Mexico Produces First Batch of Sputnik Vaccine

The Mexican pharmaceutical company Laboratorios de Biológicos y Reactivos de México (BIRMEX) produced a test batch of the Russian Sputnik V coronavirus vaccine, announced the Russian Direct Investment Fund (RDIF), which markets the preparation.

Last week, BIRMEX signed an agreement with RDIF to ship the active substance of the Sputnik V vaccine against the SARS-CoV-2 virus to Mexico for packaging, informed BIRMEX. With the arrival of the active substance, the packaging of pilot batches began. Later, the batches underwent COFEPRIS’s verification and approval process. Now, the National Center for Epidemiology and Microbiology Research Gamaleya seek to start massive packaging the Sputnik V vaccine at BIRMEX by the end of July, Pedro Zenteno Santaella, Director General of the National Center for Epidemiology.

Kirill Dmitriev, Executive Director of RDIF, said in a press release that the production of the test batch was an essential step in the technology transfer process and is expected to fully meet the most stringent safety requirements. According to FIDR, this drug has been successfully used in Mexico for several months and shows excellent safety and efficacy indicators. With the launch of local production, RDIF and its partners are striving to provide faster access to the vaccine for the Mexican population and support the vaccination campaigns in the country. Mexico has thus become "the first country in North America to register Sputnik V and launch production of this Russian vaccine," RDIF said.

The local production of Sputnik V was agreed upon during a visit of the Mexican Foreign Minister, Marcelo Ebrard, to Moscow at the end of April. The move came in response to delays in the shipments of doses from different pharmaceutical companies, including Sputnik V itself, and the packaging of AstraZeneca's vaccine in Mexico. So far, 67 countries have registered the two-dose Sputnik V, which is 97.6 percent effective, according to the FIDR. The vaccine's developers in Moscow have assured that it has an efficacy of around 90 percent against the highly contagious Delta variant of the coronavirus.

Zenteno Santaella added that this is the first of several steps. The next will be to submit the Sputnik Plus (Light), which requires a single dose, to COFEPRIS’s New Molecules Committee for its emergency use in Mexico. The results of Phase III studies of this vaccine are already underway. Once authorized, like Sputnik V, it is expected that the Gamaleya Institute will be able to negotiate the technology transfer and achieve the production, packaging and distribution of the bulk to carry out the entire process of both vaccines in Mexico.