Manama : Bahrain has authorised Russia’s Sputnik V COVID-19 vaccine for emergency use, official news agency BNA said on Wednesday.
The National Health Regulatory Authority (NHRA) of the Kingdom stated that the decision to authorise the Sputnik V vaccine was based on data provided by the manufacturing company and results of an expanded study.
The authority assessed and evaluated the safety of the vaccine demonstrated by clinical trials and studies. It also verified the quality of the vaccine by reviewing scientific data showing the quality of manufacturing and the stability of the product.
The Ministry of Health will start the import procedures according to current standards and requirements based on the approval, NHRA said.
Sputnik V is the fourth COVID-19 vaccine to be approved for emergency use in Bahrain, following Sinopharm, Pfizer/BioNTech, and Oxford-AstraZeneca Covid-19 vaccines. Bahrain has been providing vaccines free of charge to citizen and residents aged 18 years and above with an option to choose which vaccine they wish to receive.
The Sputnik V is a human adenovirus-based vaccine developed by the Russian Ministry of Health’s Gamaleya National Research Institute of Epidemiology and Microbiology.
Sputnik V vaccine had received regulatory approval for foreign markets on Aug. 11, 2020.
Bahrain is the 24th country to have registered Sputnik V.
The vaccine was approved under the emergency use authorization procedure without additional clinical trials in the country, the Russian Direct Investment Fund (RDIF) said in a press release.
“The positive decision by NHRA will pave the way for protecting the population with a safe and effective Sputnik V vaccine. Joining efforts is the key to overcoming the pandemic and we will help our partners by supplying one of the best vaccines against coronavirus in the world,” said RDIF CEO Kirill Dmitriev.
Russia named the vaccine Sputnik V after the world's first satellite, called Sputnik, launched by the Soviet Union on Oct. 4, 1957. The name signifies the country's success in being the first to have a vaccine approved.
The latest approval comes as the country witnessed a spike in new cases. Bahrain reported 797 new cases on Wednesday with four fatalities. The country so far has registered a total of 1,09,604 virus cases and 391 related deaths.