EMA starts rolling review of Sputnik V
EMA starts rolling review of Sputnik V
Moscow, March 4, 2021 – The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) announces the start of a rolling review procedure of Sputnik V vaccine against coronavirus by European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
The CHMP’s decision to start the rolling review is based on results from laboratory studies and clinical studies in adults. EMA will assess Sputnik V’s compliance with the usual EU standards for effectiveness, safety and quality.
A number of EU member states have made individual decisions to register Sputnik V without EMA approval. The vaccine is currently approved for use in Hungary and Slovakia.
The Gamaleya National Center and RDIF cooperate with national regulatory authorities around the world and provide comprehensive data on Sputnik V clinical trials. It is one of the world's top three coronavirus vaccines in terms of the number of approvals issued by government regulators. To date 42 countries with total population of more than 1.1 billion people have authorized the use of Sputnik V.
On February 2, 2021 The Lancet, one of the world's oldest and most respected medical journals, published interim results of a Phase III clinical trial of Sputnik V, confirming the vaccine’s high efficacy of 91.6% and safety. Sputnik V provides full protection against severe cases of COVID-19.
Sputnik V, which is based on a well-studied human adenoviral vectors platform, is the world’s first registered vaccine against coronavirus. The vaccine has been approved in Russia, Belarus, Argentina, Bolivia, Serbia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, UAE, Iran, Republic of Guinea, Tunisia, Armenia, Mexico, Nicaragua, Republika Srpska (entity of Bosnia and Herzegovina), Lebanon, Myanmar, Pakistan, Mongolia, Bahrain, Montenegro, Saint Vincent and the Grenadines, Kazakhstan, Uzbekistan, Gabon, San-Marino, Ghana, Syria, Kyrgyzstan, Guyana, Egypt, Honduras, Guatemala, Moldova, Slovakia, Angola, Republic of Congo and Djibouti.
Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said:
“We welcome the start of the rolling review procedure by EMA of Sputnik V. We have provided EMA with comprehensive data on the Russian vaccine, which is now approved for use in more than 40 countries. Sputnik V can make an important contribution to saving millions of lives in Europe and we are looking forward to a thorough review of data by CHMP. Vaccine partnerships should be above politics and cooperation with EMA is a perfect example demonstrating that pooling efforts is the only way to end the pandemic. Following EMA approval, we would be able to provide vaccine for 50 million Europeans starting from June 2021.”
Sputnik V has a number of key advantages:
· Efficacy of Sputnik V is 91.6% as confirmed by the data published in the Lancet, one of the world's oldest and most respected medical journals; it is one of only three vaccines in the world with efficacy of over 90%; Sputnik V provides full protection against severe cases of COVID-19.
· The Sputnik V vaccine is based on a proven and well-studied platform of human adenoviral vectors, which cause the common cold and have been around for thousands of years.
· Sputnik V uses two different vectors for the two shots in a course of vaccination, providing immunity with a longer duration than vaccines using the same delivery mechanism for both shots.
· The safety, efficacy and lack of negative long-term effects of adenoviral vaccines have been proven by more than 250 clinical studies over two decades.
· The developers of the Sputnik V vaccine are working collaboratively with AstraZeneca on a joint clinical trial to improve the efficacy of AstraZeneca vaccine.
· There are no strong allergies caused by Sputnik V.
· The storage temperature of Sputnik V at +2+8 C means it can be stored in a conventional refrigerator without any need to invest in additional cold-chain infrastructure.
· The price of Sputnik V is less than $10 per shot, making it affordable around the world.