Millions of Americans are in line to get one of three vaccines now approved by the U.S. Food and Drug Administration (FDA) for emergency use. The latest, Johnson & Johnson’s one-dose adenovirus vector, can be stored for up to three months in a regular refrigerator and is easier to transport. Johnson & Johnson is no stranger to the technology, having used it in its Ebola vaccine. Richard Nettles, MD, the vice president of medical affairs for the Johnson & Johnson subsidiary Janssen, says researchers are already looking ahead toward expanding its use to include children and pregnant women. Dr. Nettles is this week’s guest. Listen and subscribe on Apple, Stitcher, Spotify, or Google so you don’t miss the next episode. And if you like what you hear, a five-star rating goes a long way in helping us Track the Vax! Serena Marshall: One and done — that was always the goal for Janssen and Johnson & Johnson, correct? Richard Nettles: We know that organizations like the World Health Organization have put forward their recommendation that a single shot during the pandemic period has a lot of advantages with regard to being able to vaccinate with more ease. You can really simplify the logistics if you have a one-shot approach. Serena Marshall: But you’re the only company so far to offer a one-shot approach. So how does that set up your vaccine to be different? Richard Nettles: What we feel is that this allows the vaccine to be used in certain types of individuals and certain locations where bringing people back for a second vaccine is logistically challenging. Think about populations that have issues with travel or that have issues with finding themselves available for the second shot … transient populations, homeless populations. And then again in rural populations where people have to travel long distances to get that second shot, this opens up the possibility of vaccinating people like that. Serena Marshall: How does it feel to get the shot? What can people expect from your vaccine? Richard Nettles: Just like with all shots, one of the main side effects that you’ll feel is pain in the arm where you’ve been injected. But the pain with this vaccine is very similar to those vaccines that you’ve gotten in the past. So your arm will probably be sore for a day or so, just like with other vaccines, and then you may have fatigue, headache, body aches. Usually, those last for about a day. Actually, most people don’t experience those side effects. About 9 percent of individuals experience a fever. And again, that usually starts that first day and will go away after the first day or so. Serena Marshall: The J&J vaccine uses the adenovirus vector. It’s a format that you’ve used previously with the Ebola vaccine. There is some concern that people can build up immunity to adenoviruses. Is it something that you’re worried about? Richard Nettles: This is something that we’ve looked at, and we have not seen evidence that would give us concern. So we’ve looked in our other trials using this same adenovirus platform when we’ve developed vaccines for HIV, RSV, Ebola, and Zika. And in some of those trials, and some of those vaccines, it requires a series of shots. We have not seen that on the second, or the third, or the fourth time that you received the vaccine that you respond with less of an immune response. So we haven’t seen evidence that you’re developing a resistance to the vaccine. Serena Marshall: What about testing the vaccine in children? Richard Nettles: We are planning to start extremely soon. We have used the adenovirus platform in children down to the age of four months in our Ebola program. So we’re comfortable with the adenovirus platform in children, and we have plans to conduct clinical trials in children with the coronavirus vaccine. Hopefully, as soon as possible, we’re able to demonstrate that in adolescents age 16 and 17 the vaccine is safe and effective. We have plans then to start the clinical trial very soon, any day now, in children 12 and older. And if it’s found to be safe and effective in that group, [we will] dose children younger than 12. Serena Marshall: I believe you are also studying the vaccine in pregnant women and the immunocompromised. Is that a separate trial? Richard Nettles: It is a separate trial. Again, we’ve used the adenovirus platform in pregnant women in our Ebola program. We have now posted on ClinicalTrials.gov a clinical trial design to move forward and begin dosing in approximately 800 pregnant women. So again, we’ll move forward with that trial in a way that is as fast as we can, but also as safely as we can. And then later this year we’ll begin a specific trial where we vaccinate individuals who are immune compromised.
