![]() Such delays have directly impacted these countries’ ability to offer a second dose, which is more complicated to assemble in the laboratory. Countries that originally planned to use Sputnik V have been forced to turn elsewhere due to production and delivery delays. Sputnik V’s other problem is the inability of the state-controlled Russian Direct Investment Fund (RDIF) to deliver the vaccine on a mass scale. Paul Stronski was a senior fellow in Carnegie’s Russia and Eurasia Program, where his research focuses on the relationship between Russia and neighboring countries in Central Asia and the South Caucasus. And breakthrough cases involving individuals vaccinated with Sputnik V have been widely reported, including an outbreak in the Kremlin allegedly caused by senior officials failing to get booster shots (presumably Sputnik V) on time. In comparison, Chinese health regulators have admitted that “current vaccines don’t have very high protection rates.” Sputnik V clearly provides some protection against severe disease, but independently verified data remain hard to come by. This stance undermines public faith in the vaccine at home and abroad. Unfortunately, Sputnik V’s defenders have yet to acknowledge that there might be any actual safety or efficacy issues with the drug, let alone provide adequate data to satisfy the regulators that have flagged concerns. Food and Drug Administration’s regulatory review of its booster shot, Sputnik V’s Twitter account made a specious comparison to erectile dysfunction medication. For example, when Pfizer released data admitting decreasing efficacy of its COVID-19 vaccine over time as part of the U.S. Instead of tackling such challenges head on, Sputnik V’s backers and the Russian state-controlled propaganda apparatus have repeatedly tried to tarnish the reputation of Western vaccines. ![]() ![]() Delays in approving new drugs are common across the globe, but Sputnik V’s Western competitors have a better track record of navigating these processes. In fact, the most stringent international regulators have complex approval processes that mandate transparency require applicants to hand over detailed data on efficacy, safety, and production capabilities and request additional data as part of scientific and regulatory reviews. Sputnik V’s Western competitors generally are far more transparent with regulators. Western and Chinese COVID-19 vaccines that are being marketed globally have also faced a barrage of questions over safety and efficacy from regulators and citizens alike. This likely has contributed to the country’s deadly COVID-19 waves in 2021. Only about 36 percent of Russians have been fully vaccinated as of November 18, according to the Johns Hopkins University Coronavirus Resource Center vaccine database. Russia’s low vaccination rate is on par with much poorer countries. Even President Vladimir Putin hesitated to take it, waiting for roughly seven months to be jabbed. ![]() Inside Russia, vaccine hesitancy is a bigger challenge, and average Russians have proven to be especially skeptical of Sputnik V. The decision to rush Sputnik V to the market before the completion of broad-based Stage III trials also damaged the vaccine’s image inside Russia and overseas-while complicating prospects for emergency-use authorization by key international regulatory bodies, including the World Health Organization, the European Medicines Agency, and the South African Health Products Regulatory Authority. This has fed doubts about the 91– 97 percent efficacy they have claimed at various times. The developers of Sputnik V at Moscow’s Gamaleya Institute have been slow to share scientific data with international regulators and researchers for reasons that remain unclear. Hovering over the vaccine’s commercial prospects are lingering questions about its safety and efficacy-as well as Moscow’s ability to deliver promised numbers of doses and navigate complicated global supply chains. However, Sputnik V has struggled to gain mass acceptance inside Russia, let alone in other countries where it is marketed as an alternative to vaccines developed by Western and Chinese pharmaceutical firms. Since then, a relentless publicity blitz has promoted the attributes of the Sputnik V vaccine. In August 2020, Russia was the first country to announce the development of a COVID-19 vaccine.
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