The Russian Sputnik vaccine gets its 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, 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 respectively to register the shot for emergency use. .

Hungary’s decision was confirmed by President Viktor Orban’s spokesman, who said that if the country agreed to a shipping deal with Moscow, it would become the first EU country to receive the vaccine. This is because the country’s cases have fallen from a peak of more than 6000 per day in early December to below 2000 per day.

“This decision is very important because it demonstrates that the safety and efficacy of the vaccine 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 medicine regulator has yet to approve the Russian slap, although German Chancellor Angela Merkel on Thursday gave Sputnik further hope, suggesting that the German vaccine regulator could advise Russia on the EU approval process. The RDIF has submitted Sputnik for EU registration and expects it to be reviewed in February.

UAE approval comes amid dramatic increase in infections

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

Confirmed cases of coronavirus more than tripled within three weeks, prompting the Emirate authorities to suspend unnecessary operations in hospitals and “entertainment activities” in its hotels and restaurants a few days after reassuring the country that the virus had spread. is under control.

The United Arab Emirates’ daily number of cases reached a record high of 3,529 on Thursday, well above its neighbors in the Arabian Gulf, where registered infections are below 500 per day.

An Emirati man, wearing a protective mask, is walking on December 24, 2020 at the Al-Barsha Health Center in the Gulf Emirates of Dubai.

GIUSEPPE CACACE | AFP via Getty Images

Sputnik V will be the third vaccine to be deployed in the United Arab Emirates after China’s Synopharm vaccine and the US and German-developed Pfizer BioNTech jab were made available to the public in December. According to his government, the country of about 10 million is carrying out the second fastest national vaccination campaign in the world to Israel, per capita, and wants to have half of the country’s inhabitants vaccinated by the end of March.

“The decision comes as part of the United Arab Emirates’ comprehensive and integrated efforts to ensure increased levels of prevention,” the country’s health ministry said on Thursday about Sputnik’s approval. “Study results have shown that the vaccine is effective in eliciting a strong antibody response to the virus, that it is safe to use, and that it meets international standards for safety and efficacy.”

Lack of late-stage trial data

The approvals come despite detailed research data not yet published on the Phase 3 human test results of the vaccine. Abu Dhabi, the capital of the United Arab Emirates, started Phase 3 tests for Sputnik V earlier this month, but did not release information about it. The RDIF says that 1,000 volunteers in the emirate received their first dose.

Sputnik V, which according to its developer, the Gamaleya Research Institute, is 91% effective after two doses, has been used in Russia for months. Scientists have expressed concern about what many described as a hasty explosion of the vaccine, green light for mass use in Russia before Phase 3 trials were completed.

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

Patricio Murphy | SOPA Images | LightRocket | Getty Images

Analysis of Phase 1 and 2 trials of the vaccine was published in September in peer-reviewed medical journal The Lancet, which says that early results show no serious adverse side effects, but that more studies are needed.

“Phase III clinical trials are expected to be published soon, according to the official Sputnik V website.

Prior to Thursday’s announcements, it was 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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