4:13 PM, Feb 27, 2020


Ask Dr. Nandi: Moderna requests emergency FDA authorization for COVID-19 vaccine

Posted at 8:04 PM, Nov 30, 2020

A second company is requesting emergency use authorization for a coronavirus vaccine.

The biotech company Moderna completed its Phase 3 trial and says its vaccine candidate is 94.1% effective.

Moderna’s interim data showed the vaccine to be 94.5% effective and now it’s 94.1%. So super, super close.

Now, what is this percentage based on? Well, there were 30,000 participants in this study, and during the trial period, which was roughly two months, 196 people caught the virus. And of the 196, only 11 of those folks had been given the vaccine, while the rest had been given placebo shots.

Now, you might be wondering if any of those 11 people who got the vaccine ended up getting severely sick with COVID-19? And the answer is no. But there were 30 folks who did get severely ill and they were all in the placebo group.

The final analysis showed that it was safe for a diverse group of people including African Americans and Latinx groups. And it also showed it was safe for ages 18 and up. Common side effects included fatigue, headaches, and muscle and joint pain.

Moderna says it’s possible that the FDA could meet on December 17th. That’s about a week after Pfizer, the first company to apply for emergency use authorization is expected to hear from the FDA regarding their vaccine candidate.

Now Moderna has said they’ve already produced millions of doses. Because they plan to hit the ground running if the FDA grants them emergency use authorization.

I am highly concerned. Roughly 6 million people recently boarded planes to travel in the US. And when you combine that with families that gathered for Thanksgiving celebrations with those outside their household bubble, it likely means we’re headed for an increase in cases, hospitalizations, and unfortunately more deaths.

So far, the US has had over 13 million cases and more than 267,000 Americans who have died from COVID-19. And for 27 consecutive days we have had over 100,000 people test positive. And just to emphasize this, that means 100,000 positive cases EACH DAY for 27 days in a row.

Unfortunately, I don’t see our numbers dropping just yet. But I ask everyone yet again, to follow safety protocols.

Annual holidays like Christmas, Hanukkah, Kwanza are approaching. And I’m sure many of you would rather be safe at home with your loved ones, than alone in a hospital that might possibly be stretched to its limits because of virus caseloads.