Independent International Committee Confirms that the Ad5-nCoV (Convidecia) Vaccine Complies with Previously Specified Safety and Efficacy Criteria
Petrovax is pleased to announce that on February 1, the Independent Data Monitoring Committee (IDMC) confirmed that the Ad5-nCoV (Convidecia) vaccine met its pre-specified primary safety and efficacy criteria initially specified within the framework of international Phase III clinical trial. According to IDMC, volunteers showed no serious adverse reactions related to the vaccine.
The international Phase III trial aimed at evaluating efficacy and immunogenicity of the Ad5-nCoV (Convidecia) vaccine developed by the Chinese company CanSino Biologics Inc is being carried out in Russia in partnership with Petrovax. On November 10, 2020, the Ministry of Health of the Russian Federation issued a permit for the international clinical trial of the Ad5-nCoV (Convidecia) in Russia.
At present, the planned number of volunteers has been recruited – 42,957 globally, including 4,995 volunteers in Russia, where volunteers are still being recruited in two individual centers – in Saint Petersburg and Sverdlovsk Region. Volunteers from these centers will be able to take part in a cohort for extended evaluation of immunological laboratory parameters.
This clinical trial is intended to evaluate the vaccine efficacy at a long stage of observations – during 12 months, which is possible only with a sufficiently large sample of volunteers.
The new Convidecia vaccine uses human adenoviral vector platform (Ad-5) carrying the Spike (S) protein of the coronavirus. This vector acts as a "delivery vehicle", and the S-protein is an antigen to which an immune response is generated. The vaccine is inserted as a single dose and stored at the temperature of 2-8°C.
Upon its registration in Russia, the Convidecia vaccine will be manufactured at a Petrovax facility located in the Moscow region in its finished dosage form. The production facility has Russian and international GMP certificates and has all the necessary resources for large-scale production of vaccines.
The Ad5-nCov vaccine has successfully gone through preclinical and two phases of clinical trials and showed its safety and efficacy. CanSino Biologics Inc. was the first company in the world that started the human vaccine trials in March 2020. Findings of the immunogenicity and safety research have been published in the peer-reviewed general medical journal The Lancet 1, 2.
Petrovax is a Russian full-cycle biopharmaceutical company with a 25-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 700 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 CanSino Biologics Inc.
CanSinoBIO (SHSE: 688185, HKEX: 06185), founded in 2009, is dedicated to the research, production and commercialization of innovative vaccines for China and global public health security. The company possesses four integrated platform technologies, including adenovirus-based vectors, conjugation, protein engineering, 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
1 Zhu F. C. et al. Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial //The Lancet. – 2020. – Т. 395. – №. 10240. – С. 1845-1854
2 Zhu F. C. et al. Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial //The Lancet. – 2020. – Т. 396. – №. 10249. – С. 479-488