Russia is temporarily tapping the brakes on its Phase 3 COVID-19 vaccine trial as demand for its Sputnik-V vaccine surges, according to several clinical officials quoted by Reuters.
Crocus Medical, a company helping administer the vaccine, denies there is a shortage of the vaccine. “Trials are ongoing, and there is sufficient vaccine supply,” said Alexey Butylin, managing director of Crocus Medical, in a statement to the news service.
According to The Lancet, experts outside of Russia have voiced skepticism regarding the vaccine, but it has some potential advantages. It is freeze-dried, circumventing the need for ultra-cold storage during transit. And its tolerability is comparable to the other adenovirus-vector vaccines, according to Dr. Peter Hotez, a vaccinologist at Baylor College of Medicine.
The Sputnik-V vaccine became the first COVID-19 vaccine to win regulatory approval when Russia’s Ministry of Health issued a registration certificate for the vaccine in August following a combined Phase 1 and Phase 2 trial for Sputnik V.
The vaccine requires two doses for full efficacy. According to Russian officials, 20,000 people have received the first dose and 9,000 the second.
The Lancet also published results from the combined Phase 1 and Phase 2 trial in September.
Filed Under: clinical trials, Drug Discovery, Infectious Disease