Pfizer vaccine raises no specific safety concerns : US regulator
December 8, 2020 08:38 PM
Data from 38,000 trial participants involved in testing the Pfizer-BioNTech Covid-19 vaccine revealed "no specific safety concerns," a document issued by the US Food and Drug Administration (FDA) said Tuesday.
The data after two months of follow-up from the second dose of the vaccine "suggest a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA (emergency use authorization)."
The document was released two days before an advisory committee of the FDA meets to decide on emergency approval, and the statement suggests that the regulator is inclined to green light the vaccine.