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Sputnik V: what will be the role of Latin America in its development and manufacture | The race


The scientists behind the Russian coronavirus vaccine published the results of their first clinical trials. What will be the role of Latin America?

The scientists behind the Russian coronavirus vaccine have already published the results of their first clinical trials, a key step for the involvement of other countries in the development and manufacture of it.

And during the press conference that followed the publication of those results on Friday in the scientific journal The Lancet, the president of the Russian Direct Investment Fund (RDIF), Kirill Dmitriev, highlighted the possible participation of at least one Latin American country in the process.

Russia registered Sputnik V before the results of the first two phases of clinical trials were made public – which did not reveal serious side effects and did reveal an important immune response in all 76 participants – and is already applying it locally among volunteers belonging to groups at risk.

But its acquisition and use by third parties will largely depend on the results of more tests, as well as an increase in production capacity that will require the participation of other countries.

“Our main limitation right now is the availability of sufficient production capacity to meet demand, so we are actively working with many countries to produce it outside of Russia,” explained Dmitriev.

“(But) we have agreements with India, Brazil and other countries“, Assured the executive of the state fund that finances the development and production of the vaccine.

And although the RDIF has not wanted to confirm or deny it, there are elements that suggest that these “other countries” could include other Latin American nations.

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Kirill Dmitriev is the CEO of the investment fund that finances the development and production of the Russian vaccine.

“We will not comment on Latin America until September 10, when we will present our Latin American strategy“, The RDIF press secretary, Arseniy Palagin, told BBC Mundo, when asked about the statements of the authorities of Mexico and Venezuela on a possible participation of these countries in new clinical trials.

Regarding the role of these countries, there is no mention in the official website of the Sputnik V vaccine, but there, in addition to the aforementioned participation of Brazil, it is said that “the possibility of producing the vaccine in (…) is also being studied. Cuba“.

The press, for its part, has also mentioned Argentina as a possible manufacturer of the vaccine, after the governor of the province of Tierra del Fuego made public his “special interest and predisposition to work cooperatively.”

And till Nicaragua has sounded like a candidate, since in the Central American country there is a Russian capital and technology vaccine production laboratory that, according to the pine authorities, would be able to reproduce Sputnik V.

What is known so far about all these possibilities? And when would Sputnik V be available in Latin America?

Brazil, regional center?

Brazil is undoubtedly the RDIF’s main bet for the production in Latin America of the vaccine developed in Moscow by the Gamaleya Institute, although the participation of the South American giant is not yet guaranteed.

The RDIF signed an agreement with the government of the state of Paraná for the possible manufacture of Sputnik V by the Paraná Institute of Technology, TecPar, and according to Palagin they are also considering other potential partners to make Brazil the regional center for the production of the vaccine.

Woman passes in front of the Gamaleya Institute

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Sputnik V was developed by the Gamaleya National Research Center for Epidemiology and Microbiology in Moscow.

“However, it is necessary to understand that at this time the regulators in Brazil are analyzing our data and the manufacturers in Brazil are studying our manufacturing process, so it is important not to overstate this,” the RDIF spokesperson told BBC Mundo.

And, indeed, at the end of last week the National Health Surveillance Agency of Brazil, Anvisa, He had not yet given the go-ahead to Sputnik V.

“We have not received a formal request for authorization of clinical studies of the Russian vaccine, not even a request for registration,” he told BBC Mundo Anvisa.

The agency, however, mentioned holding “several preliminary preparatory meetings with those interested in the development of the vaccine, specifically the government of Paraná.”

And, on the same Friday, TecPar announced that they expected to submit the validation protocol for their phase 3 clinical trials. By the end of September, which in the event of a positive response from Anvisa would allow it to start the same at the end of October.

Sputnik V vaccines

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If all goes as planned, TecPar would begin manufacturing the vaccine in the second half of 2021.

“We received the results of phases 1 and 2 18 days ago, we translated them and they have already begun to be interpreted by our technical teams”, explained the director-president of TecPar, Jorge Calado, for whom “there is a good reliability rate for this vaccine ”which however has to be confirmed by the new tests.

For these TecPar, the participation of about 10,000 volunteers – in addition to the 40,000 already participating in the phase 3 trials in Russia – to which vaccines provided by the Gamaleya Institute would be applied.

“Once the effectiveness of the tests has been verified, which should happen 60 days after the start of immunization in the volunteers, a new registration request will be submitted to Anvisa for effective vaccination in the national territory. The first doses will be imported ”, is explained in a TecPar press release provided to BBC Mundo.

“As the protocol implies technology transfer, in a second moment there will be production in national territory by Tecpar. It is estimated that this will only occur in the second half of 2021“, It reads in it.

Competing with other vaccines

The dates do not exactly coincide with those advanced by the RDIF for the start of the production of Sputnik V abroad, since according to Dmitriev the objective is that the first doses manufactured outside Russia can be distributed abroad from November.

Brazil, however, is not the only country that could produce such vaccines, with India hinting as an especially important ally for the RDIF and the Gamaleya Institute, which have also mentioned South Korea, Saudi Arabia and Turkey as potential manufacturers.

Researcher at the Gamaleya Institute.

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Several Latin American countries participate in various ways in the development of various vaccines.

It seems unlikely, in any case, that other Latin American countries can move faster than Brazil, which the press attaché of the Russian embassy in that country, Iván Knovalov, also identifies as a “strategic ally”And“ a potential center for the production and distribution of immunizers for all of Latin America ”.

“The Brazilian technological and production base allows for rapid testing and organization of vaccine production,” Konovalov explained to BBC Mundo.

And although Brazil is not the only country in the region with proven capabilities in the manufacture of vaccines, Cuba’s interest in developing your own vaccine, Soberana 01, and the already announced commitment of Mexico and Argentina to participate in the manufacture of the vaccine developed by the University of Oxford and AstraZeneca, could pose some obstacles to their involvement with Sputnik V.

MAbxience plant in Garín, province of Buenos Aires

Insud Group
The Argentine laboratory mAbxience plans to produce up to 250 million doses of the Oxford vaccine at this plant in Buenos Aires.

Of the possible participation of Argentina in the manufacture and distribution of the Russian vaccine, to date only the proposal of the Governor of Tierra del Fuego, Gustavo Melella, to “be part of the production and promotion program” of the Sputnik V vaccine.

Mexico, however, confirmed last week that it had been invited to participate in phase 3 clinical trials of the Sputnik V vaccine, although it also said that it had not yet received the results of phases 1 and 2.

“It means that in the first days of OctoberIf the health regulatory authority considers it so, hopefully so, this vaccine can be brought to Mexico ”, said the Mexican Foreign Minister, Marcelo Ebrard of the doses that would be applied to between 500 and 1,000 volunteers.

But, for the moment, the Mexican interest does not seem to be oriented so much to a possible local manufacture of the Russian vaccine, but to “guarantee timely access” to it in case it is proven that it is “safe and effective”.

“If the results are positive, and if the regulatory authority, Cofepris, so decides, (the Russian vaccine) would already be available in the coming months in Mexico,” declared Ebrard, thus suggesting the use of doses imported from other countries.

“Assessing capabilities”

For the rest, there is still no date for Venezuela’s participation in clinical trials of the Russian vaccine, nor is there any assurance that it could be one of its manufacturers.

“In the next few days we will ask for the volunteers that are needed to get the vaccine and participate for Venezuela in phase 3 of Sputnik V“Venezuelan President Nicolás Maduro announced on August 30, without giving further details.

Researcher at the Gamaleya Institute.

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The Sputnik V vaccine is currently being tested on 40,000 volunteers in Russia, to be joined by volunteers from other countries.

“The confidentiality documents have already been signed and at any moment we will announce the beginning of the vaccine test in Venezuelan patients ”, the president insisted once again last Sunday, when he also assured that“ Venezuela has the laboratories and the industrial capacity to produce all the vaccines ”.

According to Andrey Ryaposov, press attaché at the Russian embassy in Caracas, Venezuelan productive capacities are currently being evaluated to participate in the vaccine packaging process, in a first stage, and in the possible manufacture of the vaccine later.

“Now the technical specialists from both sides work, but still no dates“, He told BBC Mundo.

And something similar could be happening in Nicaragua, where the government has taken for granted the participation of the Latin American Institute of Biotechnology Mechnikov – a local laboratory attached to the Institute for Scientific Research of Vaccines and Serums of Saint Petersburg – in the manufacture of Sputnik V for Latin America.

Researcher at the Gamaleya Institute.

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Both Nicaragua and Venezuela claim to have the capabilities to produce the vaccine.

BBC Mundo contacted the director of the center, Stanislav Uiba, to try to obtain more details, but did not receive a response.

The capacity of the laboratory, inaugurated in October 2017, has been questioned by Nicaraguan experts, who argue that in the best case scenario it could function as a packaging center for Sputnik V.

Uiba, however, told local media that his laboratory could start manufacturing the Russian vaccine in Nicaragua by the end of the year.

But whether or not it is really part of the plans of the Gamaleya Institute and the Russian Direct Investment Fund will probably be known until this September, 10th, when Russia’s plans for its vaccine in Latin America are made public.

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