Mexico has produced the first test batch of the Russian Sputnik V COVID-19 vaccine at a local plant, the Russian Direct Investment Fund (RDIF) said
With the announcement by RDIF and Mexican pharmaceutical company Laboratorios de Biologicos y Reactivos de Mexico (BIRMEX), Mexico has become the first country of North America both to register Sputnik V and to launch the local production of the Russian vaccine.
“Production of the test batch is an important step in the technology transfer process and we expect the batch to comply with strictest requirements. Sputnik V has been successfully used in Mexico for months demonstrating excellent safety and efficacy profile.
“As RDIF and partners launch the local production of the vaccine we strive to provide easier access to Sputnik V for population of Mexico and help speed up the vaccination program.” said Kirill Dmitriev, CEO of the RDIF in a statement.
The vaccine produced in the North American country will be used in the national vaccination program.
At present, Sputnik V has been registered in 67 countries globally with a total population of over 3.5 billion people. The data obtained by regulators of a number of countries during the vaccination of the population, including Mexico, Argentina, Serbia, Bahrain, Hungary, UAE and others, demonstrates that Sputnik V is one of the safest and most effective vaccines against coronavirus.
The release stated that Sputnik V is based on a proven and well-studied platform of human adenoviral vectors and uses two different vectors for the two shots in a course of vaccination, providing immunity with a longer duration than vaccines using the same delivery mechanism for both shots.
Meanwhile, on WHO concern over Sputnik V coronavirus vaccine issues with the filling of vials at one plant, the Pharmastanfar – UfaVITA said that the issues did not relate to the safety or efficacy of the vaccine itself, the plant is responsible only for pouring into vials doses of Sputnik V vaccine produced elsewhere.
WHO did not raise any questions about the safety and efficacy of the produced and finished vaccine as the “Sputnik V” vaccine undergoes strictest double quality output control of the Gamaleya Institute and the Russian health regulator (Federal Healthcare Service – Roszdravnadzor), said OJSC Pharmstandard-UfaVITA statement.
Moreover, the WHO interim inspection did not identify any critical issues with the actual vaccine’s production, quality, clinical studies, possible side effects, nor with the double quality output control by both the Gamaleya Institute and the Russian health regulator.
Instead, WHO inspectors’ attention was focused on only four technical issues mostly related to one of the filling lines that have all been subsequently fully addressed, said the statement.
Further, OJSC Pharmstandard-UfaVITA invited WHO for another inspection. (ANI)
