Sinovac Receives Conditional Marketing Authorization in China for its COVID-19 Vaccine
Sinovac Biotech Ltd. (NASDAQ:SVA) announced that the China National Medical Products Administration has granted conditional marketing authorization for CoronaVac, its COVID-19 vaccine for adults. This decision follows extensive submissions and rolling reviews by the NMPA since September 2020. Sinovac has completed over 40 submissions and applied for conditional marketing authorization on February 3, 2021, based on phase III trial data. The approval is pivotal for Sinovac's goal of increasing vaccine availability worldwide as it seeks additional regulatory approvals in multiple countries.
- Conditional marketing authorization granted for CoronaVac, allowing for broader vaccine distribution.
- Over 40 submissions made to NMPA, showcasing ongoing commitment to regulatory compliance and development.
- Active pursuit of global approvals to enhance vaccine accessibility and affordability.
- Final efficacy and safety results of phase III clinical trials are not yet available.
- Ongoing uncertainties regarding production capacity and regulatory approvals may hinder timely vaccine distribution.
Sinovac Biotech Ltd. (NASDAQ:SVA) (“Sinovac” or the “Company”), a leading provider of biopharmaceutical products in China, today announced that the China National Medical Products Administration (NMPA) has granted a conditional marketing authorization (CMA) to Sinovac for CoronaVac, Sinovac’s COVID-19 vaccine in individuals aged 18 and above.
Sinovac began rolling submission to the NMPA since September 2020 and the NMPA carried out rolling reviews when the submission was made. As of February 4, 2021, the Company made more than 40 submissions to the NMPA. After obtaining the preliminary efficacy results, Sinovac formally filed for application of a conditional marketing authorization on February 3, 2021. The approval is based on the results of the two-month data of phase III clinical trials. The final results are not yet available, and the efficacy and safety results shall be further confirmed.
Mr. Yin Weidong, Chairman, President and CEO of Sinovac, said, "Being granted a conditional marketing authorization for CorornaVac is a significant milestone for Sinovac after commencing development at the beginning of 2020. We show our respect and appreciation to the volunteers for their contribution to this research and thank all experts, scientists and partners who participated in this international collaborative project. The COVID-19 pandemic continues around the world, and the fight is far from over. We look forward to providing safe and effective vaccines to as many individuals as possible to combat this epidemic by increasing the vaccination rate. It is our sincere hope that people’s lives and social and economic activities can return to normal as soon as possible, and that we can wear a smile without masks."
CoronaVac is being used under emergency use approval (EUA) in Indonesia, Brazil, Turkey and Chile. Sinovac is also actively seeking regulatory approval of CoronaVac in other countries and regions around the world in an effort to maximize global accessibility and affordability of the COVID-19 vaccine and to ensure global prevention and mitigate spread.
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 enterovirus71 (EV71), hepatitis A and B, seasonal influenza, 23-Valent Pneumococcal Polysaccharide (“PPV”), H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), varicella vaccine and mumps. 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. The Company is developing a number of new products including COVID-19 vaccine, CoronaVac, a Sabin-strain inactivated polio vaccine and 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 announcement 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.
This announcement contains forward-looking information about the Company’s efforts to develop a potential COVID-19 vaccine that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with clinical data (including the Phase III trial data); the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase III trials or in larger, more diverse populations upon commercialization; the risk that clinical trial data are subject to differing interpretations and assessments, and by regulatory authorities; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or have access to logistics or supply channels commensurate with global demand for any potential approved vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine candidate; uncertainties regarding the ability to obtain recommendations public health authorities; uncertainties regarding the impact of COVID-19 on our business, operations and financial results; and competitive developments.
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