Is European Medicines Agency (EMA) blocking out Russia’s Sputnik from access to European markets or are Russian agencies, or some group(s) out there, putting out misinformation? The 27-nation bloc represents a lucrative market for a vaccine candidate that has a 91.6% effectivity rate against symptomatic COVID-19 cases, according to the recent Lancet entry. Apparently, there are two different narratives emerging as to why there is a purported delay in rolling review of authorization (or not) in Europe. The EU has authorized the mRNA-based vaccines from Pfizer/BioNTech and Moderna as well as the Oxford-originate vaccine now under the care of AstraZeneca. Moreover, the EU now reviews the Johnson & Johnson application while initiating rolling reviews for two others, including U.S.-based Novavax and Germany-based CureVac. Apparently, there are conflicting narratives as to whether the vaccine candidate, led by the Russian sovereign wealth fund called Russia Direct Investment Fund (RDIF), has even submitted an application to EMA. While the Russians, or some group, purportedly declared the process commenced the EU recently issued a statement declaring that no regulatory process (either rolling review or market authorization application) has in fact started, they did acknowledge they have provided the vaccine’s developer scientific and regulatory guidance like many other groups.
According to a recent entry in South African Jacaranda FM, conflicting stories emerge as to whether the Russian Sputnik V, developed by the Gamaleya National Centre of Epidemiology and Microbiology in Russia and the Russian sovereign wealth fund RDIF, has submitted the vaccine candidate for either rolling review or market authorization. And a press release by the European Medicines Agency (EMA) recognizes that other sources are claiming that there differing positions as to status of the Russia vaccine in regards to Europe’s regulators.
Russian Vaccine Status
First, TrialSite and many scientific agencies, journalists, commentators and spokespersons in the West have been critical of how this vaccine was developed. Essentially accelerated in just a few months and subject to a Russian drug regulatory “registration” at near lightspeed in the world of drug and vaccine development, the declaration of registration of the Sputnik V product so early on in the drug development lifecycle raised more than just a few eyeballs. How could a drug be approved before Phase 3 trials even start? But the data does start looking interesting for a favorable Sputnik V situation.
It was later clarified that authorities in Russia deemed it an emergency use type of authorization and most recently a Lancet study revealed that the vaccine is 91.6% effective against COVID-19.
Moreover, the RDIF reports they have entered into deal after deal distributing the vaccine with to at last 30 countries—so clearly the interest in, and demand for the Sputnik V vaccine candidate intensifies. It should be noted that these countries typically are in the low to middle-income country (LMICs) category but nonetheless that so much interest in a vaccine product combined with such a high efficacy rating signals positive momentum.
While EMA has declared a rolling review hasn’t initiated, that’s not the story from the Russian side, which according to some sources, declared that it has as the RDIF declared Russian authorities actually “Filed a registration request” in January 2019. The RDIF declares it’s working with the EMA to initiate a rolling review.
European Medicines Agency (EMA) Position
According to an EMA declaration on Feb 10, 2021, the regulatory authority covering Europe hasn’t received any rolling review applications nor a marketing authorization request for the Sputnik V vaccine developed by the Gamaleya National Centre of Epidemiology and Microbiology in Russia (Gam-COVID-Vac), despite reports declaring the opposite.
EMA did elaborate that they sent the Russian developers scientific advice sharing with them relevant regulatory and scientific guidance for the development of the vaccine. In fact, they share that Sputnik V is one of many on the list of COVID-19 medicines and vaccines that have received scientific advance from this agency represents multiple countries.
Call to Action: TrialSite will monitor whether the EU’s EMA actually enters into any regulatory process concerning the Sputnik V vaccine candidate.