The European Medicines Agency starts rolling review of Russia’s Sputnik V coronavirus vaccine

The European Medicines Agency starts rolling review of Russia’s Sputnik V coronavirus vaccine
The EMA has now received all the formal documentation to review the Sputnik V vaccine. / wiki
By Ben Aris in Belrin March 4, 2021

The European Medicines Agency has started a rolling review of Russia’s Sputnik V coronavirus (COVID-19) vaccine, the Russian Direct Investment Fund (RDIF) said in a press release on March 4.

After being widely derided last year after the Russian authorities rushed through its registration before trials were complete, sentiment towards Russia’s first vaccine has improved enormously, especially after a peer-reviewed paper in leading British medical journal The Lancet cleared it as safe and effective at the start of February.

In addition to its high efficacy rates of around 95%, the Russian vaccine is easier to transport, as it doesn't need to be kept at very low temperatures.

Europe is short of vaccinations, especially in Germany where bureaucratic public procurement rules ended up with the country failing to order enough doses to meet demand. According to local German reports, the country may not reach the 70% inoculation threshold that gives the population “herd immunity” until as late as November 2022.

In an effort to shorten the wait, Europe started the process of certifying Sputnik V in the middle of January and after Russia finally sent the full documentation required, it is expected to be approved for use in Europe in the near future.

Only a third of Russians are certainly ready to vaccinate against the coronavirus (COVID-19), while 44% are generally in favour of vaccination and 43% against, Vedomosti daily reported citing a survey in December.

The RDIF announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has started a rolling review procedure of Sputnik V vaccine against coronavirus.

The CHMP’s decision to start the rolling review is based on results from laboratory studies and clinical studies in adults, the RDIF reports. 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, including Hungary and most recently, Slovakia, where the health minister defied the government and ordered the vaccine. Other EU nations such as Estonia and Czechia say they will buy the vaccine as soon as the EMA certifies it or possibly earlier. Belarus and Turkey both have accepted the vaccine and are launching local production to serve their own markets. Many of the other Commonwealth of Independent States (CIS) countries have also turned to Russia to procure the vaccine, as they are largely cut off from Western manufacturers who have concentrated on selling to the rich countries in the West.

Ukraine has banned purchases of Sputnik V on political grounds. Instead, Ukraine is sourcing its vaccine from India and China. Ukrainian President Volodymyr Zelenskiy was inoculated at the weekend during a visit to the front line in the war-ravaged Donbas, where the first doses are being given to soldiers fighting against the Russian-backed rebels.

All in all, over 25 countries have ordered the Sputnik V vaccine but Russia is facing production bottlenecks and so has actively been seeking production partners to set up local production under licence in countries such as Belarus and Turkey. The RDIF says it has helped these projects with the transfer of technology and also with financing.

“[The inventor of the Sputnik V vaccine] the Gamaleya National Center and RDIF co-operate with national regulatory authorities around the world and provide comprehensive data on Sputnik V clinical trials,” the RDIF said in its statement. “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 1.1bn people have authorised the use of Sputnik V.”

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, according to the RDIF.

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 co-operation 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 50mn Europeans starting from June 2021.”

The epidemic in Russia is already in retreat after a large number of Russians were infected and already have anti-bodies – Moscow Mayor Sergey Sobyanin says half of the Moscow population has been infected – and the state was the first in the world to roll out its mass vaccination programme in December.

Russia recorded less than 100,000 new weekly coronavirus cases in the last week of February for the first time since October. While the situation is improving the pandemic is not over, but the spread of the virus is slowing rapidly.

Nevertheless, Russia has reported one of the highest death tolls in the world: there were 162,429 coronavirus (COVID-19) related deaths in 2020, according to the latest data from RosStat statistics agency, making a figure three times as high as the previously announced official tally.

So far it is believed that Russian President Vladimir Putin has not been vaccinated, although one of his two daughters participated in the trials at a very early stage. Observers have been surprised that Putin has refused the vaccination, leading to speculation that he suffers from some health condition that has not been shared with the public.

In the meantime Russia has developed two more vaccines. The most recent is CoviVac that has also been approved by the government before trials are completed, and building of production facilities is already underway, Prime Minister Mikhail Mishustin said on state TV last week.

The CoviVac vaccine has attracted a lot of interest, as unlike Sputnik V that uses a common cold virus with swapped out DNA from the coronavirus as a vector, the CoviVac uses actual coronavirus, but with its ability to replicate turned off. As a result it is expected that CoviVac will be more effective against mutant strains of the coronavirus.

The RDIF also listed the other various advantages that Sputnik V enjoys:

•       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 proved 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 the AstraZeneca vaccine.

•       There are no strong allergies caused by Sputnik V.

•       The storage temperature of Sputnik V at +2 to +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.