EMA Reviews Russia’s Sputnik V Vaccine

The European Medicines Agency (EMA) has begun a rolling review of the Sputnik V COVID-19 vaccine developed by Russia’s Gamaleya Research Institute, but the European Commission doesn’t appear in a rush to secure doses.

The European Commission, which has so far negotiated supply deals for up to 2.6 billion vaccine doses for the 446 inhabitants of the 27-member bloc, has so far not begun advance purchase discussions with the institute.

“Currently no talks are ongoing to integrate the Sputnik vaccine in the [EU’s vaccine] portfolio,” a commission spokesperson said yesterday.

The EMA’s human medicines committee said its decision to launch a review was supported by studies suggesting the adenovirus-based Sputnik V triggers the production of antibodies and immune cells that target the SARS-CoV-2 coronavirus and may help protect against COVID-19.

The agency said the rolling review will continue until it determines whether “the benefits outweigh the risks” and the data yield enough evidence to support an application for marketing authorization. Rolling reviews enable a faster review time because data are evaluated by regulators as soon as they become available, rather than waiting for a full application for approval is submitted.

Peer-reviewed interim results from a phase 3 trial showed Sputnik V was safe and demonstrated 91.6 percent efficacy against symptomatic COVID-19, based on data collected from 19,866 patients (DID, Feb. 3). The results, published in The Lancet early last month, correlated with findings previously released by Russian researchers.

Previously, the Russian government had received criticism for approving and distributing the Sputnik V vaccine before the phase 3 trial had concluded and adequate safety and efficacy data had been collected.

Sputnik V has been authorized for emergency use in Hungary and Slovakia and is being considered for approval in the Czech Republic, all three of which are EU member states. It is also authorized in several nonEU countries in Europe, including Serbia, Montenegro and Belarus.

Earlier this week, European Commission officials revealed they were considering an EU-wide emergency approval mechanism, instead of relying on the stricter conditional marketing authorization process, to accelerate the rollout of COVID-19 vaccines whose slow pace has frustrated member countries (DID, March 3). ― Jason Scott