture, a first step towards developing a vaccine. Initial
efforts have focused on the development of an inactivated (or killed)
virus vaccine. As more knowledge about SARS becomes available, other
types of vaccine candidates will soon follow, including novel
approaches such as vector-based and recombinant vaccines, DNA-based
vaccines, and live-attenuated vaccines.

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.
Insight from veterinary coronavirus vaccines could prove useful as we
develop vaccines to protect humans.

To accelerate SARS vaccine research and development efforts, NIAID has
initiated contracts and other relationships with companies,
institutions and other organizations with specialized technologies,
cell lines and containment facilities relevant to SARS research for
the purpose of supporting the development of reagents needed for
vaccine development, and developing animal models such as mice and
relevant species of monkeys. For example, the NIAID Vaccine Research
Center recently expanded an existing agreement with GenVec, a
biopharmaceutical company in Gaithersburg, Maryland, to begin the
development of a candidate vaccine against SARS-NIAID is negotiating
with other companies to develop additional candidate vaccines. Another
important component of SARS vaccine research will be to identify ways
to generate mucosal immunity against the SARS coronavirus.

Within the next six to 12 months, NIAID anticipates that it will be
possible to demonstrate whether an inactivated vaccine against SARS is
a workable concept, e.g., to show that we can protect a monkey against
the SARS virus. If so, Phase I trials of such a candidate vaccine can
be accelerated. If research and development proceed on schedule and if
animal testing is successful, a first-generation inactivated SARS
vaccine could become available within several years.

Therapeutics Research

With the emergence of SARS, NIAID responded rapidly to a request from
CDC to evaluate candidate antiviral agents through a collaborative
antiviral drug-screening project at the U.S. Army Medical Research
Institute of Infectious Diseases (USAMRIID). To date, NIAID has
supplied approximately 40 FDA-approved antiviral drugs to USAMRIID
such that their efficacy against the SARS coronavirus can be
evaluated. The Institute also is pursuing the development of novel
antivirals, such as compounds that block viral fusion with and entry
into host cells. In addition, NIAID has initiated discussions with the
pharmaceutical industry about candidate antiviral drugs already in the
research "pipeline," 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.

In addition to antiviral drugs, NIAID is supporting the development of
passive immunotherapy (monoclonal and polyclonal antibodies) as a
therapy for SARS. Within the next one to three years, it may be
possible to have available therapeutic monoclonal antibodies for SARS.

Clinical Research

Clinicians treating SARS patients have not yet identified treatment
strategies that consistently improve prognosis, beyond good supportive
and intensive care. Conventional antibiotics do not work, a fact that
is consistent with SARS being a viral disease. NIAID is pursuing
several strategies to determine whether any existing drugs or
combinations of treatments can simultaneously block viral replication
and boost the immune response to the virus.

At the NIH Clinical Center in Bethesda, MD, and through the NIAID
Collaborative Antiviral Study Group, NIH is developing protocols to
admit SARS patients for evaluation and treatment, should this become
necessary. This will be an opportunity to evaluate the pathogenesis of
the illness and the efficacy of antiviral and immune-based therapies
in patients with SARS. We also plan to evaluate approaches to improve
management of patients with severe forms of the disease, such as 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 severe outcomes such as acute respiratory distress and
mortality entirely caused by the presence of virus, or does the immune
system play a role in causing the severe outcomes in some patients?
What are the sites and the duration of viral shedding? What is the
nature of the immune response? These are central questions to address
because they may open up avenues for treatment as well as better
preventive strategies.

Basic Research

NIAID's long-standing commitment to and investment in emerging disease
research is allowing us to expeditiously pursue research on SARS. For
example, NIAID continues to support the Emerging Viral Disease
Research Centers, which have been conducting SARS antibody studies and
will be able to assist in the development of animal models for SARS.
NIAID currently is supporting 18 grants on coronavirus research. Also,
the study of patients, as well as specimens in NIAID laboratories,
will facilitate our understanding of the natural history of the SARS
virus and its potential animal reservoir, and help 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 bioinformatics
of coronaviruses.

The identification or development of animal models that mimic human
SARS is critical to our understanding of the SARS virus and how it
causes disease. 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 to SARS will be
evaluated and may prove an important tool for defining treatment
approaches that involve modulation of the immune system. NIAID will
also support the development of other relevant animal models for SARS.

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, towards which funds were
appropriated in FY 2003, will facilitate SARS research, as well as
planned studies of potential bioterror agents and other emerging
diseases. Research with the SARS coronavirus will occur in Biosafety
Level-3 facilities.

Conclusion

Mr. Chairman, thank you again for allowing me to discuss NIH's efforts
to address SARS. Despite ongoing research 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 positioned us well in 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)

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