Source: WSJ
Application with FDA would come if trial data, due this month, is positive
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.
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.
A third set of data—to ensure the drug can be manufactured on a large scale at the right quality and consistency—will be ready for submission before Pfizer expects to receive the safety data.
Pfizer said it laid out the timeline in an effort to clear up any confusion about the complex process. “To ensure public trust and clear up a great deal of confusion, I believe it is essential for the public to understand our estimated timelines,” Pfizer Chief Executive Albert Bourla said in an open letter released early Friday.
The best of the Muslim Times’ collection for war against Covid 19:
In this day and age, understanding bacteria and viruses and developing vaccines are national security issues. In my view sizable part of every country’s defense budget should be spent in these pursuits rather than making tanks and other weapons.
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