Russia Denies Pause in COVID-19 Vaccine Trial

Russia’s Gamaleya Research Institute has reportedly resumed dosing in a phase 3 trial evaluating its COVID-19 vaccine, Sputnik V., but a Russian government spokesperson denies that the study was ever paused.

Six of the 29 trial clinics reportedly had paused enrolling new volunteers, with some reports from October indicating enrollment had been stopped due to supply shortages.

However, a spokesperson for the Russian Direct Investment Fund (RDIF), the Russian government entity funding the global trial, told FDAnews those statements are inaccurate.

“Clinical trials never stopped … More than 19,000 participants have received both shots to date, there is no shortage of doses,” the spokesperson said. Instead, the RDIF attributes the slowdown to attempts “to narrow the gap” between dosing of the first and second shots of the vaccine regimen, which must be taken within 21 days of each other. The spokesperson went on to say more data on the trial would be available “in a matter of weeks” or possibly sooner.

Last week, the Gamaleya Research Institute claimed the Sputnik V vaccine showed a 92 percent efficacy rate from 20 confirmed COVID-19 cases (DID, Nov. 12). The vaccine, which was approved for emergency use in Russia, has been given to frontline healthcare professionals and some individuals “outside medical circles,” according to the RDIF.

The institute launched its global phase 3 study in September, enrolling participants in Belarus, the United Arab Emirates and Venezuela. An arm of the trial in Brazil is slated to begin soon while another in India is under way. The Russian government has already announced distribution deals with India, China, South Korea and Brazil.

Russia is also reported to be exploring a deal with Hungary, a move that could upset the EU’s evaluation of vaccines as Hungary is an EU member state. As things stand, the Hungarian government “has not [informed] the commission of its intention to purchase vaccines from Russia,” a European Commission spokesperson told FDAnews.

The spokesperson cautioned that the “best way to guarantee the safety” of the Sputnik V vaccine is to have the European Medicines Agency (EMA) review all available data so it can provide, if applicable, marketing authorization to member states. However, the EMA has yet to see any trial data on the vaccine.

Despite the lack of approval, an EU member state may temporarily distribute an unauthorized product using an emergency use pathway.

 “The widely supported view is that [unauthorized emergency use] should be considered very carefully … If our citizens start questioning the safety of a vaccine … it will be much harder to vaccinate a sufficient proportion of the population,” the spokesperson said. It would also entail a “fragmentation of approaches” among EU members.

Sputnik V is said to be stable at -0.4 degrees Fahrenheit (-18 degrees Celsius) in its liquid form, similar to the temperature needed to distribute the Moderna vaccine candidate, mRNA-1273. Moderna’s vaccine was reported to demonstrate 94.5 percent efficacy this week and pose fewer distribution challenges than a vaccine from rival Pfizer/BioNTech, which reported a 95 percent efficacy rate and requires extreme cold shipping conditions (DID, Nov. 17). ― Jason Scott