RACHEL MARTIN, HOST:
Coronavirus is on the rise again in this country. The seven-day average of new cases hit record highs in 20 states. This happened since Saturday. It comes as two coronavirus studies have been put on pause by drugmakers as they investigate safety concerns. One of them is a clinical trial similar to the experimental COVID-19 antibody treatment President Trump received. It makes it clear how little we actually know about these treatments.
NPR's Allison Aubrey is with us now to talk through developments on COVID-19 treatments and vaccines. Hi, Allison.
ALLISON AUBREY, BYLINE: Good morning, Rachel.
MARTIN: So this week, both a vaccine trial and a trial of a new therapy to treat COVID have been put on pause. I mean, it sounds worrisome. Is it worrisome?
AUBREY: You know, it's really not unusual to put a trial on hold or pause. And that's what has happened with the clinical trial of a Johnson & Johnson coronavirus vaccine. I should note that Johnson & Johnson is a sponsor of NPR. During the trial, a study volunteer developed an unexplained illness that is now under investigation.
I spoke to L.J Tan, a scientist with the Immunization Action Coalition, about this. He says when there are thousands of people in a clinical trial, there will be illnesses. They may or may not be related to the vaccine. That's the point of pausing the trial until more is learned.
L J TAN: They're doing exactly what they need to do. They're doing exactly what's typically done. Investigate that one reaction and make sure that it really does have nothing to do with the vaccine.
AUBREY: Now, there's another COVID vaccine trial on hold as well - the AstraZeneca trial that happened back in September - after a second participant was diagnosed with a neurological condition. So this could slow down the process, but it won't derail it.
MARTIN: OK. Eli Lilly's clinical trial has also had some problems. What can you tell us about that trial and why they put it on pause?
AUBREY: Sure. Well, it's a trial of an experimental antibody treatment that, as you said, is similar to the one President Trump received and has been touting. This has also been paused due to a potential safety concern. This is under investigation. The company that makes the drug, Eli Lilly, said it supports this decision by an independent safety monitoring board.
Again, it isn't out of the ordinary, but there's also a report from Reuters that FDA inspectors found quality control problems at an Eli Lilly plant after an inspection last year. Now, that plant is ramping up to produce the antibody therapy.
In a statement, an Eli Lilly spokesperson told me the company had received a notice from the FDA after the inspection. It included two findings related to control of what they say are electronic systems in the plant. The company says these findings do not impact product quality or patient safety, but the FDA will likely want resolution of these issues before granting emergency use authorization.
MARTIN: So until now, Allison, kids have not been included in these COVID-19 vaccine trials, but I understand that's about to change. The Food and Drug Administration has given permission to this one pharmaceutical company to get kids as young as 12 years old in its vaccine trial, right?
AUBREY: That's right, yeah. It's become increasingly clear that children get the virus. And though they often have mild cases or they're asymptomatic, they can infect other people, especially older kids. So infectious disease experts say the best way to determine if children should get a COVID vaccine is to actually include them in the trials.
Currently, about half the participants in this Pfizer vaccine trial - that's the company that made this announcement - are in their mid-50s to mid-80s. That's understandable, given that older people are at higher risk of serious illness. But L.J Tan of the Immunization Action Coalition told me it's significant that Pfizer will expand its trial to include kids 12 and up.
TAN: So I think this is a really big deal because without clinical trials actually done in children, the only way to actually extend the use of the COVID-19 vaccine into children would be to rely on the adult data. And that's not the best way to approach providing a new vaccine for a child.
AUBREY: He says he'd like to see some of the other companies testing COVID vaccines include children, too.
MARTIN: I mean, that just seems to me - even as a parent, it raises flags - like, putting kids in clinical trials. What's the reaction to this? Have pediatricians weighed in?
AUBREY: You know, yeah. I mean, the American Academy of Pediatrics says it's important for children to be in the trials because children could respond differently to the vaccine, as long as it's done safely and effectively. And so that's sort of where we are. There is support for this.
MARTIN: NPR's Allison Aubrey, thank you.
AUBREY: Thank you, Rachel.
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