The soonest that Pfizer may apply for emergency use authorization for a coronavirus vaccine is late November, the company’s chief executive said Friday, contradicting earlier assertions that the pharmaceutical giant could start seeking approval this month.

In an open letter to the public, CEO Albert Bourla said Pfizer expects to meet the Food and Drug Administration’s safety requirements for a vaccine in mid-November.

“So let me be clear, 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,” Bourla said. “All the data contained in our U.S. application would be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency.”

Bourla said Pfizer’s scientists may know by the end of October whether their vaccine is effective, but it will depend on how quickly people participating in their clinical trial become infected with the virus. The company has to accumulate a certain number of cases to compare the outcomes of people who received the vaccine candidate with those who received a placebo.

Independent scientists will review the complete data and tell Pfizer whether the vaccine is effective, Bourla said. The company will complete its trial even if the vaccine is declared effective sooner and will probably publicize any conclusive results a few days after the independent scientists notify Pfizer, he said.

Last week, the White House approved tough new vaccine safety standards proposed by the FDA and meant to increase public confidence in the development process. In addition to Pfizer, nine other companies are conducting Phase 3 trials of coronavirus vaccine candidates.

The Washington Post

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