After Sputnik V, Russian Federation grants approval to 2nd COVID-19 vaccine EpiVacCorona
Oct 15 2020
The news comes as more than 100 Covid-19 vaccine candidates are under development around the globe, many of which are in human trial phases.
The Johnson & Johnson ENSEMBLE trial had planned to enroll as many as 60,000 participants in several countries, STAT reports, making it one of the world's largest efforts to test a COVID-19 vaccine. "These ensure our studies may be paused if an unexpected serious adverse event (SAE) that might be related to a vaccine or study drug is reported, so there can be a careful review of all of the medical information before deciding whether to restart the study". Sputnik V began large-scale trials on 40,000 volunteers in September.
That vaccine, based on an adenovirus vector, was also registered before Phase III trials. The vaccine named EpiVacCorona comes after Russian Federation recently granted similar approval to its first COVID-19 vaccine named Sputnik V. Notably, Sputnik V is also the first vaccine candidate in the world to attain regulatory approval.
Meanwhile the head of the Oxford University coronavirus vaccine team said face masks and social distancing may be needed until July, even if the global trial proved successful.
Developing countries must have "equal access" to future Covid-19 vaccines, Indonesia's foreign minister warned, as wealthy nations scoop up billions of doses.
Dr Fauci's comments also underscored the importance that not just one, but all vaccine candidates succeed. Still, the side effects that have emerged so far in the 44,000-person late-stage trial are similar to those seen in these early studies, Sahin said.
A study pause, on the other hand, is a standard component of a clinical trial protocol. Students would represent an unprecedented expansion in the use of vaccines that have not completed full human testing, though the Chinese regulator can determine that the group can come under the remit of emergency use.
Russian Federation is the world's fourth-most affected country by the coronavirus pandemic with a total of 1,340,409 cases.
Russian Federation on Wednesday reported more than 14,000 new cases, its highest daily figure to date. On the same day, Russia's coronavirus crisis centre said 239 more deaths were confirmed in the last 24 hours, bringing the death toll to 23,205.