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Bob Frenck, MD, Director, Vaccine Research Center:
The past year, Cincinnati Children's hospital has been testing a number of different COVID-19 vaccines. We started in May of 2020 with the Pfizer vaccine, and we were one of four sites in the country doing the Phase 1 studies. And so, after the dosing was decided, we helped in the Phase 2-3 and enrolled, between that study and then the AstraZeneca study, about 1,400 people at Cincinnati Children's hospital.

They heard the word 'Operation Warp Speed,' and they thought that that meant that you're going to just go full speed ahead, it doesn't matter, we're never going to stop. And that really wasn't what it meant. It just means trying to do things as expeditiously as possible.

We've really telescoped things down. So, we just put a lot more hours more quickly. The other thing that helped us is that these technologies, while it was new for them to apply them to the vaccine we're testing, they've been available for over 20 years. It allowed us to develop vaccines quickly, and it allowed us to actually make lots and lots of doses very quickly.

It's very important for us to be able to enroll a very diverse and broad-spectrum population in our clinical trials. And the great news is that we found, in the Pfizer trial, we really found the same thing in Moderna and AstraZeneca and Johnson & Johnson, is that the vaccines have had the same protective effect across the age spectrum. Also, there was no disparity in race, and there was no disparity in sex. So in the end, age, sex and race all had the same efficacy, regardless of where you were on that spectrum.

Many people have had no side effects. But if they're going to have side effects, the common things are that it's a shot, so you're going to get some pain or tenderness at the site. You may get some redness, sometimes a little bit of swelling. If you're going to have any sort of total-body side effects, the common things we've had are people have had headaches or fatigue, maybe some achiness. Basically, if you think about like if you've had a bad cold and how you kind of feel like that for a day.

A lot of people said, 'Well, why do you get those side effects?' And I think about that really as showing the body is responding well to the vaccine. Because those side effects you're feeling are caused by components in our immune system called cytokines, and when those are being released, one of the side effects, unfortunately, is you feel kind of achy and have a headache, sometimes even fever. You should look at that as an OK sign.

To do testing in children, you have to show that there's a potential for direct benefit. So that that child, themselves, by participating in the study has some benefit by being in the study. So, to be able to show that we had the potential for a direct benefit, we needed to get data in adults first. Now that we were able to accumulate data in adults, and we showed that the vaccines were quite safe, and they were very effective. That really allowed us then to go in and test in children.

The first studies we did is to look at adolescents, from 12 to 17. So, we've seen that the adverse event profile look very similar to the adults. We're just finishing up on immunogenicity. By the time you see me on this video, we'll acutally have results for you to be able to tell you.

Based on those results, we're now starting to do testing in 12 years of age and below. I think what it's going to mean is that by August, maybe a little bit earlier of 2021, we'll have one or more licensed vaccines for people 12 years of age and above. I think it will still be around a year from now, so maybe late 2021, early 2022, before we have vaccines licensed for under 12 years of age.

What we've seen so far is that in-vitro, in our test tubes, that the vaccines still have been quite effective against the variants. We're going to see them. That's going to happen. It may mean that this virus becomes part of our endemic viruses and that we're going to need periodic boosters, or we may need to add it to our routine pediatric vaccine schedule. I think it may be a little bit too early to know about that. And that maybe at the next PAS (Pediatric Academic Societies meeting) and hopefully in person, I can give you an update on that.

And the great news is that the efficacy of the Pfizer and the Moderna vaccine have been 94-95 percent, again, across the age group. That the AstraZeneca has been somewhere between 70 and 90 percent, and the Johnson & Johnson also has been around 75 percent. Typically, when we're testing a vaccine, there's one or two along the way. And that's why we really started with Operation Warp Speed is having multiple vaccine platforms with the hope of having one. Now we have the problem, a good problem, of probably having five available very soon. All the vaccines have worked well. All the vaccines (MORE)