SINOVAC Receives Approval on Sabin Strain Based Inactivated Polio Vaccine (sIPV) to Support Global Polio Endgame Strategy
July 19 2021 - 7:00AM
Business Wire
SINOVAC Biotech Ltd. (NASDAQ: SVA) (“SINOVAC” or the “Company”),
a leading provider of biopharmaceutical products in China, today
announced it received a drug registration approval from the
National Medical Product Administration of China (“NMPA”) for its
Sabin strain based inactivated polio vaccine (Vero cells) ("sIPV")
on July 12, 2021. The vaccine is expected to be available on the
market by the end of 2021. SINOVAC also submitted an application
for prequalification (PQ) to the World Health Organization (“WHO”)
in early 2020 and the WHO conducted its on-site inspection in
February 2021.
SINOVAC's sIPV is approved for use on infants and children aged
2 months and above to prevent poliomyelitis due to infection of
types I, II and III polioviruses. The primary immunization requires
3 doses at least one month apart, beginning at 2 months of age. A
booster shot will be given at 18 month of age. According to the
results of phase III clinical trial, no serious or rare adverse
events were observed in relation to vaccinations, which indicates
the good safety profile of SINOVAC’s sIPV vaccine. Inactivated
polio vaccine (IPV) contains no live virus and, thus, carries no
risk of emergence from vaccine-derived poliovirus (VDPV) or
vaccine-associated paralytic polio (VAPP).
As the COVID-19 pandemic impact persists, countries where the
wild polio strain still exist have been experiencing an increase in
prevalence of polio casese. In addition, some other countries also
reported more vaccine-derived poliovirus (VDPV) and
vaccine-associated paralytic polio (VAPP) cases as a result of the
virus circulating in the environment and human body, especially as
the number of VAPP cases has reached a peak in the past 10
years.
The WHO called for Expressions of Interest (EOI) in 2010, 2011
and 2012 from vaccine manufacturers in the private or public
sectors to collaborate with the WHO and Intravacc (Institute for
Translational Vaccinology) from The Netherlands to develop and
supply sIPV under the Global Polio Eradication Initiative. SINOVAC
submitted its EOI in 2012 and was selected as a technology transfer
recipient after the qualification review and site inspection by the
WHO and Intravacc. In 2014, SINOVAC entered into a license
agreement with Intravacc to develop and commercialize the Sabin
strain based Inactivated Polio Vaccine (sIPV) for distribution to
China and other countries. According to the agreement, SINOVAC
committed to commercializing the vaccine in China, inclusive of
conducting clinical trials, obtaining regulatory approval,
commercializing the sIPV vaccine and seeking pre-qualification by
WHO. In addition, SINOVAC committed to having the capacity to
supply, or make arrangements for the supply of, sIPV to the public
sector in other countries, as well as international organizations
in sufficient quantities to ensure a meaningful contribution to the
global endgame of polio eradication.
About Poliomyelitis
Poliomyelitis, commonly shortened to polio, is an infectious
disease caused by the poliovirus, which mainly affects children
under 5 years of age. Poliovirus is usually spread from person to
person through infected fecal matter entering the mouth. It may
also be spread through food or water containing human feces and,
less commonly, from infected saliva, causing damage to motor
neurons in the anterior horn of the spinal. The main symptoms are
fever, general malaise and, in severe cases, pain in the limbs, and
irregularly distributed and mild flaccid paralysis.
The Global Polio Eradication Initiative (GPEI), launched in
1988, is dedicated to the eradication of polio worldwide. Although
global polio cases have decreased by 99.9%, there are still some
barriers to vaccinate children around the world against polio, and
polio control remains the top priority as a public health emergency
of international concern. In addition, the COVID-19 pandemic has
led to an increase in polio cases. A total of 1,226 cases of all
types of polio occurred last year, compared to only 138 cases in
2018. On June 10, the GPEI launched the Polio Eradication Strategy
2022-2026: Meeting the Promise to overcome the final challenges to
polio eradication.
About SINOVAC
SINOVAC Biotech Ltd. is a China-based biopharmaceutical company
that focuses on the research, development, manufacturing and
commercialization of vaccines that protect against human infectious
diseases. SINOVAC's product portfolio includes vaccines against
COVID-19, enterovirus71 (EV71), hepatitis A and B, seasonal
influenza, 23-Valent pneumococcal polysaccharide (“PPV”), H5N1
pandemic influenza (avian flu), H1N1 influenza (swine flu),
varicella and mumps. SINOVAC’s COVID-19 vaccine, CoronaVac®, has
been granted emergency use approval or conditional marketing
authorization by over 50 countries or regions worldwide. Healive®,
the hepatitis A vaccine manufactured by the Company, has passed the
assessment under WHO prequalification procedures in 2017. The EV71
vaccine, an innovative vaccine developed by SINOVAC against hand
foot and mouth disease caused by EV71, was commercialized in China
in 2016. In 2009, SINOVAC was the first company worldwide to
receive approval for its H1N1 influenza vaccine, which it has
supplied to the Chinese Government's vaccination campaign and
stockpiling program. The Company is also the only supplier of the
H5N1 pandemic influenza vaccine to the government stockpiling
program. In 2021, SINOVAC’s Sabin-strain inactivated polio vaccine
has approved for registration. The Company is developing several
new products including combined vaccines. SINOVAC primarily sells
its vaccines in China, while also exploring growth opportunities in
international markets. The Company is seeking market authorization
of its products in over 30 countries outside of China. For more
information, please see the Company’s website at
www.sinovac.com.
Safe Harbor Statement
This press release may include certain statements that are not
descriptions of historical facts, but are forward-looking
statements. These statements are made under the “safe harbor”
provisions of the U.S. Private Securities Litigation Reform Act of
1995. These forward-looking statements can be identified by
terminology such as “will,”“expects,”“anticipates,”“future,”
“intends,”“plans,”“believes,”“estimates” and similar statements.
Forward-looking statements involve risks, uncertainties and other
factors that could cause actual results to differ materially from
those contained in any such statements. In particular, the outcome
of any litigation is uncertain, and the Company cannot predict the
potential results of the litigation it filed or filed against it by
others. Additionally, the triggering of a shareholder rights plan
is nearly unprecedented, and the Company cannot predict the impact
on the Company or its stock price as a result of the trigger of the
rights plan.
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version on businesswire.com: https://www.businesswire.com/news/home/20210719005325/en/
Sinovac Biotech Ltd. Helen Yang Tel: +86-10-8279-9871 or
+86-10-5693-1897 Fax: +86-10-6296-6910 Email: ir@sinovac.com
ICR Inc. Bill Zima U.S.: 1-646-308-1707 Email:
william.zima@icrinc.com
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