Full Press Release Details
SINOVAC BIOTECH 6K, PRESS RELEASE 8.9.04
SINOVAC BIOTECH LTD.
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UPDATES ON PHASE I HUMAN CLINICAL TESTING OF SARS VACCINE
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ALL 36 SUBJECTS HAVE NOW BEEN INOCULATED WITH EITHER SARS VACCINE OR PLACEBO AND
ARE IN GOOD HEALTH CONDITION
BEIJING, 9 August, 2004 - Sinovac Biotech Ltd. ("Sinovac") (NASD OTC-BB: SNVBF)
announces that all 36 subjects of the Phase I human clinical trial for its
inactivated SARS vaccine have now been vaccinated with either SARS vaccine or
placebo. The final 12 subjects in the second group of 18 volunteers have
received the vaccination, 6 subjects on July 28 and 6 subjects on August 4,
2004. No adverse side-effects have been observed. As previously announced, the
first 6 of this second group of 18 volunteers in the SARS vaccine trial were
injected on July 15, 2004. These subjects together comprise the second group of
18 volunteers, which has been injected with either the high-dosage (32 su/mL
antigen) SARS vaccine or a placebo.
According to Professor Lin Jiangtao, head of the Respiratory Medical Department
with the China-Japan Friendship Hospital in Beijing, who chairs the trial, the
first group of 18 people who have been inoculated with low-dosage (16 su/mL
antigen) SARS vaccine and the second group of 18 who have been inoculated with
high-dosage (32 su/mL antigen) vaccine have not experienced any adverse reaction
and are all in good health condition.
The two-dose immunization schedule has been completed for the initial group of
18 volunteers who received low-dosage SARS vaccine or placebo. The second group
of 18 volunteers receiving high-dosage of SARS vaccine have received their first
inoculation. Each sub-group of 6 volunteers is scheduled to receive the second
inoculation 28 days after the first inoculation dates noted above.
The first phase of human testing will determine if the vaccine is safe for the
human body. During the Phase I clinical trial, Sinovac will provide continuous
updates on the status of the trial and the health condition of the volunteers.
The ultimate aim of the vaccine will be to provoke the body's immune system into
action, so that it can destroy the SARS virus if infected.
Also, and of particular note, antibody levels induced by the vaccine are also
being tested for the duration of the Phase I clinical trial. This testing has
not previously been announced. The ability of these antibodies to prevent
infection from SARS will not be tested in this trial.
Sinovac is the only company in China, and indeed the world, to have been
approved to conduct human clinical trials of a SARS vaccine.
In 2003, SARS had a devastating impact on the economy of China, many Southeast
Asian nations, and even parts of North America. A new, widespread SARS outbreak
could have a similar effect on the economies of many nations, just when these
economies are building strength. The importance and need to develop an effective
SARS vaccine is thus a paramount concern for world health authorities. The SARS
global outbreak of 2003 was eventually contained; however, it is expected that
the disease could re-emerge in an annual cycle similar to the common flu.
Clinical Trial Design
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There are 36 healthy volunteers aged from 21 to 40 that were selected for
clinical testing, who were divided into four groups. Twenty-four subjects (two
groups of 12 depending on dosage level) have received the vaccine, and the
twelve others (two groups of 6) have received the placebo. Each subject receives
two shots. The first shot was on day 0 followed by 28-day observation of the
subject. The second shot is given after the initial 28 day period and each
subject will be observed until day 210, the phase I trial end-date.
The volunteers are observed for reaction every day for the first three days, and
then less frequently throughout the whole 210-day observation process. Neither
the volunteers nor the administering doctors were informed of whether the
injection was a vaccine or a placebo.
Regulatory Approval Process
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The drug approval process regulated by the State Drug Administration (SFDA) in
China is similar to the one regulated by the FDA in the United States. The
process involves pre-clinical in vitro laboratory and in vivo animal testing;
IND study (Investigational New Drug); human clinical Phases I, II and III; New
Drug Application; and finally Marketing Approval for sale.
The SFDA has stated that it is fast-tracking the drug approval process for
Sinovac's potential SARS vaccine.
Pre-clinical trials on rhesus and macaque monkeys showed Sinovac's vaccine was
effective in preventing infection. The monkeys that were inoculated with the
vaccine experienced no serious side effects after they were exposed to the
Immune response was invoked by Sinovac's vaccine in all animal models. No immune
enhancement was observed in any of the pre-clinical testing.
Clinical protocols for the testing of Sinovac's potential SARS vaccine were
developed in accordance with stringent newly established worldwide protocols for
the conduct of SARS vaccine clinical trials. The protocols were also developed
with the cooperation of various world health authorities, as well as the Chinese
FDA (SFDA), China Centre of Disease Control, and the China Medical Academic
The ultimate aim of the vaccine will be to provoke the body's immune system into
action, so that it can destroy the SARS virus if infected.
The first phase of human testing will determine if the vaccine is safe for the
human body. During and after the Phase I trial, analysis will be conducted. The
summary report will be sent to the SFDA for its review and if the vaccine
receives SFDA approval, then it will proceed into Phase II clinical trials. A
second phase of clinical testing would have more participants from a wider
SARS, a viral respiratory illness caused by a coronavirus, was first reported in
Asia in February 2003, and over the following few months, the illness spread to
more than two dozen countries in North America, South America, Europe, and Asia.
According to the World Health Organization, during the SARS outbreak of 2003, a
total of 8,098 people worldwide became sick with SARS; of these, 774 died.
ABOUT SINOVAC BIOTECH LTD.
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Sinovac Biotech Ltd. specializes in the research, development,
commercialization, and sales of human vaccines for infectious illnesses such as
Hepatitis A and Hepatitis B, influenza and "SARS". Sinovac is one of the leading
emerging biotechnology companies in China. Working closely with Chinese public
health officials, Sinovac focuses on manufacturing and marketing human-use
vaccines and related products, and currently markets its vaccine for Hepatitis
A. Sinovac is currently the only company in the world to have commenced human
clinical trials for a vaccine to prevent SARS.