November 18 that the European Medicines Agency (EMA) said on Wednesday that Pfizer and BioNTech had submitted data from a large-scale trial of their new crown vaccine for the agency’s rolling review, but had not yet applied for approval.
Reuters reported that the two companies said in early November that based on initial test results, their experimental coronavirus vaccine was more than 90% effective. This makes them the first vaccine manufacturers to announce the results of large-scale Phase III clinical trials.
EMA said in an email statement: “The company has now submitted these data to EMA and we will evaluate it in a rolling review.” The rolling review is used by EMA to expedite the acquisition of potential drugs in a public health emergency. Or one of the regulatory tools for vaccine evaluation.