Russia and WHO disagree on approval date for Sputnik V

MOSCOW (AP) – Russia is ready to provide up to 300 million doses of its Sputnik V vaccine to the UN-backed COVAX initiative, a senior Russian official promoting the vaccine has said, even though the World Health Organization has yet to approve IT and production issues have fueled the concerns of customers around the world.

Russian Direct Investment Fund CEO Kirill Dmitriev and the World Health Organization had very different opinions on Wednesday on when the Russian vaccine would get the WHO seal of approval.

Sputnik V has been cleared for use in 70 countries around the world although it has not yet been approved by the United Nations health agency, even for emergency use. Some countries, especially in Latin America, have recently expressed concern that they will not receive the second injection of the vaccine in time to properly inoculate their populations against COVID-19.

Dmitriev told The Associated Press that the Russian vaccine will be made available to COVAX, the UN-backed program designed to share vaccines more equitably around the world, once the vaccine is approved by the WHO. He said he expects WHO approval to come within the next two months. The COVAX program cannot use a vaccine that is not approved by the WHO.

“We think we can provide COVAX with around 200 million doses per year, 200 to 300 million,” Dmitriev said in an interview. “We just need WHO approval to work with COVAX.”

But Dr Mariangela Simao, WHO deputy director general for access to health products, would not make any commitment on this timetable. She said the approval process for Sputnik V is currently on hold, and once legal procedures are settled, “we will reopen the assessment, which includes submitting data on file – it’s still incomplete – and resumption of inspections at the sites in Russia.

“The timing will depend on when we complete these legal procedures and then we can assess, with the claimant and the manufacturer, what the next step would be and how long it will take,” Simao said at a briefing in Geneva. “So we don’t know yet. “

Dmitriev’s comments came even as Russia has faced delays in delivering contracted amounts of Sputnik V to Latin American countries and faces a rise in record daily virus infections and deaths at home in the country. midpoint of a slow vaccination rate.

Dmitriev, however, insisted that Sputnik’s expeditions to Latin American countries are back on track.

“All of these issues have been fully resolved,” Dmitriev told the AP. “All issues with the second component are resolved in all countries.”

Despite his assurances, countries like Argentina and Venezuela have said they are still waiting for promised vaccine deliveries.

Dmitriev argued that “there is not a single vaccine manufacturer in the world who has not had problems with vaccine delivery.” including Russian factories manufacturing Sputnik V.

He claimed that by the end of the year there will be the capacity to produce 700 million doses of Sputnik V and its unique version, Sputnik Light. He said 50% of production will come from overseas through partnerships with more than 20 manufacturers in more than 10 countries.

Dmitriev said a new study by the developer of the vaccine shows that Sputnik Light, a unique version of Sputnik V, was 70% effective against infection with the delta variant of the coronavirus in the first three months after vaccination. . But the study he cited was not made available and was not reviewed by outside experts, so it is not possible to verify the results. Dmitriev’s fund said the study has been submitted for possible publication online.

Dmitriev noted that Russia has a three-month vaccine stock, which now allows it to boost exports, and praised the reported effectiveness of Sputnik V and the lack of side effects.

The European Medicines Agency’s fast-track approval for Sputnik V began in March. EMA experts visited some of Sputnik V’s manufacturing sites earlier this year and the agency said more visits may be needed based on the additional data submitted.

EMA vaccine strategy chief Marco Cavaleri said last month the agency was still awaiting outstanding data from Russia. He noted that the timing of a decision was “uncertain”, but estimated that the EMA could make a decision on Sputnik V by the end of the year.

Russia, meanwhile, reported another record for daily coronavirus deaths amid a slow vaccination rate and authorities’ reluctance to tighten restrictions to stem the spread of the virus.

The government coronavirus task force has reported 984 coronavirus deaths in the past 24 hours, the new pandemic record. Russia has repeatedly seen a record daily death toll in recent weeks as infections hit near historic levels, with 28,717 new cases reported on Wednesday.

The Kremlin attributed the growing contagion and deaths to a lagging vaccination rate. Prime Minister Mikhail Mishoustine said on Tuesday that around 43 million Russians, or 29% of the country’s nearly 146 million people, were fully vaccinated. Experts say vaccine skepticism and misinformation is rife in Russia.

Dmitriev attributed the low vaccination rate to Russians largely underestimating the danger of COVID-19, which is already straining hospitals in some areas.

“Russia has been a bit of a victim of its own success, because from the start it was very successful in tackling COVID,” Dmitriev said. “A lot of people basically assumed COVID was already defeated, but then the delta variant came along and that’s a big challenge.”

Russian President Vladimir Putin stressed the need to speed up the vaccination rate, but he also warned against forcing people to get vaccinated. The Kremlin has also ruled out a new nationwide lockdown like that of the first months of the pandemic, which severely crippled the economy and rattled Putin’s ratings.

Some regions of Russia have restricted attendance at major public events and limited access to theaters, restaurants and other venues. But life remains largely normal in Moscow, St. Petersburg and many other Russian cities.

Overall, the Russian Coronavirus Task Force has confirmed 219,329 deaths – the highest death toll in Europe. The national statistics agency Rosstat, which also counts deaths for which the virus was not considered the main cause, reported a much higher toll – around 418,000 deaths of people with COVID-19.

These two figures place Russia among the five countries hardest hit by the pandemic, along with the United States, Brazil, India and Mexico.


Jamey Keaten in Geneva and AP Medical Writer Maria Cheng in London contributed.


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