Nationwide - In a call to investors, Pfizer's CEO said the pharmaceutical company will not have COVID-19 vaccine information to reveal to government regulators and advisory council members just yet.

What You Need To Know

  • Pfizer marks third week of November to apply for Emergency Use Authorization

  • Vaccine announcement unlikely by Election Day

  • FDA Advisory group looking at ethical issues

  • Pfizer is at the front of the line in developing a preventative tool against the coronavirus.

This means news of a vaccine before Election Day is unlikely.

Officially, Pfizer said maybe on the third week of November it'll have the data to show.

But, the advisory council, a group of doctors and scientists who will independently assess the vaccines, recently met to tackle big questions they have ahead of a vaccine announcement.

Also on Tuesday, Dr. Paul Offit, who's a member of the FDA's advisory committee on vaccine approval, gave an update to the Journal of American Medical Association.

The most pressing issues discussed so far, according to him, are the vaccines' effectiveness.

At what level of efficacy should regulators give approval to move forward with authorizing emergency use?

On the children's vaccine, should there be a study period like the adult vaccine or should data from the adult studies be used?

And on ethical issues, what should be done with the placebo groups? Should they get the vaccine right away?

That's not usually what happens.

"If you eliminate now placebo groups going forward, you're not going to learn about these other vaccines nearly the same amount as you would,” explained Dr. Offit.  “And let's make the assumption, which I don't think it's a large assumption, that the first vaccine is not going to be the last best vaccine either with regard to safety or efficacy. How are you going to know that?"

It's not a simple question to answer.

Dr. Offit later explained the person who died in the AstraZeneca Phase 3 vaccine trial was part of the placebo group. 

The infectious disease expert said the patient may have survived had he been part of the vaccine group.

“Because he was in the placebo group, that’s probably why…he died of COVID-19. But for the flip of a coin, he ended up in the wrong group,” said Dr. Offit in the JAMA Conversations with Dr. Bauchner segment.  “I think it’s less likely he would’ve died had he been in the vaccine group.”

The FDA's advisory group will meet six more times over the next two months with government regulators, scientists and vaccine manufacturers, said the doctor.

Those dates are not yet scheduled.