EU starts review of Pfizer-BioNTech Covid-19 vaccine

Bloomberg

Europe’s drugs regulator started an early review of an experimental Covid-19 vaccine from Pfizer Inc and BioNTech SE, potentially speeding the shot’s assessment and reducing its time to market.
Called a “rolling review,” the process will allow the European Medicines Agency to look at how the vaccine is performing in real time as data emerges from trials, instead of waiting for the drugmakers to submit everything at once. BioNTech shares surged in trading before US markets opened.
Once the regulator has enough information to make a decision, the companies will submit a formal application.
The agency has sought to hurry along promising Covid-19 therapies and shots, starting a rolling review last week for a vaccine candidate from AstraZeneca Plc and the University of Oxford. The same tool was used to evaluate Gilead Sciences’s remdesivir before the antiviral was granted conditional approval in July.
The EMA said it has started looking at data from Pfizer and BioNTech’s laboratory studies — research that was done before patient trials began.