US pharmaceutical giant Pfizer Inc. said it could seek emergency-use authorization for its Covid-19 vaccine in the country by late November if the shot is shown to be effective in a large late-stage trial. In an open letter published on the company's website, Pfizer Chief Executive Officer Albert Bourla said safety reviews will dictate the timeline, with the US Food and Drug Administration requiring that at least half the people in the study be watched for side effects for two months.
Bourla wrote, “Let me be clear, assuming positive data, Pfizer will apply for emergency authorization use in the US soon after the safety milestone is achieved.” An initial readout on whether the vaccine is effective could come later this month, depending on how quickly subjects in the trial become infected with the virus.
Jeremy Faust, emergency physician at Brigham and Women's Hospital in Boston, called it a “huge win”. He said, “We don't want something that works, but we didn't give patients a full and accurate assessment of the side effects that might be expected among some people.” He was among a group of leading scientists who previously urged Pfizer to wait until at least late November before seeking emergency authorization.
The Pfizer partnership and Moderna inc. are the two front-runners in testing Covid-19 vaccines in the US. Both are testing messenger RNA Vaccines, a new type of vaccine that turns the body's own cells into tiny vaccine-making factories.
