The Russian Sputnik vaccine gets its first approval in the EU, UAE

A medical worker fills a syringe with the Gam-COVID-Vac vaccine (under the brand name Sputnik V) in Butovo, south of Moscow.

Sergei Savostyanov | TASS | Getty Images

DUBAI, United Arab Emirates – Russia’s Sputnik V Covid-19 vaccine received a series of boosts on Thursday as Hungary and the United Arab Emirates became the first countries in the European Union and the Gulf region to register the shot for emergencies.

Hungary’s decision was confirmed by President Viktor Orban’s spokesman, who said that if the country agrees with Moscow, it will become the first country in the European Union to receive the vaccine. This is because the country’s cases have fallen from a peak of over 6,000 a day in early December to below 2,000 a day.

“This decision is very important because it shows that the vaccine’s safety and efficacy of over 90% is highly valued by our partners in Hungary,” Kirill Dmitriev, head of the Russian Direct Investment Fund, said in a statement.

The EU’s drug regulator has yet to approve the Russian shot, though German Chancellor Angela Merkel Sputnik gave further hope on Thursday, suggesting that the German vaccination regulator could advise Russia on navigating the EU approval process. The RDIF has applied for Sputnik for EU registration and expects its review in February.

UAE approval comes amid a dramatic increase in infections

The UAE’s approval comes amid a record increase in the number of cases in the small Gulf sheikhdom, which stood out internationally for welcoming tourists and fully reopening its economy by late summer last year.

Confirmed cases of coronavirus have more than tripled in the space of about three weeks, putting UAE authorities in the bustling area just days after the country assured the virus was under control. hotels and restaurants stopped.

The UAE’s daily number of cases hit a record high of 3,529 on Thursday, well above the neighboring Arabian Gulf states, where recorded infections fluctuate below 500 per day.

An Emirates man wearing a protective mask walks to al-Barsha Health Center in the Gulf of Dubai emirate on December 24, 2020.

GIUSEPPE CACACE | AFP via Getty Images

Sputnik V will be the third vaccine deployed in the UAE after the Chinese Sinopharm vaccine and the Pfizer-BioNTech shot developed by the US and Germany were made available to the public in December. The country of about 10 million is running, according to the government, to be the second-fastest national vaccination campaign in the world, after Israel, per capita, and plans to release half of the country’s residents by the end of March. inoculate.

“The decision comes as part of the UAE’s comprehensive and integrated effort to ensure increased levels of prevention,” the country’s health ministry said of Sputnik’s approval in a statement Thursday. “Research results have demonstrated the effectiveness of the vaccine in eliciting a strong antibody response to the virus, its safety for use and compliance with international safety and effectiveness standards.”

A lack of data on the late phase of research

The approvals came despite detailed study data not yet published on the results of the Phase 3 human trials of the vaccine. The UAE’s capital, Abu Dhabi, began Phase 3 testing for Sputnik V earlier this month, but has not released any data on this. The RDIF says 1,000 volunteers in the emirate received their first dose.

Sputnik V, whose developer, the Gamaleya Research Institute, says is 91% effective after two doses, has been used all over Russia for months. Scientists have raised concerns about what many have described as a hasty introduction of the vaccine, which gave the green light for mass use in Russia before phase 3 studies were completed.

As the first step in Argentina’s largest vaccination campaign in history, primary health workers are getting Russia’s Sputnik V vaccine against coronavirus.

Patricio Murphy | SOPA images | LightRocket | Getty Images

Analysis of the Phase 1 and 2 trials of the vaccine was published in September in the peer-reviewed medical journal The Lancet, which said early results showed no major negative side effects, but more studies were needed.

“Results from Phase III clinical studies are expected to be published shortly,” said Sputnik V’s official website.

Prior to Thursday’s announcements, it had been approved for emergency use in 9 countries and territories outside of Russia – Algeria, Argentina, Bolivia, Belarus, Serbia, Venezuela, Paraguay, Turkmenistan, and the Palestinian Territories.

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