Russia Plans 40,000 Patient Study for Approved Coronavirus Vaccine
Following approval of its coronavirus vaccine, the first in the world, Russia plans to initiate a new study involving 40,000 people as the country looks to boost production and distribute the drug to patients in that country, as well as to patients in countries it has struck deals with.
Russia approved its vaccine against the novel coronavirus earlier this month after the government assured the medication is safe and effective. The vaccine, dubbed Sputnik V, is an adenoviral vector vaccine developed by Moscow’s Gamaleya Institute. The two-vector vaccine has been genetically modified to infect cells than make those cells manufacture spike proteins of SARS-CoV-2, the novel virus that causes COVID-19.
Russia had its vaccine in clinical testing for about two months before it approved the medication. The little data that is available, two Phase I/II studies posted to clinicaltrials.gov, show a total of 38 patients treated with the experimental vaccine. There is a question as to whether or not that is 38 per study for a total of 76, or 38 studied twice. Since its hasty approval, the vaccine has been viewed with skepticism from researchers over its potential as a long-term solution against the global pandemic, largely due to the speed with which it was approved and the small number of patients involved in the studies.