Pfizer, BioNTech to submit formal application to FDA to authorize Covid-19 vaccine
The drug maker Pfizer and its German partner BioNTech said they plan to apply Friday to the Food and Drug Administration for an emergency use authorization for their Covid-19 vaccine, a watershed moment in the effort to curb the global pandemic.
It is unclear how long the FDA will take to review the application, though the agency is expected to move swiftly. Agency officials have pledged to seek advice from an expert panel of outside experts, the Vaccines and Related Biological Products Advisory Committee or VRBPAC, before ruling on the application. VRBPAC members have been asked to hold three days in December as potential meeting dates.
