In this week’s episode we speak with science writer, author, educator and photojournalist, Tara Haelle, to discuss the vaccine approval process and how political meddling could undermine the public’s perception of a coronavirus vaccine and their willingness to get it.


Jeffrey Freedman: Hello and welcome to the RP HealthCast by Rooney Partners. I am your host Jeffrey Freedman.

Jeffrey: Our government and our scientific Community have moved mountains over the past eight months to make the idea of a Covid-19 vaccine almost a reality. To give you some perspective, I mean, the quickest vaccine ever developed was for mumps, and the approval time for that was about four years. But for other diseases like HIV/AIDS, it is been over twenty years of research and we still do not have a vaccine.

Jeffrey: So the warp speed committee is aptly aimed.  We are racing at warp speed to develop this cure, but with speed comes certain risks and we are relying on our scientists on our medical professionals and our government agencies to assess these risks for us and to make sound decisions for the better welfare of our country and for the world. If public opinion in this process turns from trust to skepticism and the acceptance of these decisions creates an atmosphere of mistrust, all this hard work of creating an approvable vaccine could go to waste, especially if a large percentage of the population will not trust or take the vaccine.

Jeffrey: To help us analyze the situation and discuss all the variables in this we are delighted to have, Tara Haley. Tara is a health journalist who specializes in writing about vaccines infectious diseases and other medical research. Her work appears in the New York Times, NPR, Forbes, Medscape, all over including her evidence-based parenting blog, Red Wine & Apple Sauce.

Jeffrey: Tara is also the author of, The Informed Parent, a science-based guide to the first four years and young adult nonfiction book. Vaccination investigation. The history and science of vaccines, and she is written about a dozen children science books as well. She frequently speaks on vaccine hesitancy, including doing a TEDx Oslo talk, on why parents fear vaccines and on public health communication and on Mental Health.

Jeffrey: Tara, thank you so much for joining us today.

Tara Haley: Thank you for inviting me to be here.

Jeffrey: So in my opening, I was discussing Operation Warp Speed as both a blessing and a curse. On one side, we move mountains to get to this point and vaccine development, but now on the other side we are at risk of making force decisions here at the very end. This could jeopardize all the good and risk the public’s trust in the overall process. So what I would like for you to do if we can, let us start here with the very basics. When we hear talk about politicization of the vaccine process, what exactly does that mean? I mean, who are the players in the vaccine approval process, and what roles do they have?

Tara: Well in what I will call normal times when we are not in the midst of a global pandemic, there is a specific process that is followed with the development of any vaccine, and that is that you have various universities, research institutes and pharmaceutical companies all trying to develop different types of vaccines. They go through the standard process of trying to do the basic science to develop the vaccine candidate and then they begin Phase one trials and then if those are successful and do not show concerns on safety issues and show some level of effectiveness, then they move on to Phase two and Phase three. Once they make it through Phase three, which only gosh, I think less than ten percent of vaccine candidates ever make it that far, that is when they… the manufacturers go ahead and compile all the evidence from the clinical trials and submit that in an application to the FDA.

Tara: The FDA then has a committee that goes through and looks at all that data that committee is called, The Vaccines and Related Biological Products Advisory Committee. They look at that, and then they make recommendations based on that data and that particular committee is an open committee in the sense that the public can view those meetings and it is all very transparent. Whatever they recommend it then goes to like the FDA as a whole and the FDA decides whether to approve that vaccine for licensing to a license it for use.

Tara: If it does make it that far and all the way through it it is licensed for use, it is then kicked over to the CDC, and the CDC has a committee, ACIP, The Advisory Committee on Immunization Practices. The people of ACIP who are all independent non-conflicted experts in a very wide range of everything from Immunology to autoimmune disease to pediatrics, nursing, I mean, cardiology, a wide range of things. They look at the data and decide who should get this vaccine. How many doses should they get and how spaced-out should those doses be, and they decide the type of recommendation. Is it a recommendation where they say everyone in this age group should get this or they might say as they have with a couple other past vaccines only get this if you are doing X, if you are pregnant or if you are going to such and such a country or have a shared decision making with your doctor to decide whether you think you should get this or not.

Tara: What ACIP then recommends gets kicked up to the whole CDC which just about always implements exactly what ACIP recommended, and those become you are officially recommended vaccines. That is the full process. Politicizing that means that you have political actors getting involved in some part of that process. Either trying to influence the speed or trying to define how the FDA will assess the evidence. The FDA does have some called, an Emergency Use Authorization. An EUA, and that is a way to speed things along fast track them. But even if they fast-track approval and licensing that can only happen if the data supports it. It is not like they are skipping steps. It is just like they are getting in the fast lane but you still have to go through all the hoops that everything else goes through. There still has to be very solid efficacy data and safety data or it is not going to get the E-Way or at least it is not supposed to and this is where we get that politicization. We have already seen the use of two different E-Ways with non-vaccines, but with therapeutics with the convalescent plasma and with hydroxychloroquine, which the FDA issued E-ways for even though the evidence did not support it. And both of those were a direct result of the administration’s interference.

Tara: Now, I do not know all the details of what goes on behind those closed doors, but it was very clear that the FDA was not following the normal procedures that they would, because the data did not support the emergency use authorization. The concern is that that will happen with the vaccine. And we are especially seeing that right now because the president is touting the idea that the vaccine will be available before the election and there is absolutely no reasonable timeline in which that can happen at all. It is not going to happen. He is insisting on it. So there are concerns that he is going to try somehow to strong-arm someone somewhere to get an actual approval and get people in line that are getting it. I do not know what exactly he has in mind for that. It would be going down a bit of a rabbit hole to try and second guess what is going on in the president’s mind, but we can safely say that the rhetoric he is currently promoting does not match up with what the science flat-out allows for.

Tara: And so the politicization is any type of meddling, influencing, attempts to change, interfere with the process that is already laid out that we have been following for decades.

Jeffrey: All right, so I guess to sum up a little bit, you are saying that the president in order to help with his chances of re-election. And to assuage the country in his handling or show the country how well he is handling the pandemic crisis is strong-arming. If that is the right word. The scientific– is it scientific leaders or is it political appointees?

Tara: That is a really good question. Robert Redfield, the head of the CDC is a political appointee as is the head of the FDA. So both of them being political appointees theoretically can be dismissed by the president. However, you have an added complication here which is VRBPAC and ACIP, those two committees I mentioned. Those two committees are our safeguard, their both fully transparent. All of their meetings are broadcast on webinars. Any person can submit questions to it. Any person can view it and the members of those are not… they are not employees of CDC or FDA. They are independent non-conflicted independent experts. They are people with MDs and PHDs and DOs who are all experts in immunology, vaccinology, all the different fields you need to have something in to assess both the efficacy and the safety data and to look for can safely concerns. They have people on their explicitly for that purpose

Tara: The president cannot interfere with those committees. There is nothing he can do in those, and there is no reason to think that the members of those committees could be influenced by the president. The concern is what happens if those committees are skipped. Especially VRBPAC in particular since that is the licensing process at the FDA. If VRBPAC is skipped, you could not pay me enough money to get the vaccine myself and I say that as someone who is fully up to date on all my vaccines on a regular basis. So that is really what the concern is… there are certain bureaucrats that the president cannot easily dismiss such as people at the NIH or it is a very complex process but the head of the CDC and the head of the FDA are much easier to kick out. I am not sure that would serve any purposes. However, it would not do any good.

Tara: It is clear that President Trump wants to appear as though, he is providing the solution to the pandemic in the form of the vaccine and then delivering on a promise of a vaccine before the election. I do not know what is going to happen when that does not happen because it just I do not know how, I do not know what he is going to try to do to show that that has happened. I do not see any scenario in which that is plausible.

Jeffrey: Now, even though the FDA has kind of a magic fast-pass if you will with this Emergency Use Authorization. With this fast-pass, can a vaccine get into the public and to distribution?

Tara: Yes, I mean if they use an EUA that is still a path to licensing. It means that it can be used in the general public. That does not mean it can skip VRBPAC or other safeguards. It is still, you still have to have the data. The data that is provided to the FDA when they apply for licensing. All of that data is required to be public. So anybody, my grandmother, my next door neighbor, my kids, should be able to go to the FDA website and download that data. Now, that does not mean that any of those people would be able to understand that data, but we do have a lot of experts out there who can look at that data and offer their perspectives on it. I would say that if the FDA uses an EUA, and if there is evidence that they have somehow by past VRBPAC, it is going to be vital that we listen to the independent experts out there who are looking at that data and can tell us whether or not the licensing with the EUA is justified or not based on the data that is in those documents.

Jeffrey: Got it. Okay, thank you. And you talked about this transparency. That all these meetings are public, but honestly, I have been doing this for a while, but this is the first time that I can recall that form a companies have been so open about the trial design and process. I mean, you can go to at any point, but they are putting out press releases and holding investor conferences about the
number of patients, timing, primary and secondary endpoints. I mean, you have Moderna and Pfizer, some of the frontrunners, they have been completely transparent to the protocols. But you have other companies like AstraZeneca who had recent significant adverse event and almost pressured be more open about it. So do you think this, Advanced Transparency, do you think that is a good thing for the public’s confidence or does it open up the process to scrutiny that goes beyond the public’s real understanding? Like you said your grandmother kids, they can go back on and learn, but they are not going to get it. So especially if there are some additional adverse events, how do you think this transparency is going to affect the future of drug development or the acceptance of this?

Tara: I have two different answers to that. First, I would challenge the statement that this is necessarily more advanced in transparency than in the past. I have been covering vaccines and drugs for a long time as well and a lot of times this information is out there on Fierce Biopharma, on other websites at conferences. You can find it. You just have to actually be looking for it. And typically we do not have so much media focused on a singular effort in the same way. So you do– you are often able to find this level of transparency with different types of things. I am not going to say that is true with all vaccines per se, but it is not unprecedented.

Tara: That said, it is certainly more front and center and there are some companies that might be more open than they normally would have. I know in the beginning Moderna was holding the cards close to its chest and was criticized as such because it was hard to get good information about what exactly they were doing and how they were creating a vaccine which since it was an RNA vaccine, which is not been successfully license before. Finding out the details of that. All in all, I do think this is positive and I think it not only helps the public. I do think it is not just out of the kindness of their hearts. I do not think the pharmaceutical companies are thinking that this is a good public relations move for them. They want to be perceived as out front and center. They want to be perceived as transparent, reliable, honest straightforward, and that is in their best interest. So I would not argue that they are necessarily doing anything just for the ethics of it per se.

Tara: That is not to say that they are intentionally trying to bypass anything or they have in the past. I mean, there is there is a checkered history there in general but this is as much in their best interest as it is in the public’s best interest. That said, I think it is also important to realize that those that are out front and center may not be the winners at the end. We have got sort of a tortoise and a hare race going on right now. And that is some of the newcomers here like Moderna that you might think of Moderna as the rabbit, right? They were the first out of the gate. They were the one racing along, they have gotten a lot of the headlines. There is also vaccines being developed by MERCK. MERCK has developed more vaccines I believe than any other pharmaceutical company out there. They know what they are doing and it is quite plausible that Moderna has vaccine may not be as good as the vaccine that later comes along from MERCK or GSK or another veteran in the field. So I think that is also worth remembering as we consider this.

Tara: In terms of whether the transparency could backfire. I think that is always a possibility, especially in the social media environment we have. I also think it should never be used as an excuse to dial down the transparency. That is not going to do anyone any good anyway, and it just allows for more of an air of suspicion. I think it is valuable to be open about the adverse events because it provides opportunities for experts on social media and for the actual traditional media to explain, “Yes, this is good.” Knowing that there are adverse events tells us the process is working. It tells us that they are paying attention to this, and this is what that means, and this is the next step. So each of those, even though it might freak out people at first when they hear about it. I have seen some pretty good responsible journalism out there trying to explain it and I think in general if I put on my optimist hat which I will admit has been very difficult in recent years, really in recent months. But if I put on my optimist hat, which is the one I usually try to whereas with a journalism and back.

Tara: Journalists, and when I hat I would say that this sets the precedent for improved scientific literacy among the public at large. And that can only be a good thing. I could also put on a pessimist or cynical hat and give you a flip side of that. I will try to stick to the optimist version of that.

Jeffrey: All right, I like it. So keep the transparency, but dial up the education.

Tara: Exactly.

Jeffrey: That is a… perfect. All right, let us take just a step back from these particular.
Coronavirus vaccines. Let us talk about vaccines in general. Now, you have studied, wrote a lot about vaccine hesitancy and have even given a TED Talk about it I believe. There is a certain percentage of the population that is hesitant to taking any vaccines and I guess you call them the anti-vaxxer movement or what not. But can you talk about this for a bit? I mean, why would people still be hesitant to take a proven vaccines for things like polio or chicken pox or the mumps?

Tara: The one thing that is important to notice right off when you are talking about vaccine hesitancy and anti-vaccination attitudes is to recognize that there is a Continuum. It is not like you are pro-vaccine or anti-vaccine. That is the binary that we often hear people whenever I– when people find out that I read about vaccines the first question they want to ask me is are you pro-vaccine or anti-vaccine? And that is a gross oversimplification of what is actually out there.

Tara: In reality the number of truly anti-vaccine advocates the, “Anti-vaxxers.” I only define those as the people who are actively publicly advocating against vaccines and or spreading misinformation about vaccines. Either online, through websites or by testifying at legislative hearings for different states when they are looking at laws related to immunization. If they are actively pushing against sound scientifically supported policy on immunizations, that is an anti-vaxxer. They are rare. They are less than one percent of the population, but they have loud microphones, megaphones, I should say. They they are very good at PR and they network across social media platforms and they are sexy from the if it is bleeds it leads, way that journalism is still often done.

Tara: So that is one group, but then after you put those off to the side, you have got a huge Continuum of people that are hesitant. You have got folks who will get all the vaccines except for the flu vaccine and the HPV vaccine or there is one vaccine they do not like. I do not want the MMR or they will get all the vaccines but they will wait really long in between each one for their kids. Or they are comfortable with two vaccines, but not the rest of them. Or they are uneasy with how many vaccines kids are offered and then they talk to their pediatrician and over a period of several months. They feel more comfortable eventually acquiescing to following the CDC recommended schedule. So that is a really broad range and it you can not make broad oversimplifications about that group, especially since going on to your other question about why? You can you also cannot generalize about their reasons. Everyone thinks it is about autism. In reality there is at least two dozen reasons that people may not want to vaccinate. Some of them have philosophical beliefs that you do not put anything unnatural into your body and therefore if your body does not produce it or if it is not a germ floating around in the atmosphere, then you should not intentionally put it into your body.

Tara: Some people are against medicine at all kinds. There are people out there who are anti anti-antibiotics, anti-chemotherapy when it is the only thing that will treat a cancer. There are people across the board that exist like that. Then you also have people who think it causes other conditions not autism but this or that autoimmune condition or other issues that they will say that they worry about. And then finally you have the people who are looking at individual ingredients that they are worried about and that could be a scientific concern where they are afraid that a particular ingredient is toxic in some way in the body, or it could be a philosophical or faith-based one, such as having a problem with using vaccines that were developed using cell lines from terminated pregnancies. And that is something that the Pope himself is actually weighed in on and said that it is greater evil to allow children not to be protected by disease, then the evil of accepting a vaccine whose initial development had to do with cell lines from terminating pregnancies.

Tara: So you can not draw too many broad generalizations about that wide range, but you can look at when you are talking about why people would take proven vaccines, you could ask the same question of why do some people think the Earth is flat. Why are there some people who believe that there is a global conspiracy to… I do not know fill in the blank. There are people across the process who do not believe other scientific concepts. People who do not believe that climate change is occurring. So we could ask the same question about any of those and there is in fact a lot of crossover. If you did one of those fancy Venn diagrams with five different circles and you went at the people who have misbeliefs about GMO Foods and the people who refuse vaccines and the people who have doubts about climate change. There is a lot of overlap there.

Tara: So that goes into a bigger epistemological set of questions that would take a whole other hour to discuss and try to unpack.

Jeffrey: Okay. Now that is unbelievably helpful. Thank you and that answers the question and actually answered my next question. Based on the severity of the global pandemic, I think you are still going to have the same percentage of the population that is not going to want to take the vaccine. And that is, that Venn diagram group that sits in the middle regardless if it has some borders.

Tara: You are going to have a similar kind of Continuum there as well. You are going to have the anti-vaxxers who are not going to take that Coronavirus vaccine no matter what. But you also have people who will say, I want the coronavirus vaccine, but I am not sure about it when it is brand new. I am going to see what happens to other people first.

Jeffrey: Yeah, I do not want to be first. Yeah.

Tara: My mom texted me on the same day that she got her flu shot and said, “I will not get the vaccine until you do.” So now, she there is the ones that do not trust vaccines, but they trust that the people that they know who are following vaccines more right.

Jeffrey: Do you know are there any legal precedents where people have to take a vaccine for the sake of Public Welfare or for employment purposes? I mean, could a regular employer have the right to dismiss an employee for refusing to take the vaccine?

Tara: A lot of that is still being played out in the courts. There are legal precedents dating back to the early twentieth century looking at here in the United States and the Supreme Court looking at vaccine mandates. Some vaccine mandates were upheld as constitutional, and the alternative if you did not take the vaccine was a fine. So there still was a way out. But it there was a consequence to that. I do not see that being likely in today’s situation. I do not think it is likely that we are going to have the kinds of red, you saw if people have seen the movies where you get the vaccine and you get a bracelet thing. You have the vaccine, I do not see that happening here. What we might see happening is what is most likely is we see a situation with what we see right now in hospitals and the flu vaccine. That is where a lot of this is playing out most where you have hospitals that require their staff and nurses and doctors to get the flu vaccine and you have some people working at that hospital who do not want to get the flu vaccine. And it is, I could not easily summarized all of that case law. I will say that if people are interested in that they can look up the Scholar Dory Reiss. R-E-I-S-S. She is a legal scholar in California who does a lot of research on this and is very, very familiar with those cases and she writes a great deal about them. But looking at that, a lot of hospitals is has been upheld that they can require a flu shot or require someone to wear a mask.

Tara: In this case people are already wearing masks. So I do not know if they would take that further and say you have to get Coronavirus vaccine or you will be terminated. I do not know. I do think we will probably see some of that. What I think will be interesting is the businesses that are not in health care. In healthcare. It is a lot easier to justify requiring the workers to get vaccinated because they are there to take care of people’s health. I am interested in whether you see States saying teachers must get the vaccine or Airlines saying, if you are going to be a flight attendant you have to get the vaccine. I do not know whether that will happen or not.

Tara: I can see it possibly happening and I can also see that it is going to get challenged and there is going to be a lot of case law coming out of that. So it is probably going to get messy and it is really hard to predict right now how that will play out.

Jeffrey: That is really interesting also with with schools with children. I mean, I know my kids need to show a vaccination report. There is no plan or there is no timing put to it for pediatric version of the Coronavirus vaccine. Do you know anything about that?

Tara: I do not. I have been looking for that. In fact, trying to recall there was a publication in pediatrics, which was calling for better quality research in Covid-19 research for children, because they are basically just is not enough attention page to that. There was just recently an article published today and it is entitled Covid-19 trial enrollment for those who can not consent. Ethical challenges posed by a pandemic.

Tara: I think that is addresses that very question and it is not something that I can necessarily summarize. It is literally a full paper looking at case studies, but there are ethical challenges to enrolling kids in a trial like this and I do not know what all of them are. It is different from the longer time period that takes place with pediatric vaccines and there have been changes in policies since then for example, after the Coronavirus vaccine first came out, there was the discovery that some adverse events… there was a higher rate of intussusception, which is a telescoping of the intestines that appeared to be associated with that vaccine and that vaccine was eventually pulled. Later Coronavirus vaccines that came out then enrolled many more people in the trials instead of having about three thousand people in the trials. They had closer to ten thousand people in the trial so that they could detect rarer adverse events in there.

Tara: I do think it is a problem that we do not have trials that I am aware of that are explicitly looking at the Covid-19 vaccine in children. On the one hand, It is clear that the threat to children is not nearly as great as it is for older adults. On the other hand, we have also seen that the most recent evidence regarding transmission shows that children are just as transmissibility… the children transmit the disease just as much as adults do. So while a child’s actual life and morbidity may not be as high a risk as an older adult, their ability to pass that virus along to relatives and family members and teachers is still a threat. I am not sure what is going to happen with that. I think that we have to give more attention to that and I do not see that happening right now. So, I would actually say that is the biggest gap that I see right now related to vaccine research.

Jeffrey: We also do not know, I mean, yes, there are unfortunately some children have died from this, but we do not know the long-term effects for those children that
it have succumbed. You know that had that I have had the virus.

Tara: Exactly. We do not know if there could be long-term tissue damage, especially not only in terms of lungs or lung scar tissue, but cardiac types of long-term damage is quite plausible given what we know about the way this virus interacts with the circulatory system and the creation of blood clots.

Jeffrey: So we should still get ready for additional homeschooling even after the announcement of a vaccine.

Tara: I can tell you that my children currently still doing distance learning and they will definitely be doing distance learning through May, because I will not send them to school before then, and I do not expect that I will have an opportunity to get a vaccine any earlier than next summer and that seems like a stretch. That seems like the very, very, very earliest of if all the stars aligned correctly. So it is we are still in this for a while. I think a lot of people have not quite come to terms with the long-term nature of the emergency that we are in right now.

Jeffrey: Well Tara, thank you so much for your time today. This has been incredibly educational, informative and entertaining. So thank you so much.

Tara: Yes. Thank you very much for inviting me.

Jeffrey: We hope you enjoyed this week’s podcast. If you have any questions comments, or a future story suggestions, please reach out to us on social media. Thank you, and we hope you enjoyed the RP HealthCast.

Comments are closed.