Many countries’ regulators were unwilling to give Sputnik V fast track approval.
Photographer: Andrey Rudakov / Bloomberg
Photographer: Andrey Rudakov / Bloomberg
Russia has accused the West of vilifying its performance in the global race to defeat Covid-19, as efforts to capture key markets for its Sputnik V vaccine run counter to regulators’ demands.
“We understand the game,” Kirill Dmitriev, chief executive officer of the Russian Direct Investment Fund, which supported Sputnik V’s development and is negotiating its international rollout, said in an interview. “It’s a combination of some misunderstanding, a strong bias and, really, some very strong attempts to undermine the Russian vaccine.”
Like neighboring China, that is While Russia struggles to reassure countries testing its vaccines, Russia’s drive to turn what it calls a scientific triumph into geopolitical dividends has met unexpected headwinds.
President Vladimir Putin has been pushing the vaccination in talks with other world leaders since praising Russia’s approval of Sputnik V as the world’s first Covid-19 vaccine in August. But the regulators of many countries have been unwilling to give Sputnik V accelerated approval – even though they welcome American and European vaccines that have completed extensive trials for the first time.
Photographer: Andrey Rudakov / Bloomberg
The contest for entry carries echoes of the Cold War space race triggered by the launch of the world’s first satellite, Sputnik, in 1957 by the Soviet Union, after which the Russian vaccine is named. While Moscow was first in space, it was overtaken by the US who landed a man on the moon 12 years later.
Russian officials blame Sputnik’s difficulties on bias. The State Department recently described the vaccination race as the final stage in a protracted disinformation “war” against Russia.
Regulators who have asked for more data say they are just trying to ensure that Sputnik V, who Russia approved weeks before the phase 3 trials to show safety and effectiveness began, is as good as his backers. .
Recording is slow. It wasn’t until December 21 that neighboring Belarus became the first country outside of Russia to adopt Sputnik V, and Argentina followed suit two days later. Argentina began vaccinations on Tuesday with about 300,000 people expected to receive the Russian shot initially, and Belarus began its program the same day.
An employee receives the Sputnik V vaccine at Isidoro Iriarte Hospital in Quilmes, Argentina on Dec. 29.
Photographer: Marcos Brindicci / Getty Images
But India, Brazil and other major markets are not expected to sign until next year, after more trials have been conducted.
“Russia is using its vaccine program for soft power diplomacy,” said John Moore, a vaccine researcher at Weill Cornell Medical College in New York. “It’s an international race, nationalism is at stake. But it all depends on whether the vaccines are effective and safe. “
The Russian vaccine got a boost earlier in December when AstraZeneca PLC agreed to test a combination of his vaccination with one of the two shots that make up Sputnik V. Putin took part in the video conference announcing the signing of the deal live on national television.
Still, the 68-year-old leader said on Dec. 17 that he was waiting to get the vaccine until it was approved for people his age.
Putin’s comments confused Argentine officials, who planned to launch their campaign against the elderly. His spokesman said this week that the president was now ready to be vaccinated after research expanded the age range for safe use of Sputnik V.
Critics say Russia’s decision to approve the vaccine so quickly, before the developers published scientific data and after only limited trials, undermined confidence. Western officials, including US Secretary of State Mike Pompeo, have described that move as premature, publicly questioning Sputnik’s security.
A health worker gets the Sputnik V vaccine from a bottle in Moscow.
Photographer: Andrey Rudakov / Bloomberg
Russian officials dismiss those attacks as unfair competition, even if polls show that many of Russia’s own citizens are skeptical about the safety of available vaccines.
The Russian drug is gaining access to some markets. Guinea became the first African nation to start this week to hand out Sputnik V, and Bolivian President Luis Arce signed one contract on Wednesday to purchase 5.2 million doses, with the first 6,000 expected in January.
Serbia received its first batch of 2,400 Sputnik V shots and will start using them in days, pending approval by the national drug regulator, Deputy Health Minister Mirsad Djerlek said Wednesday.
While Dmitriev was cheerful in a September interview with India TV, his hopes for an immediate warm reception from regulators in other countries did not materialize.
‘Absolutely Confident’
“We are confident that it will receive approval in a number of markets around the world as early as November,” he said, arguing that Sputnik is “better, much safer” than Western vaccines using other technologies.
Sputnik V uses a platform based on the adenovirus, which causes the common cold, and has been studied in vaccine development for decades, although its effectiveness has yet to be proven. AstroZeneca is similar, while drugs developed by Moderna and Pfizer and BioNTech rely on a new technology, which uses genetic instructions in a nucleic acid molecule called mRNA to program a person’s cells to make the viral protein themselves, triggering an immune response. is activated.
A health worker injects Sputnik V vaccine into the arm of a patient in Moscow on Dec.5.
Photographer: Andrey Rudakov / Bloomberg
Russian officials are downplaying the setbacks by saying they already have orders for 1.2 billion doses and plan to produce 500 million in different countries next year, while predicting that other vaccine makers will struggle to meet expected demand .
“We are targeting regulators in Asia, the Middle East, Africa and Latin America, where political sentiment is more balanced,” said Dmitriev. He added that some are expected to follow Argentina and approve Sputnik V based on the Russian trials in January and February, with Venezuela first in line. “People will understand that in 2021 and maybe 2022 there will be a major shortage of vaccines,” he said.
In India, hopes for a swift regulatory approval for Sputnik V in October were dashed after authorities demanded more extensive investigations than local partners had proposed. RDIF said it hopes to apply for emergency approval in late January, but its Indian partner said the green light is unlikely to happen until the second quarter of 2021.
It’s a similar story in Brazil, where Russia’s plan to start supplies in November failed to materialize. Anvisa’s regulator said on Tuesday that it had received an application for Phase 3 studies of Sputnik V.
A month after announcing a manufacturing and distribution deal with a Beijing company, Dmitriev said that RDIF will not sell the Sputnik V in China, but will instead export the millions of doses it plans to make there, too. Russia.
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Hungary is a member of the European Union 6,000 doses, although the regulator has not yet approved the drug for use.
While Russia may have damaged its credibility by running ahead, it will find markets for Sputnik V if it “can demonstrate that the vaccine works and is reliable,” said Anthony McDonnell, a former UK government health adviser who is now a senior policy analyst at the Washington DC-based center for global development.
– Assisted by Julia Leite, Chris Kay, Andreo Calonzo, Simone Preissler Iglesias, Dong Lyu, Jorgelina Do Rosario and Gina Turner
(Updates with countries getting Sputnik V in the 16th, 17th paragraphs)