According to local reports out of Russia (Moscow Times), the Phase 3 clinical trial investigating Cansino Biologics’ COVID-19 vaccine candidate, known as Ad5-nCoV, has been evidencing no side effects as many study participants have received the vaccine in the “large-scale clinical trial.” No specific study metrics have been shared (e.g. how many people actually were treated).
The Phase 3 clinical trial, approved last month by Russian regulators, is led by Russian pharmaceutical company Petrovax in conjunction with CanSino. Although Petrovax has shared that over 3,000 participants have submitted applications to participate, they didn’t disclose the numbers actually treated in the study. The study is supported by local contract research organization OCT Clinical Trials. This Phase 3 trial also includes the testing of approximately 5,000 subjects in Saudi Arabia.
Results Thus Far
Thus far, the first group of study volunteers were vaccinated at Moscow medical centers, reported Petrovax. The Russian pharmaceutical company issued a press release declaring that all of the volunteers “are doing well. None of them have shown any side effects.” However the number of subjects actually treated hasn’t been shared.
Phase III trial of the vaccine has also been launched in Saudi Arabia, involving about 5,000 subjects, according to CanSino.
If the vaccine produces positive results and is eventually registered in the Russian Federation, then according to their press release, the company (Petrovax) will be able to produce 4 million doses of the vaccine per month in 2020 at its Moscow Region facilities. This capacity can potentially increase to 10 million per month by 2021. Petrovax secured the exclusive rights to supply Ad5-nCOV in Russia and CIS countries.
About the CRO
OCT Clinical Trials, formed in 2005, have worked on over 300-full service for clinical development. Based in Russia, they maintain operations in Central and Eastern Europe as well as the CIS region. The CRO employs over 200 and offers a wide-range of high-quality clinical research services for Phase I-IV and BE studies.
A full-cycle biopharmaceutical company, Petrovax has been operating in the pharmaceutical sector for 20 years. According to their press release, they are in the top-5 of immunobiological manufacturers in Russia. The company maintains a modern production complex in the Moscow area and purportedly can produce 160 million doses of shots of various products. They employ over 600. The company is part of the Interros Group and exports their products to 12 countries of the EAEU, Middle East and the EU.
Moscow-based Interros Group is actually a conglomerate controlled by Russian oligarch Vladimir Potanin with large stakes in various industrial sectors ranging from mines and energy production to real estate and pharmaceuticals.
Sputnik V Status
Although Russia “registered” its home-grown Sputnik V COVID-19 vaccine (developed by Gamaleya Institute), that vaccine product must still undergo Phase 3 clinical trials in Russia to assess long-term safety and efficacy. Essentially a Phase 3 clinical trial! This study will involve 40,000 participants.
The sources for this story arise out of Russia, and the validity of the claims aren’t certain.