KANSAS CITY, Mo. — The Pfizer vaccine against COVID-19 gained full approval from the Food and Drug Administration Monday morning.
Upon the approval, KSHB 41 I-Team reporter Jessica McMaster spoke with Dr. Bechara Choucair, White House vaccination coordinator.
Below, read their conversation — which spanned topics from the approval process, vaccine safety and how adverse effects are tracked and monitored.
McMaster: Can you describe the approval process? What does [FDA approval] mean?
Choucair: "The FDA approval is a complex, very rigorous, scientific process that the FDA is going through to make sure that the vaccines meet safety and effectiveness — and it includes reviewing literally hundreds of thousands of pages worth of pre-clinical data, clinical data. It also includes information about manufacturing. It includes site visits where the vaccines are being manufactured.
So, it's a very rigorous process that the FDA has gone through, and as you know, the FDA is the gold standard when it comes to safety and effectiveness evaluation. So, we're real excited that the FDA issued its full approval for the Pfizer vaccine, ages 16 and older."
McMaster: Does getting vaccinated play a role in preventing variants? Or, is that something that's going to take its course no matter what?
Choucair: "The more we give opportunity for this virus to replicate, the more likely we're going to give this virus an opportunity to mutate. This is exactly what happened with the alpha variant, with the delta variant, and the more we get people vaccinated, the more likely we won't have an opportunity for this virus to replicate and mutate. That's why the message has been very clear: We know the vaccines work. We have three vaccines that are very safe, very effective. We have to keep up doing what we know is working to get more and more people vaccinated."
McMaster: There are a lot of people who say we're not paying attention to negative, adverse side effects — but that's not true. The very system, VAERS, is the one that caught the Johnson & Johnson rare blood clot. What is the process for monitoring adverse effects?
Choucair: "We have a tremendous monitoring process in place for side effects and adverse reactions. And, to your point, that's exactly how we detected the very rare incidences of blood clots with J & J.
The CDC and FDA monitor this very closely and we continue to be very transparent with the American public when it comes to safety issues. And, if you look at the overwhelming majority of hospitalizations today, its among those who are unvaccinated.
If you look at the overwhelming majority of people who are dying from COVID-19, by far it's among those that are unvaccinated.
So, we want to make sure that we talk to people, answer people's questions, fight the misinformation that's out there with facts, and I've no doubt when people get facts, when people get answers, they will be more inclined to getting vaccinated and we have to continue doing that day-in and day-out."
McMaster: Will we need FDA approval for the booster shots?
Choucair: "Absolutely. Last week, we rolled out the booster plan that begins starting Sept. 20, when the booster shot folks become eligible eight months after their second dose. But, that would be pending full FDA approval."
McMaster: What other information is important for Kansas Citians?
Choucair: "Look, we're seeing more and more people in Missouri and across the country getting their first shot. Just in Missouri alone we have more than 65,000 people in Missouri getting their first shot in the last 10 days alone. So, we know people who have been waiting are getting more intrigued by the vaccine, they're getting more ready to be vaccinated. And, look, I know that a lot more people are vaccinated in Missouri and those folks, please take a moment to talk to your friends, your neighbors, your relative who's not vaccinated yet. Share with them your experience and hopefully we'll get more and more folks vaccinated in the next few weeks."