European Medicines Agency begins rolling review of Russian Sputnik V Covid-19 vaccine
At this point, there's no timeline in place for the approval.
The European Medicines Agency has announced it has started a rolling review of Sputnik V (Gam-COVID-Vac), a Covid-19 vaccine developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology.
The EU applicant for this medicine is R-Pharm Germany GmbH.
The EMA’s human medicines committee's (CHMP) decision to start the rolling review is based on results from laboratory studies and clinical studies in adults.
It will evaluate data as it becomes available to decide if the benefits outweigh the risks. The rolling review will continue until enough evidence is available for formal marketing authorisation application.
This means it should take less time than normal to evaluate an eventual application due to the rolling review.
Once the CHMP decides that sufficient data is available, the company can submit a formal application. By reviewing the data as it becomes available, the CHMP can come to an opinion on the medicine’s authorisation sooner.
However, the EMA said it would be unable to put a definite timeline on the process at this point.
A decision from the EMA on the approval of the Johnson & Johnson single dose Covid-19 vaccine is expected this month.
The vaccine was shown to be 66% effective in preventing Covid-19 infections and was 100% effective in preventing hospitalisation and death, in a trial of 44,000 people.
Ireland, as part of an EU deal, is in line for roughly 2.2 million doses of the vaccine pending approval.