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, southern Moscow.

Sergei Savostyanov | TASS | Getty Images

DUBAI, United Arab Emirates – The Russian vaccine Sputnik V Covid-19 had a series of increases on Thursday, when Hungary and the United Arab Emirates became the first countries in the European Union and the Gulf region, respectively, to register the injection for emergency use.

Hungary’s decision was confirmed by President Viktor Orban’s spokesman, who said that if the country reaches a shipment agreement with Moscow, it will become the first European Union country to receive the vaccine. This is because the country’s cases dropped from a peak of more than 6,000 a day in early December to less than 2,000 a day.

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

The EU drug regulator has yet to approve the Russian vaccine, although German Chancellor Angela Merkel gave Sputnik more hope on Thursday, suggesting that Germany’s vaccine regulator could advise Russia on how to navigate the process of EU approval. RDIF has applied for Sputnik’s registration in the EU and expects its review in February.

UAE approval comes amid dramatic increase in infections

The approval of the United Arab Emirates comes amid a record increase in cases in the small kingdom of the Gulf, which stood out internationally for receiving tourists and completely reopening its economy in late summer last year.

Confirmed cases of coronavirus have more than tripled in a period of about three weeks, prompting UAE officials to stop unnecessary hospital surgery and “entertainment activities” at their busy hotels and restaurants just days after assuring the country that the virus was under control.

The UAE’s daily case count reached a record 3,529 on Thursday, far above neighboring countries in the Arab Gulf, where reported infections are below 500 a day.

A man from the Emirates, wearing a protective mask, walks at the al-Barsha Health Center in the Emirate of the Gulf of Dubai on December 24, 2020.

GIUSEPPE CACACE | AFP via Getty Images

Sputnik V will be the third vaccine to be implanted in the United Arab Emirates after the Sinopharm vaccine from China and the Pfizer-BioNTech jab developed in the United States 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 aims to have half of the country’s residents vaccinated by the end of March.

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

Lack of final stage test data

The approvals came despite detailed yet unpublished research data on the results of human phase 3 vaccine tests. The capital of the United Arab Emirates, Abu Dhabi, began Phase 3 testing for Sputnik V earlier this month, but has not released data on them. RDIF says 1,000 volunteers in the emirate received their first dose.

Sputnik V, which its developer, the Gamaleya Research Institute, claims is 91% effective after two doses, has been in use in Russia for months. The scientists expressed concern about what many described as a speedy launch of the vaccine, with the green light for mass use in Russia before Phase 3 trials were completed.

As a first step in the largest vaccination campaign in Argentine history, top health care professionals are receiving the Russian Sputnik V vaccine against coronavirus.

Patricio Murphy | SOPA images | LightRocket | Getty Images

The analysis of the Phase 1 and 2 tests of the vaccine was published in the medical journal The Lancet, peer-reviewed in September, which said that the first results showed no significant negative side effects, but that further studies were needed.

“The results of phase III clinical trials are due to be published soon,” 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 Palestinian territories.

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