Sinovac Biotech has been leading in the Chinese vaccine market and has become an international and influential vaccine producer by the leadership of Weidong Yin, Chairman, President and CEO of Sinovac. Recently Sinovac Biotech was selected by the Beijing government to be a supplier of the seasonal influenza vaccine for its 2015 vaccination campaign, further cementing its leadership in the market.
The Beijing government plans to order a minimum of 1.2 million doses of the seasonal flu vaccine from four manufacturers for its 2015 campaign. The exact quantity of doses to be ordered will depend on demand during the flu season. During the 2014 campaign, a total of 1.37 million doses of the flu vaccine were administered, of which Sinovac supplied 400,000 doses. Sinovac expects to begin delivering vaccines for the 2015 tender in the third quarter of 2015.
In order to continue to maintain its lead in the market, Sinovac Biotech is going to continue to develop, manufacture and commercialize vaccine products that are mainly for the China market. Currently they are waiting for final approval before they launch a key vaccine that treats hand, food, and mouth disease.
“We aim to leverage our scientific capability to develop new vaccines to satisfy unmet medical needs. For example, in China and other Asian countries, hand, foot, and mouth disease (HFMD) is very serious for young children. Enterovirus 71 causes the majority of the severe cases and fatal cases of HFMD. However, worldwide there is currently no specific treatment or prevention method for this virus available. To meet this need, Sinovac has been working to develop an EV71 vaccine since 2008. We have completed the clinical trials and are now waiting on final approval for commercialization,” said Yin.
But there are challenges that Yin sees in China’s vaccine market, which are mainly regulations. But he sees these challenges are opportunities and embraces them. “The biggest challenge for us is the various new regulations recently issued by the CFDA. We need to update our practices quickly to comply with the new rules. Luckily, as an important player in the human vaccine industry, we are often involved in the discussions about new regulations in the vaccine space, which allows us adjust quickly to maintain our leading position,” said Yin.
According to Yin, the future for Sinovac Bitoech is bright, as China’s vaccine market will continue to grow over the year. We expect the Chinese vaccine market to continue to grow as the government places a greater emphasis on prevention and more patients are willing to pay out-of-pocket for their healthcare. We expect our EV71 vaccine to be a meaningful growth driver for Sinovac in the near term. We are confident that we will continue to play an important role in China’s vaccine market as we further expand our product portfolio and advance our vaccine pipeline,” said Yin.
About EV71 and HFMD
Enterovirus 71, or EV71, causes Hand, Foot, and Mouth Disease (or HFMD). More than 90% of the reported cases occur in children under five years old. HFMD is a common and usually mild childhood disease. However, there has been an increase in severe HFMD cases reported associated with neurological symptoms caused by EV71. A growing number of outbreaks of EV71 HFMD have been reported since 1997 across the Asia-Pacific region, including mainland China, Hong Kong, Singapore, South Korea, and Taiwan. Outbreaks have been reported in Malaysia (1997), Taiwan (1998, 2000 & 2001), mainland China (1998-2008), Australia (1999) and Singapore (2000) among other areas in the region. No specific treatment for this enterovirus infection and no vaccine are currently available.
In China, HFMD has become a very serious problem, especially in children, given that no vaccine and specific treatment is currently available to protect against this disease. In March 2008, an EV71 outbreak in Fuyang City of China's Anhui Province caused 23 fatalities, and attracted significant attention from the government and medical communities. In May 2008, the Chinese Ministry of Health identified EV71 as a Class C infectious disease according to prevention and control regulations. EV71 outbreaks have increased over the last five years, with more than 1 million cases identified and 500 to 900 reported fatalities each year. According to the statistics from National Health and Family Planning Commission of China from 2008 to 2013, more than 9 million cases of HFMD have been reported, resulting in around 2,700 fatalities.
About Sinovac's EV71 Vaccine
Sinovac Biotech Ltd. commenced research and development for its independently developed EV71 vaccine in 2008. In December of 2009, Sinovac completed pre-clinical research and filed a clinical trial application to China Food and Drug Administration (CFDA) and in December 2010, received CFDA's approval to assess safety and immunogenicity in Phase I and II clinical trials, and to conduct an efficacy study in a Phase III clinical trial. In 2011, Sinovac conducted and completed Phase I and II clinical trials. The results demonstrated that Sinovac's EV71 vaccine has a good safety and immunogenicity profile, which was the basis for the recently concluded Phase III clinical trial for efficacy in the beginning of 2012. The phase I clinical result was published by the peer-reviewed journal Vaccine in March of 2012. The phase II clinical results were published by "The Journal of Infectious Diseases" in 2013. And also in 2013, the results on immunogenicity, safety and lot consistency study in phase III clinical trial were published in "Clinical and Vaccine Immunology."
In developing countries around the globe including China, oral polio vaccine (OPV) is widely utilized to eradicate polio. OPV is a live attenuated formulation, which contains a weakened form of poliovirus. Although OPV is considered safe and effective, in extremely rare instances, the live attenuated vaccine virus in OPV can cause paralysis, resulting in cases of vaccine-associated paralytic polio (VAPP) or circulating vaccine-derived poliovirus (cVDPVs). Therefore, to eliminate the risk of such cases, OPV will be phased out from routine immunization programs around the world. To enable countries to maintain immunity levels, inactivated polio vaccines (IPV) will be introduced. Sabin IPV is both safer to manufacturer and more affordable as compared to the currently available Salk IPV. The global demand for IPV is increasing as the Global Polio Eradication Initiative has called for IPV to be introduced into 126 countries currently using OPV only by the end of 2015. According to Eradication and Endgame Strategic Plan developed under the Global Polio Eradication Initiative, from 2014 to 2018, the use of OPV in routine immunization will be gradually ceased.
The WHO called for Expressions of Interest (EOI) in 2010, 2011 and 2012 from private or public sector vaccine manufactures interested in collaborating with the WHO and Intravacc 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.
Sabin IPV is both safer to manufacturerand potentially more affordable as compared to the currently available Salk IPV. Intravacc has developed a safer production process to manufacture IPV, using the attenuated strains from the Sabin virus as seed. In collaboration with Intravacc, clinical lots of IPV produced from Sabin poliovirus seed-strains have been developed. Salk IPV is manufactured using wild poliovirus seed-strains, and in such a case a biocontainment failure could lead to serious consequences in some areas of the world in the post-eradication era (i.e. areas with high population density, inadequate sanitation infrastructure and low population immunity levels). Therefore, the use of attenuated Sabin seed-strains for IPV has the advantage over wild polioviruses and hence is safer for handling IPV production in developing country settings.
Polio (Poliomyelitis) is a highly infectious disease caused by a virus. It invades the nervous system, and can cause total paralysis. The virus enters the body through the mouth and multiplies in the intestine. Initial symptoms are fever, fatigue, headache, vomiting, stiffness in the neck, and pain in the limbs. One in 200 infections leads to irreversible paralysis (usually in the legs). Among those paralyzed, 5-10% die when their breathing muscles become immobilized.
Global Polio Eradication Initiative
The Global Polio Eradication Initiative is a public-private partnership led by national governments and spearheaded by the WHO, Rotary International, the US Centers for Disease Control and Prevention (CDC), and the United Nations Childrens Fund (UNICEF). Its goal is to eradicate polio worldwide.
Improving immunization services globally is vital to ending polio and reducing child mortality. Strong immunization services are also essential to ensuring the success of the phased withdrawal of the OPV and the introduction of the IPV, key steps toward eradication. The Global Polio Eradication Initiatives Strategic Plan calls for IPV to be introduced into 126 countries by the end of 2015.
OPV contains an attenuated (weakened) vaccine-virus, activating an immune response in the body. When a child is immunized with OPV, the weakened vaccine-virus replicates in the intestine for a limited period, thereby developing immunity by building up antibodies. During this time, the vaccine-virus is also excreted. In areas of inadequate sanitation, this excreted vaccine-virus can spread in the immediate community (and this can offer protection to other children through passive immunization), before eventually dying out.
Polio Vaccination in China
China, together with the entire Western Pacific Region, was officially certified polio-free in 2000, and the region has maintained its certified status since then. National Health and Family Planning Commission China is developing a strategy to add at least one dose of IPV into its national EPI programme, currently it continues to recommend the use of OPV in its national EPI programme. In China, enough OPV is produced by domestic manufacturers to vaccinate all children born in the country every year. Based on the batch release data available as of December 31, 2013, approximately 145 million doses of OPV and 8.3 million doses of IPV were released in China in 2013. In 2011, China experienced an outbreak caused by imported wild poliovirus type 1 from Pakistan. China successfully stopped the importation outbreak in only three months, thereby ensuring the Western Pacific Region could maintain its certified polio-free status. The outbreak affected 10 young children and 11 adults, and resulted in two deaths. China is located next to two of the three countries globally that remain polio-endemic, Pakistan and Afghanistan.