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Shares of Pfizer Inc. rallied in premarket trading Friday, after the drug maker said it is on track to know whether its potential COVID-19 vaccine is effective by the end of October, and currently expects to apply for Emergency Use Authorization by the second half of November.
Pfizer PFE, -0.84%, which is developing its vaccine candidate with Germany-based biotechnology company BioNTech S.E. BNTX, +4.05%, said before it can apply for the EUA, it will have to prove the vaccine is safe.
To do so, the Food and Drug Administration requires two months of safety data on half of the trial participants following the final dose of the vaccine.
“Based on current trail enrollment and dosing pace, we estimate we will reach this milestone in the third week of November,” Chief Executive Albert Bourla wrote in an open letter posted on its website Thursday. He said he wrote the letter to clear up any confusion regarding the development and approval of the vaccine candidate.
Pfizer’s stock rose 1.1% in premarket trading, while BioNTech shares surged 2.4%.
Once the vaccine candidate is indicated to be effective and safe, Pfizer said another requirement will be to submit manufacturing data showing the “quality and consistency” of the vaccine that will be produced. The company said it expects to have that manufacturing data ready before the safety milestone is reached.
“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 wrote. “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 .”
Pfizer’s stock has lost 6.7% year to date through Thursday, while BioNTech shares have nearly tripled (up 166.8%). In comparison, the Dow Jones Industrial Average has slipped 0.2% this year.
