How will Latin America contribute to the development of the Sputnik V vaccine?
This Thursday, September 10, Russia confirmed that it will supply more than 130 million doses of its Sputnik V vaccine to countries in Latin America
The scientists behind the Russian vaccine against the coronavirus that causes the disease COVID-19 published the results of its first clinical tests. It is a key step to involve other countries in the development and manufacture of the vaccine.
During the press conference that followed the publication of those results last 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. None of them revealed serious side effects and it did reveal a significant immune response in the 76 participants.
The so-called “Russian vaccine” is already being applied within the Eurasian country among volunteers belonging to groups at risk.
But, its acquisition and use by third parties will largely depend on the results of more tests. Also on 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 the demand. That is why we are actively working with many countries to produce it outside of Russia”, explained Dmitriev.
“We have agreements with India, Brazil and other countries”, said the executive of the Russian state fund that finances the development and production of the vaccine.
Which countries will develop the vaccine?
This Thursday, September 10, Russia confirmed that it will supply more than 130 million doses of its Sputnik V vaccine to countries in Latin America.
“We see that we are going to supply more and more doses of our vaccine to Latin American countries, and as you know, yesterday [September 9] we agreed to deliver 32 million doses of the vaccine to Mexico and soon, literally tomorrow [September 11] we will announce a supply of up to 100 million doses to other countries in Latin America”, Dmitriev told a conference call on the Sputnik V vaccine organized for countries in the region.
It is still unknown what the participation of nations such as Nicaragua or Venezuela will be, as there is still no mention in the official portal of the Sputnik V vaccine on the subject. But there, in addition to the aforementioned participation of Brazil, it is said that “the possibility of producing the vaccine in (…) Cuba is also being studied”.
The press, for its part, also mentions Argentina as a possible manufacturer of the vaccine. This, after the government of the province of Tierra del Fuego made public its “special interest and predisposition to work cooperatively”.
Even Nicaragua sounds like a candidate. In the Central American country there is a vaccine production laboratory of Russiian capital and technology that, according to the authorities, can reproduce Sputnik V.
When would Sputnik V be available in Latin America?
Brazil is the RDIF’s main commitment to produce in Latin America the vaccine developed in Moscow by the Gamaleya Institute. However, the participation of the South American giant is not yet guaranteed.
The RDIF signed an agreement with the Paraná state government for the possible manufacture of the vaccine, by the Paraná Institute of Technology (TecPar). According to Palagin, they are also considering other potential partners to make Brazil the regional hub for vaccine production.
“However, right now, regulators in Brazil are analyzing our data and manufacturers are studying our manufacturing process. For this reason, it is important not to overstate”, the situation, the RDIF spokesperson told BBC Mundo.
In fact, at the end of last week the National Health Surveillance Agency of Brazil (Anvisa) 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”, Anvisa told BBC Mundo.
The agency, however, mentioned holding “several preliminary preparatory meetings with those interested in the development of the vaccine, specifically the government of Paraná”.
TecPar could produce by the second half of 2021
On the same day, TecPar announced that they expected to submit the validation protocol for their phase 3 clinical trials at the end of September, which in the event of a positive response from Anvisa would allow them to start the tests at the end of October; And if all goes well, they would start 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”, although it has to be confirmed by new tests.
TecPar expects 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, about 60 days after the start of the immunization in the volunteers, a new application for registration will be submitted to Anvisa for effective vaccination in the national territory. The first doses will be imported ”, explained 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″, reports TecPar.
Russians believe their vaccine will be ready in November
Tecpar’s dates do not exactly coincide with those advanced by the RDIF for the start of production of Sputnik V abroad, since according to Dmitriev the objective is that the first doses manufactured outside of Russia can be distributed in November.
However, Brazil is not the only country that could produce these vaccines. India is hinted 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.
In any case, it seems difficult that other Latin American countries can move faster than Brazil. The press attaché of the Russian embassy in Brasilia, Iván Knovalov, considers this country 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.
Brazil is not the only country in the region with proven vaccine manufacturing capabilities. But, Cuba’s interest in developing its own vaccine, Soberana 01, and the 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 producing Sputnik V.
However, the recent announcement of the Oxford vaccine being stopped after serious side effects were detected, would be a ‘blow on the table’. This further opens the possibilities for the Russian drug to mass its acquisition and production in Latin America.
Regarding 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 Sputnik V is known.
Meanwhile, Mexico confirmed that it was invited to participate in phase 3 of the Sputnik V vaccine clinical trials. However, it also said that it had not yet received the results of phases 1 and 2.
“It means that in the first days of October, if the health regulatory authority considers it so, this vaccine can be brought to Mexico”. This was expressed by the Mexican Foreign Minister, Marcelo Ebrard, days before confirming the acquisition of 32 million doses of Sputnik V.
For now, the Mexican interest seems to be oriented towards the possible local manufacture of the vaccine and “guaranteeing timely access” to it.
“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”, stated Ebrard, thus suggesting the use of imported doses from other countries.
Venezuela is also interested
For the rest, there is still no date for Venezuela’s participation in clinical trials of the Russian vaccine. There is also no certainty that it could be one of its manufacturers.
“In the next few days we will ask for the volunteers that are needed to try out the vaccine and participate for Venezuela in phase 3 of Sputnik V”. This was announced by President Nicolás Maduro on August 30, without giving further details.
“The confidentiality documents have already been signed and at any time we will announce the start of the tests in Venezuelan patients”, he added in another statement.
Maduro also assured that “Venezuela has the laboratories and the industrial capacity to produce all the vaccines”.
According to Andrey Ryaposov, press attaché of the Russian embassy in Caracas, they are currently evaluating Venezuelan productive capacities to participate in the packaging process in a first stage, and in the possible manufacture of it later.
“Now the technical specialists on both sides are working, but there are still no dates”, he told BBC Mundo.
Nicaragua could help
Something similar occurs in Nicaragua, where the Government takes the participation of the Mechnikov Latin American Institute of Biotechnology as an ‘automatic’ fact. It is a local laboratory attached to the Saint Petersburg Institute for Scientific Research on Vaccines and Serums.
According to BBC Mundo, they tried to contact the director of the center, Stanislav Uiba, to try to obtain more details, but received no response.
Nicaraguan experts, cited by the BBC, said that the laboratory, inaugurated in 2017, would serve more as a packaging center for Sputnik V than as a producer.
However, Uiba told local media that his laboratory could start manufacturing the Russian vaccine in Nicaragua by the end of the year.
These proposals and the plans of each Latin American country will be confirmed by the Gamaleya Institute and the Russian Fund for Direct Investment. It will be this Friday, September 11, when Russia’s plans for its vaccine in Latin America are made public.
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