One in seven Russian COVID-19 vaccine recipients display side-effects, says Health Minister

pharmafile | September 18, 2020 | News story | Medical Communications, Research and Development COVID-19, Russia, Sputnik V, Vaccine 

Around one in seven patients who have received Russia’s vaccine against COVID-19 have displayed side-effects in clinical studies, according to the country’s Health Minister.

Russian Minister of Health Mikhail Murashko told journalists on 15 September that, so far, more 300 people have been vaccinated with Sputnik V, with 14% displaying undesirable side-effects. These include muscle pain, weakness, fever, and high temperature.

Murashko said “these are the complications that are predictable”, lasting only a day or so.

Russia’s vaccine has attracted criticism since it was announced as the first approved COVID-19 prophylactic anywhere in the world on 11 August – a decision based only on data from a Phase 1/2 study of just 38 participants.

The Health Minister defended the development programme, arguing that the vaccine has navigated a platform of evaluation that has been successfully used for past vaccines.

“We have very large data on this platform, and we can safely talk about the safety of this drug,” he said. “But any drug that goes into widespread use should receive more detailed data on [its] use already in a large number of patients with different diagnoses, with different states of immunity.”

To generate the necessary additional data, vaccinated trial participants are observed in a special telemedicine facility where all emerging symptoms can be identified. Participants also have access to a specially designed mobile app, with which they can set up video calls with the study operators, all of whom are medical specialists with access to participant medical records. Some subcategories of patients are also having their reactions to the vaccine recorded via wearable electronic bracelets.

Earlier this week, the Russian Direct Investment Fund announced a deal with prominent Indian pharma firm Dr Reddy’s Laboratories to deliver 100 million doses of Sputnik V to the country’s citizens, provided it can navigate additional clinical testing.

Matt Fellows

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