4:13 PM, Feb 27, 2020


Pfizer and BioNTech to submit to FDA today for emergency authorization for their coronavirus vaccine

Posted at 7:01 PM, Nov 20, 2020

After announcing their coronavirus vaccine candidate was 95% effective, Pfizer planned to file for the FDA’s emergency use authorization.

If granted, the drug could potentially be rolled out starting in December.

The submission will be based on data from Pfizer’s on-going phase 3 clinical trial. And so far, the vaccine candidate has shown that it’s safe, has an efficacy rate of 95%, and has no serious side effects. This is all amazing news.

Now, once Pfizer applies for emergency use authorization, here’s what’ll happen. The FDA will first review and analyze the data. Then they’ll get a group of outside experts together. This group will also scrutinize the data looking at safety, how the drug works, and if it’s ready for the public. And once they weigh-in, then the FDA will make a final decision on whether to approve the vaccine for emergency use authorization.

No one can get vaccinated until a CDC advisory committee looks at the data. This committee is also an independent panel of experts.

Now the good news is that this committee typically meets within 24 to 48 hours after emergency use authorization is granted. Which is fairly fast. And what this committee does, is decide who will be first in line to get vaccinated, and who should not be vaccinated.

I expect pregnant women to be excluded because they weren’t part of the study. As well as children under the age of 12.

Now, who might be the first in line to get the shots? I’m expecting it will be health care workers, older folks, essential workers, and people with underlying health conditions.

It’s been reported that the FDA has set up meetings on December 8th through the 10th with its Vaccines and Related Biological Products Advisory Committee. So we could hear a yes or no decision around that time.

If it’s approved, Pfizer has said they’ll be ready to distribute the vaccine right away. They are still planning on delivering 50 million doses globally by the end of this year.

As for the details of where vaccination clinics will be, that is still being worked out. But if all goes well, vaccinations for high-risk groups could begin somewhere between the middle to end of December. So very exciting news.

I talked before about how Pfizer only tested participants who had symptoms. That’s important to know. Since not everyone was tested, we don’t know if the folks who were vaccinated still ended up getting infected - and just didn’t develop symptoms.

Now, this is not a bad thing. We’ve seen how the hospitalization rates have skyrocket here in MI and across the nation. So if the vaccine only lowers those rates, it still helps.

Now Pfizer’s trial will last for two years. And I expect we’ll learn a lot more as time goes on.

This week on The Dr. Nandi Show we’re discussing the “New Age of Parenting”. Raising children in today’s ever-changing world is certainly a challenge. With the internet and smartphones, life for our children is vastly different than when we were growing up. So in this episode, Dr. Nandi talks with several parents and experts on what we can do to raise healthy, well-balanced children. Tune in this Sunday, November 22nd at 1 pm.