The first group of volunteers are vaccinated…
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The Petrovax company, CanSino Biologics Inc. and the contract research organization OCT Clinical have launched the vaccination of their first volunteers at Moscow medical centers.
This month, our first group of volunteers participating in an international Phase III clinical trial of the vaccine candidate Ad5-nCoV in Russia were vaccinated at Moscow medical centers, co-developed by CanSino Biologics Inc. (“CanSinoBIO”) (SHSE: 688185, HKEX:06185) and Beijing Institute of Biotechnology, Academy of Military Medical Science.
At the moment, the volunteers are doing well. None of them have shown any side effects. According to clinical regulations, study participants will be under direct supervision for the first 28 days after vaccination and will have to undergo four interim face-to-face examinations at treatment centers. According to expert forecasts, during this period, the vaccinated subjects will develop an antibody and cellular immune response to COVID-19. The volunteers will also have to undergo a control examination after six months.
Mikhail Tsyferov, president of Petrovax Pharm, said, “We are pleased to announce the vaccination of the first group of volunteers in Russia. This is an important step for us that will bring us closer to the earliest possible resolution of the coronavirus situation, not only in Russia, but throughout the world. Thanks to the efforts of our team and partners, we are optimistic about the continuation of a large-scale study that can offer an effective means to protect the population against COVID-19.”
OCT Clinical’s president Dmitry Sharov said, "We are extremely honored to be able to contribute to this vaccine research and eventually help combat the pandemic. Our in-depth local expertise and experience of over 15 years allow us to accomplish project milestones in a timely manner. All volunteers will be vaccinated in the short run."
Petrovax is recruiting volunteers at other medical centers, and has received over 3,000 applications so far. After signing informed consent, candidates undergo a preliminary screening for compliance with research criteria.
The clinical trial of Ad5-nCov is being carried out in compliance with the Declaration of Helsinki and appropriate clinical practices. The Ad5-nCoV vaccine uses a platform of an adenoviral vector carrying the S-protein of the coronavirus. This vector acts as a delivery vehicle, while the S-protein acts as genetic information, which should trigger an immune response.
Once the vaccine is registered in the Russian Federation, Petrovax will be able to produce more than 4 million doses of the vaccine per month in 2020 at its Moscow Region facilities. Vaccine production can be increased to 10 million doses per month in 2021 due to the planned expansion of production capacity. The company’s production complex has Russian and international GMP certificates and has all the necessary resources for large-scale production of vaccines. As a Russian vaccine manufacturer, Petrovax will have exclusive rights to supply it in Russia and the CIS countries.
Petrovax is a Russian full-cycle biopharmaceutical company with a 20-year successful experience of operating in the pharma market. It is a Top-5 immunobiological manufacturer in Russia.
Petrovax’s product portfolio includes its own original pharmaceutical products and vaccines produced in cooperation with leading domestic and foreign companies, as well as generic products. The company's production operates in full compliance with Russian and international GMP and ISO: 9001 standards. A modern pharmaceutical production complex located in the Moscow region is one of the most high-tech biopharmaceutical facilities in Russia. The plant's capacities allow the annual production of 160 million doses of shots of pharmaceutical products - from the synthesis of substances to finished medical products. The Petrovax staff numbers over 600 highly qualified specialists. The company is part of the Interros Group. The company exports the products to 12 countries, including the countries of the EAEU, the Middle East (Iran) and the EU (Slovakia).
Additional information can be found online at www.petrovax.ru
About OCT Clinical
OCT Clinical is the leading CRO in Russia, with operations in Central and Eastern Europe and the CIS region. With a team of over 200 professionals, the company provides a full range of high-quality clinical research services for phase I-IV and BE studies. With strong local expertise and focus on quality, OCT ensures seamless clinical trial conduct and drug registration on time and within budget. OCT’s experienced team delivers both standalone services such as medical writing, consultancy, project management/monitoring, data management/biostatistics and turnkey service for clinical development. Since 2005, OCT Clinical Trials has worked on over 300 full-service and functional service projects in more than 20 therapeutic areas. Learn more at www.OCT-ClinicalTrials.com
OCT Clinical, a CRO operating in 12 countries, was selected as a principal CRO, responsible for the full range of activities for the vaccine trial in Russia, including medical writing, regulatory and logistic support, project management, subject enrollment, site monitoring, data management and biostatistics.
About CanSino Biologics Inc.
Incorporated in 2009, CanSinoBIO (SHSE: 688185, HKEX:06185) commits to research, production and commercialization of innovative vaccines for China and global public health security. It possesses four integrated platform technologies including adenovirus-based vectors, conjugation, protein design and recombination and formulation. As of today, it has established a robust pipeline of 16 vaccines covering 13 diseases, including a globally innovative Ebola virus vaccine approved in 2017 as well as the investigational Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector).
Additional information can be found online at www.cansinotech.com