Pfizer Inc. PFE -0.84% said it could be ready to apply for emergency-use authorization of its Covid-19 vaccine by late November, assuming it receives positive efficacy and safety data from late-stage human trials, the first time it or any other leading Western vaccine developer provided such a specific timeline.
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The drug giant, which is developing its vaccine candidate with German partner BioNTech SE, BNTX 4.05% said it continues to expect to have data on the vaccine’s effectiveness—whether it protects at least a majority of vaccinated people from the disease—later this month. It then expects to have data on the drug’s safety by the third week of November.
Assuming positive results with both sets of data, Pfizer said it then plans to file for emergency-use authorization for the vaccine in the U.S. from the Food and Drug Administration soon after receiving the safety data. It didn’t disclose timing for similar applications anywhere else in the world. Read more at WSJ