Russia’s Sputnik vaccine receives first approval in the EU, the UAE

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

Sergei Savostyanov | TASS | Getty Images

DUBAI, UAE – Russia’s Sputnik V Covid-19 vaccine gained momentum on Thursday as Hungary and the United Arab Emirates became the first countries in the European Union and the Gulf region to shoot for emergency use, respectively. .

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

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

The EU drug regulator has not yet approved the Russian jab, although German Chancellor Angela Merkel on Thursday gave Sputnik hope, suggesting that the German vaccine regulator could advise Russia on the EU approval process. RDIF has submitted Sputnik for registration in the EU and is awaiting its review in February.

UAE approval comes amid dramatic increases in infections

The approval in the United Arab Emirates comes amid a record increase in cases in the small Gulf sheikh, which has stood out internationally for welcoming tourists and completely reopening its economy by the end of last summer.

Confirmed coronavirus cases have tripled in about three weeks, prompting emirates to suspend non-essential hospital surgeries and “entertainment activities” in its lively hotels and restaurants just days after securing the country. that the virus was under control.

The UAE’s daily number of cases reached a record 3,529 on Thursday, well above its neighboring countries in the Arabian Gulf, where registered infections are below 500 a day.

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

GIUSEPPE CACACE | AFP through Getty Images

Sputnik V will be the third vaccine to be implemented in the United Arab Emirates after the Sinopharm vaccine in China and the Pfizer-BioNTech vaccine developed by the US and Germany were made available to the public in December. The country of about 10 million is carrying out what its government says is the second fastest national vaccination campaign in the world after Israel, per capita, and plans to have inoculated half of the country’s population by the end of March.

“The decision comes as part of the UAE’s comprehensive and integrated efforts to ensure increased levels of prevention,” his country’s health ministry said on Thursday about Sputnik’s approval. The results of the study demonstrated the effectiveness of the vaccine in triggering a strong response to antibodies against the virus, its safety for use and its compliance with international safety and efficacy standards.

Lack of late test data

The approvals came despite detailed research data, which have not yet been published in the results of the phase 3 human vaccine studies. Abu Dhabi, the capital of the United Arab Emirates, began phase 3 testing for Sputnik V earlier this month, but has not released any data on it. RDIF says 1,000 volunteers from the emirate received the first dose.

Sputnik V, which its developer, Gamaleya Research Institute, says is 91% effective after two doses, has been in use in Russia for months. Scientists have expressed concern about what many have described as a hasty release of the green-lighted vaccine for mass use in Russia before the completion of phase 3 studies.

As a first step in the largest vaccination campaign in Argentina’s history, front-line health workers receive the Russian Sputnik V vaccine against coronavirus.

Patricio Murphy | Images SOUP | LightRocket | Getty Images

The analysis of the phase 1 and 2 studies of the vaccine were published in the medical journal reviewed by colleagues The Lancet in September, which said that the early results did not show major negative side effects, but that more studies are needed.

“The results of the phase III clinical trials are expected to be published shortly,” according to the official website of Sputnik V.

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

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