4:13 PM, Feb 27, 2020


Ask Dr. Nandi: Quick okay of first US COVID-19 vaccine cut no corners FDA officials promise

Posted at 10:33 PM, Dec 14, 2020

(WXYZ) — As Pfizer’s vaccine begins distribution, the FDA has assured the public that no corners were cut despite quickly granting Emergency Use Authorization.

Yet some Americans remain skeptical.

I can understand why people are feeling a little anxious, I’m hearing concerns from patients and family too.

But I can assure you, that the FDA is not interested in cutting corners. I’ve said this before, they are one of the most stringent organizations in the world. And not only do they have top-notch scientists, they also consult with an independent advisory committee made up of leading experts. And together, what they do is conduct a rigorous scientific review. Because it’s the science that drives their decisions.

The science, in this case, is based on a double-blind clinical study with 40,000 volunteers. Half got the vaccine and the other half got a placebo. And after analyzing the raw data - the original source - it showed that the vaccine has a 95% protection rate against COVID-19 and that it’s very safe.

Let me say that if someone is going to have a bad reaction to a vaccine, it typically happens within the first few weeks. As for long term side effects, those are very rare. So yes, the timeline for the trials did take place over 2 to 3 months, which might seem short. But in reality, it’s roughly the same criteria used for other vaccines.

And, what some people don’t know is that health officials are constantly monitoring for any adverse effects for current vaccines that we are already administering. Like the flu vaccine. So it’ll be the same for the coronavirus vaccine.

That way if any bad reaction or adverse effect pops up, it will be dealt with quickly.

Yes, the Pfizer vaccine has to be kept at a chilly minus 94 Fahrenheit. In fact, it’s now the coldest vaccine here in the US. But I feel confident that Pfizer has taken the appropriate steps to protect their vaccine. They have special thermal containers filled with dry ice that will keep the interior temperature ultra-cold for 15 days.

Plus the vaccines can stay refrigerated for a few days after they’ve been thawed. Plus, both the CDC and the FDA are working together to make sure that shipments are handled appropriately so that the vaccine doesn’t lose its effectiveness.