Amid the frenzied race for a COVID-19 vaccine, Pfizer may have early efficacy results in just a matter of weeks.
During a digital event Thursday, Pfizer CEO Albert Bourla said the company has enrolled about 23,000 people for its phase 3 coronavirus vaccine trial so far. The company expects initial results in late October. If the results are positive, the company would be ready to ask the FDA to authorize vaccinations as soon as possible.
In fact, the company is already preparing its application to submit quickly if the vaccine shows promise, he added. The FDA has set an advisory panel meeting for October 22 to discuss COVID-19 vaccine progress.
Bourla’s timeline would have been unthinkable at the beginning of the year, when the novel coronavirus started spreading and researchers got to work on the first vaccine candidates. Moderna entered the clinic in record time, while partners Pfizer and BioNTech started U.S. human testing in early May.
At the start of the R&D process, experts predicted a vaccine could be available in 12 to 18 months if all went smoothly. Now, experts are still skeptical that a vaccine could be ready in late October.
As the programs raced ahead, Americans grew wary about getting a shot developed and approved in short time. In a recent survey conducted by Stat and Harris Poll, more than 80% of people responded that they’d worry about safety for a hastily approved vaccine. Nearly 80% see politics driving the approval process rather than science.
After controversial decisions by the FDA on hydroxychloroquine and convalescent plasma, some medical experts have raised concerns over politics entering science. One prominent physician, Dr. Eric Topol, this week called on FDA commissioner Stephen Hahn to “tell the truth or resign” after the plasma move. Trump and allies have said they’re pushing for a vaccine by the end of the year or earlier, apparently seeking a political boost from COVID immunizations.
Bourla’s briefing comes right after news that the Centers for Disease Control and Prevention is prepping for possible vaccine deliveries by November 1. In a note to states last week, CDC director Robert Redfield asked them to consider waiving restrictions to ensure vaccine distribution sites could be up and running in a matter of months. All of this comes as the U.S. election is just two months away.
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Still, in speaking to CNN on Wednesday, NIH director Francis Collins said it remains “unlikely” a vaccine will be ready in late October. Fauci said the same on Thursday, but he said it’s not impossible.
Meanwhile, a group of biotech CEOs wrote this week that COVID data releases should only come through academic conferences or peer-reviewed journals, not press releases. It’s unclear how long that process—or a potential FDA review—would take under the circumstances.
Aside from Pfizer, Moderna and AstraZeneca are also in phase 3 testing in the U.S. AstraZeneca CEO Pascal Soriot recently said the company won’t have efficacy data until the end of the year, and Moderna hasn’t said exactly when it expects early efficacy data. Behind those players, Sanofi and GSK just entered human testing with their promising program, with aims at producing 1 billion doses in 2021.
As the vaccines move forward, the FDA is gearing up for the vaccine advisory committee meeting Oct. 22. No specific application will be reviewed, according to the agency, but the experts plan to discuss “in general, the development, authorization and/or licensure of vaccines to prevent COVID-19.”
