Ask Dr. Nandi: FDA wants two months of safety data before considering COVID-19 vaccine

Posted at 5:42 PM, Oct 07, 2020
and last updated 2020-10-07 17:42:48-04

(WXYZ) — There are new FDA guidelines for coronavirus vaccine developers. Two months of follow-up data on volunteers in phase 3 trials are now needed before Emergency Use Authorization will be considered.

This is definitely good news for Americans, except for maybe President Trump. I know the President was hoping for a vaccine before Election Day. And that is now not likely going to happen.

The Food and Drug Administration’s new guidelines are making sure that safety is a priority. Which is why they want vaccine developers to monitor thousands of participants for two months after they’ve been fully vaccinated. To see if any adverse events like rare spinal cord injuries or Guillain-Barré syndrome come up.

Plus, the FDA is requesting that five cases of severe infection be documented in trial participants who were given a placebo and not a vaccine.

If a participant is going to have a reaction to an experimental vaccine, it’s often around the two and three-month mark. So the FDA went with two months as they felt that it wasn’t too aggressive or too conservative.

Now, clinical trials do typically take years to make sure a vaccine is safe and effective. So any vaccine that is granted Emergency Use Authorization within a short timespan will be unprecedented for sure. But the virus is killing a thousand or more Americans every single day. So the FDA is trying to balance speed, safety, and saving American lives.

Moderna and Pfizer are right now in phase 3 trials. And both these vaccines require participants to get two doses. Moderna’s is 28 days apart and Pfizer’s is 21 days apart.

Now, the FDA’s two-month timeframe begins right after the second shot. So based on this, if all goes well, it looks like the earliest we’d see emergency use authorization for a coronavirus vaccine would be towards the end of November.

Now, I am pretty happy with the new recommendations. It shows that the FDA is not bending to politics and is putting the health of Americans first. So if a vaccine is granted Emergency Use Authorization, in my opinion, people should feel that overall it is safe and effective.

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