Russia’s 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, in southern Moscow.
Sergei Savostyanov | TASS | Getty Images
DUBAI, United Arab Emirates – Russian vaccine Sputnik V Covid-19 saw a number of improvements on Thursday as Hungary and the United Arab Emirates became the first countries in the European Union and the Gulf region to register the emergency shot.
Hungary’s decision was confirmed by President Viktor Orban’s spokesman, who said that if the country agrees to a shipping agreement with Moscow, it will be the first country in the European Union to receive the vaccine. This is because the country’s cases have fallen from a high of more than 6,000 a day in early December to below 2,000 a day.
“This decision is very important as it shows that over 90% of the vaccine’s safety and efficacy is valued by our partners in Hungary,” said Kirill Dmitriev, head of the Russian Direct Investment Fund, in a statement.
The EU drug regulator has not yet approved the Russian stab, although Chancellor Angela Merkel gave Sputnik further hope on Thursday, suggesting that the German vaccine regulator could advise Russia on steering the EU approval process. The RDIF has submitted Sputnik for EU registration and expects its review in February.
UAE approval comes amid a dramatic surge in infections
The UAE approval comes amid a record spike in cases in the little Gulf Sheikh, which excelled internationally by welcoming tourists and fully reopening its economy by late summer last year.
Confirmed coronavirus cases have more than tripled in about three weeks, prompting Emirati authorities to suspend unnecessary hospital surgery and “entertainment” activities in their busy hotels and restaurants just days after the country gave assurances that the virus was under Control was to fail.
The UAE’s daily number of cases hit a record high of 3,529 on Thursday, well above neighboring Gulf states, where registered infections are below 500 per day.
A man from the Emirates wearing a protective mask walks at al-Barsha Health Center in the Gulf of Dubai on December 24, 2020.
GIUSEPPE CACACE | AFP via Getty Images
Sputnik V will be the third vaccine to be used in the United Arab Emirates after China’s Sinopharm vaccine and the Pfizer BioNTech vaccine developed in the US and Germany were released to the public in December. The country of around 10 million people is running the second fastest national vaccination campaign in the world after Israel per capita, according to the government, and aims to vaccinate half of the country’s population by the end of March.
“The decision is part of the UAE’s comprehensive and integrated efforts to ensure a higher level of prevention,” the country’s health ministry said in a statement on Thursday about Sputnik’s approval. “The study results have demonstrated the vaccine’s effectiveness in eliciting a strong antibody response to the virus, its safety to use and its compliance with international safety and efficacy standards.”
Lack of late-stage experimental data
The approvals were granted despite the fact that no data on the results of the phase 3 human study of the vaccine have been published. The capital of the United Arab Emirates, Abu Dhabi, began phase 3 testing for Sputnik V earlier this month but has not released any data on it. 1,000 volunteers in the emirate have received their first dose, according to RDIF.
Sputnik V, which according to its developer, the Gamaleya Research Institute, is 91% effective after two doses, has been used across Russia for months. Scientists expressed concern about what many have described as the rush to launch the vaccine, which gave the green light for mass use in Russia ahead of the completion of Phase 3 trials.
As the first step in the largest vaccination campaign in Argentina’s history, first line health workers are receiving the Russian Sputnik V vaccine against the coronavirus.
Patricio Murphy | SOPA pictures | LightRocket | Getty Images
Analysis of the phase 1 and phase 2 studies of the vaccine was published in The Lancet in September, which found that the initial results did not show any significant negative side effects, but further studies were required.
“The results of the Phase III clinical trials are expected to be published shortly,” according to the official Sputnik V.
Prior to Thursday’s announcements, it had been approved for emergencies in 9 countries and territories outside of Russia – Algeria, Argentina, Bolivia, Belarus, Serbia, Venezuela, Paraguay, Turkmenistan and the Palestinian Territories.