La Jornada – Sputnik V vaccine will be produced in Mexico

Mexico City. The laboratories of Biologicals and Reactives of Mexico (Birmex) signed a cooperation agreement with the Russian Direct Investment Fund (RDIF) in Moscow on Thursday, in order to carry out the “process of technological and analytical transfer for the production of the vaccine “against Covid-19 Sputnik V in Mexican territory, said the director of the state firm, Pedro Zenteno Santella.

“This agreement establishes the necessary mechanisms and conditions to carry out the packaging of the vaccine in Mexican territory, as well as giving rise to the strengthening of the relationship between our countries,” the general director of Birmex told the Sputnik agency shortly after. of the signing of the agreement.

Zenteno Santaella held meetings this week with Kirill Dmitriev, general director of the Direct Investment Fund in Moscow, to finalize the details of the bilateral agreement.

The head of Birmex made the visit together with the team of the regulatory body of the Mexican health sector, the Federal Commission for the Prevention of Sanitary Risks (Cofepris) “to establish a work route between Mexico and Russia regarding the vaccines” that will be filled in Mexican state laboratories.

Cooperation between nations is a factor that “strengthens us to combat the recent pandemic with new technologies,” said the Mexican official within the framework of the visit.

On his social networks, Zenteno Santaella released a video of the signing of the agreement.

The official reported that yesterday he met with members of the Research and Development Department of the Gamaleya Research Institute of Epidemiology and Microbiology, in order to exchange information regarding quality controls during the production process of Sputnik V.

He explained that the director of Research, Denis Lugonov, engineer Alexander Semikhin, director of Production, Azer Mamedov, head of the RDIF and Ruslan Sigeda, promoter of the FIDR participated in the meeting.

Platform for Central America and the Caribbean

“What they have told us in the Russian Fund is that they hope that Mexico will be a platform to be able to send their vaccine to the countries of the Caribbean and to the countries of Central America, (…) Birmex is interested in this,” said Zenteno.

“We consider that in January we are already ending the Mexican contract, if it is necessary to package it in Mexico. If not, in January we are already packaging (the) Sputnik V vaccine in Mexico for sale to Central America and the Caribbean, (…) outside the contract, “he said.

In the coming weeks, according to the Birmex director, Mexico and Russia will agree on the delivery schedule for the rest of the vaccines – both packaged and, according to Zenteno, “in bulk” – to complete the initial contract.

In addition, within the framework of the agreement agreed on Thursday, “a training route for colleagues for the process of technology transfer” and analytics will be established.

The idea is, as he explained, to enable the Cofepris specialists so that they can themselves give their approval for the commercialization of the vaccines packaged by Birmex, without the need for them to be sent to Russia for certification by the Gamaleya Institute (designer of the vaccine) and from there back to Mexico.

The Birmex boss said, before traveling to Russia, that the objective of the state company is to complete the “technology transfer” to begin a first stage with the packaging of some 24 million doses of Sputnik V, and then acquire the capacity. installed for the production of up to 20 million doses per year.

Zenteno said at the beginning of last September, in an interview with the Sputnik agency, that Mexico could begin to package 4.5 million monthly doses of Sputnik V vaccines against Covid-19 at the end of this month of October and begin its commercialization in December of this anus.

On September 9, the head of Birmex announced that Gamaleya had approved “the packaging procedure for component number one” and only the second component was missing, recalling that the Sputnik V treatment has two different adenoviruses.

Indeed, the Russian biological compound against the new SARS CoV2 coronavirus consists of two doses applied with an interval of 21 days: the first is based on human adenovirus type 26 (Ad26) and the second, on recombinant human adenovirus type 5 (Bd5).

With the authorizations of the pilot packaging of the two compounds, “we practically closed the analyzes that the Gamaleya Institute is doing so that the simulated packaging process that was carried out in Mexico is approved,” said the health officer on that occasion.

At the beginning of February, the prestigious British scientific magazine The Lancet published the results of the Sputnik V clinical trial, which confirm 91.6 percent safety and effectiveness.

(With information from Carolina Gómez Mena)

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