Pfizer Inc. Chief Executive Officer Albert Bourla said that a key safety milestone had been reached in the study of its Covid-19 vaccine, and the drugmaker is now preparing to seek an emergency-use authorization.
Speaking at a conference hosted by the New York Times on Tuesday, Bourla said the company was preparing to submit its data to the U.S. Food and Drug Administration. Last week, Pfizer and partnerBioNTech SE reported that an interim analysis showed their vaccine was more than 90% effective in preventing Covid-19.
“We are preparing now for submissions,” Bourla said at the conference.
Nonetheless, Bourla added, important questions about the vaccine still remain to be answered. “When it comes to how durable the protection could be, this is something we don’t know yet,” he said.
The company will follow study participants for a significant period of time after they receive the shots, Bourla said at the conference.
Pfizer shares were up 2.2% at 1:54 p.m. in New York.
The safety data Bourla was referring two was two months of follow-up data on volunteers in the company’s Covid-19 vaccine trial. The FDA has said it is requiring this safety data before any Covid-19 vaccine can gain emergency clearance.
Pfizer had previously said it would get the data sometime this week, one of the last hurdles needed before it can apply for regulatory authorization.
Bourla also addressed concerns that he sought to report the effectiveness of the vaccine before Election Day, potentially influencing the outcome of the U.S. election.
“The election for us was always an artificial line,” he said. “It may have been important for the president, but it wasn’t for us.”
The trial results are “a glorious confirmation of the power of the technology,” according to Bourla, referring the the novel messenger RNA platform used in Pfizer’s vaccine. The technology has a lot to offer against other viruses, and in terms of medical areas like cancers, Bourla said.
Bourla spoke alongside Bill Gates and Heidi J. Larson, director of the Vaccine Confidence Project, in a discussion about vaccine development, distribution and uptake.
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