U.S. pharmaceutical giant Pfizer and its German partner BioNTech said they have applied to the European Medicines Agency for the conditional marketing authorization of their coronavirus vaccine.
If the authorization is granted, it could enable use of the vaccine in Europe this month, BioNTech said.
Such authorization is granted to medicines “that address unmet medical needs of patients on the basis of less comprehensive data than normally required,” the EMA says on its website.
“In the interest of public health, applicants may be granted a conditional marketing authorisation for such medicines where the benefit of immediate availability outweighs the risk of less comprehensive data than normally required,” it adds. The applicant should be in a position to provide comprehensive clinical data in the future.
“Today’s announcement marks another key milestone in our efforts to fulfill our promise to do everything we can to address this dire crisis given the critical public health need,” Pfizer Chairman and CEO Dr. Albert Bourla said in a statement.
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