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Coronavirus Latest: Friday, October 16

On Friday, Pfizer announced that it may attempt to file for emergency use authorization with the FDA by late November. This comes as the WHO says Remdesivir has ‘little or no effect’ in preventing deaths in patients with coronavirus. Yahoo Finance’s Anjalee Khemlani joins The Final Round to discuss the latest on the coronavirus.

Video Transcript

SEANA SMITH: All right. We want to get to another big story, of course, that we are closely watching here on Yahoo Finance, and that is the latest one it comes to coronavirus. Pfizer today is saying that it could be ready to file for emergency use authorization for its COVID-19 vaccine in late November.

Anjalee joins us now with a little bit more on this. And Anjalee, when we talk about just how significant this is, I guess my first question is, what exactly needs to happen in order for Pfizer to file with the FDA next month.

ANJALEE KHEMLANI: So in order for Pfizer to file, they definitely have to pay attention to the FDA guidelines to begin with and have enough data to support that authorization. And that includes proving that the vaccine candidate is safe and effective and that their manufacturing quality is up to par to manufacture and then distribute the vaccine.

As it stands right now, this is a significant step for Pfizer to look at the end of November, that third week of November, as their deadline to file, because it incorporates that additional month of observation period that the FDA is looking to have. That has been a controversy, and the White House had been initially pushing back against that, but then that at least got figured out.

So we're looking two-month follow-up [? post-last ?] dosage for the vaccine participants. And that is going to give an update. And now, as it stands right now, the CEO has said that by the end of October is when they're likely to get that data, and that has remained unchanged. But the difference here is that rather than filing immediately for the EUA, which was the plan, they're now looking to wait until that November deadline.