EMA Investigates Deaths and Complications Following Sputnik V Vaccination in Russia
Key Insights
The European Medicines Agency (search) (EMA) is reviewing reports of four deaths and six cases of medical complications in Russia following administration of the Sputnik V vaccine.
The cases, detailed in leaked internal files from RosPotrebNadzor (search), involve symptoms ranging from breathing difficulties to cardiovascular issues.
The EMA has confirmed it is taking the reports seriously, though the total number of cases is small relative to the millions vaccinated with Sputnik V.
The European Medicines Agency (search) (EMA) is currently investigating reports of four deaths and six cases of medical complications in Russia following vaccination with Sputnik V. These cases, previously unreported, have been brought to the attention of the EMA, which is currently evaluating Sputnik V for potential EU-wide approval.
According to internal case files from RosPotrebNadzor (search), the Russian body responsible for administering vaccines, the deaths involved three women aged 51, 69, and 74, and one unidentified individual. The leaked documents indicate the deaths were related to heart, lung, or blood sugar issues, but causation has not been definitively established. The six individuals who experienced medical complications included younger men and women, with one as young as 25. Their symptoms encompassed a range of issues, including difficulty breathing, convulsions, swelling, muscle weakness, high blood pressure (search), headaches, dizziness, and fever.
The authenticity of one of the RosPotrebNadzor (search) case files was confirmed by Denis Logunov, a senior virologist at the Gamaleya Research Institute of Epidemiology and Microbiology (search) in Moscow, the developer of Sputnik V. He specifically acknowledged the case of the 51-year-old woman who died suddenly after receiving the second dose of the vaccine. The EMA confirmed receipt of the RosPotrebNadzor files, which were sent anonymously, and stated that all reports are being treated seriously and directly assessed.
While the total number of reported cases (10) is small compared to the millions of doses of Sputnik V administered, concerns have been raised regarding Russia's data transparency and data collection standards. This lack of transparency raises questions about the potential underreporting of adverse events following vaccination. The Russian Direct Investment Fund, responsible for the export of Sputnik V, and RosPotrebNadzor (search) have not commented on the matter.