In this week’s episode, we speak with Zachary Brennan of Politico about the newly approved coronavirus vaccines, their distribution plans, and how these advances are poised to change the course of the pandemic.
Jeffrey: Hello and welcome to the RP HealthCast by RooneyPartners. I’m your host Jeffrey Freedman.
Jeffrey: I have never run a marathon, but I can only imagine that this is what it feels like towards mile marker twenty. I mean, it is 2020 and I am physically, mentally, emotionally drained right now. But I see an end. I could literally see the finish line in the distance. Just like my runner friends at mile twenty, who still have to push through and find that mental toughness to cross the finish line, our nation also, has to buckle down. We have to be safe. We have to find that mental toughness and wait for enough vaccines to get us through to the end of the pandemic. And again just like our runner friends at mile twenty, our country is at its most fatigue point in this pandemic. And because of that, we are at its deadliest. But this pandemic’s finish Line is in sight. The FDA has now authorized a second vaccine. And very shortly, millions of people around the country will start getting vaccinated.
Jeffrey: To talk about the two different vaccines and the distribution plans, I am delighted to be joined by Zachary Brennan. Zach is a healthcare reporter for Politico.
Jeffrey: Zach thank you so much for joining us today.
Zach: Thank you so much for having me.
Jeffrey: Yeah. Now 2020, it is almost behind us and we have some pretty good news on a couple of the vaccines. Now the first, the Pfizer-BioNTech vaccine, which has been pretty well documented, and it is already going into people right now, and now the vaccine from Moderna, which may get emergency use authorization later this week, can you talk to us a little bit about the types of vaccines that these are and what makes them different from vaccines we have seen in the past and what makes them different from each other.
Zach: Sure. So both the Pfizer and the Moderna vaccines are what are known as mRNA vaccines which have never previously been FDA approved or authorized to prevent infections from any other viruses. So what they effectively do is explain to ourselves the instructions on how to make this particular type of protein, known as the spike protein, on the coronavirus. And that is exactly what triggers a response in us and can protect us in the future from getting infected with the coronavirus. So as far as differences from each other, the Pfizer one actually requires a little bit colder conditions for distribution and storage. The Pfizer one has to be refrigerated for up to about five days and the Moderna one is more like up to thirty days. So there is a bit of an advantage for the Moderna vaccine there. But overall, in terms of safety and efficacy, I think the data have shown that they are pretty similar, both are about ninety-five percent effective overall. Both were tested and more than thirty thousand participants in each of their trials. And the Moderna one actually might be a little bit better at protecting against severe COVID. But again, the data is very limited and we really will not find out more until both of them are used in much wider general populations.
Jeffrey: Right. And you said this is the first time, anything like this mRNA type of technology is being used. I mean historically, we are so used to whether it be the flu or the chicken pox or the mumps. Those are like the infection that disease itself or dormant parts of that disease that has been given to us and you are saying this is completely different?
Zach: Yeah, exactly. So basically, this is inserting a piece of this mRNA in a certain way into ourselves. So as to teach our bodies how to fight against the coronavirus rather than introducing, as you mentioned, like a live attenuated vaccine or you are basically introducing a form of a piece of the vaccine straight into the body to teach your body in that way.
Jeffrey: Got it. Thank you. Now, listening to the operation warp-speed, press conferences months ago. They were talking about eight or nine different types of vaccines that were supposed to come to market and what happened to some of these others? What is going on with the AstraZeneca or Johnson & Johnson or Novavax’s vaccine?
Zach: Yeah. Exactly. So the federal government has funded six vaccine so far and there might be additional funding for more on the future. But right now, we are looking at these three upcoming ones from AstraZeneca J&J and Novavax. The AstraZeneca one has been a little bit of a surprise. US, early on, purchased about three hundred million doses of this vaccine and in early trials in the UK and Brazil, they showed that two doses of the vaccine was about sixty percent effective. But then for this other sub part of the trial, one and a half dose has proved to be about ninety effective. So they are still trying to figure out what is going on, why the dose and a half worked better than the two doses? Although there is a trial in the US still ongoing for the AstraZeneca vaccine that is two doses. And we should know more later this year or early next year. The J & J one is very interesting because it is a single shot vaccine. So unlike the Moderna or the Pfizer or the AstraZeneca or the Novavax, it is one of the only ones that is a single shot. And again, we should know more information about their trial in about forty thousand people later this year, sometime early next year. And then I would say Novavax is a little bit further behind than J&J and AstraZeneca. They have just completed an enrollment in a UK trial in about fifteen thousand people and they are hoping to start a US trial pretty soon, hopefully later this month or early next month, so we should know more.
Jeffrey: Yeah, I mean, it seems like hundreds of millions of dollars and maybe even billions of dollars are still being spent on the R&D and the research of all these different therapies in trial but from a financial point of view, or I actually I do not even know, if the expectation that the majority of Americans that want vaccinations are going to get vaccinations by the summer, what type of market is there going to be for these other vaccines?
Zach: So there actually should be a pretty big market for these other types of vaccines. We have heard estimates of anywhere from five to ten vaccines being necessary to vaccinate not just the US and Europe, but the entire world. So, we will have to wait and see how the data read out on these other vaccines but I think all estimates point to needing more beyond the Moderna and the Pfizer vaccines particularly for more rural areas of the globe. But yeah, I mean, hopefully the US market will be all set by late 2021.
Jeffrey: Okay. Earlier, you mentioned that being able to store these cold or distribute these cold and, we are talking the Moderna and the Pfizer vaccines, and the distribution plan seems very very difficult. The logistics for this is just astronomical. Can you talk a little bit about the distribution plans and how it is being handled and you know why is it so difficult?
Zach: Sure. So basically, the way that it is working in the US is that each state has pretty much come up with its own plan and designated certain sites where the federal government or Pfizer can distribute individual shipments of the doses to specific places. It is, again, as you said, very tricky because Pfizer’s are coming in batches of nine hundred and seventy-five doses and Moderna’s are coming in batches of a hundred doses. So, Pfizer, for example, you say[?] the first two point nine million doses that are going out earlier this week and later on this week and those went out to about six hundred sites nationwide. So, this is just an incredible amount of manpower in terms of getting all the doses in Pfizer’s case from their manufacturing plant in Kalamazoo to the various far-flung places across the country. And with the help of UPS and FedEx and some other companies, so I guess we will see over the next few months if there are any hiccups. If states need to kind of adjust the process a little bit to ensure that the appropriate people are being vaccinated at the right time.
Jeffrey: Yeah, I guess also to add another, I guess hiccup to this is you mentioned that with these vaccines, you need two doses. So, can you tell us how this is supposed to work? I mean, especially that the vaccine in such short supply. How do you know it is going to be available when you need it? And what happens if you miss the window? And one other question too, you just mentioned that Pfizer ships it in batches of nine hundred and seventy-five, now that is an odd number. So, it cannot meet the need.
Zach: Yeah. It is interesting that you asked that because that was actually a question that I asked operation warp-speed officials was if you have one shipment of the nine hundred and seventy-five doses and you send it to a hospital with 47 doctors, what do you do with the remaining doses? And that is where coordination among states and among the different jurisdictions is going to be really key and among the different sites within states is going to be really key to keep all available communications open so that they can quickly transport vaccines. As I said earlier, they need to be refrigerated for up to five days so there is only a limited window in which they can work. Going back to what you said, as you as you noted, they both require two doses either three three weeks apart for Pfizer or four weeks apart for Moderna, which does create all sorts of logistical issues. The government is providing everyone with this little piece of paper. That is a card that tells you when you should go in for your second dose, what vaccine you received. And some of the some pharmacies like CVS and Walgreens are also setting up a little bit more detailed reminder systems to provide everyone with information on what is going on and when they should come back for their second dose. But as we saw with the AstraZeneca trial, which was halted for a lot of month, pretty considerable time, they investigated as a safety event that was actually not a major issue. So but first say for the first batch of 2.9 million doses of the Pfizer vaccine, they actually have 6.4 million on hand. So they are only sending out the first batch to 2.9 million people to get their first dose and then saving another 2.9 million for all those who received their first dos.
Zach: The sites themselves will administer one dose, too for every dose that they have. But it is the federal government, that is controlling the supplies, is holding back the second shot for each person that they sent out the first dose for.
Jeffrey: It just adds another layer of risk to the logistics to ensure that these deliveries get there in time. But you also mentioned that it is okay to get it past the three week or for week timeline. It is just not good to get it before that three-week or four-week timeline. Since these are in such short supply and you said they are both made from an mRNA technology, this is probably a silly question, but can you take the Pfizer vaccine if your first shot was the Moderna version?
Zach: No. So they have not run any trials yet in terms of mixing and matching doses between the different vaccines. So no, that is not a possibility yet. But hopefully at some point there will be a little interchangeability between some of the doses.
Jeffrey: Okay. And you mentioned before, that you mentioned the efficacy for those two are 95 percent approximately. You also said they seem to be safe so far, but I understand there are some side effects and there was a warning and I guess it came up in the UK that people with significant allergies probably should not take the shots. Can you talk a little bit about that?
Zach: Sure. So yeah, as you mentioned, in the UK, on the the first day that the visor vaccines were actually administered, two people had severe reactions and both had had a history of severe allergic reactions in the past. And this was not a group of people who were included in the Pfizer trial. So I think that is kind of why people were a little bit surprised. But basically, the FDA said in the warning section of the Pfizer label that those with a history of allergies to vaccine ingredients or other components should not take the Pfizer vaccine. There was a lot of discussion at the FDA advisory committee meeting on this topic and the members actually seem to suggest that the warning was very necessary because there are millions of Americans with these types of allergies and who carry an EpiPen with them in case something like this pops up, but overall they did not seem to think that this was going to be a major concern that would slow the launch of the Pfizer. vaccine.
Jeffrey: Okay. That is great. Now, lastly, while these vaccines coming for wishing[?] are certainly turning point in our fight against the pandemic, in terms of what is going on right now in the world, the severity of the spread, what do you see happening over the six to nine months to the majority of the country gets vaccinated? Do you think we are in the worst of it right now? And do you see it scaling or sliding down or? What is your opinion? What are you thoughts on this?
Zach: Yeah. I mean we have heard recently that COVID cases will hopefully peak sometime in January, but this month, next month, and February are really going to be difficult months for this country and hopefully vaccines will help some of the more vulnerable populations. But it really will not have as big of an impact until we get into, say, later next summer or even later next fall. And again, hopefully by then, we will have more than just the Pfizer and the Moderna vaccines and we will have hundreds of millions more doses of some of these other vaccines that proved to be effective and can really do some damage against this virus.
Jeffrey: Do you think people will have choices in which vaccine they will be able to take? Or you get what you get?
Zach: Yeah, so I get that question a lot. I do not think so. Certainly, not in the beginning of 2021 but hopefully by the end of 2021, there will be enough vaccines that are marketed either via approval or authorization and everybody will get to pick whichever one they want. But no, hopefully by then the entire American population has already been vaccinated. So we will see.
Jeffrey: And I hope they do. I mean there is a whole rash of vaccine hesitancy, which I have covered a few times over the past couple months. But I think, well, let me get your opinion. Do you think that the FDA has handled this approval process? The EU, emergency use authorization process wisely? Would you have liked to have seen them do anything different?
Zach: Yeah, I think that they have done a really good job in kind of explaining all of the safety concerns that they have had with both the Moderna and the Pfizer vaccine and they have been very upfront that they have not seen anything significant and yes, there are minor side effects like, injection site pain and fatigue and headache but you know overall there were not concerning trends and they are going to be following each and every person who has been vaccinated very closely and very carefully to make sure that they really hone in on whatever side effects are out there. So I guess I am confident in the system working. But it is going to get really difficult, especially when you know some members of the elderly or other people that are prone to heart attacks and other things, get sick and there needs to be a little bit of process where they try and figure out whether or not it is vaccine related and things like that. So there are going to be bumps along the road ahead of us. For sure.
Jeffrey: Yeah. I hope those bumps are slight and I, for one, am very much looking forward to taking the vaccine. I probably will not be until the middle of the year, when when my number comes up, but I look forward to it.
Jeffrey: Zach, thank you so much for joining me today. This has been really educational and very helpful and insightful. So, thank you so much for your time.
Zach: Excellent. Thank you for having me.
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