The U.S., Especially the Nation’s Children, Need Extra Protection Against COVID-19, Says Chair of FDA Advisory Panel

The U.S. Food and Drug Administration approved the emergency use of a third, so-called booster shot of Pfizer’s COVID-19 vaccine for people age 65 and older, those with underlying health conditions or who work in a high-risk environment.

The agency’s advisory panel on COVID-19 vaccines did not recommend booster shots for most people younger than 65 unless they fall into one of the high-risk categories.

The Centers for Disease Control and Prevention’s advisory committee initially went further, voting against providing booster shots to those in high-risk jobs as well. But the CDC’s director overrode that decision, aligning the agency with FDA’s recommendation.

Health experts say they believe there is an ample supply of vaccine for those eligible for booster shots.

The chair of the FDA advisory panel on COVID-19 vaccines, University of Michigan epidemiologist Arnold Monto, says the age limit for being inoculated against the coronavirus soon could expand, along with the number of companies allowed to provide booster shots.

Monto says the U.S., especially the nation’s children, need extra protection against COVID-19.

Listen: FDA advisory panel chair Arnold Monto talks about people who are seeking treatments against COVID-19 rather than vaccinating themselves against it.

Arnold Monto, chair, FDA advisory panel on COVID-19 vaccines:

We may go rather quickly to, let’s say, 40 years of age and above. Younger individuals, we’ll want to have more information on the occurrence of the one side effect that has been linked to receipt of these vaccines. And that’s heart inflammation or myocarditis. It is very infrequent, but it is occurring. And we want to make sure that we don’t see an increase in that frequency. So far, Israel, which is ahead of us in terms of the time schedule, they’re now giving it to younger individuals as well. They haven’t seen an increase in myocarditis. And actually they were the first country that noticed this. So what they’re actually seeing is less myocarditis on the third dose and the second dose.

Quinn Klinefelter, WDET News: There have been reports that FDA could soon authorize at least a Pfizer vaccine against COVID-19 for young children. In recent days kids accounted for about a quarter of all the COVID-19 cases. But I’ve also heard that they could have particularly strong immune systems, at least compared to adults. So, in your view, do you think it’s really necessary to vaccinate young children?

I think it may not be necessary, but it certainly is desirable, given what we’re seeing now. If everybody were vaccinated we probably could lower the frequency of infections in these younger individuals. But that’s not happening, unfortunately. That’s where we really need more people of older ages being vaccinated. So vaccinating children is becoming important. I think it will come. What’s delaying things is that they are now working on a lower dose for children, which seems to be just as effective, and probably is going to have less likelihood of even the rare side effects.

But there’s still a good number of people, it seems, who fear the vaccine. That it could be dangerous, that it was developed too fast, that there’s not enough known about long-term effects. What would you say to somebody that has those concerns?

I’d say that these vaccines are among the safest we’ve used. Most side effects are seen early. That’s one of the reasons why the emergency use authorization came along after two months of observation. Certainly, for those who were vaccinated in some of the clinical trials, which occurred sometime earlier, in 2020, we’ve had a reasonably long time to see any long-term effects. Of course there’s no predicting whether something is going to occur very late. But that is so rare. Most of our vaccines that have been used, like the polio vaccine, had been used extensively almost immediately after approval. So this is not unprecedented.

With this one there’s been an increase in people, at least lately, it seems, searching for ways to treat COVID-19 as opposed to getting vaccinated against it. You hear people talk about preferring to use drugs like hydroxychloroquine, or what they call the Zelenko Protocol. I’ve heard some people say they want the drugs that help de-worm horses. And some people have even taken to, apparently, repeatedly counting antibodies almost like they would count calories. What’s your reaction to these kinds of approaches?

I think this is a form of Russian roulette. They’re hoping that they will be able to treat an infection should it occur. And we know there are ample data to support the fact that ivermectin and hydroxychloroquine do not work. They are not effective in treatment. People who get on these drugs do not do better than those who do not. The only thing that seems to be working with reasonable frequency in terms of benefits is the steroids, which are being used and also, in early treatment, monoclonal antibodies.

“I think this is a form of Russian roulette. They’re hoping that they will be able to treat an infection should it occur… And some people, I’ve heard, are waiting to get infected.” –Dr. Arnold Monto, chair of the FDA advisory panel on COVID-19 vaccines

The antibodies have to be given early and they don’t ensure better response. They do improve response. And some people, I’ve heard, are waiting to get infected and then trying to get treated with monoclonal antibodies. Now that’s another little game that people are playing, which I simply do not understand. Because we don’t have any longer term safety about the monoclonal antibodies than we do about the vaccines. I think you need to remember that the situation is very fluid. It’s hard to predict exactly what’s going to happen. And we do have vaccines that are effective. This is still basically a pandemic currently of the unvaccinated in the United States. Breakthrough infections, which is a term that a lot of people don’t like, are occurring in the vaccinated. But they are much less frequent than infections in the unvaccinated.

You’ve laid out the facts and the figures and what you see happening in terms of the data. From your point of view, how would you try, or can you try, to persuade somebody to follow your recommendation? To get the unvaccinated vaccinated?

I think we should not give up in trying to present the data, the facts. It’s frustrating to those of us who live in a world of facts to see distortions and things like that taking place, which really put people at risk. And that’s the bottom line. People are being put at risk by alternate interpretations of data. We’ve got the facts, we should act on them.