Pfizer says it could seek COVID-19 vaccine emergency authorization in November
Pfizer could apply for emergency use authorization for its potential COVID-19 vaccine next month, its CEO says.
Pfizer CEO Albert Bourla on Friday provided an update on when the company may potentially seek emergency use authorization from the Food and Drug Administration for its coronavirus vaccine candidate, should it prove to be safe and effective.
"In the instance of emergency use authorization in the U.S. for a potential COVID-19 vaccine, FDA is requiring that companies provide two months of safety data on half of the trial participants following the final dose of the vaccine," Bourla explained. "Based on our current trial enrollment and dosing pace, we estimate we will reach this milestone in the third week of November."
Subscribe to The Week
Escape your echo chamber. Get the facts behind the news, plus analysis from multiple perspectives.
Sign up for The Week's Free Newsletters
From our morning news briefing to a weekly Good News Newsletter, get the best of The Week delivered directly to your inbox.
From our morning news briefing to a weekly Good News Newsletter, get the best of The Week delivered directly to your inbox.
Bourla added that "assuming positive data, Pfizer will apply for emergency authorization use in the U.S. soon after the safety milestone is achieved in the third week of November."
With this announcement, The New York Times noted that Pfizer was "ruling out President Trump's assertion that a vaccine would be ready before Election Day." The CEO of Moderna, another company that has a potential COVID-19 vaccine in development, recently told the Financial Times it would likely not have enough data to seek FDA emergency use authorization until at least Nov. 25. At the time of those comments, the Financial Times wrote that this meant that Trump's "most realistic hope of a pre-election vaccine" would be from Pfizer.
Bourla also reiterated on Friday that Pfizer may know whether its vaccine is effective by the end of October, although the data required to make this determination "may come earlier or later based on changes in the infection rates."
Create an account with the same email registered to your subscription to unlock access.
Sign up for Today's Best Articles in your inbox
A free daily email with the biggest news stories of the day – and the best features from TheWeek.com
Brendan worked as a culture writer at The Week from 2018 to 2023, covering the entertainment industry, including film reviews, television recaps, awards season, the box office, major movie franchises and Hollywood gossip. He has written about film and television for outlets including Bloody Disgusting, Showbiz Cheat Sheet, Heavy and The Celebrity Cafe.
-
The importance of discussing and dealing with debt
The Explainer Increasing numbers of people have 'problem debt' – but there are ways to tackle it
By Marc Shoffman, The Week UK Published
-
'Trump heavy on retribution, light on cash'
Today's Newspapers A roundup of the headlines from the US front pages
By The Week Staff Published
-
Crossword: March 19, 2024
The Week's daily crossword
By The Week Staff Published
-
Seattle Children's Hospital sues Texas over 'sham' demand for transgender medical records
Speed Read Texas Attorney General Ken Paxton subpoenaed records of any Texan who received gender-affirming care at the Washington hospital
By Peter Weber, The Week US Published
-
Afghanistan has a growing female suicide problem
Speed Read The Taliban has steadily whittled away women's and girls' rights in Afghanistan over the past 2 years, prompting a surge in depression and suicide
By Peter Weber, The Week US Published
-
US life expectancy rose in 2022 but not to pre-pandemic levels
Speed Read Life expectancy is slowly crawling back up
By Devika Rao, The Week US Published
-
Vallance diaries: Boris Johnson 'bamboozled' by Covid science
Speed Read Then PM struggled to get his head around key terms and stats, chief scientific advisor claims
By The Week UK Published
-
An increasing number of dog owners are 'vaccine hesitant' about rabies
Speed Read A new survey points to canine vaccine hesitancy
By Devika Rao, The Week US Published
-
Anger may be a powerful motivator for tough goals, new study suggests
Speed Read Keeping your cool might actually be less efficient than letting your anger drive you
By Theara Coleman, The Week US Published
-
A tropical skin disease is making the rounds in the US
Speed Read Leishmaniasis is endemic to the country and can cause ulcers and disfiguration
By Devika Rao, The Week US Published
-
FDA moves to ban menthol cigarettes
Speed Read It's been a long time coming
By Devika Rao, The Week US Published