Professor at Johns HopkinsBloomberg School of Public Health. Doctor moss thank you for joining us today. Thank you for having me. Host a little bit about your work on the Vaccine Access center. Talk about your international aspect. Guest International Vaccine axes center we celebrated our tenth anniversary just last year and our main focus has been to ouincrease access to lifesaving vaccines throughout the world. Traditionally we have been focused on childhood vaccines particularly making sure that those acts as in africa and asia and that the vaccines are reaching the most Vulnerable Children but weve also been very involved in thinking about covid19 vaccine and particularly how such a vaccine might be distributed, how we will ensureow its safety and efficacy and how we will get equitable distribution of a vaccine around the world. Host with that in mind how does that apply to the current efforts going on with coronavirus . Guest there are a number of initiatives both at National Levels and particularly here in the United States and that the global level led by the Global Health organization and trying to think about how we are going to distribute the safe and effective vaccine to those people who most need it and particularly given that we are not going to have sufficient number of vaccines doses initially to cover all people interested in getting the vaccine so we are working on thinking through ways in which a chvaccine should be allocated. We are thinking about how to buildt trust in communities and this will be a very important issue for our covid19 vaccine because many of the most vulnerable populations have some mistrust and something about vaccines in general and others about this particular vaccine. Host you wrote in a recent piece in the atlantic that the topic of coronavirus the success of vaccine hinges on community trusted backed scientists which requiren transparent evaluatios of honest commute occasional potential harms. Your stand on that. Guest you know, as everyone knows and your listeners will know that this, these efforts to develop and evaluate and approve a vaccine for sars, coronavirus two or covid19 has been accelerated and we want to accelerate that process. We are in the midst of a terrible, tragic pandemic. We need ways to shorten that traditional timeline in order to have a safe, effective vaccine approved and available for those who need it. Part of this, part of having a vaccine work and other people have said this, just having a vaccine is not good enough. People have to be willing to take that vaccine so we need to build the trust in the process. There are ways to accelerate the Vaccine Development and we are seeing that in full force but that doesnt mean that safety and our knowledge of vaccine efficacy needs to be compromised in any way. I think this is a important point to get to listeners that there are ways to move a vaccine forward more quickly than is traditionally been done in the midst of a pandemic and yet maintaining the integrity of the science and maintaining the ethical standards that are required and we can talk more about these but some of them are combining some of the early phases of vaccines testing, particularly phases one and phase two that we have two find those more and i think particularly what we are seeing with the covid19 vaccine is the large investment, largely funds in the United States government to build a manufacturing capacity while the trials are going on and that can greatly expedite access to a vaccine. Host 2,027,488,000st1 mac 2eastern, 202 7488001 fountan and pacifics so the trust doctor when you see then astrazeneca saying theyre putting a pause on some of their testing for concerns house of the public take that . Guest thats a very good question. What we need to reassure the public is that this is how to process should work. Astrazeneca is testing a vaccine that we developed at the Oxford University. It is what we call and add no virus vaccine and we can talk about the different types of covid19 vaccines and c they are conducting large phase three trials in a number of countries, some combined phase two, phase three trials that are ongoing and what they identified was an adverse event. What we call an adverse event. That is exactly what these trials are meant tot detect. We heard through the news that one individual who received their vaccine developed a condition called transverse myelitis in this is an inflammation of the spinal cord that can be triggered by autoimmune diseases, immune system disorders and possibly by prior infections and even vaccines although we dont really understand in detail how this disease comes about but it is some type of immune reaction of the body against a part of the spinal cord. This was detected and they rightfully paused the trial and what they are going to try to do is see if there is any reasonable evidence to even suggest that this adverse event might have been related to the vaccine but i want to point out that very difficult, very difficult to determine whether a vaccine causes this type of rare serious adverse events but i would state the first thing the public should know about this is this is the process as it should work. Adverse event is identified in the study is paused and they look very carefully at the evidence and all these trials have what are called independent data safety and monitoring board which is a independent scientists who are invested in the vaccine, arent part of the Research Team and they look very carefully at the evidence. They will make a determination as to if and when the trials should we start. Host since you talked about the International Nature of the Vaccine Development and who gets the vaccine it is interesting that the majority of cases in the United States says that automatically suggests that those in the u. S. Will be the first ones to get the vaccine. Guest rswell, it will depend first of all in parts where the vaccine developed and which country has put the investment, Financial Investment and there is no doubt that we are going to have a limited supply of a vaccine or one or more vaccines early on and they will have to be decisions made on prioritizing who gets it. Because of the large investments made by the u. S. Government it is highly likely that citizens of the United States could be one of the first to get eight covid19 vaccine. We already know the vaccine being administered, perhaps prematurely and we can talk about this in russia and they have granted limited approval for vaccines to be used and this received a lot of criticism justifiably because they had not sufficiently completed the large phase two trial and they demonstrate efficacy. I think it is the largescale rollout may happen first in the United States because of the large investment of the u. S. Government into Vaccine Development and the commitment of several pharmaceutical companies and vaccine manufacturers to provide vaccines to the United States but we will face a very challenging set of decisions about who in the United States gets prioritized for a vaccine early and there are a number of groups thinking through that process. Host doctor william moss our guest to talk about Vaccine Development with john hopkins. Our first call from you comes from washington dc, doctor. You are on with doctor william moss. Good morning, go ahead. Caller thank you. Y when you called in [inaudible] i have a general comment to make that trust and building trust. I think that the key is to get politics out of medicine. I think it plays two for large a role. I have a rare cancer [inaudible] would like to thank President Trump w for getting a drug approved that prolonged my life and it was not a cure but it has kept me alive and it was [inaudible] and this drug was available in europe for decades and we didnt bring it to this country and i think it had to do with money and that doesnt make sense to me but anyway the fda would not approve this drug and it had been discovered in the netherlands at the university of erasmus i think and so Much Research has been done, so much scientific documentation in the fdad could have rubberstamped te Clinical Trials and all the research and approved this drug. Host we appreciate it. Doctor, go ahead. Guest yes, thank you. The caller makes an interesting point. First of all the role of the food and Drug Administration and the fda to ensure that drugs and vaccines that are approved in the United States are safe and effective and that is their main goal. The public needs to have trust in that process and i agree with the caller that if politics is even perceived to be involved in that process that results or can result in serious mistrust in the public and i think unfortunately there have been a number of instances in the past few months within this pandemic where decisions by the fda have been questioned related to the emergency use authorization of hydroxychloroquine and some of the statements around convalescent plasma. That kind of mistrust of the decisionmaking process t and te approval process at the fda has serious implications potentially for the approval process for thl vaccine. We have been assured that process will be free of politics and we have seen nine vaccine manufacturers pledge that that process will uphold scientific integrity so having politics even the perception of politics, interfering with the approval process, undermines trust in the vaccines. I will also point out and i think its important for listeners to be aware that we need to be much more rigorous in the approval process for vaccines then we are for drugs for diseases. This is because one vaccine are given to Healthy People, rather than people with disease so that riskbenefit ratio is different for vaccine they are given two huge numbers of people rather than compared to drugs for individuals with diseasespe. Covid19 vaccine could potentially be given to hundreds of millions, if not billions of people in the world and lastly if there is mistrust of a cove in 19 vaccine there is a potential for spillover effect where that leads to mistrust of other vaccines and could undermine our whole immunization system that has been so highly successful in preventing many lifethreatening diseases in the United States or globally. Host barbara in massachusetts. Good morning, you are next up. Caller i have an idea for confidence building which is this. We have seen once a video of emergency docs and nurses and respiratory therapists and hospitals treating the people and it makes complete rational sense that those people should be the first frontline people to get the vaccinesto but what s also important is they are the most highly educated in medical and scientific fields so if those emergency room doctors have a professional association through which they can communicate the fact that they have reviewed the data and they trust it and furthermore they are taking it. Even if there is some way to have a simple website that has the names of the nurse or person who administered the vaccine to doctor and then theyre both going public same i have administered it and i took it. That would be a tremendous confidence boosting. If my gp takes it and he tells me i took it because i validated the data and i consider it personally save that would go a huge weight and buildingui confidence for me. Last thing i want to say, on the estrogenic at trialhe did the person who got the negative meningitis thing himself or herself have the meningitis vaccine . That would be fascinating to know. Host thank you so much. Guest barbara, she makes a good point about she is addressing the issue of how dow we build trust among the general public and in specific communities. She is raising the point that one of the most trusted voices and this may be emergency room doctors and people who are on the frontline fighting and working to save patients with covid19. There have been and there are ongoing efforts to try to think through what that prioritization process or allocation process would be. One came out of the center for Health Security which is my own institution at john Hopkins Bloomberg of health and the National Academy j of medicine also has a High Level Committee of thinking through these issues and as barbara raised frontline healthcare workers in addition to people who are most vulnerable from severe disease or dying from disease, essential workers in the economy those are the type of people who will be prioritized for a vaccine andr i completely agree with barbara that if those people can come out and say that they have reviewed the data and they have felt that this vaccine is likely to be both safe and effective and they tested the vaccine, that could be a powerful voice in the community. We also need to go beyond that and have other community leade leaders, celebrities, people who have influence come out when the data is available and the experts agree that they have a safe and effective vaccine and to help build the trust within the communities. I want to highlight the fact that we need to build trust in communities of color. Justifiablyities have had mistrust of the government and of science, scientific experiments because of some of the history but these are the communities that had been really most effected by the pandemic and working through Community Leaders whether these are religious leaders or other Leaders Within the community that can help build trust. This is really important. I want to clarifyy one point tht the adverse event as reported in the astrazeneca trial that is something called transverse myelitis, it is not meningitis and it is not due to the bacterial causes of meningitis for which we have vaccines. Host follow up to that, this is from a viewer on twitter that when a trial is paused the study and adverse event does they tweaked the vaccine based on the event or does the entire process stop . Guest good question. The process stops in order for the data safety and monitoring board, this group of independent investigators as well as the investigators engaged in the Vaccine Development and testing can do their best to try to understand, whether that adverse event is likely related to the vaccine. As i said, from one single instance it is impossible to directly say that the vaccine was the cause so it is a judgment call of a probability and it is important that this deliberation and view of the evidence goes forward as rigorously as possible. I think it is unlikely after a single adverse event like this that there would be any modifications made to the vaccine and certainly one would have to have a better understanding of first whether this adverse event was thought to be causally related to the vaccine and what the actual pathology might be. My own speculation is that there are not makingti changes to the vaccine but doing their best to try to understand whether it is possible that this adverse event was related to the vaccine. Just to give you an example what they might be looking at, look at the timing for example. When did this occur after vaccination . If this occurred, lets say one, two days after the vaccine, its probably less likely that due to the vaccine. That is too early to develop or for the body to develop this autoimmune phenomenon. To that is one example that the investigators will look at in the timing. Host North Carolina lori, hello. Caller hello. Host you are on, go ahead. Caller i would like to say i appreciate doctor moss acknowledging the vaccine history here in america and that you know it is not been a good one. I would also like to ask about people with preexisting conditions taking this vaccine. There were numerous gulf war veterans who took experimental vaccines who have had Adverse Reactions and how this new vaccine would interact with vaccines that w already have ben administered to them and i would also like to have doctor moss address Robert F Kennedy juniors lawsuit against the government over vaccines and there are 32 years of not doing any kind of studies on some of these vaccines. I would like to get his comments on those. N thank you. Guest yes, first let me say that vaccines have been and continue to be one of our, if not the most important Public Health intervention. Vaccines have saved hundreds of millions of lives around the world and there have been adverse events, numerous adverse events following some vaccines and some vaccines have been withdrawn because of that but the vast majority of vaccines have been well studied and have been shown to be safe and effective. I am a big vaccine proponent and i dont want to give listeners the indication that vaccines are not an important part of our toolkit in fighting diseases. That said,d, the purpose of the Clinical Trials, the phase i, phase ii and phase three Clinical Trials that enroll an increasing number of individuals art is designed to detect adverse events and to make sure that the vaccine is both safe and efficacious against the disease of interest. That is the process that we are going through. In terms of comorbidities i dont think that there is a likelihood that any prior vaccine will have any impact on a covid19 vaccine. The caller does raise an important point about this, a new covid 19 vaccine being effective in people with comorbidities and what the particular interest are people with those cold morbi