Thank you for joining us. Guest thank you for having me. Host a little bit about your work at the Vaccine Access center, talk about that and in the international aspect. Guest yes, so the international Vaccine Access doctor william moss the executive director of the international Vaccine Access center and a professor at Johns HopkinsBloomberg School of Public Health. Doctor moss thank you for joining us today. A little bit of your work at the Vaccine Access center with the international aspecth. We celebrated our tenth anniversary in the last year and the main focus is to increase access to lifesaving vaccines. Traditionally focused on childhood vaccines particularly to make sure there is access in africa and asia and they are reaching the most vulnerable. But also we have been very involved in thinking about covid19cu Covid Vaccine and how we ensure the safety and efficacy with equitable distribution around thehe world. Host how does that apply to the current efforts with coronavirus . There are a number of initiatives that National Levels here in the United States and that the global level to think about how we are going to distribute a safe and effective vaccine to those people who most need it and that we will not have sufficient number of doses initially to cover all people who are interested in getting the vaccine. We are working on thinking through ways it could be advocated and how to build trust this is a very important issue because many of the most vulnerable populations and with those particular vaccine. So that hinges on Community Trust and science which is evaluation of risk and communication can you expand . As everyone knows these efforts to evaluate and approve a vaccine for the coronavirus or covid19 have been accelerated. We want to accelerate the process were in the middle of a i pandemic and we need ways to shorten that traditional timeline in order to have a safe and effective vaccine approved in available to those who need it. And other people have said this people have to be willing to take the vaccine so we need to build the trust in the process so there are ways to developmentaccine and we see that but it doesnt mean safety and the knowledge of the efficacy should be compromised so there are ways to move the vaccine forward in the midst of a pandemic and maintaining the integrity of the science and the ethical standards required and we can talk more but some are combining testing phase one and phase two and particularly with covid19 is the large ovinvestment of funds from the United States government and then to greatly expedite. And then to say they are putting a positive how does the public take that quick. And then to reassure the public this is how the process should work. At Oxford University and to talk about the different types of covid19 vaccines and in phase three trials in a number of countries. And what they identified was the adverse event. And what these trials are meant to detect we heard to the news that one individual who received their vaccine developed a condition called transverse myelitis and inflammationor of the spinal cord that can be triggered by autoimmune diseases and disorders or prior infections or vaccines. But we dont understand in detail how this comes about. With this immune reaction against the spinal c cord. This was detected so they pause the trial. What they will try to do or even to suggest this adverse event was related to the vaccine but that is very difficult to determine whether a vaccine causes this type of serious adverse event. But the first thing the public should know is this is the work. S as it should and adverse event is identified then they pause and not carefully all of these trials have independent data safety with a group of independent scientist that are not invested or part of the Research Team and they look very carefully at the evidence to make the determination if and when the trial should start. Host talk about the International Nature of Vaccine Development you are seeing a majority of cases that they are the first ones to get the vaccine . It depends first of all where the vaccine was developed and to put the financial investment. No doubt we will have a limited supply of a a vaccine early on in there will have to be decisions made to prioritize who gets it because of those large investments made by the Us Government its highly likely citizens of the United States would be the first to get a covid19 vaccine. We already know those vaccines administered, perhaps prematurely they have granted limited approvals for vaccines to be used. This received allied of criticism justifiably because they havent completed the large trials that demonstrate efficacy. But it is likely the largescale rollout may have been first in the United States into Vaccine Development and the commitment of several manufacturers to provide them to the United States. But we will face f a very challenging set of decisions who when the United States is prioritized. And those that are thinking tthrough the process. Host and doctor moss is our guest from Johns Hopkins the first call comes from washington dc good morning go ahead. Caller i have a general comment to make about trust and building trust. I think the key is to get politics out of medicine. I think that place too large of a roll. And then thank you to President Trump who gets the drug approved it is not a cure but certainly has kept me alive. This drug has been available in europe for decades. We didnt bring it to this country. I think it had to do with money. That doesnt make sense to me but the fda would not approve this drug and if its discovered in the netherlands and so Much Research has been done and scientific documentation and then to rubberstamp the to approve the drug. The collar makes san interesting first of all it is the role of the fda to ensure that the drugs and vaccines are safe and effective. That is the main goal and the public needs to have trust in that process. I agree with a collar that if politics is even perceived to be involved in that process, that results or can result in serious mistrust of the public. Unfortunately there have been a number of instances in the past few months where decisions by the fda have been questioned related to convalescent asthma soha that mistrust of the decisionmaking process has serious implications now we avhave been assured it would be free of politics weve seen nine vaccine manufacturers prpledge they would uphold scientific integrity. But even in that perception with the approval process undermines the trust and vaccines. We need to be much more rigorous in the approval process then we are foror drugs for diseases. And given to Healthy People that riskbenefit ratio is to huge numbers of people comparing two drugs for individuals with diseases. Covid vaccine given to hundreds of millions if not billions of people in the world. Lastly, if there is mistrust there is the potential for the spillover effect with mistrust of other vaccines to undermine the whole immunization system so highly successful in preventing many lifethreatening diseases. Barbara from massachusetts. Caller with confidence building months video a respiratory therapist. It makes complete rational sense that those people are the first frontlinele to get the vaccine. Its the most highly educated in those fields. If they have a professional association to communicate the fact and that they take it and then to have a simple website to show the person who administers the vaccine and then they go public to say i took it. Thats a Tremendous Positive builder for me. If my gp takes it and says i validated thect data i consider personally safe that goes a huge way to build confidence for me. With astrazeneca trial getting the meningitis type to have that meningitis vaccine that would be fascinating to know. She makes a very good point to address the issue of how do we build trust amongs. The public and communities . One of the most trusted voices may be emergency room doctors. People who are on the front lines fighting and working to save patients with covid19 and there are ongoing a efforts to think through what that be. Cation process would one cannot the center of healthth security and the National Academy of medicine also has a high level of looking through these issues and frontline healthcare workers in addition to people who are vulnerable are dying from disease those are the type of people that would be prioritized for the vaccine. I completely agree that if those people can come out and say they review the data this vaccine is safe and effective that can be a powerful voice in the community. We need to go beyond that and those who have influence come out when the data is available to help build the trust within the community. We particularly need to build trusting communities of color. Vethey justifiably have mistrust of the government and science with scientific experiments. These are the communities that have been most affected by the pandemic. Working through Community Leaders whether religious leaders or other Leaders Within the community to help build trust this is important. I just want to clarify the adverse event transverse myelitis is not meningitis and its not due to the bacterial causes. Host as a followup to that when the trial is paused does the entire process stop . Thats a good question. The process stops in order for the data safety monitoringg board this group of investigators so they can do their best to try to understand whether that adverse event is related to the vaccine. From one single instance it is impossible to directly say it was the cause. Its a judgment call the probability. Its important this deliberationth goes forward as rigorous as possible. Its unlikely after a single adverse event there would be any modifications made certainly one would have to think of that was related to the vaccine and what that pathology might be. My own speculation is they are not making changes to the vaccine but to understand whether it is possible this adverse event was related to the vaccine. They will look at the timing. When did this occur after vaccination . If this is one or two days after the vaccine is less likely is due to the vaccine its too early to develop the autoimmune phenomenon. Es they will be looking at the timing. Host north carolina. Caller good morning. I would like to say to acknowledge the vaccine history in americat ey it has nt been a good one. And those with preexisting conditions. And with the gulf war veterans who took experimental vaccines and then how that interacts with those in the contraindications. And then to have doctor moss address the lawsuit against the governmentarsy and then noto do any kind of studies. And with those comments on those. Vaccines have been and continue to be one of the most public Important Health interventions. And those adverse events following some vaccines but the vast majority and to be shown to be safe and effective. And not to give the indication that vaccines are not an important part and in the United States and around the world. But phase i and phase ii and phase three Clinical Trials and the number of individuals and with those adverseac events. To be efficacious of those of interest. An thats a process we are going through. And with that comorbidity but there is a likelihood that any prior vaccine will have any impact on covid19 but the caller does raise the important point of a new covid19 vaccine to be effective with core morbidity but of particular interest that place them in a higher risk of severe disease so we know those individuals of asthma or diabetes are higher risk of severe disease the elderly or higher risk of severe disease we went to make sure the new covid19 vaccine is effective in these populations that are the most vulnerable to severe disease. So those that could be effective may be elderly or older adults need more doses. And then to understand with the comorbidity in the most vulnerable population and that those are participating in the phase three trial a before that becomes approved. Host talking about russia and chinas role can you clarify . Both china and russia are working and have worked on covid19 vaccines. The Chinese Companies and my understanding is the Chinese Government has approved the use of these vaccines in limited populations like military. And in Russia Vladimir Putin announced the vaccine after some very early phase studies so what it showed is the vaccine some 26 and 25 those are two different viruses. And then but these early publications from phase i and phase ii trials in the short term are safe. And then the immune response potentially protected. And with those phase three trials on the order of 30,040,000 people. There is a story in usa today coming to research there is a monkey shortage can you explain what that means with the Testing Process . Yes. Most if not all vaccines i will tell you all, before they enter to humans go frequent testing that means preclinical means to be tested outside of humans. The very Early Research can just be cells growing in plate or a test tube in a laboratory. But then what happens the next phase if it looks promising that vaccines moved to animal studies. They begin with small rodents like mice. But the monkeys provide with human primate studies a better glimpse what could happen in humans and mouse studies because the immune system, the immune response so a shortage of monkeys that preclinical testing stage we now have more than 130 potential Covid Vaccine vaccines and development so there is a very large pipeline already and those. That that explanation with weeks of trials. There ever been any more coronavirus that you cannot cure the common cold and to be caused by other coronavirus is. Seventy Elderly Population how the people pass away from National Causes that we test positive for a virus. Just looking for the dna sequence at this point and then to discover that sequence in a large population. Ill take your answers off the air. Two interesting questions. So with regard to the second question to detecting viruse viruses, the collar raises the point in the nasopharynx we can have viruses such as corona where the rhinovirus that causes the disease that causes the illness like a cold but thes viruses can persist for some time but the nucleic acid can persist in the body for some time. It still not entirely clear if these are just fragments or complete viral particles. Of the nucleic acid that can be transmitted. I dont think thats a big problem in estimating the covid19 death i think that implication that of what we would call a postmortem study looking for potential pathogens we can find evidence and its not always clear whether that was positive in the death orca not. But we do have good evidence and with regard to the first question and then people will remember the coronavirus one was an epidemic in 2003 that affected a number of countries throughout the world. There was work to develop a vaccine. And then to test the vaccine. And those that have resulted in some sporadic cases. It is not a pathogen. And we could nothe do those but then those laboratories and then they had a jump start in developing the v vaccine. Especially sars to there are many types of rhinore viruses and thats one of the problems to develop a vaccine is there are multiple different types it just makes Vaccine Development that much harder. This is the first time youve ever answered. And meeting all of these wonderful people i would be willing to set myself up to get the virus with the injection but my children wouldnt want me to do that. Im glad we had these wonderful scientists and doctors with everybody working on the virus. Host now that you are on do you want to ask a question . Caller how long do you think it will be before we get the virus injection for the average person. God bless you. And the question of when we can get a vaccine for the general public is important and one that is asked over and over again and maybe we can try to give listeners why there is some uncertainty about that and for the general public until late 2212 manufacturing is scaled up perhaps its earlier than that and here is the timeline from the phase three Clinical Trials first we went to ensure it is efficacious and the way the space three trials work is that i to determine who gets the vaccine or who gets the placebo. And then to determine if this is effective so what happens is the volunteers are randomized so who gets the vaccine and who doesnt and then they are followed over time and if it is effective then there are fewer cases of covid19 in the group that got the vaccine then the group that didnte. It takes time to accumulate these cases in the vaccine arm compared to the placebo arm. With those that are getting infected that happens much earlier and faster than other vaccines and for them to accumulate. So the one thing that determines that timeline is just how fast people are infected that were participating in the trials. And then to set up the trials and places and the changes the behavior mask wearing, social distancing and to slow down the number of cases. And then the other thing as we talk about the safety of the vaccine. What we can determine in thein phase three trial city are shortterm side effects. Those i get the pain at the site of injection. Those are the kind of things we can see early on in the phase two trial so perhaps at the end of the phase three or even after and then to have rare adverse events. They are just impossible a very difficult to detect so its very important those introduce said have a Surveillance System set up with those rare adverse events. Good morning. Largely because of money but back in the eighties a friend of mine had aids and they were dying from pneumonia and then waiting for the trials. I am in my mid sixties. I am healthier than all of the people my age to get the flu shot and at the first sign of any problem i wash my hands and face and nostrils after ive beene, outside during flu sign and im concerned about mask wearing. And those that have to wear than eight hours a day the cdc said in the eighties i could not feed my friend any food that was left over because the wgerms multiply. I intend to take the shot do you have any comments on that . I know there are many people in the United States who feel similar. That a Healthy Lifestyle, Good Nutrition no doubt and exercise and frequent washing of hands are very important as a Public Health measure. People who practice a Healthy Lifestyle are at a lower risk of severe disease and death from covid19. I and a Public Health practitioner and researcherti and i firmly believe in the value of vaccines. They are not perfect i think part of the problem in the United States some people may want, the perfect vaccine to protect everyone with no side effects. We live in the imperfect world with imperfect vaccines. But the benefit far outweigh from the Public Health plaintiff you. There are diseases in the United States that used to kill many many children. Smallpox, measles, polio. We dont have those problems anymore in the United States. We dont have to worry about children dying of measles because of vaccines. I also understand that callers concern of the new covid19 vaccine. We are in unprecedented times for a number of reasons. The pipeline has been accelerated. But i dont think that has compromisedd our safety and efficacy. Some vaccines are moving forward and those that we do not have the license vaccine and was just licensed this year for ebola so i can understand people have concerns and rightly so. We want to make sure that the community on the communication and those that come out of the phase three trials and that is communicated to the public at home. And i see there will any be government mandates that some employers could require they get it. Than those dealing with patients that people will have a choice and then to communicate very clearly and the benefits of the vaccine. M 76 years old and healthy the 40 years ago i was tired all the time my doctor sent me to a cancer doctor to say that e had epsteinbarr and by the way you are immune from hivaids. I do get colds and i still suffer from epsteinbarr could i be immune from coronavirus . Could my blood help a person who is infected help him cure his coronavirus . By the way Rolling Stones gathers no moss. The caller raises a number of questions epsteinbarr is a very common viral infection but it can cause it is a itfascinating virus that can cause mononucleosis but also associated with cancer including one in africa actually the first virus known to cause cancer now we know of others like hpv im not sure of the statement about resistance or immunity to hiv but coronavirus is a different type of virus i wouldnt expect a crossreactivity but the color makes an important point whether infection with other coronavirus is that we alluded to earlier it is still unclear if there is any cross protection but that is an important area of research. So thats the whole issue it is the old idea going back to the late 19th century if you can take blood or the plasma from individuals who have recovered and it has antibodies and then to administer those antibodies erom those who have recovered9 and there is some evidence that it could be valuable. Hello doctor. Are they still using the macaque monkey . And talk about the efficacys ea common ailment like asthma . Guest there are a number of interesting questions. Of first one around the use animals to study vaccines, the answer is yes. Theyre one of the most commonly used monkey in biomedical research. Second question is around trials and iii measuring efficacy. Assessed inonly phase iii trials. And is assessed in phase i ii does the vaccine induced a measurable immune response . Whether thatell immune response is protective. Efficacy really only comes out trial. Phase iii host you were talking about the international efforts, is there a combination of countries that Work Together on various stages of trials . Guest yes. First of all, i will answer that question that there is an effort it is called covax. It is a large, global effort to coordinate the development, distribution and allocation of covid19 vaccines. It is a Coalition Led by three large and very important a vaccineons alliance, a really important Global Institution that gets vaccines to those, particularly children, in low income countries, and the World Health Organization the develops the policies around who should be prioritized. There is this global effort to coordinate responses. For individual vaccines, like lets say a vaccine we have been talking about, they will conduct their phase iii trials in multiple countries brazil, for example and the United States. Vaccinendividual manufacturer level, there is coordination. What i really want to emphasize is this Covax Initiative that is a coordinated global effort. Host in a matter of politics, the president of the United States is speaking out against the World Health Organization as far as pulling funds. Does that affect the work on a vaccine . Guest i am very troubled by that. With the World Health Organization, many of my friends are there. These are the most dedicated, committed people to Public Health i know of. To hear them disparaged like that really pains me. The United States not being part of this global effort, i see it as a real tragedy. They will move forward, other countries will step up, but this really should be an effort in which the United States is fully engaged. Host dr. William moss, he is director, heonal is also professor at the Johns HopkinsBloomberg School of Public Health. He has