Personally, I have been very reluctant to get the COVID-19 vaccine made by Pfizer & Moderna… the process that is used to create those vaccines has never been used before and they have been brought to market after a couple of months of clinical trials and EMERGENCY USE AUTHORIZATION… as opposed to most clinical trials on new med lasting 10 + YEARS. The bureaucrats – think Dr Fauci and other bureaucrats – have stated that there is no proof that a person getting a Pfizer or Moderna vaccine that the pt will have antibodies after as few as 90 days…. still recommending wearing masks, social distancing and hand washing and they are just now doing some research if those vaccines will be effective on the African and Brazilian mutations.
The new J&J/Jansen vaccine was approved last Friday and Barb and I have our reservations to get this SINGLE DOSE vaccine on March 13th. Why do I chose this particular vaccine over the other ? This vaccine was developed using a tried and true methodology that has been used for decades to make flu vaccines every year. It also only has to be stored at normal refrigeration temperature…. little/no chance of it being outside of its recommended storage temp too long and pt being given a vaccination that could be compromised and potentially WORTHLESS.
The percentage numbers may have numbers that compare to the other two vaccines – at first glance – less desirable than the Pfizer and Moderna versions, but this J&J/Jansen version has had people in the clinical trials that had been exposed to the African and Brazilian variants of COVID-19 and people who became infected with those two variants – THERE WERE NO DEATHS. IMO… that is a GREAT OUTCOME for any medication… treating a serious health issue.
None of these vaccines may provide a really good long term protections… personally, I am just hedging my bets on which one may produce the best and longest antibodies… there are no guarantees on any of them.
Latest COVID Vax: One and Done?
https://www.medpagetoday.com/podcasts/trackthevax/91436
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Millions of Americans are in line to get one of now three vaccines approved by the FDA for emergency use. The latest — Johnson & Johnson’s one-dose adenovirus vector — can be stored for up to three months in a fridge and is easier to transport.
Johnson & Johnson is no stranger to the technology, having used it in its Ebola vaccine. Despite its rollout goals of 100 million doses by June, Rick Nettles, MD, vice president of medical affairs at J&J’s Janssen division, says researchers are already looking ahead to expanding its use for children and pregnant women. He joins this week’s episode.
The following is a transcript of his interview with “Track the Vax” host Serena Marshall:
Marshall: Dr. Nettles, welcome to Track the Vax. I want to jump right in. One and done. That was always the goal for Janssen and Johnson & Johnson. Correct?
Nettles: Well, we know that organizations like the World Health Organization have put forward their recommendation that a single shot during pandemic period has a lot of advantages with regard to being able to vaccinate with more ease. You know, you can really simplify the logistics if you have a one-shot approach.
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 outside of, you know, just getting the single dose, not having to go back for a second one in a couple of weeks?
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. And so you can 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.
Marshall: One of the big questions a lot of people have for the current ones that are on the market here in the U.S. is reactogenicity for the mRNA ones: how does it feel to get the shot? So what can people expect from your vaccine?
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.
And usually those last for about a day. Actually most people don’t experience those side effects, but if you’re going to have side effects, that might be what you have. And then about 9% of individuals experienced a fever. And again, that usually starts that first day and will go away after the first day or so.
Marshall: And that fever often is your immune system responding. So it could be a good sign, right?
Nettles: Yeah, it is a sign that your immune system has recognized that the vaccine has been injected and it is starting to mount a response. So it is a good sign.
Marshall: Now in your study, you found that full immunity was at the 28 day mark. We’ve heard that it normally takes about two weeks for your immune system to respond. So, is 28 days the sweet spot after vaccination? When you don’t have to really be concerned about getting sick anymore?
Nettles: Well, everybody’s immune system reacts somewhat differently. We do see response, based on some measures, as early as seven days after this vaccine. So the best guidance that you can give with this vaccine, and with all the vaccines, is that you need to continue to socially distance and wear a mask.
Until we have really tamped down the pandemic to a greater extent. But yeah, after 28 days, that’s really where we started to see the strong protection against the severe disease or need for hospitalization or death.
Marshall: No, that’s an interesting marker, too… the need for hospitalization or death. Because that was really what was quite remarkable. A 100% of zero hospitalization or death after the 28 day mark. But I want to ask you about your definition of moderate to severe COVID, at the committee meeting they pointed out that your definition was two symptoms and a positive test, which the FDA committee had said was basically symptomatic COVID for everyone else.
Can you explain for us how you guys came up to your definitions and why you chose different definitions than some of the other vaccine makers?
Nettles: The science of the coronavirus infection has changed so rapidly. This is a disease that we didn’t even know existed a little over a year ago. We used definitions that the FDA has set forth in our protocol and comparing to other vaccine trials, slightly different definitions were used for moderate or severe disease.
That’s just a manifestation of how our definitions have changed over time with some of these endpoints.
Marshall: But even the FDA adcomm committee, the committee did say that it’s basically symptomatic COVID, as moderate to severe. So does that mean that after 28 days there were zero cases of symptomatic COVID
Nettles: No. So our primary endpoint was moderate to severe COVID. If you included all the cases, there were just a very small number. So what you’re seeing overall is 66% efficacy, prevention of symptomatic COVID in the clinical trial.
We completely agree with the FDA and with the ACIP. What I’m saying is that if you take all cases of COVID, regardless of how many symptoms they had, there were very small number that you would add to that count.
And so statistically, all symptomatic COVID versus mild to severe COVID, you’re going to see the same level of efficacy in our trial.
Marshall: When it comes to asymptomatic transmission, did you look at that? And what is your data show so far?
Nettles: We did. We looked at that question by looking at people who had no diagnosis of COVID. But then during the followup time they had a positive antibody test. And they had a negative antibody test at baseline. So if you follow what I just said, this is somebody who didn’t know that they had been infected, but their antibody tests had become positive. Indicating that sometime after the start of the test, they had experienced COVID and they had no symptoms of it.
And what we saw in our trial is evidence that those who received the active vaccine had protection against even that asymptomatic COVID situation. Now, the trial wasn’t designed for that.
And the real way to look at prevention of asymptomatic COVID would be to do periodic nasal swabs. And the design of the trial did not allow for that. So we see evidence that it might be working, but it’s not definitive and more work needs to be done along these lines.
Marshall: Are you guys doing that more work? Are you following that up to see if it will prevent against asymptomatic transmission?
Nettles: We’re in discussions with CDC and others on what that trial design would look like. And yes, we’ll look to do that.
Marshall: And just going back to the data that you did collect. You said the study wasn’t designed for it, but you do have some of that data and it looks promising?
Nettles: It does. There is a signal that the vaccine may be demonstrating protection, even against asymptomatic COVID.
Marshall: And now you guys did include some of the different strains that we’ve seen pop up globally as part of your study?
Nettles: It’s one of the most important aspects of our phase III trial, which was called ENSEMBLE. We conducted the trial in South Africa, in South America and in the U.S. So the trial was actually done really at the height of the global pandemic. And we know that the variant, which was first identified in South Africa. Over 90% of the samples from South Africa, that variant was present.
So we know that that trial was conducted while the South African variant was circulating. Likewise in South America, we did see the one of the variants that has been circulating in Brazil present. And despite that we showed that after 28 days, we had no deaths and no COVID related hospitalizations, even in South Africa and in Brazil where those variants were predominant.
In our current phase III trial, that we’re discussing here today, we were not located in England, so we don’t have data with that variant. However, we have other trials going and in those trials we will gain that type of information.
Marshall: And your current trial, that ENSEMBLE one was not being run in the U.S. as we started to see the U.K. strain spread stateside. Correct?
Nettles: The ENSEMBLE one was enrolling in the U.S. We just don’t have very many of those variants in our clinical trial.
Marshall: Okay, but that is something that you guys are looking at…would you be able to tweak the current vaccine to meet the need? If it was necessary to be tweaked?
Nettles: We actually think that we will have activity against that variant. So, based on that variant, we don’t think that we need to make that adjustment. We’re always looking at our vaccine carefully and monitoring the variant status. And we would be in a position where we could alter this vaccine, if we would need to do that.
Marshall: You guys use the adenovirus vector. It’s a format that Johnson & Johnson has used previously with the Ebola vaccine. Now there is some concern though that with Adenovirus that people can build up immunity to them. The type of adenovirus vector that you’ve used, it sounds like that hasn’t been the case at all. Is it something that you’re worried about?
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.
And 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. And the other way we’ve looked at it is, looking at individuals who have natural immunity to the adenovirus, they’ve experienced the adenoviruses as an infection in the past.
And again, in those individuals, we don’t see less of an immune response. For instance, many of the individuals in South Africa had baseline adenovirus antibodies. And again we saw that complete protection against hospitalization or death after 28 days with the vaccine. So that’s promising.
Marshall: And you mentioned some of those other vaccines that J&J is used with adenovirus vectors. Do you research that it’s translatable to the ENSEMBLE and to the COVID vaccine to say how long we can expect immunity to last? That’s a big question for a lot of folks across America and the world, is how long will I be protected?
Nettles: One of the reasons that we like this platform is that we do see a very nice antibody response, but also a cellular response. And one of the most important jobs with that cellular response is to develop an immune memory. So it’s promising that you will have a nice cellular response to this vaccine, as well.
But to directly answer your question, we don’t know yet. It’s one of the most important questions that all of the different vaccine makers are trying to understand. When you’re going to need a booster shot. Do you need one six months later, a year later, two years later, five years later, we just don’t know yet. We have the studies ongoing to prove that, but right now I can’t give you a good answer.
Marshall: Not for COVID, but for perhaps some of your other vaccines that use this technology. Is there anything that might be a little translatable to say: well, that one that lasted for two years or five years.
Nettles: No. I think that each of the vaccine types will have to be studied on their own.
Marshall: Okay. That’s good to know. I know a lot of folks are looking at this and saying: Oh, you’re using the same thing that you used for Ebola. So maybe it means it’ll last a little bit longer in my system.
Now when can we expect these to roll out? The Biden team has just said that they expect to have about 4 million shots this week, but none the following week.
I know, Dr. Nettles, you had told a congressional committee that by the end of March, you’d have 20 million Americans vaccinated. A big goal that everyone’s waiting on, but what can we really expect, reality wise.
Nettles: We have approximately 4 million of the doses available to ship now. We will have 20 million by the end of March. And we’ll have enough to vaccinate 100 million Americans by the end of June.
Marshall: I want to switch gears a little bit here. You’re already testing this in kids, right? Over the age of 12. That’s a study that’s currently ongoing?
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.
We really, hopefully, as soon as possible, are able to demonstrate that in adolescents 16 and 17 that we show that 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 to dose children and younger than 12.
Marshall: Now you just mentioned 16- and 17-year-olds. That’s the one that’s ongoing. Then when do you expect to have that research available and request approval for that group?
Nettles: it depends on how quickly the trial enrolls, but we hope over the next several months.
Marshall: And then the children 12 and up, and then followed up by the infant and older groups. When would you expect those vaccines to be approved and rolled out?
Nettles: Again, it depends on how fast the trials are able to enroll. The 12 to 17 we hope to have that information later this year.
Marshall: Okay. And what about the infant and up? You mentioned that you use a platform that’s studied previously and four months and older. So when do you think this vaccine that you guys use, if it proves effective and high efficacy for that age group, to be recommended for infants?
Nettles: Again, it gets harder and harder to predict the further we go out. But we’re going to conduct the trials as soon as we possibly can. And in a way that is safe and driven by the science. So hopefully sometime over the next year, but very hard to predict how fast the trials will move.
Marshall: Sure. No, that’s understandable. And one of the groups that I believe you guys are also studying is pregnant women and immunocompromised. Is that a separate trial?
Nettles: It is a separate trial. Again, we’ve used 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 have an immune compromise.
Marshall: And you’re also doing another trial, Dr. Nettles, with two doses. Is that correct?
Nettles: Yes, that’s right. That trial is a phase III trial called ENSEMBLE-2.
Marshall: What made you guys decide if you had great efficacy with one dose to go ahead and enroll another 30,000 individuals and try this with two doses?
Nettles: We planned the two-dose trial, you know, right from the start, in parallel with the one dose trial. And so as we started with, during the conversation, during a pandemic period, a one-dose clinical trial has many advantages allowing you to more efficiently vaccinate a large number of people.
But we also planned a two-dose trial at the same time. Though that’s lagged somewhat behind. It’s a little bit more complicated and you have to bring individuals back for that second dose. So we don’t have results of the two-dose trial. But we use science to guide our clinical trial program. So if at the end of the day, we see some advantages to a two-dose approach, after the pandemic, that’s likely how we would recommend our vaccine to be used.
For instance, maybe the durability is better when you use a two-dose approach. We just don’t know yet. So it’s part of a comprehensive and thorough research and development program that led us to do both the one- and the two-dose approach.
Marshall: Would you see a scenario in which those who got the one dose would then be recommended to get another one? Or would they start the regimen all over again?
Nettles: It depends on what the results that we see from the trial that we’ve conducted. I think the important message though is that with that one-dose vaccine we see extremely promising results. And people can expect that that high level of protection against severe COVID will be achieved at the one dose approach.
Marshall: I think that’s part of the reason a lot of folks are looking at this and saying: well, if it’s so great with one dose, why even bother trying with two?
Nettles: It’s not as if we saw the results of the one dose and said: Uh-oh, we need to study it as a two-dose approach. We planned both at the start and now knowing that the one dose works so well I’m not sure we would’ve made the same decision. But part of a thorough approach to fully understand your vaccine, it’s pretty common that you would study multiple different ways to give it and multiple different doses. But we’re extremely happy with the results that we’ve seen from ENSEMBLE-1. And the one dose approach we think is extremely promising.
Marshall: If the two-dose regimen proves more effective or effective in a different way, would you recommend the one-dose versus two-dose for different populations?
Nettles: It’s too early to say. We would have to see the results of the trials to make that decision.
Marshall: Okay. So there’s not like a certain demographic you’d be targeting for two-dose versus one.
Nettles: No, it would really depend upon, you know, what is the status of the pandemic and what were the results of the clinical trials. I think people should be assured that with that one-dose approach, we’re seeing results that are very, very promising.
Marshall: And Dr. Nettles, I want to wrap up here by asking you about heterogeneic studies. It’s something we’ve talked to some experts about. That they mentioned that that might be something we’re looking at in the future, where you get an mRNA vaccine and an adenovirus vector vaccine, in order to just improve your immunity.
Is that something J&J has considered doing in any format? Perhaps partnering up with one of the mRNA vaccines, or are you doing your own study on those?
Nettles: It’s not something that I’m aware of that we’re having discussions about right now. We’ve been really focused on gaining that FDA authorization, and the CDC recommendation. And we’re having similar discussions with health authorities around the world about that. If we see a need or a potential benefit, we’re always very willing to partner with others in our development program or to partner with investigators, who’d like to explore alternative approaches. So certainly if we see that there’s a potential benefit of something like that, we’d be interested in, in exploring.
Marshall: A lot of science is still out there to be discovered and researched.
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Filed under: General Problems | 3 Comments »
Today, I got my first email from a pt that some data keying errors from a Walgreen Rx dept staff… has caused the pt to get toss from one of his/her practitioner’s practices. It would seem that whoever keyed in one of the pt’s routine C-II Rxs that she gets from a large multi prescriber practice. Apparently, whoever keyed the Rxs into the system did not know which prescriber that the pt saw – signature was probably not legible – so they just chose one of the names on the top of the paper Rx at random and over several months… the state’s PDMP was showing that the pt was getting the same medication FROM FOUR DIFFERENT PRESCRIBERS – never mind that all the prescribers were at the same address, same practice… apparently Narxcare picked this up from the state’s PDMP database and their computer assigned this pt a HIGH OD RISK SCORE… and everything started hitting the fan when the pt’s prescriber pulled the state’s PDMP report and the Narxcare report was attached.
When Narxcare was first announced, it was not clear how many different databases that they were going to pull information from on a pt to determine the final risk score. This one incident clearly shows how the careless input of data at the pharmacy Rx dept… can SNOWBALL thru the PDMP to Narxcare and who knows what other databases Narxcare picks up data points that may – or may not – actually belong to the pt. Never the less, Narxcare publishes a “OD RISK SCORE” for the pt… there are some “warning” footnotes on these reports… but don’t expect a lot of medical professionals to read them.
