U.S. pharmaceutical giant Pfizer submitted to regulators on Wednesday the documentation on phase 3 trials of its coronavirus vaccine, developed in partnership with German biotechnology company BioNTech.
Pfizer, however, states that it has not asked for emergency use clearance. Instead, its move was part of the continuous process of providing data to prove the vaccine’s effectiveness and safety. “This process has been ongoing since late in November,” said the company in a statement to the press.
Also in a statement, federal health watchdog Anvisa said safety, efficiency, and quality controls will only be completed with the full data — and only then clearance will become a possibility.
At this point, no company has requested authorization for emergency use in Brazil.
Support this coverage →
Search
