RIO DE JANEIRO, BRAZIL – Until a few weeks ago, the Russian Sputnik V vaccine was a distant possibility for much of Latin America in the fight against Covid-19. Brazil and Chile were betting on the Coronavac, the Chinese Sinovac pharmaceutical company’s immunizer.
Peru had its eye on the Sinopharma laboratory. Mexico became one of the first countries in the world to close a deal with Pfizer and begin its vaccination campaign. Argentina was one of the few that advanced negotiations for the Sputnik V, which according to a study published on Tuesday in the renowned The Lancet scientific journal, reaches 91.6% efficacy.
A number of unforeseen events in the race for immunization changed everything and forced other governments in the region to seek alternatives to protect their population in a pandemic that has already killed over one million people across the continent. Then Russia launched its main vaccine, hoping to distribute more than 300 million doses before the end of the year, an effort in which the government of Argentine President Alberto Fernández played a major role and which Mexico and other countries – like Brazil – now view with hope following its efficacy results, given the tremendous challenge it is facing with its vaccination plan.
On Wednesday, Brazil thickened the list of Latin countries that opened the way for the Russian immunizer. The Brazilian Health Regulatory Agency ANVISA has removed a step in the emergency use authorization process for immunizers in the country – which has now approved the Coronavac and Astrazeneca/Oxford vaccines – by dropping its requirement for Phase 3 clinical trials on Brazilian soil.
“Vaccines with Phase 3 trials in Brazil or abroad will need to follow the same safety, efficacy and quality criteria. The only difference will be to provide data in order for us to have confidence in foreign trials,” said the Agency’s General Manager of Medicines and Biological Products, Gustavo Mendes. The application for emergency use of the immunizer in Brazil, requested by União Química pharmaceutical company, is still under review.
The surge of Sputnik V (the “V” is for “vaccine”) in the Latin American scenario was marked by controversy. After agreeing to send 20 million doses to Argentina, 10 million to Venezuela and 24 million to Mexico, questions of all kinds arose: from doubts about the lack of scientific data published in the West when the first agreements were signed and political attacks criticizing the management of the pandemic, to fears and delusions surrounding conspiracy theories.
“Remember that the Sputnik has a communist, Castrist and Chavista chip,” posted a Twitter user. “It’s a cheap vaccine, that’s why the government chose it,” accused Mexican Senator Lilly Téllez. “It’s a huge fraud,” said Argentine opposition leader Elisa Carrió, who denounced President Fernández for a potential “poisoning” of the population. The Russian embassy in Mexico itself published on its social networks last week that it was the target of a “disinformation” campaign.
The trial’s preliminary results published on Tuesday, with 20,000 subjects – 75% of whom were administered the vaccine and the remainder a placebo – show that only 16 had symptomatic Covid-19 among those vaccinated (0.1%), and 62 among the unvaccinated (1.3%). The publication of these figures provided a new boost to immunization, faced with the initial skepticism of the international scientific community.
With the Sputnik V, Russia aspires to remain in the top ranks of the scientific race, a game reserved for the great powers. But it’s not just a matter of prestige. The vaccine “is a good deal, with a clear humanitarian component,” Russian president Vladimir Putin said in October to a group of Russian tycoons, encouraging them to invest in production and capitalize on a business opportunity that, he said, could represent US$100 billion (R$538 billion) in revenues worldwide.
On August 11th, at a cabinet meeting, Putin announced the special authorization for the coronavirus vaccine developed by the Gamaleya Institute in Moscow. The Russian leader noted that the immunizer was “safe” and “quite effective”. But until then, his scientists had not published any data from Phases 1 or 2 trials, which had already sparked certain doubts within the scientific community for its speed. And they had not begun Phase 3 trials, which involve a larger number of subjects. Putin, who assured in earnest that the vaccine had passed “all required tests”, solved the issue when declaring that one of his daughters had already been vaccinated. “She is well. Everything is proceeding as if nothing had happened”, he added.
Shortly after the statement, the Russian Direct Investment Fund (RDIF), a sovereign fund with a reserved capital of US$10 billion (R$53.8 billion), which financed the vaccine’s development and is coordinating export agreements, announced the name of the Gamaleya Institute’s immunizer for the foreign market. The vaccine, based on modified cold adenovirus, is now called Sputnik V, reminding the world of the Sputnik satellite that the Soviet Union orbited in 1957 during the Cold War, thus becoming the first country to do so and beating the United States in the space race.
In addition to Argentina, Mexico and Bolivia, Russia has distributed the vaccine to a dozen other countries, including Belarus, Serbia, Israel and the Arab Emirates, and has pre-agreements in place with others.
The Sputnik V ranks third worldwide in doses ordered by low- and middle-income countries, according to data from Duke University’s Global Health Innovation Center, ahead of vaccines that Russian authorities consider its main competitors: Pfizer/BioNTech and Moderna.
“The pandemic has only strengthened the distribution of power in the international system, with blocs such as the United States, Europe and China,” comments Stephan Sberro, professor at the Autonomous Technological Institute of Mexico. “But Russia was the big surprise.”
The Kremlin’s excitement over the vaccine, however, was met with reservations abroad, where criticism again emerged for the lack of transparency of its data and the speed with which it was registered for use. Among these concerns were those of American epidemiologist Anthony Fauci, who leads the U.S. anti-coronavirus strategy.
“I hope the Russians have definitely proved that the vaccine is safe and effective. I have serious doubts that they have done that,” he told ABC TV. Hugo Lopez-Gatell, the Mexican Tsar in the fight against the pandemic, was “surprised” the day the Sputnik V was presented. “You definitely can’t start using a vaccine that hasn’t satisfactorily completed Phase 3 trials, nor should you, for ethical reasons,” the undersecretary of Health pointed out.
In August and September, Mexico explored with the Russian Ambassador the possibility of clinical trials, but this was not accomplished. On September 9th, the Kremlin announced the signing of an agreement to send 32 million doses to Mexico. In fact, it involved a deal to distribute the vaccines along with Landsteiner Scientific, a private laboratory. “It has nothing to do with the Government of Mexico,” replied López-Gatell.
After a diplomatic effort spanning several months, the first 3,000 doses of Pfizer’s vaccine reached Mexico on December 23rd. “It’s an historic day,” celebrated Foreign Minister Marcelo Ebrard. As in countries like Spain, it was a “symbolic” delivery. One day later, Argentina received its first shipment: a batch of 300,000 doses of the Sputnik V.
In Russia, the main state networks released footage of the aircraft landing and boxes with the Russian vaccine logo being unloaded. Soon after, vaccination began, and Russia’s RDIF urged on social networks that people who had been immunized with the Russian vaccine to upload their pictures signaling the “V for victory”.
The fact that Argentina had received 100 times more doses than Mexico attracted the attention of Mexican President Andrés Manuel López Obrador, who began to wonder if the government had closed its doors to Moscow too soon.
Two weeks later, a Mexican delegation headed by López-Gatell left for Buenos Aires to learn about the Gamaleya Institute’s vaccine, an immunizer composed of two doses (the second should be administered 21 days after the first), with two distinct adenovirus vectors.
The Argentine capital as a destination was not by chance. In mid last year, while López-Gatell refused to open its doors to Moscow, Fernández’s admnistration had established negotiation channels with several manufacturers to acquire vaccines, among them, the Gamaleya Institute. The goal was to achieve large-scale shipments of “safe and effective” doses as soon as possible, says Cecilia Nicolini, advisor to the Argentine president. “As the institute is a small pharmaceutical that doesn’t have the impact of large pharmaceutical companies, we decided to go to Russia to get first-hand information,” she says.
Nicolini boarded on October 17th along with Carla Vizzotti, Health Access Secretary, bound for Russia. During this first trip, which lasted ten days, the two officials had access to Phase 3 data. After this visit, Fernández had a phone conversation with Vladimir Putin on November 5th to complete the purchase details.
Finally, on December 10th, the Argentine president announced that he had signed the third agreement to purchase vaccines, after an agreement with AstraZeneca and another with Covax – the initiative supported by the World Health Organization to ensure global access to vaccines against Covid-19.
With the Casa Rosada’s go-ahead, the Argentinean delegation again traveled to Russia on December 12th to gather, over two weeks, all the required information for the vaccine to be approved. “Much information was not available to our countries or our language,” says Nicolini, “because Gamaleya is a pharmaceutical company used to supplying the domestic market, complying with Russian laws.”
It was days of dozens of video calls and visits to Gamaleya Institute facilities and hundreds of pages of translations from Russian to Spanish. The President’s rush was added to the magnitude of the task – Fernández wanted the credit for starting vaccination before the end of the year.
On December 23rd, Argentina became the second country in the world to approve the Sputnik V, after Belarus. The Argentine Health Regulatory Agency issued a statement recommending its “emergency authorization” to citizens aged 18 to 60. A day later, the Argentine delegation returned from its second trip with the first shipment of 300,000 doses of the Russian vaccine, the first to reach Latin America.
This digital file with hundreds of pages that the Fernández government brought from Moscow and translated to present to the Argentine regulatory agency was the same that the Mexican delegation brought from its trip to Buenos Aires and then presented to the Mexican Health Regulatory Agency. “They had an interest, they wanted to have access to information,” says Nicolini, who was also part of the team that welcomed the Mexican anti-pandemic head.
The Argentine government then played the role of bridging Mexico and Russia. “We placed them in contact and in 24 hours we organized a call,” points out Fernández’s advisor.
At the time, Mexican government sources said that the shipment of 24 million doses to Mexico was agreed, a number that was officially announced after the telephone conversation between López Obrador and Putin on January 25th. It had been months since Mexico, with a population almost three times larger than Argentina, was a priority market for the Kremlin.
And Mexico was not the only one. The Argentine government provided the same documents to Bolivia, Uruguay and Peru. “That’s how Bolivia approved the Russian vaccine,” says Nicolini. The government of Bolivian President Luis Arce authorized the Russian vaccine on January 6th and received the first shipment with 20,000 doses last Thursday.
Fernandez’s boost to the Sputnik V also crossed political divides on the regional map, building bridges with Sebastian Piñera’s government in Chile and sharing the technical file with him on a presidential visit to Santiago last week. “The virus has no ideology, and neither does the cure,” Nicolini said.
In addition to the geopolitical move that the Sputnik V means for Russia, the vaccine also started the game in Latin America, where Fernández seeks to establish himself as one of the political leaders, along with López Obrador. “The relationship between Buenos Aires and Mexico City must be the backbone of the region,” adds the presidential advisor.
Last Friday, on his first public appearance after contracting Covid-19, López Obrador said he expected a first shipment of 200,000 doses of the Sputnik V for this first week of February.
The announcement of the agreement with the Kremlin was made before the vaccine was approved, the same pattern followed by countries like Argentina and Venezuela. According to epidemiologist Mauricio Rodríguez of the National Autonomous University of Mexico, the fact that Mexican regulators have been slow to grant authorization means that technical rather than political criteria are being enforced.
“It will be a gradual process, we cannot neglect the precautions against the disease with the arrival of a vaccine,” he says. After the data were published in The Lancet, Mexico’s regulatory agency approved the Sputnik V’s emergency use on Tuesday evening.
Amid a more political than scientific discussion, experts choose caution and state that there is no reason to suspect the vaccine’s efficacy and safety.
“The subject has been politicized, but we need to look at the hard data, and the results are good,” says Jorge Geffner, immunology specialist at the University of Buenos Aires. His laboratory performs, along with two others, the monitoring of antibodies produced by people already vaccinated in Argentina. “The preliminary results are similar to those of the Gamaleya Institute,” he says.
The mistrust that settled in Argentina regarding the main Russian immunizer led President Fernández to ask the population to seek vaccination with the Sputnik V. “Being vaccinated means being immune. Let’s do this,” he said on January 21st, after being administered the first Sputnik dose.
“Many politicians said ‘I will not be vaccinated with it, I’m not crazy,’ without knowing what it is,” says Argentine Daniela Hozbor, researcher at the National Council of Scientific and Technical Research (CONICET). “We can’t mistrust the regulatory agency unfounded,” she adds. “This is very detrimental, because it is playing with people’s lives.”
In Russia, criticism of the Sputnik V vaccine has been labelled russophobia. Last month, powerful Kremlin spokesman Dmitri Peskov said some countries and global pharmaceutical companies are using poorly reputed methods to undermine Russia’s leading immunizer.
“The competition here is being politicized, and they are resorting to dirty tricks to discredit the vaccine,” he said. Kirill Dmitriev, head of the Russian Direct Investment Fund, believes double standards are being used against Sputnik V for being Russian.
Ilya Yasni, head of scientific research at Inbio Ventures, a specialized Russian investment fund, says much of this skepticism towards the Gamaleya Institute’s vaccine is due to the fact that the registration and vaccination processes were begun without the disclosure of data, when only press releases were available.
“There is a worldwide mistrust of all vaccines because they were developed too quickly. But the pandemic and its threat called for exceptional deadlines,” points out the expert, who explains that, as a general rule, a vaccine takes at least four years to be developed – and that time frame is considered “fast”.
Yasni also says that while Pfizer, AstraZeneca and Moderna have mobilized to promote trust in vaccines with the release of articles and debates, this was a pending chapter for Sputnik V developers.
Some of the Russian volunteers who participated in the Gamaleya Institute’s vaccine trials organized themselves to share information and say how they felt in Facebook groups and Telegram messaging app, very popular in Russia. With this much information, if serious cases had occurred, they would have emerged on social networks at the very least, Yasni believes.
In fact, some analysts pointed out that, with all the data now available, their main doubts are about the Sputnik V’s efficacy and length of protection, rather than its safety. “We also have to look at it from another angle: we are facing a raging pandemic, people are dying. In some scenarios, it’s better to inject something rather than absolutely nothing,” Yasni says.
The vaccine has also raised concerns within Russia itself: in December, a survey by the Centro Levada showed that almost 60% of the Russian population does not want to be immunized. However, Denis Volkov, deputy director of this research center, the only independent one in the country, believes that this percentage is not only due to mistrust of the vaccine, but also to the lack of trust in the government and also to the fact that many Russians do not understand the gravity of the pandemic.
In this 145 million inhabitants country, the data on deaths from Covid-19 is not known for its transparency, and the true number of deaths is much higher than officially reported, as the government itself was forced to concede.
“Our Sputnik V is modest and reliable, like the Kalashnikov rifle,” said the famous state television host Dmitri Kiseliov, considered the Kremlin’s chief propagandist. In addition, the main Russian vaccine, which is not yet certified by the World Health Organization (on which many developing countries rely to bet on it), has certain advantages over its competitors, given its price and the logistics required for its distribution.
But it also stands out because its main clients have less negotiating power than wealthy or group countries, such as the European Union. Those responsible for the Sputnik V are in talks with the European Medicines Agency (EMA) to apply for its registration and use authorization in Europe – where Hungary has already given the go-ahead for the immunizer, amid criticism of Brussels for its slow pace in securing more vials, and has already bought two million doses from the Gamaleya.
The RDIF, the Russian fund that financed the vaccine, does not disclose how much it has invested in the immunizer. Nor does it publish the value of the contracts it signed, although it details that the price of the two doses amounts to less than US$20 (R$107), compared to the US$30 to US$40 (R$161 to R$214) cost for Pfizer and Moderna’s (made with a totally different method, of more recently approved); the vaccine developed by AstraZeneca in partnership with Oxford University is much cheaper.
Moreover, explains RDIF’s director Kirill Dmitriev, the Sputnik V storage requirements are also an advantage: the vials, which contain five doses each, must be stored at -18°C in their liquid form and last six months; whereas in their freeze-dried form, they must be stored at a temperature between 2ºC and 8°C, which eases their transport. Moderna’s must be transported at a temperature of -20ºC and Pfizer’s at -75ºC.
In early December, at the height of the second wave of the pandemic, Putin asked his team to expedite efforts to immunize the population. On December 5th, Moscow began its campaign to vaccinate risk groups: healthcare professionals, education and social services. On December 23rd, Gamaleya vaccine officials reported that, with the data available and taking into account that the campaign had already begun, they were ceasing to administer a placebo to volunteers taking part in their clinical trials, which had already exceeded 20,000.
The Gamaleya researchers themselves -in some cases, also their relatives- took part in these trials. Some high-ranking Russian officials and large entrepreneurs were immunized before the Sputnik V was available to risk groups. Since January 18th, the vaccine has been available to the entire population free of charge, and about 1.5 million people have been immunized, according to RDIF.
Now, one of the key challenges is to step up production. Russian authorities were forced to reduce the initial production estimate of 30 million doses by the end of 2020, because it was impossible to meet. Russia has six laboratories producing the Sputnik V, although vaccines for the foreign market are generally produced outside Russia – in South Korea, Kazakhstan and India, according to the RDIF. Moreover, Moscow is closing agreements with countries for their own production of the Sputnik V.
Fernández spoke with Putin on Tuesday about the supply in Argentina and the feasibility of the vaccine being produced in the South American country. But this is neither quick nor simple, says Ilya Yasni of Inbio Ventures, because it requires a “complex process of data transfer”.
Therefore, scientists who are also studying the combined use of the Sputnik V with the AstraZeneca vaccine are now working on a “light version” of the immunizer, which involve a single dose and would have a lower but “acceptable” efficacy, between 73% and 85%.
Source: El Pais