EU agency fast-tracks process on 2nd COVID-19 vaccine candidate
The European Union's drug regulator has started reviewing a second potential vaccine for COVID-19, which is being developed by Germany's BioNTech in collaboration with American pharmaceutical company Pfizer.
The European Medicines Agency (EMA) announced Tuesday that it has begun a "rolling review" of the latest vaccine candidate in an accelerated regulatory approval process, examining the data as it becomes available rather than waiting for the trial to end.
"The start of the rolling review means that the committee has started evaluating the first batch of data on the vaccine, which come from laboratory studies (non-clinical data)," the EMA said in a statement. "This does not mean that a conclusion can be reached yet on the vaccine's safety and effectiveness, as much of the evidence is still to be submitted to the committee."
The agency added that its decision to start the expedited approval process for the vaccine candidate was based on preliminary results from non-clinical and early clinical studies in adults which suggest that the drug triggers the body's immune system to fight COVID-19.
Last week, the EMA began its first review process of a COVID-19 vaccine candidate -- a rolling review of one being developed by U.K.-based pharmaceutical company AstraZeneca in collaboration with England's University of Oxford.